Author: Rachael Hansford

Music Therapy strikes a chord with traumatised emergency workers ​

The Blue Light Symphony Orchestra (BLSO), in collaboration with Chroma, successfully completed a pilot project delivering group Music Therapy to emergency service workers to help them recover from traumatic experiences.

Working with Surrey and Sussex Police, Surrey and East Sussex Fire and Rescue and Southeast Coast Ambulance Service, the project, a UK first, delivered a bespoke music therapy program for emergency workers. It drew inspiration from the USA where music therapy is widely used to treat PTSD and trauma-related issues is in army veterans.

The BLSO was awarded £10,000 funding from the Coronavirus Community Support Fund, distributed by The National Lottery Community Fund, recognising that Emergency Workers have been exposed to increased levels of trauma while responding to the Covid-19 pandemic.

Over 12 weeks, using a combination of psychodynamic music therapy, neurologic music therapy and dialectical behaviour techniques, emergency service personnel were able to experience, reflect, learn, and then transfer coping strategies into everyday life.

The group incorporated free improvisation, the learning of simple drumming techniques, blended with health and wellness education and interactive improvised music-making. Throughout the programme, the sense of camaraderie increased, alongside the enjoyment and playfulness that developed.

Seb Valentine, founder of the BLSO and serving Detective Sergeant with Surrey Police said: “We are extremely happy with the success of this project, bringing music therapy to emergency workers who develop mental health issues relating to the trauma they experience daily.

“Positive feedback from participants has meant we are planning to run another project in the Surrey Sussex area. I hope that when my colleagues see how successful this pilot was, it will reduce scepticism and encourage more to take advantage and benefit from the healing power of music.  

I would love to hear from any other emergency services organisations in England or Wales that would like to host a Music Therapy project. We are actively seeking funding opportunities and know that music therapy can help support the mental wellbeing of emergency service workers, so please do get in touch.

Seb Valentine, founder of the BLSO and serving Detective Sergeant with Surrey Police

Chroma will also be expanding the support, with the West Midlands Ambulance Service starting a similar project in May 2022.

Daniel Thomas, managing director at Chroma, added: “This was a wonderful project to be a part of. By the end of the 12 weeks, 71% of the participants’ recorded reduced levels of distress compared to their CORE-OM scores when they signed up for the program. “As a result of this success, we are pleased to be able to expand the project to offer more emergency service personnel vital support to support their physical, emotional and mental wellbeing.”

Click here for further information and a documentary video: https://www.bluelightsymphony.org/charity/bluesandtunes/
For more information regarding hosting a music therapy project, contact: Seb Valentine on 0777 337 2575 or via email Seb@bluelightsymphony.org

Copaxone® for use in breastfeeding mothers with RMS

  • Change to COPAXONE® (Glatiramer Acetate (GA)) Summary of Product Characteristics (SmPC) in breastfeeding is relevant for the Multiple Sclerosis (“MS”) community and provides information for neurologists and patients of the positive benefit/risk balance of use in breastfeeding
  • Relapsing Multiple Sclerosis (RMS) is 2-3 times more likely to affect womeni, with diagnosis most common during childbearing years
  • The SmPC update follows the recent COBRA Real World Evidence study of infants breastfed by mothers with MS undergoing GA treatment

Teva Pharmaceuticals Europe BV confirmed on 10th February 2022 that the SmPC for COPAXONE® (Glatiramer Acetate (GA) injection) 20mg/mL and 40mg/mL, indicated for the treatment of relapsing forms of multiple sclerosis (RMS) in Europe, has been updated. The product is now approved by EU health authorities for use in breastfeeding. The label update follows the review of clinical and non-clinical evidence, including latest data from the COBRA real world evidence study that investigated safety outcomes in infants breastfed by mothers with MS undergoing GA treatment during the first 18 months of life.ii

COBRA, the largest standardised analysis of data from the National German Multiple Sclerosis and Pregnancy Registry, assessed safety outcomes in a total of 120 infants including 60 of them breastfed by mothers under GA. It concluded that no evidence was found to suggest that infants were adversely affected by maternal exposure to GA during breastfeeding. This was measured by number of hospitalisations, antibiotic treatments, developmental delays and growth parameters in the first 18 months of life.iii The label update provides information for neurologists and other healthcare professionals treating MS patients of GA’s positive benefit/risk balance in breastfeeding.

