Safety and Efficacy of Pyridoxal 5′ -Phosphate in the Treatment of Tardive Dyskinesia

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Brief Title

Safety and Efficacy of Pyridoxal 5' -Phosphate in the Treatment of Tardive Dyskinesia

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

Brief 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.
    

Detailed 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.
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

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. .

Secondary Outcome

 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.

Condition

Tardive Dyskinesia

Intervention

Pyridoxal 5'-Phosphate

Study Arms / Comparison Groups

 Pyridoxal 5'-Phosphate
Description:  Pyridoxal 5'-Phosphate, enteric-coated 2x 250mgs po bid.

Publications

* 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

Drug

Estimated Enrollment

53

Start Date

May 2009

Completion Date

August 2014

Primary Completion Date

August 2012

Eligibility Criteria

        Inclusion Criteria:

          1. Patients must have signed an informed consent document indicating that they understand
             the purpose of the study, its objectives, and the expectations of participation in the
             study and that they agree to participate in the study.

          2. Meet current diagnostic criteria for Schizophrenia (Disorganized [295. 10], Paranoid
             [295.30], or Residual [295.60]), or Schizoaffective Disorder [295.70] as defined by
             the DSM-IV for at least 3 months before screening.

          3. Have been on a stable dose and regime of a LAI for at least 3 injection intervals or
             oral antipsychotic for at least 1 month prior to randomization and are expected to
             remain on this stable dose and regime throughout their participation in the study.

          4. Meet current diagnostic criteria for Neuroleptic Induced Tardive Dyskinesia [333.82]
             as defined by the DSM-IV.

          5. Scoring ≥3 (moderate) on item 8, the "severity of abnormal movements overall" section
             of the AIMS.

          6. Score ≥3 (moderate) on at least one item, or ≥2 (mild) on at least 2 items, and an
             overall total score of ≥5 on items 1 through 7 (facial and oral movements, extremity
             movements and trunk movements) sections of the AIMS.

          7. Female patients must be post-menopausal for at least 2 years or surgically sterile.
             Women of childbearing potential must be using or agree to use a reliable form of
             contraception before entry into and during participation in the study. Reliable
             contraception can include an oral or other hormonal contraceptive started at least 4
             weeks prior to randomization, a barrier method such as condoms or a diaphragm used
             with spermicide, or an intrauterine device (IUD).

          8. Patients must be capable of administering study medication themselves or will have
             assistance with the administration of the study medication consistently available
             throughout the study.

        Exclusion Criteria:

          1. Involuntarily committed to a psychiatric hospital or correctional facility.

          2. A primary active DSM-IV diagnosis or co-morbid Axis 1 diagnosis other than
             schizophrenia or schizoaffective disorder.

          3. PANSS Score > than 120 at the screening visit.

          4. Current medical diagnosis that which could confound the interpretation or evaluation
             of the indication under study (i.e. Parkinson's Disease, Huntington's Chorea, Muscular
             Dystrophy, Tourette's Syndrome).

          5. History of liver cirrhosis, chronic active hepatitis (known positive serum test within
             6 months of enrollment) or severe liver dysfunction, or liver transaminase ≥3 times
             ULN at screening (or obtained within 30 days prior to screening visit)

          6. History of malignancy during the last 5 years.

          7. Pregnant or any woman of childbearing potential who is not using a reliable form of
             contraception (this can include an oral or other hormonal contraceptive started at
             least 4 weeks prior to randomization, a barrier method such as condoms or a diaphragm
             used with spermicide, or an intrauterine device (IUD)). Women who have been
             post-menopausal for at least two years or who have undergone surgical sterilization
             are considered to be not of childbearing potential.

          8. Any medical, such as unstable cardiovascular, respiratory, neurological, renal,
             hepatic, immunological or endocrine, or psychiatric condition which in the opinion of
             the investigator makes the patient an unsuitable candidate for the study.

          9. History of any pre-existing gastrointestinal narrowing or inability to swallow the
             oral study medication whole with the aid of water.

         10. Male and female patients with a BMI of ≥20.

         11. Significant, ongoing alcohol or drug dependency within 3 months before screening as
             defined by the DSM-IV (nicotine will not be exclusionary).

         12. Significant risk of suicide or violent behavior as clinically assessed by the
             investigator.

         13. Participation in any other investigational drug or device study within 30 days of
             randomization.

         14. Patients who have previously participated in this study.
      

Gender

All

Ages

18 Years - 65 Years

Accepts Healthy Volunteers

No

Contacts

Gary J. Remington, MD, PhD, , 

Location Countries

Canada

Location Countries

Canada

Administrative Informations


NCT ID

NCT00917293

Organization ID

08030


Responsible Party

Sponsor

Study Sponsor

Medicure


Study Sponsor

Gary J. Remington, MD, PhD, Principal Investigator, Centre for Addiction and Mental Health


Verification Date

February 2019