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

Primus Pharmaceuticals

Status and phase: Completed; Phase 4

Conditions: Cognitive Impairment

Treatments: Drug: metaxalone m640; Drug: tizanidine

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT06382662

PMDAC-01

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 20 patients

Sex: All

Ages: 20 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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20 participants in 2 patient groups

metaxalone m640 mg

Active Comparator group

Description:

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

Treatment:

Drug: metaxalone m640

tizanidine 8 mg

Active Comparator group

Description:

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

Treatment:

Drug: tizanidine