Professor Kerstin Hellwig, Principal Investigator of COBRA RWE Study, Department of Neurology, Katholisches Klinikum Bochum, Germany says: “The benefits of breastfeeding for both mothers and their offspring are clinically meaningful and well-documented, but historically there has been limited clinical safety data for infants breastfed by mothers undergoing MS treatment. It is now believed breastfeeding could be protective for mothers with MS. The COBRA study results support mothers with MS in their choice to breastfeed without having to preclude MS treatment. This is an important contribution to current significant medical need.”

There are almost half a million women in Europe living with MS1; it is most common during childbearing age and about half of mothers with MS start their families after diagnosis. The pregnancy rate in MS is constantly increasingiv and recent research shows pregnancy does not worsen the disease progression (which traditionally has been a concern for patients).v

However, studies have found an increase in relapse incidence after child birth, in the postpartum periodvi, so MS treatment may need to be resumed. The majority of MS therapies’ labels advise against breastfeeding, so mothers are often faced with a choice to breastfeed their babies or restart their treatment. Given that according to a U.S. study approximately half of women with MS want to breastfeed vii, the safety of medications used to treat MS while breastfeeding is of concern to mothers. A further treatment option that can be used during breastfeeding may help address a significant medical need for mothers with MS.

Danilo Lembo M.D. VP Medical Europe, Teva Pharmaceuticals comments: “Our mission at Teva is to improve the lives of patients. This includes addressing gender inequalities in healthcare and understanding the unique challenges that women face during pregnancy and breastfeeding. The COPAXONE® label change provides breastfeeding patients with MS the choice to breastfeed while on MS treatment.”

References

i Pugliatti M et al. The epidemiology of multiple sclerosis in Europe. Eur J Neurol 2006;13(7):700-22.

ii Ciplea A, Kurzeja A, Thiel S, Haben S, Alexander J, Adamus E, Hellwig K. Safety analysis of offspring breastfed by mothers on glatiramer acetate therapy for relapsing multiple sclerosis. Eur.J.Neurol. 2021; 28(SUPPL 1): 201-202. 10.1111/ene.14973

iii Teva Pharmaceutical Industries Limited, 2021. New Safety Data on treatment with COPAXONE® (glatiramer acetate) of Breastfeeding Mothers who Live with Relapsing Multiple Sclerosis: COBRA study presented at the 7th Congress of the European Academy of Neurology (EAN). [online] Available at: https://www.tevapharm.com/news-and-media/latest-news/new-safety-data-on-treatment-with-copaxone-glatiramer-acetate-of-breastfeeding-mothers-who-live-with-r/ [Accessed 1 February 2022].

iv Maria K. Houtchens, MD, Natalie C. Edwards, MSc, Gary Schneider, ScD, Kevin Stern, BA and Amy L. Phillips, Pregnancy rates and outcomes in women with and without MS in the United States, Neurology® 2018;91:e1559-e1569. doi:10.1212/WNL.0000000000006384

v Langer-Gould AM, Multiple Sclerosis & other CNS Inflammatory Diseases p. 773-792 June 2019, Vol.25,No.3,doi: 10.1212/CON.0000000000000745

vi Manson J. European Women With Multiple Sclerosis Feel Unprepared and Uneducated About Family Planning and Their Ability to Have Children – How Do We Improve Patient Education? European Neurological Review. 2018;13(1):21–4 DOI: https://doi.org/10.17925/ENR.2018.13.1.21

vii Lorifice L, et al. Neurol Ther 2021; doi: 10.1007/s40120-021-00297-6. Online ahead of print.

UCB announces positive data in myasthenia gravis with zilucoplan phase 3 study results

  • Positive topline results show the Phase 3 RAISE (NCT04115293) zilucoplan trial met primary and all key secondary endpoints in adults with generalised myasthenia gravis
  • The results show a favourable safety profile and good tolerability  
  • UCB plans to proceed with zilucoplan regulatory submissions later this year 
  • Results follow recent positive topline data from the Phase 3 MycarinG study investigating rozanolixizumab, a monoclonal antibody also being developed by UCB in the same indication
  • These results are the latest in a series of positive phase 3 data announcements by the company across its product pipeline

February 04, 2022 – 07:00 CET: UCB, a global biopharmaceutical company, announced positive topline results from the RAISE (NCT04115293) trial1 evaluating its investigational treatment zilucoplan, a self-administered, subcutaneous (SC) peptide inhibitor of complement component 5 (C5 inhibitor), versus placebo in adults with generalised myasthenia gravis (gMG).

