Status:
COMPLETED
A Study of TEV-50717 (Deutetrabenazine) for the Treatment of Dyskinesia in Cerebral Palsy in Children and Adolescents
Lead Sponsor:
Teva Branded Pharmaceutical Products R&D, Inc.
Conditions:
Cerebral Palsy, Dyskinetic
Eligibility:
All Genders
6-18 years
Phase:
PHASE3
Brief 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 abn...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 6 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 21 2022
Estimated Enrollment :
63 Patients enrolled
Trial Details
Trial ID
NCT03813238
Start Date
August 6 2019
End Date
July 21 2022
Last Update
September 8 2023
Active Locations (70)
Enter a location and click search to find clinical trials sorted by distance.
1
Teva Investigational Site 14137
Birmingham, Alabama, United States, 35233
2
Teva Investigational Site 14224
Phoenix, Arizona, United States, 85016
3
Teva Investigational Site 14227
Loma Linda, California, United States, 92354
4
Teva Investigational Site 14295
San Diego, California, United States, 92123