Safety and Efficacy of Pyridoxal 5' -Phosphate in the Treatment of Tardive Dyskinesia
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00917293|
Recruitment Status : Terminated (modified formulation under investigation)
First Posted : June 10, 2009
Last Update Posted : February 15, 2019
|Condition or disease||Intervention/treatment||Phase|
|Tardive Dyskinesia||Drug: Pyridoxal 5'-Phosphate Drug: Placebo||Phase 2|
This study will assess the effect of Pyridoxal 5'-Phosphate on the reduction of expressed symptoms of moderate to severe tardive dyskinesia in patients with schizophrenia and schizoaffective disorders who are on a stable dose, and regime, of either a long acting (i.e. depot/IM) or oral antipsychotic medication, as compared to placebo.
Symptoms will be assessed through the administration and scoring of Abnormal Involuntary Movement Scale (AIMS), specifically on items 1 through 7 (facial and oral movements, extremity movements and trunk movements) at each visit.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||53 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Randomized, Double-Blind, Placebo-Controlled, Comparative Study to Evaluate the Safety and Efficacy of Pyridoxal 5' -Phosphate in the Treatment of Tardive Dyskinesia in Patients With Schizophrenia and Schizoaffective Disorders|
|Study Start Date :||May 2009|
|Actual Primary Completion Date :||August 2012|
|Actual Study Completion Date :||August 2014|
Experimental: Pyridoxal 5'-Phosphate
Pyridoxal 5'-Phosphate, enteric-coated 2x 250mgs po bid.
Drug: Pyridoxal 5'-Phosphate
Pyridoxal 5'-Phosphate 500mgs po bid for 12 weeks.
Other Name: Tardoxal
Placebo Comparator: Placebo
Placebo 2 pills, po bid.
Placebo 2 pills, po bid.
- The primary outcome measure will be a reduction in the total AIMS score for items 1 through 7 (facial and oral movements, extremity movements and trunk movements) across treatment groups. . [ Time Frame: From baseline through to week 12 ]
- An AIMS score reduction (items 1-7) across arms over course of study amongst completers; determine whether the proportion of responders differs between treatment arms; a reduction in the AIMS score, items 1 - 7 total, across treatment arms. [ Time Frame: From baseline through to Week 12 and Baseline compared to Week 12 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00917293
|Canada, British Columbia|
|Vancouver Island Health Authority|
|Victoria, British Columbia, Canada, V8R 4Z3|
|Centre for Addiction and Mental Health|
|Toronto, Ontario, Canada, M5T 1R8|
|Windsor Regional Hospital|
|Windsor, Ontario, Canada, N9C 3Z4|
|Schizophrenia Research Foundation (SCARF) Mental Health Centre|
|Chennai, TamilNadu, India, 600101|
|Principal Investigator:||Gary J. Remington, MD, PhD||Centre for Addiction and Mental Health|