The primary endpoint of the trial was met; a clinically meaningful and statistically significant improvement from baseline in Myasthenia Gravis-Activities of Daily Living Profile (MG-ADL) total score at Week 12 was observed for the zilucoplan treatment group vs placebo.

All key secondary endpoints were also met, including statistically significant improvements from baseline in Quantitative Myasthenia Gravis (QMG) score, Myasthenia Gravis Composite (MGC) score and MG-QoL15r score at Week 12 for the zilucoplan treatment group vs placebo. 

The results show zilucoplan was well-tolerated and no major unexpected safety findings were identified compared to earlier zilucoplan studies. The incidence of serious treatment emergent adverse events (TEAEs) in the zilucoplan and placebo treatment arms was similar.

The safety and efficacy of zilucoplan have not been established, and it is not approved for use in any indication by any regulatory authority worldwide. 

Based on these results, UCB plans to progress with regulatory filings for zilucoplan in gMG in the United States (US), European Union (EU) and Japan, beginning later this year.  

gMG patients can experience varying and debilitating symptoms that impact their everyday lives in unique ways,” said James F. Howard, MD, Distinguished Professor of Neuromuscular Disease, Chief, Neuromuscular Disorders Section, University of North Carolina School of Medicine and lead investigator in the RAISE trial. “These exciting results give us additional reason to believe that zilucoplan can offer an important step forward in addressing the unmet needs of people living with gMG. As we strive to improve the management of this complex and unpredictable disease, any new medicines will be welcomed by physicians to help us realize our goal of offering effective and flexible treatment approaches in gMG which are tailored to the needs of individual patients.”

These findings from RAISE build on the positive results from the Phase 3 MycarinG study evaluating UCB’s investigational treatment rozanolixizumab, an SC-infused monoclonal antibody targeting the neonatal Fc receptor (FcRn) which also met its primary and secondary endpoints with statistical significance in gMG.2

UCB is currently the only company investigating two potential treatments with different mechanisms of action in gMG. Detailed results from both Phase 3 trials will be presented at forthcoming medical meetings in 2022.

While there has been recent progress in the treatment of MG, there is still a significant unmet need for new, effective treatment options that address the unpredictable, fluctuating symptoms of MG – some of which require urgent treatment or hospitalisation – to improve patient outcomes and quality of life. New research into additional treatment options will be welcomed by the global MG community.

Raquel Pardo, Spanish Myasthenia Association (AMES), Spain

Iris Loew-Friedrich, Executive Vice-President and Chief Medical Officer added: “This is the latest in a series of positive Phase 3 data announcements across UCB’s product pipeline validating our patient value strategy and laying foundations for future sustainable growth. Today’s results represent another significant milestone in UCB’s efforts to bring transformational outcomes to those living with myasthenia gravis. Positive results for zilucoplan and rozanolixizumab – each with a different mechanism of action – bring us one step closer to achieving our ambition of delivering choice and flexibility for a broad range of patients and physicians at each step of their treatment journey, addressing significant unmet needs and offering unique patient value. We thank the MG community for their continued insights, partnership and participation in this study.”

About Generalized Myasthenia Gravis (gMG)

Myasthenia gravis is a rare disease impacting almost 200,000 patients in the U.S., EU and Japan. ,  People living with gMG can experience a variety of symptoms, including drooping eyelids, double vision and difficulty swallowing, chewing and talking, as well as severe life- threatening weakness of the muscles of respiration.5-8

gMG is a chronic and unpredictable auto-immune disease in which pathogenic autoantibodies can inhibit synaptic transmission at the neuro-muscular junction by targeting specific proteins on the post-synaptic membrane. This disrupts the ability of the nerves to stimulate the muscle and results in a weaker contraction. gMG can occur at any age and in any race, although previous studies have shown that women are more often impacted than men.9 Complement activation, a key mediator of antibody function, is recognized as an important driver of pathology in gMG. 

