Assess the Effect of Metaxalone 640 mg (M640) Compared to Tizanidine 8 mg on Truck Driving Ability and Cognition

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-29

Study Completion Date

2025-03-06

Brief Summary

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Every participant will receive active study drug and one (1 )comparator, in two (2) stages, one after the other. Each drug will be taken one (1) time after a high fat meal. Vital signs and discussion of medications, illness or injury are considered safety assessments and will be discussed at every visit. There will be ( four (4) visits.

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Detailed Description

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Every participant will receive active study drug and one (1) comparator in two (2) stages, one after the other. Each drug will be taken one (1) time after a high fat meal. Vital signs and discussion of medications, illness or injury are considered safety assessments and will be discussed at every visit.

The Screening Visit will be followed by the Baseline (Visit 1) 1-14 days later. At the Baseline Visit participants will be given written tests to measure thinking process. You will also be asked to take a computer driving simulation test.

Visits 2 and 3 approximately one (1) week apart will be the dosing days after eating a high fat meal within 30 minutes. The testing from the Baseline Visit will be repeated at four (4) hours and 1.5 hours after dosing with comparator drug.

The End of Study safety visit will take place two (2) weeks later. Participants will be given discharge instructions.

Conditions

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Cognitive Impairment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

This is a prospective, randomized, single-blind, pilot study to assess degree of drowsiness, cognition, and driving risk following a single dose of oral metaxalone 640 mg (M640) compared to tizanidine 8 mg in healthy subjects.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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metaxalone m640 mg

metaxalone micronized 640 mg tablet, single dose at Visit 2 or Visit 3

Group Type ACTIVE_COMPARATOR

metaxalone m640

Intervention Type DRUG

A single dose of micronize metaxalone 640 mg

tizanidine 8 mg

tizanidine 8 mg tablet, single dose at Visit 2 or Visit 3

Group Type ACTIVE_COMPARATOR

tizanidine

Intervention Type DRUG

A single dose of tizanidine 8 mg

Interventions

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metaxalone m640

A single dose of micronize metaxalone 640 mg

Intervention Type DRUG

tizanidine

A single dose of tizanidine 8 mg

Intervention Type DRUG

Other Intervention Names

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Metaxalone 640 Zanaflex

Eligibility Criteria

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Inclusion Criteria

* equal to or greater than 20 years old
* weight at least 120 pounds
* medically healthy
* able to eat a high fat meal

Exclusion Criteria

* medications known to affect sleep-wake cycle
* current use of cimetidine
* current use of certain anti-depressants
* current us of certain antibiotics
* positive urine drug test for mind altering medications

Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes