Tourette Syndrome Clinical Trial
OBJECTIVES:
I. Evaluate the presumed mechanism of action of low dose pergolide to act acutely through
the dopaminergic autoreceptor or postsynaptically at D2 sites in children 7 to 17 with
tourette syndrome (GTS).
II. Compare tolerability and safety of pergolide in these patients to standard neuroleptic
therapy via naturalist assessment after 3-6 months of treatment using matched historical
controls on neuroleptics.
III. Determine efficacy of pergolide for tic control in these patients.
PROTOCOL OUTLINE:
This is a three part study: part I is a randomized, double blind, fixed single dose study;
part II is a randomized, open label, stratified study; and part III is a randomized, double
blind, placebo controlled study.
Part I patients are randomized to receive oral pergolide at one of three dose levels or
placebo for 10 weeks. Part II patients are randomized to receive either low or high dose
pergolide for 4 weeks.
Part III patients are randomized to first receive either pergolide or placebo by oral fixed
doses twice daily followed by flexible clinically adjusted dosing for the next 3 weeks after
a 2-week placebo run-in. Patients then cross over to receive the other treatment after
another 2 weeks of placebo run-in. Total treatment duration is 16 weeks.
Patients are followed at 6 months.
Completion date provided represents the completion date of the grant per OOPD records
;
Allocation: Randomized, Primary Purpose: Treatment
| 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 |
NCT01719523 -
Open-Trial of EPI-743 for Adults With Tourette Syndrome
|
Phase 1 | |
| Completed |
NCT01702077 -
Neurofeedback for Tourette Syndrome
|
N/A | |
| 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 |