Safety and Tolerability of Once-daily Oral Aripiprazole in Children and Adolescents With Tourette's Disorder
This study is ongoing, but not recruiting participants.
Sponsor:
Otsuka Pharmaceutical Development & Commercialization, Inc.
Information provided by (Responsible Party):
Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier:
NCT01727713
First received: November 12, 2012
Last updated: April 3, 2013
Last verified: April 2013
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Purpose
The goal of the current trial is to determine safety of Once-daily aripiprazole in reducing Total Tic Severity in children and adolescents with Tourette's Disorder.
| Condition | Intervention | Phase |
|---|---|---|
|
Tourette's Disorder Tic Disorder |
Drug: Aripiprazole |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | An Open-Label, Multicenter Study Evaluating the Safety and Tolerability of Once-daily Oral Aripiprazole in Children and Adolescents With Tourette's Disorder |
Resource links provided by NLM:
Genetics Home Reference related topics:
Tourette syndrome
MedlinePlus related topics:
Brain Diseases
Mental Disorders
Movement Disorders
Neurologic Diseases
Tourette Syndrome
Drug Information available for:
Aripiprazole
U.S. FDA Resources
Further study details as provided by Otsuka Pharmaceutical Development & Commercialization, Inc.:
Primary Outcome Measures:
- Number and percentage of subjects with adverse events [ Time Frame: Baseline to Week 52 ] [ Designated as safety issue: Yes ]
- Number and percentage of subjects with clinically significant abnormal laboratory test results, vitals, and ECGs [ Time Frame: Baseline to Week 52 ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Change from Baseline to endpoint on the Total Tic Score (TTS) of the Yale Global Tic Severity Scale(YGTSS) [ Time Frame: Baseline to Week 52 ] [ Designated as safety issue: No ]
- The long-term effect of Once-daily aripiprazole measured by the Gilles de la Tourette Syndrome-Quality of Life Scale (GTS-QOL) [ Time Frame: Baseline to Week 52 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 96 |
| Study Start Date: | January 2013 |
| Estimated Study Completion Date: | October 2014 |
| Estimated Primary Completion Date: | September 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Aripiprazole
Aripiprazole Immediate Release Once-Daily
|
Drug: Aripiprazole
Open Label: Once-Daily formulation of aripiprazole flex dose regimine
Other Name: Abilify
|
Detailed Description:
Tourette's Disorder is a neuropsychiatric condition that is characterized by the appearance of tics that can be simple or complex in nature. A tic is a sudden, rapid, recurrent, non-rhythmic, stereotyped motor movement or vocalization. There are a very limited number of medications approved for the treatment of Tourette's Disorder. The goal of the current trial is to obtain additional efficacy, safety, and tolerability data in a controlled condition of a Once-daily aripiprazole formulation in children and adolescents with Tourette's Disorder. The trial is a 52-week extension to the double-blind trial.
The Once-daily tablet formulation that will be evaluated in this trial represents a daily dosage regimen that is intended to be administered to children and adolescents.
Eligibility| Ages Eligible for Study: | 7 Years to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Completed participation in Trial 31-12-293
- Written ICF obtained from a legally acceptable representative & informed assent at Baseline as applicable by trial center's IRB/IEC
- The subject, designated guardian(s) or caregiver(s) are able to comprehend and satisfactorily comply with the protocol requirements, as evaluated by the investigator
Exclusion Criteria:
- Experienced AEs during the double-blind trial (31-12-293) that would, in the investigator's judgment, preclude further exposure to aripiprazole.
- The subject had protocol violations during the double-blind trial considered major in the judgment of the investigator which would deem the subject a poor candidate for the trial
- A positive drug screen
- Sexually active patients not using 2 approved methods of contraception
- Females breastfeeding or pregnant (positive blood pregnancy test prior to receiving trial drug)
- Risk of committing suicide
- Body weight lower than 16 kg
- Abnormal laboratory test results, vital signs and ECG results
Contacts and Locations More Information
No publications provided
| Responsible Party: | Otsuka Pharmaceutical Development & Commercialization, Inc. |
| ClinicalTrials.gov Identifier: | NCT01727713 History of Changes |
| Other Study ID Numbers: | 31-12-294 |
| Study First Received: | November 12, 2012 |
| Last Updated: | April 3, 2013 |
| Health Authority: | United States: Food and Drug Administration Canada: Health Canada Bulgaria: Ministry of Health Finland: Finnish National Agency for Medicines Germany: Federal Institute for Drugs and Medical Devices Hungary: National Institute of Pharmacy Italy: Ministry of Health Netherlands: Medicines Evaluation Board (MEB) Sweden: Medical Products Agency United Kingdom: Medicines and Healthcare Products Regulatory Agency Poland: Ministry of Health Spain: Spanish Agency of Medicines Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica Mexico: Ministry of Health Peru: Ministry of Health |
Keywords provided by Otsuka Pharmaceutical Development & Commercialization, Inc.:
|
Tourette Syndrome Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Tic Disorders |
Tics Movement Disorders Mental Disorders Aripiprazole |
Additional relevant MeSH terms:
|
Tic Disorders Tics Tourette Syndrome Movement Disorders Central Nervous System Diseases Nervous System Diseases Mental Disorders Diagnosed in Childhood Mental Disorders Dyskinesias Neurologic Manifestations Signs and Symptoms Basal Ganglia Diseases Brain Diseases |
Heredodegenerative Disorders, Nervous System Neurodegenerative Diseases Genetic Diseases, Inborn Aripiprazole Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Psychotropic Drugs |
ClinicalTrials.gov processed this record on June 18, 2013