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TEV-50717 for Cerebral Palsy

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
Patient is able to swallow TEV-50717 whole.
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 14 to week 54
Awards & highlights

Study Summary

This trial will last 55 weeks and is for patients who have completed the parent study. The primary objective is to evaluate the safety and tolerability of long-term therapy with TEV-50717 in children and adolescents with DCP. The secondary objective is to evaluate the efficacy of long-term therapy with TEV-50717 in reducing the severity of DCP.

Eligible Conditions
  • Cerebral Palsy Dyskinetic Type

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You can swallow TEV-50717 pill without crushing or breaking it.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 14 to week 54
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 14 to week 54 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Child Behavior Checklist (CBCL)
Columbia-Suicide Severity Rating Scale
Epworth Sleepiness Scale
+2 more
Secondary outcome measures
Canadian Occupational Performance Measure
Caregiver Global Impression of Improvement
Clinical Global Impression of Improvement
+12 more

Side effects data

From 2019 Phase 2 & 3 trial • 119 Patients • NCT03452943
12%
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

Trial Design

1Treatment groups
Experimental Treatment
Group I: TEV-50717Experimental Treatment1 Intervention
The dose of the TEV-50717 should be increased on a weekly basis to reach a clinically meaningful reduction in dyskinesia, as indicated by a reduction in the Clinical Global Impression of Improvement;(CGI-I).
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
3,485,332 Total Patients Enrolled
1 Trials studying Cerebral Palsy
63 Patients Enrolled for Cerebral Palsy
Teva Medical Expert, MDStudy DirectorTeva Branded Pharmaceutical Products R&D, Inc.
93 Previous Clinical Trials
38,727 Total Patients Enrolled
1 Trials studying Cerebral Palsy
63 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.

Does this research break new ground in the medical field?

"There are currently 5 ongoing clinical trials for TEV-50717 in 21 cities and 11 countries. The earliest study was completed in 2020 and involved 45 patients. It successfully completed Phase 3 drug approval. In the two years since, 9 more trials have been initiated."

Answered by AI

How many individuals are enlisted in this clinical trial?

"This specific trial has completed recruitment, with the last update on November 9th, 2020. However, there are presently 174 other studies related to cerebral palsy and 5 trials for TEV-50717 that are actively enrolling participants."

Answered by AI

How can I sign up to participate in this research project?

"This trial is looking for 45 young patients, aged 6 to 18, that have been diagnosed with cerebral palsy. Most importantly, potential participants must meet the following conditions: The patient must be able to swallow TEV-50717 whole, additional criteria apply (please contact the study's lead investigator for more information), the patient completed parent Study TV50717-CNS-30080, and finally the patient must weigh a minimum of 12 kg (26 lb) on day 1 of this study."

Answered by AI

Does this experiment allow for elderly participation?

"In order to qualify for this clinical trial, applicants must be between 6 and 18 years old. Out of the 163 total clinical trials involving patients under the age of 18, this is one of 32 that also includes patients over the age of 65."

Answered by AI

What is the existing research on TEV-50717?

"Presently, 5 different clinical trials are underway that focus on TEV-50717. Of these active studies, 2 have reached Phase 3. Most of the research locations for this potential treatment are situated in Philadelphia; however, there are a total of 70 sites running trials across the United States of America."

Answered by AI

What are researchers hoping to achieve with this experiment?

"This study's primary goal is to monitor the number of participants with adverse events over a 54-week period. Secondary outcomes include the Unified Huntington's disease Rating Scale-Total Maximal Chorea (centrally read) and the Movement Disorder - Childhood Rating Scale Part II (centrally read). The former assesses the severity of the movement disorder, while the latter provides a general assessment of motor function."

Answered by AI

In how many hospitals is this research project taking place?

"20 enrolment centres for this trial exist, some of which are Teva Investigational Site 14227 in Loma Linda, Teva Investigational Site 14228 in Houston, and Teva Investigational Site 14295 in San Diego."

Answered by AI

Has the FDA greenlit TEV-50717 for public consumption?

"There is some efficacy data from Phase 3 trials to support the safety of TEV-50717, which our team has rated a 3."

Answered by AI

Are participants currently being recruited for this trial?

"This medical trial is not currently looking for participants, as reflected on clinicaltrials.gov. The listing was originally posted on February 4th 2020 and last updated on November 9th 2022. There are, however, 179 other trials actively recruiting patients at this time."

Answered by AI
~9 spots leftby Apr 2025