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Muscle Relaxant

Pharmacokinetic and Bioequivalence Comparison of Baclofen and Chlorzoxazone Administered Individually or Concurrently

Phase 1
Waitlist Available
Led By Vikram Shakkottai, MD, PhD
Research Sponsored by University of Texas Southwestern Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pre-dose and 1, 2, 3, 4, 6, 8, 10, 12, 24 hours post-dose
Awards & highlights
All Individual Drugs Already Approved
No Placebo-Only Group

Summary

This trial is testing a combination of two muscle-relaxing drugs, baclofen and chlorzoxazone. It targets patients with spinocerebellar ataxia types 1 and 2. Baclofen and chlorzoxazone both help to relax muscles but work in different ways. Baclofen is used clinically to treat muscle spasticity and has shown promise in addiction medicine, while chlorzoxazone is proposed for treating cerebellar symptoms in spinocerebellar ataxia.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre-dose and 1, 2, 3, 4, 6, 8, 10, 12, 24 hours post-dose
This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-dose and 1, 2, 3, 4, 6, 8, 10, 12, 24 hours post-dose for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Compare the area Under the Plasma Concentration Versus Time Curve (AUC) of baclofen and chlorzoxazone administered separately with baclofen-chlorzoxazone administered concurrently.
Comparison of the maximum measured plasma concentration (Cmax) of baclofen or chlorzoxazone administered separately with baclofen-chlorzoxazone administered concurrently.
Other study objectives
Number of adverse events reported as mild, moderate, or severe

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Group I: Chlorzoxazone 500mg tabletExperimental Treatment1 Intervention
Single oral dose of chlorzoxazone, 500 mg
Group II: Baclofen 20mg tabletExperimental Treatment1 Intervention
Single oral dose of baclofen, 20 mg
Group III: Baclofen 20 mg tablet and chlorzoxazone 500 mg tabletExperimental Treatment1 Intervention
Concurrent doses of baclofen, 20 mg, and chlorzoxazone, 500 mg
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Baclofen
FDA approved
Chlorzoxazone
FDA approved
Chlorzoxazone
FDA approved

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

University of Texas Southwestern Medical CenterLead Sponsor
1,086 Previous Clinical Trials
1,058,643 Total Patients Enrolled
2 Trials studying Pharmacokinetics
36 Patients Enrolled for Pharmacokinetics
Tufts UniversityOTHER
270 Previous Clinical Trials
594,872 Total Patients Enrolled
Vikram Shakkottai, MD, PhDPrincipal InvestigatorUT Southwestern Medical Center
1 Previous Clinical Trials
200 Total Patients Enrolled
~5 spots leftby Dec 2025
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