Guanfacine in Children With Tic Disorders

checkorphan
Learn more about:
Tourette syndrome
Related Access Program
DEKK-TEC, Inc. – Document Safety for DM-CHOC-PEN in AYA Subjects With Advanced Cancer Eastern Regional Medical Center – Oncology Patients With Gastroparesis DEKK-TEC, Inc. – Document Safety for DM-CHOC-PEN in Pediatric and Adolescent Subjects With Advanced Cancer
Related Clinical Trial
Pilot Trial of Comprehensive Behavioral Intervention for Tics-Enhanced (CBIT-E) Investigating Distress Tolerance in Adults With Tourette Syndrome Open-label MNS for Tourette Syndrome Transcranial Magnetic Stimulation to Augment Behavior Therapy for Tics Internet-based Cognitive Behavioral Therapy for Chronic Tic Disorder and Tourette’s Disorder: a Feasibility Trial Longitudinal Impact of Stressors in Adults With Tourette Syndrome Effects of Lactobacillus Plantarum PS128 in Patients With Tourette’s Syndrome Combined CBIT and rTMS to Improve Tourette’s Syndrome Pimavanserin Treatment in TS Median Nerve Stimulation (MNS) Pilot Extinction Learning in Adults With Tourette Syndrome Observational Database on Deep Brain Stimulation in Tourette Syndrome Influence of Stress and Psychiatric Symptoms on Children With Tourette Syndrome D-cycloserine Augmented Treatment for Youth With Tic Disorders Sensory Symptoms in Tourette Syndrome and Obsessive-Compulsive Disorder Atomoxetine in Patients With Tourette’s Syndrome Deep Brain Stimulation in Forel’s H Field in Tourette’s Syndrome Psychosocial Intervention for Young Children With Chronic Tics Brain Tissue Collection for Neuropathological Studies New Stereotactic Frame System for Neurosurgery Sedation During Microelectrode Recordings Before Deep Brain Stimulation for Movement Disorders. Outcomes Mandate National Integration With Cannabis as Medicine Reliability and Validity of the MINI International Neuropsychiatric Interview for Children and Adolescents (MINI-KID) Brain-Behavior Interactions in Tic Suppression Phase III Study of 5LGr to Treat Tic Disorder Effects of Ondansetron in Obsessive-compulsive and Tic Disorders I-123 Brain Studies of Serotonin Metabolism in Psychiatric Patients and Normal Volunteers Physiological Investigations of Movement Disorders Dissemination of Comprehensive Behavioral Intervention for Tics (CBIT) to Occupational Therapists: A Feasibility Study TicHelper: A Computerized Comprehensive Behavioral Intervention for Tics (CBIT) Safety Study of Galantamine in Tic Disorders Internet-based Coaching for Young Adults With Neuropsychiatric Disorders Modified Comprehensive Behavioral Intervention for Tics (M_CBIT) Incorporating teleCBIT Into a Hospital-Based Tic Program Cognitive Behavior Therapy and Habit Reversal Training for the Treatment of Chronic Tic Disorders in Children An Exploratory Study of Transcranial Magnetic Stimulation (TMS) Based on Functional Magnetic Resonance Imaging (fMRI) in the Treatment of Tic Disorder Brain Stimulation in Movement Disorders Augmentation of Brief Habit Reversal Training With D-cycloserine or Placebo Central Mechanisms in Speech Motor Control Studied With H215O PET Comparison of Keppra and Clonidine in the Treatment of Tics Brain Activation in Vocal and Motor Tics Trial to Demonstrate the Efficacy and Safety of Internet-delivered Behavioral Treatment for Adults With Tic Disorders Assessment of Children With Tic Onset in the Past 6 Months Repetitive Transcranial Magnetic Stimulation to Reduce Tics Guanfacine in Children With Tic Disorders Neuropsychological Functioning Among Children With Tourret’s Disorder and ADHD Investigating Circadian Rhythms in Youth With Persistent Tic Disorders The Role of Probiotics PS128 in Movement Disorders Online Mindfulness-based Tic Reduction (Phase Two) Online Mindfulness-based Tic Reduction Investigation of Neurofeedback With Real-Time fMRI in Healthy Volunteers and Patients With Hyperkinetic Movement Disorders A Handwriting Intervention Program for Children With Tic Disorders Study of Clonidine on Sleep Architecture in Children With Tourette’s Syndrome (TS) and Comorbid ADHD National Gilles De La Tourette Study Group Evaluating the Efficacy and Safety of Yi-Gan San in Children and Adolescents With Tourette’s Disorder Evaluation of a Cognitive Psychophysiological Treatment for Tourette Syndrome and Tic Disorders Magnetic Resonance Spectroscopy to Evaluate Tourette s Syndrome Group Intervention for Children With