Tardive DyskinesiaPhase 2NCT00917293
Safety and Efficacy of Pyridoxal 5' -Phosphate in the Treatment of Tardive Dyskinesia
A Phase 2 study testing Pyridoxal 5'-Phosphate in people with Tardive Dyskinesia, run by Medicure at 4 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Tardive Dyskinesia
- What is being tested?
- Pyridoxal 5'-Phosphate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 53 participants
- Where
- 4 sitesin 2 countries
- Study dates
- May 2009to Aug 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- 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.
- 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.
- Meet current diagnostic criteria for Neuroleptic Induced Tardive Dyskinesia [333.82] as defined by the DSM-IV.
- Scoring ≥3 (moderate) on item 8, the "severity of abnormal movements overall" section of the AIMS.
- 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.
- 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).
- 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.
Who cannot join
- Involuntarily committed to a psychiatric hospital or correctional facility.
- A primary active DSM-IV diagnosis or co-morbid Axis 1 diagnosis other than schizophrenia or schizoaffective disorder.
- PANSS Score > than 120 at the screening visit.
- 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).
- 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)
- History of malignancy during the last 5 years.
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- 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.
- 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.
- History of any pre-existing gastrointestinal narrowing or inability to swallow the oral study medication whole with the aid of water.
- Male and female patients with a BMI of ≥20.
- Significant, ongoing alcohol or drug dependency within 3 months before screening as defined by the DSM-IV (nicotine will not be exclusionary).
- Significant risk of suicide or violent behavior as clinically assessed by the investigator.
- Participation in any other investigational drug or device study within 30 days of randomization.
- Patients who have previously participated in this study.
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
Canada3 sites
Centre for Addiction and Mental Health
Toronto, Ontario, M5T 1R8
Vancouver Island Health Authority
Victoria, British Columbia, V8R 4Z3
Windsor Regional Hospital
Windsor, Ontario, N9C 3Z4
India1 site
Schizophrenia Research Foundation (SCARF) Mental Health Centre
Chennai, Tamil Nadu, 600101
About this study
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
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.
Read the 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.
- Conditions
- Tardive Dyskinesia
- Being tested
- Pyridoxal 5'-Phosphate, Placebo
- Keywords
- Tardive Dyskinesia, Schizophrenia, Pyridoxal 5'-phosphate
- Medical subject headings
- Tardive Dyskinesia, Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pyridoxal 5'-PhosphateDrug
Also called Tardoxal
Pyridoxal 5'-Phosphate 500mgs po bid for 12 weeks.
PlaceboDrug
Placebo 2 pills, po bid.
| Study group | Role | What they receive |
|---|---|---|
| Pyridoxal 5'-Phosphate | Experimental | Pyridoxal 5'-Phosphate, enteric-coated 2x 250mgs po bid. Receives: Drug: Pyridoxal 5'-Phosphate |
| Placebo | Placebo comparator | Placebo 2 pills, po bid. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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. .
Measured: From baseline through to week 12
Secondary outcomes (1)
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.
Measured: From baseline through to Week 12 and Baseline compared to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2009 (estimated)
- Study startMay 2009
- Primary completionAug 2012
- Study completionAug 2014
Why it stopped: modified formulation under investigation
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tardive DyskinesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medicure
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gary J. Remington, MD, PhD, Principal investigator, Centre for Addiction and Mental Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00917293
- Sponsor's protocol ID
- 08030
- Status last verified
- Feb 2019
- First submitted
- 8 Jun 2009
- Last updated
- 15 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00917293
- Acronym / sponsor ID
- 08030
- Conditions
- Tardive Dyskinesia
- Keywords
- Tardive Dyskinesia, Schizophrenia, Pyridoxal 5'-phosphate
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: modified formulation under investigation
- Enrolment
- 53 participants (actual)
- Lead sponsor
- MedicureIndustry (pharma, biotech, devices)
- Study start
- May 2009
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 10 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pyridoxal 5'-Phosphate | Experimental | Drug: Pyridoxal 5'-PhosphatePyridoxal 5'-Phosphate, enteric-coated 2x 250mgs po bid. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo 2 pills, po bid. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
- 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.
- 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.
- Meet current diagnostic criteria for Neuroleptic Induced Tardive Dyskinesia [333.82] as defined by the DSM-IV.
- Scoring ≥3 (moderate) on item 8, the "severity of abnormal movements overall" section of the AIMS.
Key exclusion criteria (14 listed)
- Involuntarily committed to a psychiatric hospital or correctional facility.
- A primary active DSM-IV diagnosis or co-morbid Axis 1 diagnosis other than schizophrenia or schizoaffective disorder.
- PANSS Score > than 120 at the screening visit.
- 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).
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pyridoxal 5'-PhosphateAlso: TardoxalPyridoxal 5'-Phosphate 500mgs po bid for 12 weeks. | Drug | Pyridoxal 5'-Phosphate |
| PlaceboPlacebo 2 pills, po bid. | Drug | Placebo |
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. .
Time frame: From baseline through to week 12
1 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.
Time frame: From baseline through to Week 12 and Baseline compared to Week 12
Results and safety
The study was stopped early (reason given: modified formulation under investigation). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gary J. Remington, MD, PhD principal investigator
Centre for Addiction and Mental Health
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pyridoxal 5'-Phosphate in people with Tardive Dyskinesia, run by Medicure at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Canada, India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: modified formulation under investigation). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2019.