Primary: To compare the efficacy of aripiprazole with placebo in the suppression of tics in children and adolescents (7-17 years) with a diagnosis of Tourette*s Disorder. The primary efficacy measure is change from Baseline to endpoint (Week 8) on…
ID
Source
Brief title
Condition
- Cognitive and attention disorders and disturbances
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary Endpoint: Change from Baseline to endpoint (Week 8) in YGTSS TTS.
Secondary outcome
Key Secondary Endpoints: Mean CGI-TS Change score at endpoint (change score
obtained from CGI-TS improvement scale assessment)
Background summary
There are a very limited number of medications approved for the treatment of
Tourette*s Disorder, including the typical neuroleptics haloperidol and
pimozide. These medications have been available for decades and exhibit all the
known side-effects of the typical neuroleptic medications. Currently, the
alpha-2 receptor agonist clonidine is the first-line treatment for Tourette*s
Disorder; however, the level of efficacy is limited and the side effect of
sedation is not well tolerated.
See Protocol 31-12-293 Version 2.0 16 October 2012 Section 2.1 Trial Rationale
Study objective
Primary: To compare the efficacy of aripiprazole with placebo in the
suppression of tics in children and adolescents (7-17 years) with a diagnosis
of Tourette*s Disorder. The primary efficacy measure is change from Baseline to
endpoint (Week 8) on the Total Tic score (TTS) of the Yale Global Tic
Severity Scale (YGTSS). The secondary efficacy measure is the Clinical Global
Impressions Scale for Tourette*s Syndrome (CGI-TS).
Secondary: To evaluate the safety and tolerability of aripiprazole Once-daily
treatment with oral tablets in children and adolescents with a diagnosis of
Tourette*s Disorder.
(See Protocol 31-12-293 Version 2.0 16 October 2012 Section 2.3 Trial
Objectives)
Study design
Study 31-12-293 is a Phase 3, multicenter, randomized, double-blind,
placebo-controlled trial designed to assess the safety and efficacy of
fixed-dose oral aripiprazole once-daily tablets in children and adolescents,
7-17 years of age at Screening (the time at which they sign the informed
consent), with Tourette*s Disorder. A total of 126 subjects in 2 weight groups
(low: < 50 kg; high: >= 50 kg) will be randomized to aripiprazole low dose,
aripiprazole high dose, or placebo in a 1:1:1 ratio. The aripiprazole low dose
is 5.0 mg/day for the low-weight group and 10.0 mg/day for the high-weight
group; the aripiprazole high dose is 10.0 mg/day for the low-weight group and
20.0 mg/day for the high-weight group.
For full overview see Protocol 31-12-293 Version 2.0 16 October 2012 Section 3
Trial Design
Study burden and risks
The most common side effects may include headache, nausea, vomiting,
constipation, anxiety, insomnia (problems sleeping), dizziness
(lightheadedness), akathisia (unpleasant sensations of "inner" restlessness
that make you unable to sit still or remain motionless), restlessness. The most
common side effects in pediatric patients may include: vomiting, extrapyramidal
disorder (extreme restlessness, involuntary movements, and uncontrollable
speech), fatigue (feeling tired), increased appetite, insomnia (problems
sleeping), headache, nausea, nasopharyngitis (swelling of nasal passages),
somnolence (sleepiness) and increased weight.
There have been a few reports of high blood sugar in subjects treated with
aripiprazole. Your blood sugar level will be monitored closely.
Inactive ingredients of aripiprazole tablets include lactose. Please discuss
with your trial physician if you think that your child has lactose intolerance
(problem tolerating milk and other dairy products). In clinical trials with
aripiprazole, the incidence of this effect was comparable to placebo.
(Source Risk section of Main Study ICF Version 2.0 Netherlands Template in
English dated 29NOV2012)
Research Boulevard, Rockville 2440
Maryland 20850
US
Research Boulevard, Rockville 2440
Maryland 20850
US
Listed location countries
Age
Inclusion criteria
1. The subject is a male or female child or adolescent, 7-17 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, ie, 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.
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
• Stroke
• 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.;Other criteria see Protocol 31-12-293 Version 2.0 16 October 2012 Section 3.4.3 Exclusion Criteria
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2012-003488-23-NL |
| ClinicalTrials.gov | NCT01727700 |
| CCMO | NL42749.042.12 |