Safety and Tolerability Study of Once-weekly Oral Aripiprazole in Children and Adolescents With Tourette's Disorder

NCT ID: NCT01416441

Last Updated: 2021-10-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 170 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-10-19
• Study Completion Date: 2014-03-13

Brief Summary

The goal of the current trial is to obtain long term efficacy, safety and tolerability data of once weekly aripiprazole in children and adolescents with Tourette's Disorder.

Conditions

Tourette's Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Aripiprazole

Participants received oral aripiprazole tablets once weekly (QW) with a titrated dose starting from 52.5 milligram (mg), on Day 1 and increasing to 77.5 mg and 110 mg for the remainder of the trial (Up to Week 52), the dose could be adjusted between these 3 dose levels as determined by investigator's discretion based on safety and tolerability.

Group Type: EXPERIMENTAL

Aripiprazole

Intervention Type: DRUG

Aripiprazole tablets orally once daily.

Interventions

Aripiprazole

Aripiprazole tablets orally once daily.

Intervention Type: DRUG

Other Intervention Names

ABILIFY

Eligibility Criteria

Inclusion Criteria

• The participants successfully completed the final assessment visit in either Study 31-10-272 (NCT01418339) or 31-10-273 (NCT01418352). The participants completed all required assessments for the Week 8/Early Termination Visit to be eligible for rollover in to this open-label trial.
• Written informed consent form (ICF) obtained from a legally acceptable representative & informed assent at Baseline as applicable by trial center's Institutional review board/independent ethics committee (IRB/IEC).
• The participant, designated guardian(s) or caregiver(s) are able to comprehend and satisfactorily comply with the protocol requirements, as evaluated by the investigator.

Exclusion Criteria

• The participants experienced adverse events (AEs) during the double-blind study 31-10-272 (NCT01418339) or 31-10-273 (NCT01418352) that would, in the investigator's judgment, preclude further exposure to aripiprazole.
• The participants had protocol violations during the double-blind trial considered major in the judgment of the investigator which would deem the participant a poor candidate for the trial.
• A positive drug screen at baseline for cocaine, alcohol or other drugs of abuse which will result in early termination at Week 1.
• Sexually active patients who will not commit to utilizing 2 of the approved birth control methods or who will not remain abstinent during the trial and for 90 and 30 days following the last dose of study drug for male and female respectively.
• Participants representing Risk of committing suicide.
• Body weight lower than 16 kg.
• Abnormal laboratory test results (Platelet, Hemoglobin, Neutrophils, Aspartate aminotransferase, Alanine aminotransferase, Creatinine) vital signs and Electrocardiogram (ECG) results.

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Otsuka Pharmaceutical Development & Commercialization, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Eva Kohegyi, MD

Role: STUDY_DIRECTOR

Otsuka Pharmaceutical Development & Commercialization, Inc.

Locations

Dothan, Alabama, United States

Little Rock, Arkansas, United States

Los Angeles, California, United States

Sacramento, California, United States

San Diego, California, United States

San Francisco, California, United States

Santa Ana, California, United States

Wildomar, California, United States

Gainesville, Florida, United States

Hialeah, Florida, United States

Miami, Florida, United States

Orange City, Florida, United States

St. Petersburg, Florida, United States

Atlanta, Georgia, United States

Atlanta, Georgia, United States

Chicago, Illinois, United States

Indianapolis, Indiana, United States

Overland Park, Kansas, United States

New Orleans, Louisiana, United States

Bloomfield Hills, Michigan, United States

Omaha, Nebraska, United States

Manhasset, New York, United States

Staten Island, New York, United States

Avon Lake, Ohio, United States

Cincinnati, Ohio, United States

Cleveland, Ohio, United States

Middleburg Heights, Ohio, United States

Oklahoma City, Oklahoma, United States

Philadelphia, Pennsylvania, United States

Dallas, Texas, United States

San Antonio, Texas, United States

San Antonio, Texas, United States

Salt Lake City, Utah, United States

Charlottesville, Virginia, United States

Bothell, Washington, United States

La Crosse, Wisconsin, United States

Rousse, , Bulgaria

Sofia, , Bulgaria

Varna, , Bulgaria

Calgary, , Canada

Kelowna, , Canada

Toronto, , Canada

Toronto, , Canada

Whitby, , Canada

Aachen, , Germany

Dresden, , Germany

Hanover, , Germany

München, , Germany

Ulm, , Germany

Budapest, , Hungary

Szeged, , Hungary

Culiacán, , Mexico

Durango, , Mexico

León, , Mexico

Miguel Hidalgo, , Mexico

Monterrey, , Mexico

Bucharest, , Romania

Cluj-Napoca, , Romania

Craiova, , Romania

Iași, , Romania

Gyeonggi-do, , South Korea

Gyeongsang, , South Korea

Incheon, , South Korea

Seoul, , South Korea

Seoul, , South Korea

Seoul, , South Korea

Changhua, , Taiwan

Kaohsiung City, , Taiwan

Taichung, , Taiwan

Taipei, , Taiwan

Taipei, , Taiwan

Donetsk, , Ukraine

Kharkiv, , Ukraine

Kharkiv, , Ukraine

Kyiv, , Ukraine

Kyiv, , Ukraine

Luhansk, , Ukraine

Poltava, , Ukraine

Stepanovka, , Ukraine

Vinnytsia, , Ukraine

Countries

United States; Bulgaria; Canada; Germany; Hungary; Mexico; Romania; South Korea; Taiwan; Ukraine

Other Identifiers

2011-000469-11

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

31-10-274

Identifier Type: -

Identifier Source: org_study_id