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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00917293
Other study ID # 08030
Secondary ID
Status Terminated
Phase Phase 2
First received
Last updated
Start date May 2009
Est. completion date August 2014

Study information

Verified date February 2019
Source Medicure
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The primary objective is to assess the safety and effectiveness of Pyridoxal 5'-Phosphate on the reduction of expressed symptoms of tardive dyskinesia in patients with schizophrenia and schizoaffective disorders.


Description:

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.


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Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Pyridoxal 5'-Phosphate
Pyridoxal 5'-Phosphate 500mgs po bid for 12 weeks.
Placebo
Placebo 2 pills, po bid.

Locations

Country Name City State
Canada Centre for Addiction and Mental Health Toronto Ontario
Canada Vancouver Island Health Authority Victoria British Columbia
Canada Windsor Regional Hospital Windsor Ontario
India Schizophrenia Research Foundation (SCARF) Mental Health Centre Chennai TamilNadu

Sponsors (1)

Lead Sponsor Collaborator
Medicure

Countries where clinical trial is conducted

Canada,  India, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. . From baseline through to week 12
Secondary 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. From baseline through to Week 12 and Baseline compared to Week 12
See also
  Status Clinical Trial Phase
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Completed NCT01688037 - NBI-98854 for the Treatment of Tardive Dyskinesia in Subjects With Schizophrenia or Schizoaffective Disorder (KINECT Study) Phase 2
Completed NCT01391390 - Melatonin Treatment for Tardive Dyskinesia in Schizophrenia N/A
Withdrawn NCT03254186 - Safety and Efficacy of Propranolol in the Treatment of Tardive Dyskinesia Phase 2/Phase 3
Completed NCT02291861 - Addressing Involuntary Movements in Tardive Dyskinesia Phase 3
Completed NCT02274558 - A Phase 3 Study of NBI-98854 for the Treatment of Tardive Dyskinesia Phase 3
Completed NCT02198794 - Reducing Involuntary Movements in Participants With Tardive Dyskinesia Phase 3
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Terminated NCT02524886 - Deep Brain Stimulation for Patients With Tardive Dyskinesia and or Dystonia N/A
Completed NCT02195700 - Aim to Reduce Movements in Tardive Dyskinesia Phase 2/Phase 3
Completed NCT02736955 - Rollover Study for Continuing Valbenazine (NBI-98854) Administration for the Treatment of Tardive Dyskinesia Phase 3
Completed NCT03497013 - Effect of tDCS on Cognition, Symptoms in Chronic Schizophrenia Patients With Tardive Dyskinesia N/A
Withdrawn NCT01908452 - Pyridoxal Kinase Activity in Tardive Dyskinesia Phase 3