Tourette Syndrome Clinical Trial
Official title:
Guanfacine in Children With Tic Disorders: A Multi-site Study
The goal of this pilot study is to obtain preliminary information on the tolerability and efficacy of extended release guanfacine (trade name Intuniv) in children with Tourette Disorder (TD, also called Tourette syndrome).
Guanfacine is commonly used for the treatment of tics in children with Tourette Disorder, but neither the immediate release compound nor the new extended release formulation have been evaluated for tics as a primary outcome. This pilot study is not designed to demonstrate efficacy of extended release guanfacine in the treatment of tics in children with TD. Rather, the goal of this trial is to determine whether extended release guanfacine warrants further study in a large scale trial. Immediate-release guanfacine is frequently used in children with TD, but dosing, time to effect and adverse effects with the new extended release guanfacine are unknown. The use of placebo in this trial reduces bias in the measurement of outcomes because it ensures blindness in the parent and clinician ratings. This is a three-site, investigator-initiated, randomized, double-blind, placebo-controlled, parallel-group study. Subjects who show a positive response to extended release guanfacine in the 8-week double-blind phase will continue on the the drug in an 8-week extension phase. Subjects who are randomly assigned to placebo and do not show improvement will be offered 8-weeks of open-label treatment with Intuniv. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT04851678 -
Longitudinal Impact of Stressors in Adults With Tourette Syndrome
|
||
| Completed |
NCT02605902 -
Trial to Demonstrate the Efficacy and Safety of Internet-delivered Behavioral Treatment for Adults With Tic Disorders
|
N/A | |
| Completed |
NCT04007913 -
Incorporating teleCBIT Into a Hospital-Based Tic Program
|
N/A | |
| Completed |
NCT02900144 -
Modified Comprehensive Behavioral Intervention for Tics (M_CBIT)
|
N/A | |
| Completed |
NCT02256475 -
Safety, Pharmacokinetics, and Pharmacodynamics of NBI-98854 in Children and Adolescents With Tourette Syndrome
|
Phase 1 | |
| Completed |
NCT02216474 -
Brain Stimulation in Movement Disorders
|
N/A | |
| Completed |
NCT01329198 -
Brain Stimulation for the Treatment of Tourette Syndrome
|
N/A | |
| Terminated |
NCT00952601 -
Pilot Study of the Modified Atkins Diet for Tourette Syndrome
|
Phase 1 | |
| Enrolling by invitation |
NCT00355927 -
Sedation During Microelectrode Recordings Before Deep Brain Stimulation for Movement Disorders.
|
N/A | |
| Completed |
NCT00206323 -
A Randomized, Placebo-controlled, Tourette Syndrome Study.
|
Phase 3 | |
| Completed |
NCT00004376 -
Phase III Randomized, Double-Blind, Placebo-Controlled Study of Guanfacine for Tourette Syndrome and Attention Deficit Hyperactivity Disorder
|
Phase 3 | |
| Completed |
NCT04498364 -
Extinction Learning in Adults With Tourette Syndrome
|
N/A | |
| Completed |
NCT00755339 -
Role of the Sensory Experience in Generating Motor Tics in Tourette Syndrome
|
||
| Completed |
NCT03325010 -
Safety, Tolerability, and Efficacy of NBI-98854 for the Treatment of Pediatric Subjects With Tourette Syndrome
|
Phase 2 | |
| Not yet recruiting |
NCT06081348 -
Sertraline vs. Placebo in the Treatment of Anxiety in Children and AdoLescents With NeurodevelopMental Disorders
|
Phase 2 | |
| Completed |
NCT01702077 -
Neurofeedback for Tourette Syndrome
|
N/A | |
| Completed |
NCT01719523 -
Open-Trial of EPI-743 for Adults With Tourette Syndrome
|
Phase 1 | |
| Completed |
NCT00231985 -
Effectiveness of Behavior Therapy and Psychosocial Therapy for the Treatment of Tourette Syndrome and Chronic Tic Disorder
|
Phase 2 | |
| Completed |
NCT00206336 -
An Open-label Study to Determine the Efficacy and Safety of Topiramate in the Treatment of Tourette Syndrome.
|
Phase 3 | |
| Terminated |
NCT03732534 -
Rollover Study for Continuing NBI-98854 Administration in Pediatric Subjects With Tourette Syndrome
|
Phase 2 |