Open-Label Safety and Tolerability Study of NBI-98854 for the Treatment of Pediatric Subjects With...
Tourette SyndromeThis is a Phase 2b, multicenter, open-label study to evaluate the safety and tolerability of optimized doses of NBI-98854 administered once daily for 24 weeks in pediatric subjects with Tourette Syndrome.
Developing New Treatments for Tourette Syndrome: Therapeutic Trials With Modulators of Glutamatergic...
Tourette SyndromeA joint NIH -Tourette Syndrome Association Conference has emphasized the critical need for the testing and development of new pharmacotherapy for tic suppression in Tourette syndrome (TS). This submission is a safety, tolerability and efficacy pilot study using two medications that modulate glutamate neurotransmission, riluzole, a glutamate antagonist, and D-serine, a glutamate agonist. Glutamate is the primary excitatory neurotransmitter in the central nervous system, an essential component of pathways implicated in TS and an extensive modulator of dopamine, the major neurotransmitter associated with tics. This is a single site, short-term, proof of concept study of riluzole and D-serine for the treatment of tics. Each medication will be evaluated and compared to placebo as part of a double-blind, randomized, parallel, flexible dose, three-arm, 8-week, treatment protocol (D-serine, riluzole, or placebo). A total of sixty patients (age 8-17 years) with TS and moderate to moderately-severe tics will receive study medication according to a 2:1 (dopamine modulating drug: placebo), randomized schedule, i.e., riluzole (n=24), D-serine (n=24), placebo (n=12). The primary outcome measure is tic suppression as determined by changes in the Total Tic Subscore of the Yale Global Tic Severity Scale (YGTSS). Secondary tic outcome measures include changes in the YGTSS Total Score and two Global Impression Scales. Further, since both riluzole and D-serine have been proposed as treatments for obsessive-compulsive behaviors, a TS co-morbidity, these symptoms will be followed. Safety measures include serial physical examinations, vital signs, laboratory studies (comprehensive metabolic panel, complete blood count, plasma amino acids, and urine analyses), documentation of side effects and adverse events, and measurement of changes in ADHD, depression and anxiety. This pilot investigation will provide important proof-of-concept data on glutamate therapies for TS and, in turn, evidence for large-scale, multi-center clinical trials.
Pallidal Stimulation and Gilles de la Tourette Syndrome
Gilles de la Tourette SyndromeThe aim of this study is to evaluate the efficacy and safety of bilateral pallidal stimulation in patients with a severe form of Gilles de la Tourette syndrome.
Effectiveness of Behavior Therapy and Psychosocial Therapy for the Treatment of Tourette Syndrome...
Tourette SyndromeTic DisordersThis study will compare the efficacy of supportive therapy versus habit-reversal therapy for the treatment of Tourette syndrome and chronic tic disorder.
Cognitive Behavior Therapy and Habit Reversal Training for the Treatment of Chronic Tic Disorders...
Tourette SyndromeTic DisordersThis study will determine the effectiveness of cognitive behavior therapy (CBT) with habit reversal training (HRT) in treating chronic tic disorders (CTDs) in children and adolescents.
Thalamic Deep Brain Stimulation for Tourette Syndrome
Tourette SyndromeThe purpose of this study is to determine whether deep brain stimulation is effective at reducing tic frequency and severity in adults with Tourette syndrome.
High Frequency Stimulation of the GPi or Thalamus in Tourette's Syndrome
Tourette's SyndromeTourette's syndrome is a disabling neuropsychiatric disorder with major psychosocial consequences in some patients. The pathophysiology is still unknown. Some data suggest an dysfunction of limbic circuits in basal ganglia. The aim of this study is to evaluate the effect of high frequency stimulation of the internal part of the globus pallidus and/or parafascicular-median centre of the thalamus, two structures implicated in the limbic circuit, in patients with severe Tourette's syndrome.
Randomized Study of Pergolide in Children With Tourette Syndrome
Tourette SyndromeOBJECTIVES: 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.
Alternatives for Reducing Tics in Tourette Syndrome (TS): A Study of TEV-50717 (Deutetrabenazine)...
Tourette SyndromeThis is a study to evaluate the efficacy and safety of deutetrabenazine (TEV-50717) tablets for the reduction of motor and phonic tics associated with TS in children and adolescents 6 through 16 years of age.
Study of ABX-1431 in Adult Patients With Tourette Syndrome or Chronic Motor Tic Disorder
Tourette SyndromeMotor Tic DisorderTwo-part study consisting of a double-blind, randomized, placebo-controlled, study at two target dose levels (Part 1) and an open-label, non-randomized study (Part 2) to determine the efficacy of ABX-1431 in treating adult patients with Tourette syndrome or Chronic Motor Tic Disorder as measured by the change from baseline in Total Tic Score of the Yale Global Tic Severity Scale (YGTSS-TTS) compared with placebo.