TerminatedPhase 3

A Study to Test if TEV-50717 is Safe and Effective in Relieving Abnormal Involuntary Movements in Cerebral Palsy

Stopped: Failure of TV50717-CNS-30080 (parent study) to meet the primary efficacy endpoint

United States44 participantsStarted 2020-02-04

Plain-language summary

Study TV50717-CNS-30081 is a 55-week study in which participants who have successfully completed the parent study (Study TV50717-CNS-30080) may be eligible to enroll in this study. The primary objective of this study is to evaluate the safety and tolerability of long-term therapy with TEV-50717 in children and adolescents with DCP. The secondary objective of this study is to evaluate the efficacy of long-term therapy with TEV-50717 in reducing the severity of DCP.

Who can participate

Age range6 Years – 18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Participant has completed parent Study TV50717-CNS-30080. * Participant weighs at least 12 kg (26 lb) on day 1 of this study. * Participant is able to swallow TEV-50717 whole. NOTE- Additional criteria apply, please contact the investigator for more information Exclusion Criteria: * Participant has clinically significant depression at screening or day 1 of this study. Note: Participants receiving antidepressant therapy may be enrolled if on a stable dose for at least 6 weeks before screening or day 1 (whichever comes first) and anticipated to remain stable (dose and frequency) within the study duration. * Participant has a history of suicidal intent or related behaviors based on medical or psychiatric history or the C-SSRS at screening visit, if performed, or at the day 1 visit, as applicable according to the participant's age: * intent to act on suicidal ideation with a specific plan, irrespective of level of ambivalence, at the time of suicidal thought * 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 any of the following concomitant Participant has received any of the following concomitant medications within the specified exclusionary windows from screening or day 1 (whichever comes first) of this study: * within 30 days: tetrabenazine or valbenazine * within 21 d…

What they're measuring

Number of Participants With Adverse Events (AEs)

Timeframe: Baseline up to Week 55

Number of Participants (Aged ≥12 Years) With Columbia-Suicide Severity Rating Scale (C-SSRS) Outcomes (Worst Overall Finding)

Timeframe: Baseline to Week 54

Change From Baseline in Extrapyramidal Symptom Rating Scale (ESRS) Subscale I Total Score at Week 54

Timeframe: Baseline, Week 54

Change From Baseline in ESRS Subscale II Total Score at Week 54

Timeframe: Baseline, Week 54

Change From Baseline in Child Behavior Checklist (CBCL) Competence Total Score at Week 53

Timeframe: Baseline, Week 53

Change From Baseline in CBCL Syndrome Total Score at Week 53

Timeframe: Baseline, Week 53

Change From Baseline in Epworth Sleepiness Scale (ESS) Total Score at Week 54

Timeframe: Baseline, Week 54

Trial details

NCT IDNCT04200352

SponsorTeva Branded Pharmaceutical Products R&D, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-02-14

Results submitted2024-01-26

View on ClinicalTrials.gov More Cerebral Palsy, Dyskinetic trials

Plain-language summary

Who can participate

Age range6 Years – 18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Number of Participants With Adverse Events (AEs)

Timeframe: Baseline up to Week 55

Number of Participants (Aged ≥12 Years) With Columbia-Suicide Severity Rating Scale (C-SSRS) Outcomes (Worst Overall Finding)

Timeframe: Baseline to Week 54

Change From Baseline in Extrapyramidal Symptom Rating Scale (ESRS) Subscale I Total Score at Week 54

Timeframe: Baseline, Week 54

Change From Baseline in ESRS Subscale II Total Score at Week 54

Timeframe: Baseline, Week 54

Change From Baseline in Child Behavior Checklist (CBCL) Competence Total Score at Week 53

Timeframe: Baseline, Week 53

Change From Baseline in CBCL Syndrome Total Score at Week 53

Timeframe: Baseline, Week 53

Change From Baseline in Epworth Sleepiness Scale (ESS) Total Score at Week 54

Timeframe: Baseline, Week 54