RECLAIM-DCP TEV-50717 for Treatment of Dyskinesia in Cerebral Palsy

• Research type

  Research Study

• Full title

  A Randomized, Double-Blind, Placebo-Controlled Study of TEV-50717 (Deutetrabenazine) for the Treatment of Dyskinesia in Cerebral Palsy in Children and Adolescents

• IRAS ID

  259687

• Contact name

  Daniel Lumsden

• Contact email

  daniel.Lumsden@gstt.nhs.uk

• Sponsor organisation

  Teva Branded Pharmaceutical Products R&D, Inc.

• Eudract number

  2018-003742-17

• Clinicaltrials.gov Identifier

  NCT03813238

• Clinicaltrials.gov Identifier

  139700, IND Number:

• Duration of Study in the UK

  2 years, 1 months, 12 days

• Research summary

  Cerebral Palsy (CP) refers to a group of neurological disorders that appear in infancy or early childhood and permanently affect body movement and muscle coordination. CP is caused by damage to or abnormalities inside the developing brain that disrupt the brain’s ability to control movement and maintain posture and balance. The signs of CP usually appear in the early months of life, although specific diagnosis may be delayed until the age of 2 years or older. TEV-50717 (deutetrabenazine, also known as SD-809) has already provided evidence for safe and effective use in 2 other hyperkinetic movement (excessive involuntary movements) disorders, namely chorea in Huntington’s disease (HD) and tardive dyskinesia (TD). Currently, there is no approved treatment available for Dyskinesia (abnormal, uncontrolled, involuntary movement) in CP (DCP). The available treatment options address some of the manifestations of DCP. The study population will include paediatric and adolescent patients (6 through 18 years of age) with DCP with predominant choreiform movement disorder, who have had non-progressive CP symptoms since infancy (≤2 years of age). Diagnosis of DCP is based on the Surveillance of Cerebral Palsy in Europe criteria.
  This is a Phase 3 study that will evaluate the efficacy and safety of TEV-50717 administered as oral tablets at a starting dose of 6 mg once daily in approximately 185 patients (age 6 through 18 years, inclusive) with DCP with predominant choreiform movement (repetitive and rapid, jerky, involuntary movement that appears to be well-coordinated) disorder. The study will be conducted in multiple centres and will use 2 parallel treatment groups (ie, TEV-50717 and placebo [dummy drug]) in which patients will be randomised in a 2:1 ratio.
  Summary of results
  https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fu2790089.ct.sendgrid.net%2Fls%2Fclick%3Fupn%3DXv3JSvJ-2B3M71ppf7N9agba4yu73OCS9U-2BkKS40W1kfatiYvtk1-2B2gi1K6vKImual9G6VG4-2FeFhNKGHEnJKTVSou1S5tXqmXwSltsb2CxP7apLB3qQMgLtu1qqR9nc1uVUbg1_E1aO2-2BZlVOSJJV-2FajQqskegTd6IRomHYTi-2Fbt8SH3YIBPyJWqDxePTCn0T8AgVBrVQFLqXXs19CHkUdYGzSmKpMad9x8HOxQBrIV7e2Bsy2grYLTX5Yk0PmPTfqufXH50ti0-2FIEzYBKcZyhTROIkYrfk-2BzR6YSbJOzBHy8hY4-2BylC5GT6LW4dsYd0iDxz2RDBafRum6rAz0vwH0D2uRyfw-3D-3D&data=05%7C01%7Cleicestercentral.rec%40hra.nhs.uk%7C669a0e59c0e140496d7c08dbb54d185c%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638303114941550971%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=CYpmcH%2F6ACfEz8p0QeH9AFFGzQ1Xdg6twO2zGooTtcg%3D&reserved=0

• REC name

  East Midlands - Leicester Central Research Ethics Committee

• REC reference

  19/EM/0151

• Date of REC Opinion

  12 Jul 2019

• REC opinion

  Further Information Favourable Opinion