A Study to Test if TEV-50717 is Safe and Effective in Relieving Abnormal Involuntary Movements in Cerebral Palsy
NCT ID: NCT04200352
Last Updated: 2024-04-22
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
44 participants
INTERVENTIONAL
2020-02-04
2023-02-14
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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TEV-50717
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).
TEV-50717
Oral tablets are 6, 9, and 12 mg.
Interventions
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TEV-50717
Oral tablets are 6, 9, and 12 mg.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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 days: reserpine
* within 14 days: levodopa, dopamine agonists, and monoamine oxidase inhibitors
* Participant has received treatment with stem cells, deep brain stimulation, transmagnetic stimulation, or transcranial direct current stimulation for treatment of abnormal movements or CP since the week 15 visit of Study TV50717-CNS-30080, or the participant is not in a stable clinical condition.
* Participants with a history of torsade de pointes, congenital long QT syndrome, bradyarrhythmias, other cardiac arrhythmias, or uncompensated heart failure.
* Participant has a known allergy to any of the components of TEV-50717.
* Participant has participated in an investigational drug or device study other than Study TV50717-CNS-30080 and received IMP/intervention within 30 days or 5 drug half-lives of day 1 of this study, whichever is longer.
* Participant is pregnant or breastfeeding. NOTE- Additional criteria apply, please contact the investigator for more information
6 Years
18 Years
ALL
No
Sponsors
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Teva Branded Pharmaceutical Products R&D, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Teva Medical Expert, MD
Role: STUDY_DIRECTOR
Teva Branded Pharmaceutical Products R&D, Inc.
Locations
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Teva Investigational Site 14137
Birmingham, Alabama, United States
Teva Investigational Site 14295
San Diego, California, United States
Teva Investigational Site 14122
Voorhees Township, New Jersey, United States
Teva Investigational Site 14299
Charleston, South Carolina, United States
Teva Investigational Site 14129
Nashville, Tennessee, United States
Teva Investigational Site 39058
Blegdamsvej 9, , Denmark
Teva Investigational Site 80146
Tel-Aviv, Tel-Aviv District, , Israel
Teva Investigational Site 80147
Zerifin, Central District, , Israel
Teva Investigational Site 30214
Milan, , Italy
Teva Investigational Site 30216
Pisa, , Italy
Teva Investigational Site 53434
Gdansk, , Poland
Teva Investigational Site 53428
Gdansk, Pomerania Province, , Poland
Teva Investigational Site 53427
Krakow, , Poland
Teva Investigational Site 53430
Wiazowna, Mazovia Province, , Poland
Teva Investigational Site 50477
Kazan', , Russia
Teva Investigational Site 50475
Khabarovsk, Khabarovsk Krai Region, , Russia
Teva Investigational Site 50470
Moscow, Moscow Region, , Russia
Teva Investigational Site 50485
Nizhniy Novgorod, Nizhny Novgorod Region, , Russia
Teva Investigational Site 50468
Novosibirsk, Novosibirsk Region, , Russia
Teva Investigational Site 50469
Smolensk, Smolensk Region, , Russia
Teva Investigational Site 50478
Stavropol, Stavropol Krai Region, , Russia
Teva Investigational Site 50474
Tyumen, Tyumen Region, , Russia
Teva Investigational Site 31254
Valencia, , Spain
Teva Investigational Site 58313
Dnipro, Dnipropetrovsk Province, , Ukraine
Teva Investigational Site 58309
Kyiv, Kyiv Province, , Ukraine
Teva Investigational Site 58311
Odessa, Odessa Province, , Ukraine
Teva Investigational Site 58310
Vinnytsya, Vinnytsia Province, , Ukraine
Teva Investigational Site 34245
Edinburgh, Edinburgh, , United Kingdom
Teva Investigational Site 34243
London, Greater London, , United Kingdom
Teva Investigational Site 34244
Sheffield, South Yorkshire, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2019-001807-19
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
TV50717-CNS-30081
Identifier Type: -
Identifier Source: org_study_id
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