Safety Study of Galantamine in Tic Disorders

Tourette's Syndrome Clinical Trial

Official title:

Pilot Examination of Galantamine in the Management of Tic Disorders

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00226824
• Other study ID #: GAL-EMR-4017
• Status: Terminated
• Phase: Phase 4
• First received: September 23, 2005
• Last updated: August 21, 2009
• Start date: September 2005
• Est. completion date: May 2007

Study information

• Verified date: August 2009
• Source: Parkinson's Disease and Movement Disorders Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine the safety, tolerability and efficacy of galantamine in tic disorders. The impact of galantamine on commonly associated behaviors (i.e. attention, obsessions, etc.) will also be examined.

Description:

Modulation of cholinergic activity is a growing focus in neurologic therapeutics especially for dementing disorders such as Alzheimer disease. Treatment with the recently developed cholinesterase inhibitor, galantamine, has demonstrated significant improvement with few issues related to tolerability. In addition to inhibiting the activity of acetylcholinesterase, galantamine also modulates the activity of nicotinic cholinergic receptors by an allosteric mechanism. As a result, galantamine therapy may be beneficial when the response to other agents has been limited.

Cholinesterase inhibitor therapy has been reported to improve motor tics in children with TS refractory to more traditional therapies. Symptoms of co-morbid behavioral disorders, primarily inattention, were also improved. Cholinergic modulation appears a promising avenue for managing tic disorders.

Men and women (18 - 50 years of age) fulfilling DSM IV criteria for the diagnosis of chronic motor tic disorder, chronic vocal tic disorder or Tourette Syndrome and experiencing suboptimal control of tics on current therapy will be enrolled into this open label evaluation of galantamine. A total of 6 visits will be required over 22 weeks. Participants will follow a standard 4 week titration schedule achieving 12 mg bid after 8 weeks. They will maintain at 12 mg bid, or the maximum tolerated dose, for a further 8 weeks and then be withdrawn from therapy. The difference in tic severity prior to and upon completion of therapy will be examined. The impact of treatment upon obsessions/compulsions, attention/concentration, depression, anxiety and quality of life will also be determined.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: May 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• DSM IV criteria for the diagnosis of Tourette's syndrome, chronic motor or chronic vocal tic disorder

• Accepted method of birth control

Exclusion Criteria:

• Preganancy or nursing

• Unstable medical illness

• Unstable psychiatric illness

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Disease
• Motor Tic Disorder
• Tic Disorders
• Tics
• Tourette Syndrome
• Tourette's Syndrome
• Vocal Tic Disorder

Intervention

Drug:
• galantamine

Locations

Country	Name	City	State
United States	Parkinson's Disease and Movement Disorders Center of Albany Medical Center	Albany	New York

Sponsors (2)

Lead Sponsor	Collaborator
Parkinson's Disease and Movement Disorders Center	Ortho-McNeil Neurologics, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (4)

Burt T. Donepezil and related cholinesterase inhibitors as mood and behavioral controlling agents. Curr Psychiatry Rep. 2000 Dec;2(6):473-8. Review. — View Citation

Hayslett RL, Tizabi Y. Effects of donepezil on DOI-induced head twitch response in mice: implications for Tourette syndrome. Pharmacol Biochem Behav. 2003 Dec;76(3-4):409-15. — View Citation

Hoopes SP. Donepezil for Tourette's disorder and ADHD. J Clin Psychopharmacol. 1999 Aug;19(4):381-2. — View Citation

Wilens TE, Biederman J, Wong J, Spencer TJ, Prince JB. Adjunctive donepezil in attention deficit hyperactivity disorder youth: case series. J Child Adolesc Psychopharmacol. 2000 Fall;10(3):217-22. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment related adverse experience
Primary	Severity Score of the Yale Global Tic Severity Scale
Secondary	Yale-Brown Obsessive-Compulsive Survey
Secondary	Connors Adult Attention Deficit Hyperactivity Rating Scale
Secondary	Hamilton Rating Scale for Depression
Secondary	Hamilton Rating Scale for Anxiety
Secondary	Short Form 36