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Vesicular Monoamine Transporter 2 (VMAT2) Inhibitor
TEV-50717 for Cerebral Palsy (RECLAIM-DCP Trial)
Phase 3
Waitlist Available
Research Sponsored by Teva Branded Pharmaceutical Products R&D, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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
Participant weighs at least 26 pounds (12 kg) at baseline.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline up to week 17
Awards & highlights
RECLAIM-DCP Trial Summary
A Study of TEV-50717 (Deutetrabenazine) for the Treatment of Dyskinesia in Cerebral Palsy in Children and Adolescents
Eligible Conditions
- Cerebral Palsy
RECLAIM-DCP Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
and for 28 days after the last dose of study drug
For the duration of the study and for 28 days after the last dose of study drug, postmenarchal females aged ≥12 years whose male partners are potentially fertile must use highly effective birth control methods.
Select...
At baseline, the participant weighs at least 26 pounds (12 kg).
Select...
The participant has had symptoms of cerebral palsy since infancy.
Select...
The participant is aged between six and eighteen years at the baseline.
Select...
The participant can swallow the study medication whole.
Select...
Please contact the investigator for more information if you are interested in this study
RECLAIM-DCP Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline up to week 17
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline up to week 17
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change From Baseline in the Movement Disorder-Childhood Rating Scale (MD-CRS) Part II Total Score (Movement Disorder Severity, Centrally Read) at Week 15
Secondary outcome measures
Caregiver Global Impression of Improvement (CaGI-I) Scale Score (Global, Caregiver Rated) at Week 15
Change From Baseline in Child Behavior Checklist (CBCL) Competence Total Score at Week 15
Change From Baseline in Child Behavior Checklist (CBCL) Syndrome Total Score at Week 15
+25 moreSide effects data
From 2019 Phase 2 & 3 trial • 119 Patients • NCT0345294312%
Weight increased
12%
Fatigue
10%
Headache
9%
Somnolence
7%
Diarrhoea
7%
Nausea
7%
Enuresis
5%
Increased appetite
5%
Vomiting
5%
Pyrexia
3%
Depressed mood
3%
Anxiety
2%
Abdominal pain
2%
Suicidal ideation
100%
80%
60%
40%
20%
0%
Study treatment Arm
TEV-50717
Placebo
RECLAIM-DCP Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: TEV-50717Experimental Treatment1 Intervention
administered as oral tablets at a starting dose of 6 mg once daily
Group II: PlaceboPlacebo Group1 Intervention
Matching placebo
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
TEV-50717
2018
Completed Phase 3
~340
Find a Location
Who is running the clinical trial?
Teva Branded Pharmaceutical Products R&D, Inc.Lead Sponsor
251 Previous Clinical Trials
3,485,313 Total Patients Enrolled
1 Trials studying Cerebral Palsy
44 Patients Enrolled for Cerebral Palsy
Teva Medical Expert, MDStudy DirectorTeva Branded Pharmaceutical Products R&D, Inc.
93 Previous Clinical Trials
38,708 Total Patients Enrolled
1 Trials studying Cerebral Palsy
44 Patients Enrolled for Cerebral Palsy
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Who else is applying?
What state do they live in?
Virginia
How old are they?
18 - 65
What site did they apply to?
Teva Investigational Site 14293
What portion of applicants met pre-screening criteria?
Met criteria
How responsive is this trial?
Most responsive sites:
- Teva Investigational Site 14293: < 48 hours
Average response time
- < 2 Days
Typically responds via
Phone Call
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