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 States, Denmark, Israel44 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 range

6 Years – 18 Years

Sex

ALL

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…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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 range

6 Years – 18 Years

Sex

ALL

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