A Study to Test if TEV-50717 is Effective in Relieving Abnormal Involuntary Movements in Cerebral Palsy
- Conditions
- Dyskinesia in cerebral palsy (DCP)MedDRA version: 20.1 Level: LLT Classification code 10068804 Term: Athetoid cerebral palsy System Organ Class: 100000004850Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2018-003742-17-GB
- Lead Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Not specified
- Target Recruitment
- 185
1. Patient is 6 through 18 years of age (inclusive) at baseline.
2.Patient weighs at least 26 pounds (12 kg) at baseline.
3.Patient has had CP symptoms since infancy (=2 years), and CP is judged by the investigator to be of a non-progressive nature.
4.Patient has a diagnosis of DCP according to the Surveillance of Cerebral Palsy in Europe criteria.
5.Patient has an MD-CRS part II total score of =10 at the baseline visit, based on investigator scoring of chorea.
6.Patient’s symptoms are causing functional problems determined by a CGI-S score of 4 or greater based on investigator scoring.
7.Choreiform is the predominant (ie, the main cause of impairment or distress) movement disorder as assessed at screening.
8.Patient is able to swallow study medication whole.
9.Patient and caregiver are willing to adhere to the medication regimen and to comply with all study procedures.
10.Patient is in good general health, as indicated by medical and psychiatric history, as well as physical and neurological examination.
11.In the investigator’s opinion, the patient and caregiver have the ability to understand the nature of the study and its procedures, and the patient is expected to complete the study as designed.
12.For a patient who is a minor, the parent(s)/legal guardian(s) provide written informed consent, and the patient provides assent (in accordance with local regulations). Adult patients provide their own written informed consent (in accordance with local regulations).
13.Caregivers provide written informed consent after being assigned the role by an adult patient, or if this role is delegated by the parent/legal guardian of a patient who is a minor.
14.Females who are postmenarchal or =12 years of age may be included only if they have a negative beta-human chorionic gonadotropin test at baseline or are sterile. Definitions of sterile, premenarchal, and postmenarchal are given in Appendix F.
15.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 (ie, starting at screening) and for 30 days after the last dose of IMP. Further details are included in Appendix F of the protocol.
Are the trial subjects under 18? yes
Number of subjects for this age range: 185
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 15
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
1.a. Patient has a predominant movement disorder other than dyskinesia.
b. Patient’s predominant motor symptoms are dystonic.
c. Patient’s predominant motor symptoms are spastic.
d. Patient has another other movement disorder that could impair the motor assessment in the MD-CRS part II.
e. Patient has choreiform movement disorder that has not been consistent throughout the life of the patient.
2.Patient has clinically significant depression at screening or baseline.
Note: Patients receiving antidepressant therapy may be enrolled if on a stable dose for at least 6 weeks before screening.
3.Patient 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
4.Patient has a history of a previous actual, interrupted, or aborted suicide attempt.
5.Patient has a first-degree relative who has completed suicide.
6.Patient who is currently receiving or who, in the last 4 months before screening, has received botulinum neurotoxin (BoNT) in an investigational clinical trial.
Note: Patients may be included in the study if they have at least 2 treatments of Food and Drug Administration-approved BoNT at a regular interval (eg, every 3 to 4 months), in reasonably stable dosages and locations (subject to investigator’s judgement) to treat lower limb spasticity or dystonia, and if they are expected to continue this stable regimen of BoNT injections for the duration of this study. The patient is expected to continue on this stable regimen of BoNT injections on a regularly scheduled interval every 3 months for the duration of this study. The injection for spasticity or dystonia must be in a muscular region that is separate from the main areas affected by choreiform movement disorder.
Note: Patients who received BoNT injections more than 4 months before screening and who do not plan to continue these injections may be considered for this study.
7.Patient has received any of the following concomitant medications for dystonia or chorea within the specified exclusionary windows of screening:
Within 3 months: depot neuroleptics
Within 30 days: tetrabenazine, deutetrabenazine, or valbenazine
Within 21 days: reserpine
Within 14 days: neuroleptics (oral), typical and atypical antipsychotics (see Appendix H), metoclopramide, levodopa, dopamine agonists, and MAOIs
Note: Use of benzodiazepines, muscle relaxants, trihexyphenidyl, baclofen (oral and intrathecal), gabapentin, and levetiracetam is allowed if the dosing has been stable for at least 4 weeks before screening.
Note: Use of topiramate (up to 200 mg/day) is allowed if dosing has been stable for at least 4 weeks before screening.
8.Patient 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 patient is not in a stable clinical condition.
9.Patient has recent surgi
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method