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Pyridoxine for Tardive Dyskinesia

N/A
Waitlist Available
Led By Lars F Jarskog, MD
Research Sponsored by University of North Carolina, Chapel Hill
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, week 8
Awards & highlights

Study Summary

This trial will test if vitamin B6 can help treat tardive dyskinesia, a condition that causes involuntary muscle movements and for which few treatment options exist.

Eligible Conditions
  • Tardive Dyskinesia
  • Antipsychotics

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 8
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 8 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Mean Difference in AIMS scores
Secondary outcome measures
Mean Difference in Barnes Akathisia Rating Scale Scores
Mean Difference in Simpson Angus Scale Scores

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: PyridoxineActive Control1 Intervention
Pyridoxine will be administered in dosages of 200 mg with a maximum dose of 400 mg.
Group II: PlaceboPlacebo Group1 Intervention
Matching placebos will be administered for each active drug.

Find a Location

Who is running the clinical trial?

University of North Carolina, Chapel HillLead Sponsor
1,508 Previous Clinical Trials
4,191,025 Total Patients Enrolled
Foundation of Hope, North CarolinaOTHER
15 Previous Clinical Trials
535 Total Patients Enrolled
Lars F Jarskog, MDPrincipal InvestigatorUniversity of North Carolina, Chapel Hill

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the enrollment for this investigation currently open?

"The clinical trial is currently seeking participants; this information can be confirmed on clinicaltrials.gov where the study was initially published on December 1st 2017 and subsequently updated most recently on April 12th 2022."

Answered by AI

Are octogenarians accepted into this scientific investigation?

"This medical trial is accepting individuals from 18 to 80 years old. Additionally, there are 11 studies for minors and 29 studies open to seniors over 65."

Answered by AI

Is it possible to be included in this clinical trial?

"Individuals between the ages of 18 and 80, with a diagnosis of tardive dyskinesia, can be considered for this research. Aspiring participants should note that they need to compete against up to 50 other applicants."

Answered by AI

What is the size of the cohort being monitored for this research?

"Affirmative. Clinicaltrials.gov data shows that this clinical trial, initially posted on December 1st 2017, is searching for participants at present. The study seeks to enrol 50 people from a single location."

Answered by AI

Who else is applying?

What state do they live in?
Virginia
How old are they?
18 - 65
What site did they apply to?
University of North Carolina at Chapel Hill
What portion of applicants met pre-screening criteria?
Met criteria
~2 spots leftby Apr 2025