A Study of TEV-50717 (Deutetrabenazine) for the Treatment of Dyskinesia in Cerebral Palsy in Children and Adolescents

NCT ID: NCT03813238

Last Updated: 2023-09-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 63 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-06
• Study Completion Date: 2022-07-21

Brief Summary

CP (cerebral palsy) refers to a group of neurological disorders that appear in infancy or early childhood and permanently affect body movement and muscle coordination. CP is caused by damage to or abnormalities inside the developing brain that disrupt the brain's ability to control movement and maintain posture and balance. The signs of CP usually appear in the early months of life, although specific diagnosis may be delayed until the age of 2 years or older. TEV-50717 (deutetrabenazine, also known as SD-809) has already provided evidence for safe and effective use in 2 other hyperkinetic movement disorders, namely chorea in Huntington's disease (HD) and tardive dyskinesia (TD). Currently, there is no approved treatment available for Dyskinesia in cerebral palsy (DCP). The available treatment options address some of the manifestations of DCP. The study population will include pediatric and adolescent participants (6 through 18 years of age) with DCP with predominant choreiform movement disorder, who have had nonprogressive CP symptoms since infancy (≤2 years of age). Diagnosis of DCP is based on the Surveillance of Cerebral Palsy in Europe criteria.

This is a Phase 3 study that will evaluate the efficacy and safety of TEV-50717 administered as oral tablets at a starting dose of 6 mg once daily in participants (age 6 through 18 years, inclusive) with DCP with predominant choreiform movement disorder. The study will be conducted in multiple centers and will use 2 parallel treatment groups (ie, TEV-50717 and placebo) in which participants will be randomized in a 2:1 ratio.

"Predominant" in this instance indicates that the choreiform movement disorder is the main cause of impairment or distress.

Conditions

Cerebral Palsy, Dyskinetic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

TEV-50717

administered as oral tablets at a starting dose of 6 mg once daily

Group Type: EXPERIMENTAL

TEV-50717

Intervention Type: DRUG

Dosage ranging from 6 mg to 48 mg.

Placebo

Matching placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Dosage ranging from 6 mg to 48 mg.

Interventions

TEV-50717

Dosage ranging from 6 mg to 48 mg.

Intervention Type: DRUG

Placebo

Dosage ranging from 6 mg to 48 mg.

Intervention Type: DRUG

Other Intervention Names

Deutetrabenazine, (previously SD-809)

Eligibility Criteria

Inclusion Criteria

• Participant is 6 through 18 years of age (inclusive) at baseline.
• Participant weighs at least 26 pounds (12 kg) at baseline.
• Participant has had CP symptoms since infancy (≤2 years)
• Choreiform is the prevalent movement disorder as assessed by the EAB at screening.
• Participant has a diagnosis of DCP
• Participant is able to swallow study medication whole.
• 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
• Additional criteria apply, please contact the investigator for more information

Exclusion Criteria

• Participant has a predominant movement disorder other than dyskinesia.
• Participant's predominant motor symptoms are dystonic.
• Participant's predominant motor symptoms are spastic.
• Participant has choreiform movement disorder that has not been consistent throughout the life of the participant.
• Participant has clinically significant depression at screening or baseline.
• Note: Participants receiving antidepressant therapy may be enrolled if on a stable dose for at least 6 weeks before screening.
• Participant 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
• 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 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 participant is not in a stable clinical condition.
• Participant has recent surgical procedure or is anticipated to have a surgical procedure during the study that, in the opinion of the investigator, makes the Participant unsuitable for the study.
• Participant has a severe mental disability or an unstable or serious medical illness (eg, epilepsy) at screening or baseline that, in the opinion of the investigator, could jeopardize or would compromise the Participant's ability to participate in this study.
• Participant has a known allergy to any of the components of the investigational medicinal product (IMP).
• Participant is pregnant or breastfeeding.
• Participant has a history of or acknowledges alcohol or substance abuse in the 12 months before screening
• Participants with a history of torsade de pointes, congenital long QT syndrome, bradyarrhythmias, other cardiac arrhythmias, or uncompensated heart failure.
• Additional criteria apply, please contact the investigator for more information

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Teva Branded Pharmaceutical Products R&D, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Teva Medical Expert, MD

Role: STUDY_DIRECTOR

Teva Branded Pharmaceutical Products R&D, Inc.

