Safety Study of Galantamine in Tic Disorders

This study has been terminated.
(Unable to recruit subjects into the trial.)
Sponsor:
Collaborator:
Ortho-McNeil Neurologics, Inc.
Information provided by:
Parkinson's Disease and Movement Disorders Center
ClinicalTrials.gov Identifier:
NCT00226824
First received: September 23, 2005
Last updated: August 21, 2009
Last verified: August 2009

September 23, 2005
August 21, 2009
September 2005
Not Provided
  • Treatment related adverse experience
  • Severity Score of the Yale Global Tic Severity Scale
Same as current
Complete list of historical versions of study NCT00226824 on ClinicalTrials.gov Archive Site
  • Yale-Brown Obsessive-Compulsive Survey
  • Connors Adult Attention Deficit Hyperactivity Rating Scale
  • Hamilton Rating Scale for Depression
  • Hamilton Rating Scale for Anxiety
  • Short Form 36
Same as current
Not Provided
Not Provided
 
Safety Study of Galantamine in Tic Disorders
Pilot Examination of Galantamine in the Management of Tic Disorders

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.

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.

Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Tourette's Syndrome
  • Motor Tic Disorder
  • Vocal Tic Disorder
Drug: galantamine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
1
May 2007
Not Provided

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
Both
18 Years to 50 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00226824
GAL-EMR-4017
Not Provided
Not Provided
Parkinson's Disease and Movement Disorders Center
Ortho-McNeil Neurologics, Inc.
Principal Investigator: Donald S Higgins, M.D. Parkinson's Disease and Movement Disorder Center of Albany Medical Center
Parkinson's Disease and Movement Disorders Center
August 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP