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

Teva Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Cerebral Palsy, Dyskinetic

Treatments: Drug: Placebo; Drug: TEV-50717

Study type: Interventional

Funder types: Industry

Identifiers

NCT03813238

TV50717-CNS-30080

2018-003742-17 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 63 patients

Sex: All

Ages: 6 to 18 years old

Volunteers: No Healthy Volunteers

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 level of ambivalence, at the time of suicidal thought
• Previous suicidal preparatory acts or behavior
• 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 investigational medicinal product (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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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63 participants in 2 patient groups, including a placebo group

TEV-50717

Experimental group

Description:

administered as oral tablets at a starting dose of 6 mg once daily

Treatment:

Drug: TEV-50717

Placebo

Placebo Comparator group

Description:

Matching placebo

Treatment:

Drug: Placebo