A Study of TEV-50717 (Deutetrabenazine) for the Treatment of Dyskinesia in Cerebral Palsy in Children and Adolescents (RECLAIM-DCP)

  • STATUS
    Recruiting
  • days left to enroll
    12
  • participants needed
    185
  • sponsor
    Teva Branded Pharmaceutical Products R&D, Inc.
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Updated on 16 May 2022
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Summary

CP (cerebral palsy) 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 disorders, namely chorea in Huntington's disease (HD) and tardive dyskinesia (TD). Currently, there is no approved treatment available for Dyskinesia in cerebral palsy (DCP). The available treatment options address some of the manifestations of DCP. The study population will include pediatric and adolescent participants (6 through 18 years of age) with DCP with predominant choreiform movement disorder, who have had nonprogressive 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 participants (age 6 through 18 years, inclusive) with DCP with predominant choreiform movement disorder. The study will be conducted in multiple centers and will use 2 parallel treatment groups (ie, TEV-50717 and placebo) in which participants will be randomized in a 2:1 ratio.

"Predominant" in this instance indicates that the choreiform movement disorder is the main cause of impairment or distress.

Details
Condition Cerebral Palsy, Dyskinetic
Treatment Placebo, Deutetrabenazine
Clinical Study IdentifierNCT03813238
SponsorTeva Branded Pharmaceutical Products R&D, Inc.
Last Modified on16 May 2022

Eligibility

 Yes No Not Sure

Inclusion Criteria

Participant is 6 through 18 years of age (inclusive) at baseline
Participant weighs at least 26 pounds (12 kg) at baseline
Participant has had CP symptoms since infancy (≤2 years)
Choreiform is the prevalent movement disorder as assessed by the EAB at screening
Participant has a diagnosis of DCP
Participant is able to swallow study medication whole
Females who are postmenarchal or ≥12 years of age whose male partners are potentially fertile (ie, no vasectomy) must use highly effective birth control methods for the duration of the study
Additional criteria apply, please contact the investigator for more information

Exclusion Criteria

Participant has a predominant movement disorder other than dyskinesia
Participant's predominant motor symptoms are dystonic
Participant's predominant motor symptoms are spastic
Participant has choreiform movement disorder that has not been consistent throughout the life of the participant
Participant has clinically significant depression at screening or baseline
Note: Participants receiving antidepressant therapy may be enrolled if on a stable dose for at least 6 weeks before screening
Participant has a history of suicidal intent or related behaviors within 2 years of
screening
Previous intent to act on suicidal ideation with a specific plan, irrespective of
Previous suicidal preparatory acts or behavior
level of ambivalence, at the time of suicidal thought
Participant has a history of a previous actual, interrupted, or aborted suicide attempt
Participant has a first-degree relative who has completed suicide
Participant has received treatment with stem cells, deep brain stimulation, transmagnetic stimulation, or transcranial direct current stimulation for treatment of abnormal movements or CP within 6 months of the screening visit, or the participant is not in a stable clinical condition
Participant has recent surgical procedure or is anticipated to have a surgical procedure during the study that, in the opinion of the investigator, makes the Participant unsuitable for the study
Participant has a severe mental disability or an unstable or serious medical illness (eg, epilepsy) at screening or baseline that, in the opinion of the investigator, could jeopardize or would compromise the Participant's ability to participate in this study
Participant has a known allergy to any of the components of the IMP
Participant is pregnant or breastfeeding
Participant has a history of or acknowledges alcohol or substance abuse in the 12 months before screening
Participants with a history of torsade de pointes, congenital long QT syndrome, bradyarrhythmias, other cardiac arrhythmias, or uncompensated heart failure
Additional criteria apply, please contact the investigator for more information
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