Safety Study of Galantamine in Tic Disorders

NCT ID: NCT00226824

Last Updated: 2009-08-25

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-09-30
• Study Completion Date: 2007-05-31

Brief 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.

Detailed 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 They will maintain at 12 mg bid, or the maximum tolerated dose, for a further 8 weeks and then be withdrawn from therapy.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.

Conditions

Tourette's Syndrome; Motor Tic Disorder; Vocal Tic Disorder

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

galantamine

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ortho-McNeil Neurologics, Inc.

INDUSTRY

Sponsor Role: collaborator

Parkinson's Disease and Movement Disorders Center

OTHER

Sponsor Role: lead

Principal Investigators

Donald S Higgins, M.D.

Role: PRINCIPAL_INVESTIGATOR

Parkinson's Disease and Movement Disorder Center of Albany Medical Center

Locations

Parkinson's Disease and Movement Disorders Center of Albany Medical Center

Albany, New York, United States

Countries

United States

References

Hoopes SP. Donepezil for Tourette's disorder and ADHD. J Clin Psychopharmacol. 1999 Aug;19(4):381-2. doi: 10.1097/00004714-199908000-00019. No abstract available.

Reference Type: BACKGROUND

PMID: 10440471 (View on PubMed)

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. doi: 10.1089/10445460050167322.

Reference Type: BACKGROUND

PMID: 11052411 (View on PubMed)

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. doi: 10.1016/j.pbb.2003.08.015.

Reference Type: BACKGROUND

PMID: 14643839 (View on PubMed)

Burt T. Donepezil and related cholinesterase inhibitors as mood and behavioral controlling agents. Curr Psychiatry Rep. 2000 Dec;2(6):473-8. doi: 10.1007/s11920-000-0005-7.

Reference Type: BACKGROUND

PMID: 11122998 (View on PubMed)

Other Identifiers

GAL-EMR-4017

Identifier Type: -

Identifier Source: org_study_id