Treatment of Tardive Dyskinesia With Galantamine

Learn more about:
Related Clinical Trial
A Dose-escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetic of LPM3770164 in Healthy Subjects Reduction of Demoralization After Treatment of TD With Valbenazine Efficacy Study of Panax Ginseng to Boost Antipsychotics Effects in Schizophrenia The Potential for Clinical Dependence and Withdrawal Symptoms Associated With Valbenazine Dysport for the Treatment of OMD Validation of the Implantation of a New Electrode for the Treatment of Dystonia Smoking Cessation With Varenicline in Schizophrenia: Antipsychotic-Induced Neurological Symptoms as Correlates Safety and Tolerability Study of NBI-98854 for the Treatment of Tardive Dyskinesia Randomized Controlled Trial of Pyridoxine for Tardive Dyskinesia D-Serine Treatment For Tardive Dyskinesia Deep Brain Stimulation for Patients With Tardive Dyskinesia and or Dystonia Persistence of Effect and Safety of Valbenazine for the Treatment of Tardive Dyskinesia Levetiracetam Treatment of Tardive Dyskinesia The Assessment of Movement Disorders Utilizing Live Two-Way Video Real‐World Evaluation Screening Study and Registry of Dyskinesia in Patients Taking Antipsychotic Agents Xenazine in Late Dyskinetic Syndrome With Neuroleptics Safety and Efficacy of Propranolol in the Treatment of Tardive Dyskinesia Effect of tDCS on Cognition, Symptoms in Chronic Schizophrenia Patients With Tardive Dyskinesia Melatonin Treatment for Tardive Dyskinesia in Schizophrenia Extract of Ginkgo Biloba and Tardive Dyskinesia Aim to Reduce Movements in Tardive Dyskinesia Reducing Involuntary Movements in Tardive Dyskinesia A Phase 3 Study of NBI-98854 for the Treatment of Tardive Dyskinesia NBI-98854 Dose Titration Study for the Treatment of Tardive Dyskinesia Pyridoxal Kinase Activity in Tardive Dyskinesia Rollover Study for Continuing Valbenazine (NBI-98854) Administration for the Treatment of Tardive Dyskinesia NBI-98854 for the Treatment of Tardive Dyskinesia in Subjects With Schizophrenia or Schizoaffective Disorder (KINECT Study) NBI-98854 for the Treatment of Tardive Dyskinesia in Subjects With Schizophrenia or Schizoaffective Disorder Repetitive Transcranial Magnetic Stimulation for the Treatment of the Tardive Dyskinesia. Efficacy and Safety of NBI-98854 in Subjects With Tardive Dyskinesia Efficacy and Safety of MT-5199 in Subjects With Tardive Dyskinesia Piracetam for Treatment Tardive Dyskinesia Treatment of Tardive Dyskinesia With Galantamine Tardive Dyskinesia and Cognitive Function Safety and Efficacy of Pyridoxal 5′ -Phosphate in the Treatment of Tardive Dyskinesia Addressing Involuntary Movements in Tardive Dyskinesia Efficacy of Docosahexaenoic Acid on Tardive Dyskinesia

Brief Title

Treatment of Tardive Dyskinesia With Galantamine

Official Title

Treatment of Tardive Dyskinesia With Galantamine

Brief Summary

      Tardive dyskinesia (TD), a form of movement disorder, remains a problem for some patients who
      received antipsychotic medications. Increasing evidence suggests that TD may result from
      antipsychotic-induced dysfunction in striatal cholinergic neurons. To test whether
      cholinesterase inhibitors compensate for diminished cholinergic activity underlying TD, we
      conducted a 30-week randomized, double-blind, placebo-controlled crossover study of
      galantamine in 36 patients with TD.

Detailed Description

      BACKGROUND: Tardive dyskinesia (TD) is an infrequent but important complication of treatment
      with antipsychotic medications. Although newer antipsychotics may be less likely to cause TD,
      it still occurs among some mentally ill patients previously treated with typical
      antipsychotics. Although usually mild, TD may be more troublesome in some patients. There is
      no proven curative or suppressive treatment that is effective in all patients. Suppressive
      treatment with cholinergic agents derives from a hypothesized balance between dopaminergic
      and cholinergic neurotransmission in the extrapyramidal system. Although previous trials of
      cholinergic precursors have been unsuccessful in treating TD, their effect on central
      cholinergic neurotransmission remains uncertain in view of evidence of damage to striatal
      cholinergic neurons in patients with TD. In contrast, the recent development of
      cholinesterase inhibitors that are effective in modifying the central cholinergic deficit in
      Alzheimer's disease, prompted us to investigate the therapeutic effect of galantamine in
      patients with TD.

      RESEARCH OBJECTIVES: We propose to complete a randomized, double-blind, placebo-controlled
      crossover trial in 36 patients to test; (1) whether galantamine is pharmacologically active
      in suppressing TD; (2) whether doses of 8-24 mg/day are sufficient for improvement; (3)
      whether there are any significant side effects in these patients.

      METHODS: Thirty-six patients with abnormal involuntary movements meeting research criteria
      for TD, who are on stable doses of psychotropic medications, will be randomized to receive
      galantamine alternating with placebo in addition to their standard medications. After 2
      baseline measurements, each patient will undergo 12-week treatment periods of galantamine and
      placebo with a 4-week washout period between treatments. Patients will be evaluated every 2
      weeks throughout the study, using standardized rating scales for TD (AIMS) and other
      extrapyramidal side effects (SIMPSON, BARNES. During the active treatment period, patients
      will receive galantamine 4 mg BID for 4 weeks followed by 8 mg BID for 4 weeks, and 12 mg BID
      for an additional 4 weeks. Placebo-galantamine differences will be examined by repeated
      measures analysis of covariance for a two-period crossover design.

Study Phase

Phase 4

Study Type


Primary Outcome

Change in Abnormal Involuntary Movement scale at 3 months.

Secondary Outcome

 Change in Simpson-Angus and Barnes Akathisia scales at 3 moths.


Tardive Dyskinesia




* 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


Estimated Enrollment


Start Date

January 2002

Completion Date

October 2004

Eligibility Criteria

        Inclusion Criteria:

          -  Clinical diagnosis of tardive dyskinesia lasting at least 3 months

          -  Treatment with antipsychotic drugs at least for 3 months

          -  18 years old or older

        Exclusion Criteria:

          -  Significant active medical illness

          -  Allergy to galantamine

          -  Pregnancy

          -  Drug or alcohol dependence

          -  Necessary use of anticholinergics or vitamin E




18 Years - 0 Years

Accepts Healthy Volunteers



Stanley N Caroff, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations



Organization ID


Secondary IDs


Study Sponsor

Caroff, Stanley N., M.D.


 Ortho-McNeil Neurologics, Inc.

Study Sponsor

Stanley N Caroff, MD, Principal Investigator, Corporal Michael J. Crescenz VA Medical Center

Verification Date

September 2005