EUCTR2011-000467-27-HUActive, not recruitingNot Applicable
A Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Safety and Efficacy of Flexible-Dose Once-weekly Oral Aripiprazole in Children and Adolescents with Tourette's Disorder - AWARE 272
Otsuka Pharmaceutical Development & Commercialization, Inc.0 sites126 target enrollmentStarted: November 9, 2011Last updated:
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Enrollment
- 126
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •1. The subject is a male or female child or adolescent, 7 to 17 years of age (inclusive) at the time of signing the informed consent/assent.
- •2. The subject meets current DSM-IV-TR diagnostic criteria for Tourette’s Disorder, as confirmed by the K-SADS-PL, including the Diagnostic Supplement 5 (Substance Abuse and Other Diseases, i.e., Tic Disorders).
- •3. The subject has a TTS = 20 on the YGTSS at Screening and Baseline (randomization).
- •4. The subject, a caregiver, and the investigator must all agree that the presenting tic symptoms cause impairment in the subject's normal routines, which include academic achievement, occupational functioning, social activities, and/or relationships.
- •5. Females of childbearing potential (defined by menarche and not having undergone surgical sterilization/hysterectomy) must have a negative pregnancy test, must be practicing acceptable double-barrier methods of contraception (or can confirm abstinence at each scheduled visit), and must not be pregnant or lactating.
- •6. Written informed consent must be obtained from a legally acceptable representative (eg, guardian or caregiver), in accordance with local law and the requirements of the trial center’s institutional review board (IRB) or independent ethics committee (IEC), prior to the initiation of any protocol-required procedures. In addition, the subject, as required by the trial center’s IRB/IEC, must provide informed assent at Screening and as such must be able to understand that he or she can withdraw from the trial at any time.
- •7. The subject and the designated guardian(s) or caregiver(s) are able to comprehend and satisfactorily comply with the protocol requirements, as evaluated by the investigator.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 126
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
Exclusion Criteria
- •1. The subject presents with a clinical presentation and/or history that is consistent with another neurologic condition that may have accompanying abnormal movements.
- •These include, but are not limited to:
- •Transient Tic disorder
- •Huntington's disease
- •Parkinson's disease
- •Sydenham's chorea
- •Wilson's disease
- •Mental retardation
- •Pervasive developmental disorder
- •Traumatic brain injury
- •Restless Legs Syndrome
- •2. The subject has a history of schizophrenia, bipolar disorder, or other psychotic disorder.
- •3. Subjects who receive psychostimulants for the treatment of ADD/ADHD and who have developed and/or had exacerbations of the tic disorder after the initiation of stimulant treatment. (Note that subjects with ADD/ADHD who are treated with psychostimulants and have not developed new tics or a worsening of their current tics can be included if all other enrollment obligations are met).
- •4. The subject currently meets DSM-IV-TR criteria for a primary mood disorder.
- •5. The subject has severe obsessive-compulsive disease (OCD), as evidenced by a Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS) score > 16.
- •6. The subject has taken aripiprazole within 1 month (30 days) of the Screening visit.
- •7. Subjects who received any investigational agent in a clinical trial within 30 days prior to Screening or who were randomized into a clinical trial with Once-weekly aripiprazole at any time.
- •8. The subject has a history of neuroleptic malignant syndrome.
- •9. Sexually active males 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 days following the last dose of study drug, or sexually active females of childbearing potential who will not commit to utilizing 2 of the approved birth control methods or who will not remain abstinent during the trial and for 30 days following the last dose of study drug. Abstinence will be permitted if it is confirmed and documented at every trial visit. If employing birth control, 2 of the following precautions must be used: vasectomy, tubal ligation, vaginal diaphragm, intrauterine device, birth control pill, birth control depot injections, implant, condom or sponge with spermicide.
- •10. Females who are breast-feeding and/or who have a positive serum pregnancy test result prior to receiving trial drug.
- •11. The subject represents a significant risk of committing suicide based on history (suicide attempt in past 1 year), routine psychiatric status examination, investigator’s judgment, or who have an answer of yes” on any question other than 1-3 (current or over the last 30 days) on the Baseline/Screening version of the Columbia-Suicide Severity Rating Scale (C-SSRS).
- •12. Body weight is lower than 16 kg.
- •13. Subjects who have taken neuroleptic or antiparkinson drugs less than 14 days prior to randomization.
- •14. Subjects requiring cognitive-behavioral therapy (CBT) for Tourette’s Disorder during the trial period. CBT for other non-exclusionary disorders must remain consistent throughout the trial.
- •15. The subject has met DSM-IV-TR criteria for any significant psychoactive substance use disorder (abuse, dependence, and/or withdrawal) within the past 3 months.
- •16. A positive drug screen for cocaine, alcohol, or other drugs of abuse (excluding caffeine, nicotine, or prescribed psychostimulants for ADD/ADHD). Investigators can chose to repeat a positive drug screen one time during Screening period af
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