Chronic Tics Syndrome or Tourette Syndrome: CBIT vs Psycho-Educational Intervention Study of the Neurobiology of Tourette Syndrome and Related Disorders Brain Dynamics Involved in Generating Tics and Controlling Voluntary Movement Dopaminergic Effects on Cortical Function in Tourette’s (Levodopa Protocol) Developmental Phenomenology of Obsessive Compulsive Disorder and Tourette Syndrome in Children and Adolescents Online Remote Behavioural Intervention for Tics (ORBIT) CANNAbinoids in the Treatment of TICS (CANNA-TICS) A Study to Test if TEV-50717 is Effective in Relieving Tics Associated With Tourette Syndrome Internet-delivered Behaviour Therapy for Children and Adolescents With Tourette’s Disorder A Study to Evaluate the Effects of ABX-1431 on Patients With Tourette Syndrome Aripiprazole in the Treatment of Tourette’s Syndrome Aripiprazole in Children and Adolescents With Chronic Tic Disorder or Tourette’s Disorder Phase II Double Blind Placebo Controlled Trial of Risperidone in Tourette Syndrome Phase III Randomized, Double-Blind, Placebo-Controlled Study of Guanfacine for Tourette Syndrome and Attention Deficit Hyperactivity Disorder Randomized Study of Pergolide in Children With Tourette Syndrome Phase II Pilot Controlled Study of Short Vs Longer Term Pimozide (Orap) Therapy in Tourette Syndrome tDCS in Tourette (TIC-TDCS) Anger Control Training for Youth With Tourette Syndrome Safety and Tolerability Study of NBI-98854 for the Treatment of Subjects With Tourette Syndrome Neurofeedback for Tourette Syndrome Brain Stimulation for the Treatment of Tourette Syndrome Study of Tics in Patients With Tourette’s Syndrome and Chronic Motor Tic Disorder Timing of Voluntary Movement in Patients With Tourette Syndrome and Chronic Tic Disorder Repetitive Transcranial Magnetic Stimulation of the Posterior Parietal Cortex in Patients Suffering From Gilles de la Tourette Syndrome Methylphenidate for Treating Children With ADHD and Tourette Syndrome Safety and Tolerability of Once-daily Oral Aripiprazole in Children and Adolescents With Tourette’s Disorder Tourette Syndrome and Seasonality (Stagionalità Tourette) Study Evaluating the Safety and Efficacy of Fixed-dose Once-daily Oral Aripiprazole in Children and Adolescents With Tourette’s Disorder Role of the Sensory Experience in Generating Motor Tics in Tourette Syndrome Effectiveness of Behavior Therapy and Psychosocial Therapy for the Treatment of Tourette Syndrome and Chronic Tic Disorder Proof of Concept Study of an Oral Orthotic to Reduce Tic Severity in Chronic Tic Disorder and Tourette Syndrome Evaluation of Safety and Tolerability of Long-term TEV-50717 (Deutetrabenazine) for Treatment of Tourette Syndrome in Children and Adolescents Multi-site Transcranial Magnetic Stimulation Therapy of the Supplementary Motor Area in Children With Tourette Syndrome Open-Label Safety and Tolerability Study of NBI-98854 for the Treatment of Pediatric Subjects With Tourette Syndrome A Randomized, Placebo-controlled, Tourette Syndrome Study. A Trial of Bilateral Deep Brain Stimulation to the Globus Pallidus Internum in Tourette Syndrome A Study of the Effectiveness and Safety of Tetrabenazine MR in Pediatric Subjects With Tourette’s Syndrome An Open-label Study to Determine the Efficacy and Safety of Topiramate in the Treatment of Tourette Syndrome. Thalamic Deep Brain Stimulation for Tourette Syndrome Exploration of Glutamatergic System With PET Radiotracer in Gilles de la Tourette Patients: Pilot Study (GlutaTour) ABF Tourette’s Disorder Post Marketing Surveillance Study Safety and Efficacy of NBI-98854 in Pediatric Subjects With Tourette Syndrome Brain Activity Associated With Tics in Patients With Tourette Syndrome Safety, Tolerability, and Efficacy of NBI-98854 for the Treatment of Pediatric Subjects With Tourette Syndrome Internet-based Behaviour Therapy for Tourette’s Disorder and Chronic Tic Disorder Pramipexole Pilot Phase II Study in Children and Adolescents With Tourette Disorder According to DSM-IV Criteria Response Inhibition in Tourette Syndrome Alternatives for Reducing Tics in TS: A Study of TEV-50717 (Deutetrabenazine) for the Treatment of Tourette Syndrome in Children and Adolescents. Safety, Pharmacokinetics, and Pharmacodynamics of NBI-98854 in Children and Adolescents With Tourette Syndrome Pallidal Stimulation and Gilles de la Tourette Syndrome Developing New Treatments for Tourette