About the zilucoplan RAISE study10,11 

The RAISE study (Safety, Tolerability, and Efficacy of Zilucoplan in Subjects With Generalized Myasthenia Gravis (NCT04115293)) is a multi-center, Phase 3, randomized, double-blind, placebo-controlled study to evaluate the efficacy, safety, and tolerability of zilucoplan in adult patients with gMG. 

Patients were randomised in a 1:1 ratio to receive daily subcutaneous (SC) doses of zilucoplan or placebo for 12 weeks. The study was designed to determine if complete complement inhibition can bring clinical benefit to people with gMG and if complement inhibition was effective across a broad spectrum of patients with acetylcholine receptor antibody positive (AChR Ab+) MG regardless of disease duration, prior treatment or response to previous therapies. 

The primary endpoint for RAISE study is change from baseline at Week 12 in the Myasthenia Gravis-Activities of Daily Living (MG-ADL) score, an eight-item patient-reported scale developed to assess MG symptoms and their effects on daily activities. Secondary endpoints include change in the Quantitative Myasthenia Gravis (QMG) score, the Myasthenia Gravis Composite (MGC) and the Myasthenia Gravis Quality of Life 15 revised (MG-QoL15r) from baseline to Week 12; time to rescue therapy; the percentage with minimum symptom expression (MSE) (defined as MG-ADL of 0 or 1), the percentage with a ≥3-point reduction in MG-ADL and the percentage with a ≥5-point reduction in QMG, all measured at Week 12.

For more information about the trial visit https://clinicaltrials.gov/ct2/show/NCT04115293

About the rozanolixizumab MycarinG study12 

The MycarinG study (NCT03971422) is a completed multi-center, Phase 3, randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of rozanolixizumab in adult patients with gMG, with an open-label extension. 

The primary endpoint for the MycarinG study is change in the Myasthenia Gravis-Activities of Daily Living Profile (MG-ADL) score. Secondary endpoints include response rates, changes in the Myasthenia Gravis Composite (MGC) score, the Quantitative MG (QMG) score, patient-reported outcomes and adverse events (AEs). 

A preliminary analysis of results shows the trial met its primary endpoint, demonstrating a statistically significant and clinically meaningful change from baseline in the MG-ADL total score at Day 43. All secondary endpoints were also met with statistical significance. Overall, rozanolixizumab was well tolerated and no new safety signals were identified.13  

For more information about the trial, visit https://clinicaltrials.gov/ct2/show/NCT03971422

About Zilucoplan11,14

Zilucoplan targets complement component 5 (C5), a component of the terminal complement activation pathway, and binds to C5 with high affinity and specificity. This prevents its cleavage by C5 convertases into the complement components C5a and C5b. In addition, zilucoplan is understood to bind to the domain of C5 that corresponds to C5b and thereby block binding of C5b to complement component C6. 

Inhibition of C5 cleavage prevents the downstream assembly and activity of membrane attack complex (MAC). This dual mechanism of action of zilucoplan has the potential to prevent activation of the terminal complement pathway and downstream assembly and activity of MAC that can damage and destroy the postsynaptic membrane, disrupt ionic channel conductance and impair neuromuscular transmission. 

Zilucoplan is being investigated in the RAISE study, a multi-center, Phase 3, randomized, double-blind, placebo-controlled study to evaluate the efficacy, safety, and tolerability of zilucoplan in subjects with gMG.
Further indications that are potentially addressable by zilucoplan include amyotrophic lateral sclerosis (ALS) and other tissue-based complement-mediated disorders with high unmet medical need. 

Zilucoplan was selected as one of the first drugs to be tested in a multi-center ALS platform study sponsored by the Sean M. Healey & AMG Center for ALS at Massachusetts General Hospital, Boston, MA. 

The safety and efficacy of zilucoplan have not been established and it is not currently approved for use in any indication by any regulatory authority worldwide.

About Rozanolixizumab
Rozanolixizumab is a subcutaneously infused humanized monoclonal antibody that specifically binds, with high affinity, to human neonatal Fc receptor (FcRn). It has been designed to block the interaction of FcRn and Immunoglobulin G (IgG), accelerating the catabolism of antibodies and reducing the concentration of pathogenic IgG autoantibodies.15,16 

Rozanolixizumab is under clinical development with the aim of improving the lives of people with pathogenic IgG-autoantibody-driven autoimmune diseases, including gMG, primary immune thrombocytopenia (ITP), myelin oligodendrocyte glycoprotein antibody-associated disease (MOG-AD) and autoimmune encephalitis (AIE) by driving removal of pathogenic IgG autoantibodies.

