CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 11 enrolled
Drug / intervention
Aripiprazoledrug
Likely dose
Aripiprazole 1.25–5 mg/day initial dose based on weight (25–50 kg: 1.25 mg/day; 50–70 kg: 2.5 mg/day; >70 kg: 5 mg/day), titrated based on YGTSS and CGI-TS responseAI-extracted
Key inclusion· 7
  • ✓Age 7–18 years (inclusive) at informed consent
  • ✓Confirmed diagnosis of Tourette's Disorder or chronic motor tic disorder
  • ✓Failed adequate prior trial of clonidine, guanfacine, or neuroleptic medication
  • ✓Tics causing significant distress or impairment on current treatment
Key exclusion· 12
  • ✕Organic brain disease (e.g., traumatic brain injury residua)
  • ✕Developmental delay (mental retardation as defined by DSM-IV-TR)
  • ✕History of seizure disorder (other than febrile seizure)
  • ✕History of Sydenham's Chorea

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00241176
NCT00241176Phase 4Completed
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Open Label Trial of Aripiprazole in Children and Adolescents With Tourette's Disorder

NYU Langone Health·interventional·Posted Oct 18, 2005·Updated Dec 9, 2016

In Brief

A Phase 4 clinical trial evaluating Aripiprazole for Tourette's Syndrome and Tic Disorders. Completed, enrolled 11 participants across 1 site.

Detailed Summary

The purpose of this study is to determine if Abilify will reduce tics (repetitive, uncontrollable movements or vocalizations) in children and adolescents ages 7-18 with Tourette's Disorder (TD) or a chronic motor tic disorder (either repetitive, uncontrollable movements or vocalizations).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTourette's Syndrome, Tic Disorders
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 18, 2005
Enrollment StartSep 1, 2005
Primary CompletionAug 1, 2008
Study CompletionFeb 1, 2010
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 20.7 years ago

Interventions

Aripiprazoledrug

Baseline Visit 2: Subjects btw 25-50kg start on 1.25mg/day, btw 50-70kg start on 2.5mg/day, greater than 70kg start on 5mg/day Visit 3: Titrated based on YGTSS \& CGI-TS ratings at investigator discretion. Subjects who show evidence of response (reduction in CGI-TS by 1-2 points) may remain on same dose. Subjects who show no response may increase as follows: btw 25-50kg increase to 2.5mg/day, btw 50-70kg increase to 3.75mg/day, greater than 70kg increase to 7.5mg/day Visit 5: Subjects who show no response may increase as follows: btw 25-50kg increase to 3.75mg/day, btw 50-70kg increase to 5mg/day, greater than 70kg increase to 10mg/day Visit 6: Subjects who show no response may be increase as follows: btw 25-50kg increase to 5mg/day, btw 50-70kg increase to 7.5mg/day, greater than 70kg increase to 12.5mg/day Visit 7: Subjects who how no response may be increase as follows: btw 25-50kg increase to 7.5mg/day, btw 50-70kg increase to 10mg/day, greater than 70kg increase to 15mg/day