Safety Study of Galantamine in Tic Disorders

NCT00226824 | Terminated Phase 4

• 1 other identifier: GAL-EMR-4017
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Tourette's disorder; tic

Outcome Measures

Primary Outcomes (2)

• Treatment related adverse experience

• Severity Score of the Yale Global Tic Severity Scale

Secondary Outcomes (5)

• 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

Interventions

galantamine DRUG

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Preganancy or nursing
• Unstable medical illness
• Unstable psychiatric illness

Sponsors & Collaborators

• Parkinson's Disease and Movement Disorders Center: lead
• Ortho-McNeil Neurologics, Inc.: collaborator

Study Sites (1)

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

Albany, New York, 12205, United States

Location

Related Publications (4)

• 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.

  PMID: 10440471 BACKGROUND

• 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.

  PMID: 11052411 BACKGROUND

• 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.

  PMID: 14643839 BACKGROUND

• 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.

  PMID: 11122998 BACKGROUND

MeSH Terms

Conditions

Tourette Syndrome; Tic Disorders; Tics

Interventions

Galantamine

Condition Hierarchy (Ancestors)

Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Neurodevelopmental Disorders; Mental Disorders; Dyskinesias; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Amaryllidaceae Alkaloids; Alkaloids; Heterocyclic Compounds; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Donald S Higgins, M.D.

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 23, 2005
• First Posted: September 27, 2005
• Study Start: September 1, 2005
• Study Completion: May 1, 2007
• Last Updated: August 25, 2009

Record last verified: 2009-08

Locations

US (1)