Syndrome: Therapeutic Trials With Modulators of Glutamatergic Neurotransmission Evaluation of the HBDL Coil Transcranial Magnetic Stimulation (TMS) Device – Safety and Feasibility Study for the Treatment of Tourette Syndrome Pilot Study of the Modified Atkins Diet for Tourette Syndrome Trial to Evaluate the Long-term Efficacy of Oral Aripiprazole in the Treatment of Pediatric Subjects With Tourette’s Disorder Efficacy of a Therapeutic Combination of Dronabinol and PEA for Tourette Syndrome Pilot Study for Use of Dysport in Treatment of Vocal Tics in Patients With Tourette’s Syndrome A Study to Examine the Efficacy of a Therapeutic THX-110 for Tourette Syndrome Open Label Trial of Aripiprazole in Children and Adolescents With Tourette’s Disorder Open-label Extension Study of Pramipexole in the Treatment of Children and Adolescents With Tourette Syndrome Study Evaluating The Safety And Efficacy Of PF-03654746 In Adult Subjects With Tourette’s Syndrome Safety & Tolerability Study of Once-weekly Oral Aripiprazole in Children and Adolescents With Tourette’s Disorder Hypersensitivity in Tourette Syndrome Role of Frontal Cortex in the Pathophysiology of Gilles de la Tourette Syndrome (GTS) Efficacy & Safety Study of Once-weekly Oral Aripiprazole in Children and Adolescents With Tourette’s Disorder Efficacy & Safety Study of Once-weekly Oral Aripiprazole in Children and Adolescents With Tourette’s Disorder Safety and Efficacy Study of NBI-98854 in Adults With Tourette Syndrome VoIP Delivered Behavior Therapy for Tourette Syndrome Safety and Efficacy Study of NBI-98854 in Children and Adolescents With Tourette Syndrome Study of ABX-1431 in Adult Patients With Tourette Syndrome or Chronic Motor Tic Disorder Subthalamic Stimulation in Tourette’s Syndrome Study of GABA-A Receptors in the Generation of Tics in Patients With Tourette’s Syndrome Transcranial Magnetic Stimulation (TMS) for Individuals With Tourette’s Syndrome Neural Correlates of Sensory Phenomena in Tourette Syndrome Sensory Symptoms in Tourette Syndrome Tourette Syndrome Deep Brain Stimulation The Safety and Efficacy of Long-term Treatment of PINS Stimulator System for Tourette Syndrome Safety, Tolerability, Pharmacokinetic, and Efficacy Study of AZD5213 in Adolescents With Tourette’s Disorder Aripiprazole Oral Solution in the Treatment of Children and Adolescents With Tourette’s Syndrome Facial Expression Recognition of Emotion and Categorization of Emotional Words in Gilles de la Tourette’s Syndrome Thalamic Deep Brain Stimulation for Tourette Syndrome Rollover Study for Continuing NBI-98854 Administration in Pediatric Subjects With Tourette Syndrome The Effect and Safety of Plum-blossom Needle for Tourette Syndrome Proof-of-Concept Safety Study of CPP-109 (Vigabatrin) for Treatment Refractory Tourette’s Disorder Ecopipam Treatment of Tourette Syndrome High Frequency Stimulation of the GPi or Thalamus in Tourette’s Syndrome Computerized Working Memory Training in Children With ADHD and Comorbid Tourette Syndrome Optimising Anterior Pallidal Deep Brain Stimulation for Tourette’s Syndrome MRI Study of Tic Remission in Tourette Syndrome Thalamic Deep Brain Stimulation for the Treatment of Refractory Tourette Syndrome Selective Microbiota Transplantation for Tourette’s Syndrome Parent Behavioral Training for Disruptive Behaviors in Tourette Syndrome A Pilot Study Of SD-809 (Deutetrabenazine) In Moderate To Severe Tourette Syndrome (TS) Impulsivity in Tourette Syndrome : Behavioral and Neuroimaging Study Developing Cognitive Training for Tourette Syndrome A Trial Evaluating the Efficacy, Safety, and Pharmacokinetics of SNC-102 in Subjects With Tourette Syndrome Safety and Efficacy of Cannabis in Tourette Syndrome Activity in Tourette Syndrome FAAH Inhibitor Trial for Adults With Tourette Syndrome Open-Trial of EPI-743 for Adults With Tourette Syndrome Omega-3 Fatty Acids in Tourette’s Disorder Do Mirror Neurons Play a Role in Tourette Syndrome Physiopathology? A Pilot Study. Apathy in Tourette Syndrome and Changes in Quality of Life Sensory Processing in Tourette Syndrome The Pathophysiology of Tourette Syndrome: a Multimodal Study Behavioral Therapy for Tourette Syndrome Behavioral Therapy for Children and Adolescents With Tourette Syndrome Ecopipam Treatment of Tourette’s Syndrome in Subjects 7-17 Years Transcranial Magnetic Stimulation for Children With Tourette’s Syndrome

Brief Title

Guanfacine in Children With Tic Disorders

Official Title

Guanfacine in Children With Tic Disorders: A Multi-site Study

Brief Summary

      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).

Detailed Description

      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.

Study Phase

Phase 4

Study Type

Interventional

Primary Outcome

Yale Global Tic Severity Scale (YGTSS)

Condition

Tourette Disorder

Intervention

placebo

Study Arms / Comparison Groups

 Inactive placebo
Description:

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Drug

Estimated Enrollment

34

Start Date

April 2012

Completion Date

December 2016

Primary Completion Date

December 2016

Eligibility Criteria

        Inclusion Criteria:

          -  Diagnosis of Tourette Disorder or chronic motor or vocal tic disorder.

          -  Between ages 6 yrs 0 mos and 17 years 0 months.

          -  Weight >/= 15 kg (33 lbs).

          -  Ability to swallow pills whole.

        Exclusion Criteria:

          -  IQ < 80.

          -  Positive pregnancy test.

          -  Positive drug test.

          -  Low blood pressure.

          -  Prior history of hypersensitivity to guanfacine.

          -  Prior failed treatment with an adequate trial of guanfacine in last 2 years.

          -  Concurrent treatment with another psychoactive medication for tics, stimulant
             medication, or Habit Reversal therapy.

          -  Medication for OCD, anxiety or depression will be allowed if dose is stable for 8 wks
             with no planned changes; SSRIs are allowed.

Gender

All

Ages

6 Years - 17 Years

Accepts Healthy Volunteers

No

Contacts

Lawrence D Scahill, MSN, PhD, ,

Location Countries

United States

Location Countries

United States

Administrative Informations

NCT ID

NCT01547000

Organization ID

1004006635

Responsible Party

Sponsor

Study Sponsor

Yale University

Collaborators

 Icahn School of Medicine at Mount Sinai

Study Sponsor

Lawrence D Scahill, MSN, PhD, Study Director, Emory University

Verification Date

August 2021