Locations

Teva Investigational Site 14137

Birmingham, Alabama, United States

Teva Investigational Site 14224

Phoenix, Arizona, United States

Teva Investigational Site 14227

Loma Linda, California, United States

Teva Investigational Site 14295

San Diego, California, United States

Teva Investigational Site 14293

Washington D.C., District of Columbia, United States

Teva Investigational Site 14127

Miami, Florida, United States

Teva Investigational Site 14125

Tampa, Florida, United States

Teva Investigational Site 14136

Atlanta, Georgia, United States

Teva Investigational Site 14291

Atlanta, Georgia, United States

Teva Investigational Site 14130

Savannah, Georgia, United States

Teva Investigational Site 14290

New Orleans, Louisiana, United States

Teva Investigational Site 14226

Saint Paul, Minnesota, United States

Teva Investigational Site 14134

Lincoln, Nebraska, United States

Teva Investigational Site 14122

Gibbsboro, New Jersey, United States

Teva Investigational Site 14297

New Brunswick, New Jersey, United States

Teva Investigational Site 14225

New York, New York, United States

Teva Investigational Site 14123

Rochester, New York, United States

Teva Investigational Site 14348

Portland, Oregon, United States

Teva Investigational Site 14299

Charleston, South Carolina, United States

Teva Investigational Site 14129

Nashville, Tennessee, United States

Teva Investigational Site 14228

Houston, Texas, United States

Teva Investigational Site 14223

Richmond, Virginia, United States

Teva Investigational Site 14135

Everett, Washington, United States

Teva Investigational Site 37100

Luxembourg City, , Belgium

Teva Investigational Site 37102

Woluwe-Saint-Lambert, , Belgium

Teva Investigational Site 11165

Nepean, Ontario, Canada

Teva Investigational Site 39058

Copenhagen, , Denmark

Teva Investigational Site 80144

Jerusalem, , Israel

Teva Investigational Site 80145

Safed, , Israel

Teva Investigational Site 80146

Tel Aviv, , Israel

Teva Investigational Site 80147

Ẕerifin, , Israel

Teva Investigational Site 30217

Florence, , Italy

Teva Investigational Site 30214

Milan, , Italy

Teva Investigational Site 30213

Napoli, , Italy

Teva Investigational Site 30216

Pisa, , Italy

Teva Investigational Site 30215

Roma, , Italy

Teva Investigational Site 30212

Roma, , Italy

Teva Investigational Site 53434

Gdansk, , Poland

Teva Investigational Site 53428

Gdansk, , Poland

Teva Investigational Site 53433

Gmina Strzelin, , Poland

Teva Investigational Site 53427

Krakow, , Poland

Teva Investigational Site 53431

Lublin, , Poland

Teva Investigational Site 53432

Poznan, , Poland

Teva Investigational Site 53430

Wiązowna, , Poland

Teva Investigational Site 50477

Kazan', , Russia

Teva Investigational Site 50475

Khabarovsk, , Russia

Teva Investigational Site 50473

Moscow, , Russia

Teva Investigational Site 50470

Moscow, , Russia

Teva Investigational Site 50485

Nizhny Novgorod, , Russia

Teva Investigational Site 50468

Novosibirsk, , Russia

Teva Investigational Site 50469

Smolensk, , Russia

Teva Investigational Site 50478

Stavropol, , Russia

Teva Investigational Site 50474

Tyumen, , Russia

Teva Investigational Site 62054

Banská Bystrica, , Slovakia

Teva Investigational Site 62053

Dubnica nad Váhom, , Slovakia

Teva Investigational Site 31259

Córdoba, , Spain

Teva Investigational Site 31256

Granada, , Spain

Teva Investigational Site 31255

Madrid, , Spain

Teva Investigational Site 31257

Madrid, , Spain

Teva Investigational Site 31258

Seville, , Spain

Teva Investigational Site 31254

Valencia, , Spain

Teva Investigational Site 58313

Dnipropetrovsk, , Ukraine

Teva Investigational Site 58312

Kharkiv, , Ukraine

Teva Investigational Site 58309

Kyiv, , Ukraine

Teva Investigational Site 58311

Odesa, , Ukraine

Teva Investigational Site 58310

Vinnytsia, , Ukraine

Teva Investigational Site 34246

Bristol, , United Kingdom

Teva Investigational Site 34245

Edinburgh, , United Kingdom

Teva Investigational Site 34243

London, , United Kingdom

Teva Investigational Site 34244

Sheffield, , United Kingdom

Countries

United States; Belgium; Canada; Denmark; Israel; Italy; Poland; Russia; Slovakia; Spain; Ukraine; United Kingdom

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2018-003742-17

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

TV50717-CNS-30080

Identifier Type: -

Identifier Source: org_study_id