The safety and efficacy of rozanolixizumab have not been established and it is not approved for use in any indication by any regulatory authority worldwide.

References

  1. Data on file. UCB. February 2022.
     
  2. UCB Press Release, December 10. 2021 https://www.ucb.com/stories-media/Press-Releases/article/UCB-announces-positive-Phase-3-results-for-rozanolixizumab-in-generalized-myasthenia-gravis Accessed February 2022
  3. Chen J, et al. Incidence, mortality, and economic burden of myasthenia gravis in China: A nationwide population-based study. Lancet Reg Health West Pac.2020;5:10063.
  4. Gilhus N. Myasthenia Gravis. N Engl J Med. 2016;375:2570-2581.
  5. Lisak, RP. Best Practice Myasthenia gravis. BMJ Best Practice. 2021. Last accessed December 2021
  6. Robertson NP, et al. Myasthenia gravis: a population based epidemiological study in Cambridgeshire, England. J Neurol Neurosurg Psychiatry. 1998;65:492-496.
  7. Kupersmith MJ et al. Development of generalized disease at 2 years in patients with ocular myasthenia gravis. Arch Neurol. 2003;60(2):243-248. 
  8. Hansen JS, et al. Mortality in myasthenia gravis: A nationwide population-based follow-up study in Denmark. Muscle Nerve. 2016;53:73-77.
  9. Myasthenia Gravis Foundation of America. Clinical Overview of MG. https://myasthenia.org/Professionals/Clinical-Overview-of-MG. Accessed November 2021.
  10. Clinical Trials.gov ‘Safety, Tolerability, and Efficacy of Zilucoplan in Subjects With Generalized Myasthenia Gravis (RAISE)’: https://clinicaltrials.gov/ct2/show/NCT04115293. Accessed November 2021.
  11. Howard JF, Jr., et al. JAMA Neurol 2020;77:582–92.
  12. Clinical Trials.gov ‘A Study to Test Efficacy and Safety of Rozanolixizumab in Adult Patients With Generalized Myasthenia Gravis’:  https://clinicaltrials.gov/ct2/show/NCT03971422. Accessed February 2022.
  13. Data on file. UCB. December 2021
  14. Ricardo A, et al. Blood 2015;126:939.
  15. Kiessling P, et al. The FcRn inhibitor rozanolixizumab reduces human serum IgG concentration: A randomized phase 1 study. Sci Transl Med. 2017;9(414).eaan1208
  16. Smith B, et al. Generation and characterization of a high affinity anti-human FcRn antibody, rozanolixizumab, and the effects of different molecular formats on the reduction of plasma IgG concentration. MAbs.2018;10:1111-30.

Positive phase III data for Neurocrine’s Ingrezza in Huntington’s disease

Neurocrine Biosciences has recently announced that its pipeline asset, Ingrezza (valbenazine), achieved the primary endpoint of reducing the symptoms of chorea (involuntary muscle movements) associated with Huntington’s disease (HD) in the Phase III clinical trial, KINECT-HD (NCT04102579). This will propel Ingrezza into a dominant position in the HD market, due to its convenient once-daily dosing regimen and improved safety profile, according to GlobalData, a data and analytics company.


GlobalData’s report, ‘GlobalData (2021) Huntington’s Disease: Opportunity Assessment and Forecast to 2030’, reveals that given Ingrezza’s competitive advantage and the sparseness of the US HD therapeutics market, it is set to generate strong sales of $326m for HD in the US through 2030*.


Compared to available competitors within the same therapeutic class, Ingrezza requires less-frequent dosing and does not pose the risk of increasing depression and suicidality. This is a key advantage, as the development of psychiatric and cognitive symptoms is a common comorbidity in HD patients.”

Sarah Elsayed, Neurology Analyst at GlobalData


Neurocrine plans to submit a supplemental new drug application in HD chorea, meaning that the drug could be available for HD patients in the US by Q1 2023. Key opinion leaders (KOLs) previously interviewed by GlobalData highlighted that one of the most pressing unmet needs in HD is for improved symptomatic treatments that can demonstrate superior clinical efficacy and/or safety to the current standard of care.


