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Muscle Relaxant

Baclofen 20mg tablet and Chlorzoxazone 500 mg tablet for Pharmacokinetics

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

No current or past history of significant medical or psychiatric disease

Ambulatory

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

Study Summary

This trial is investigating whether baclofen and chlorzoxazone, when given together, are more effective than either drug given alone for spinocerebellar ataxia types 1 and 2. The trial will also evaluate the pharmacokinetic properties of the two drugs and assess any adverse events attributed to them.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ pre-dose and 1, 2, 3, 4, 6, 8, 10, 12, 24 hours post-dose

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

Number of adverse events reported as mild, moderate, or severe

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

0 / 6Eligibility criteria met

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

1,047 Previous Clinical Trials

1,053,780 Total Patients Enrolled

2 Trials studying Pharmacokinetics

36 Patients Enrolled for Pharmacokinetics

Tufts UniversityOTHER

263 Previous Clinical Trials

661,755 Total Patients Enrolled

Vikram Shakkottai, MD, PhDPrincipal InvestigatorUT Southwestern Medical Center

1 Previous Clinical Trials

200 Total Patients Enrolled

Frequently Asked Questions

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

Has the FDA cleared Baclofen 20mg tablet and Chlorzoxazone 500 mg tablet for use?

"This medication, which is currently in Phase 1 testing, has received a score of 1 for safety. This is due to the lack of extensive data supporting both its efficacy and safety."

Answered by AI

For which patients is this research project intended?

"Up to 15 patients that match the following profile can join this trial: Between 18-50 years old, currently have pharmacokinetics, healthy male or female, non-smoker without significant medical or mental health history, not regularly taking prescription medication."

Answered by AI

Does this research project have an age limit for participants?

"According to the inclusion criteria, only patients aged 18-50 can enroll in this clinical trial. There are 3 other studies for children under the age of 18 and 31 trials for seniors above 65 years old."

Answered by AI

Are people with the condition being sought out for this research project?

"That is correct, the clinicaltrials.gov website has information indicating that this study is presently looking for patients. This trial was initially posted on 4/27/2022 and was most recently updated on 4/27/2022. A total of 15 patients will be admitted at 1 location."

Answered by AI

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