Chorea occurs in over 80% of patients with adult-onset HD and is not effectively managed by current treatment options. Thus, KOLs believed that Ingrezza will be a welcome addition to the HD armamentarium and will fulfill a key unmet need.”

Sarah Elsayed, Neurology Analyst at GlobalData


Currently, there are only two drugs approved in the US for the treatment of chorea associated with HD: Bausch’s Xenazine (tetrabenazine) and Teva’s Austedo. Additionally, several generic versions exist for tetrabenazine in the US, offering comparable efficacy at lower costs.

Elsayed continues: “That said, tetrabenazine generics may not be preferred by many patients as they require dosing three times per day and have a boxed warning on the label regarding the increased risk of suicidality. These issues directly affect patient compliance and subsequently limit the utility of those treatments. Ingrezza is therefore more likely to compete for new patients against Teva’s Austedo, which has been widely adopted by physicians since its launch in 2017, owing to the convenience of its twice-daily dosing. However, like tetrabenazine, Austedo also has a boxed a warning regarding the risks of depression and suicidality.”


GlobalData believes that the clinical advantages Ingrezza has shown so far in trials will allow it to move to the front lines of treatment for HD chorea and gain significant market share upon launch in the US.”

Sarah Elsayed, Neurology Analyst at GlobalData

WFNR celebrates 25th anniversary

WFNR image

“Congratulations to the WFNR for all that it has achieved over the last 25 years.  Today the WFNR is a true advocate for neurorehabilitation” said Professor David Good, WFNR President as the organisation celebrates its 25th anniversary.  He continued: “We’re extremely grateful to all our members who have contributed to the success of the organisation in so many ways”.

The WFNR is a vibrant and dynamic multidisciplinary organisation, advancing the development and improving neurorehabilitation services across the world.  In addition to over 5000 members and 37 Special Interest Groups, the WFNR is now affiliated to 41 National Societies in various countries.  It hosts a biennial World Congress for Neurorehabilitation that rotates around the continents with the next WCNR heading to Vienna, Austria from the 14-17 December 2022.

Reflecting on the last 25 years Professor Michael Barnes, the founder of the WFNR said: “Our original aim has been met – to create a global organisation bringing together health professionals with an interest in neurorehabilitation.  It is now a recognised and respected sub speciality of neurology.  We now serve our patients much better than we used to and I think the WFNR has played a major role in that change. Thank you everyone!”

“Neurorehabilitation has an exciting future.  The WFNR will continue to play a major role as a ‘translational hub’, educating members about new science and technology.  There are so many new advances on the horizon; the use of brain computer interfaces, virtual and augmented reality, artificial intelligence, and better biomarkers to name just a few. The future looks bright for our patients.”  

Professor Volker Hoemberg, President-Elect

In celebration the WFNR has just launched its new website www.wfnr.co.uk and new members are always welcome.   

PhD Opportunity: Computer games to support arm rehabilitation after stroke 

Background

Stroke is one of the most common causes of disability across the world. Up to 80% of acute stroke patients experience loss of arm function, which affects quality of life. Arm impairment often persists after rehabilitation has ceased. Recovery may be optimised by intensive functional training, but this can be difficult after stroke e.g. due to fatigue, pain, or depression.  Commercial games may improve arm function after stroke (Thomson et al, 2014), by increasing engagement with activities at home, providing a low-cost adjunct to rehabilitation with off the shelf technology. However, most commercial games have not been designed for people with disabilities and require adaptation. Additionally, music psychology research demonstrates the benefits of preferred music listening on mood and of rhythmic auditory stimulation on arm function in stroke survivors. At GCU, we have developed a bespoke prototype music game, which integrates rhythmic auditory stimulation with repetitive practice, based on individuals’ preferred music. This game, which uses off-the-shelf technology, has been specifically designed for stroke survivors with a range of impairments (Averell & Knox, 2019).

Aims & Objectives

To further develop this prototype to optimise its therapeutic potential and usability by considering design requirements from stroke survivors/carers, and health professionals such as occupational therapists/ physiotherapists. Based on the applicant objectives may comprise:

  1. To conduct a systematic review of music-based gaming for stroke arm rehabilitation.
  2. To further develop, with engineers in audio-technology, a prototype music-based game, through involvement of stroke survivors/carers, and health professionals.
  3. To conduct a feasibility study, exploring the feasibility, acceptability and preliminary effects of using the prototype.

Specifications

The successful applicant will be an Occupational Therapist or Physiotherapist holding the minimum of a first degree (2:1 or above). An interest in games for health, and previous experience of mixed methods or qualitative research is desirable.  This project is available as a 3 years full-time or 6 years part-time PhD study programme with expected start date of 1 October 2021

Deadline is Monday, February 22, 2021. Apply at: https://gcu.radiusbycampusmgmt.com/ssc/aform/EBc05sBc086G0x671m0xK.ssc

Contact Katie.thomson@gcu.ac.uk for more information

Reference:SHLS20061

Consistency in migraine days over course of Ajovy®

Analysis of consistency in migraine days over the course of a dosing regimen for AJOVY® (fremanezumab-vfrm) Injection published in Headache – Analysis assessed migraine days at the beginning and end of quarterly and monthly dosing intervals

Results from a post hoc analysis of a long-term, open-label extension study assessing migraine days at the beginning and end of quarterly and monthly dosing intervals of AJOVY® (fremanezumab-vfrm) injection were published in the October 2020 issue of HeadacheThe Journal of Head and Face Pain.

“We are proud to share this analysis and demonstrate our continued commitment to advancing the understanding of treatment options for patients living with migraine,” said Denisa Hurtukova, MD, Vice President, Head of North America Medical Affairs, Teva. “This analysis helps us better understand patients’ experience with AJOVY, as well as the impact of quarterly and monthly dosing options.”

The post hoc analysis compared migraine days in the initial and final weeks of quarterly or monthly dosing regimens of AJOVY during up to 15 months of treatment. The analysis included 1,043 patients with chronic migraine (CM) (n=611) and episodic migraine (EM) (n=432) who were initially enrolled in the pivotal placebo controlled HALO CM and EM studies and then continued in the long-term, 12-month, multicenter, randomised, parallel group Phase 3 study with double blind dosing regimens. Patients received AJOVY either quarterly or monthly.

Utilising patients within each dosing group as their own control, we were able to analyse whether there was variability in migraine days over the course of a dosing regimen. For all time intervals analysed, the frequency of migraine days was the same in the beginning and end of the dosing period, said Joshua M. Cohen, MD, MPH, FAHS, Global Medical Therapeutic Area Lead for Migraine & Headache, Teva.

This is an important analysis for the migraine community since clinical symptoms often return or worsen before the next dose of many preventive migraine medications is due. Migraine can be a debilitating disease, so evaluating migraine days throughout a dosing regimen can be significant for healthcare providers when considering treatment options. Whenever the brain is exposed to a migraine attack, there is the possibility of increased sensitisation with progressive worsening of the frequency of migraine. A key clinical goal is to limit the amount of time the brain is exposed to migraine to reduce this risk and the number of migraine days impacting a patient before their next dose.

Andrew Blumenfeld, MD, Headache Center of Southern California, The Neurology Center, Carlsbad, CA.

The mean weekly number of migraine days at baseline was 4.0 for patients with CM taking quarterly or monthly AJOVY. For patients with EM, the mean weekly number of migraine days at baseline in the quarterly and monthly AJOVY groups were both 2.3 days.

Read more.

ACNR joins Crossref

We’re delighted to announce that ACNR has joined Crossref, and will be allocating DOI’s to new articles. We have also started adding DOI’s to existing articles, but as we have been publishing for almost 20 years we have quite a lot of content to work through!

If you have published an article with us in the past and would like a DOI allocated to it, please  email the Publisher Rachael Hansford, who will be happy to organise this for you.

Why have we joined Crossref?

ACNR is fully open access, peer reviewed and widely read around the world. 

Joining Crossref will allow us to connect our articles with a global network of online scholarly research, making content even more visible – and linking to other members within article references.

Publish with ACNR

There are no article processing or other charges for ACNR authors or their  institutions. If you would like more information about publishing with us, please see https://www.acnr.co.uk/author-guidelines/ or get in touch. We’d love to hear from you!