COMPLETED

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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. There will be ( four (4) visits.

Official Title

Assessment of the Effect of Metaxalone 640 mg (M640) on Truck Driving Ability and Cognition Compared to Tizanidine 8 mg: A Prospective, Single-blind, Within-subject Pilot Study

Quick Facts

Study Start:2024-04-29
Study Completion:2025-03-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT06382662

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:20 Years to 70 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * equal to or greater than 20 years old
  2. * weight at least 120 pounds
  3. * medically healthy
  4. * able to eat a high fat meal
  1. * medications known to affect sleep-wake cycle
  2. * current use of cimetidine
  3. * current use of certain anti-depressants
  4. * current us of certain antibiotics
  5. * positive urine drug test for mind altering medications

Contacts and Locations

Principal Investigator

J C Lukban, DO
STUDY_DIRECTOR
Sponsor GmbH

Study Locations (Sites)

Sun Valley Arthritis Center
Peoria, Arizona, 85381
United States

Collaborators and Investigators

Sponsor: Primus Pharmaceuticals

  • J C Lukban, DO, STUDY_DIRECTOR, Sponsor GmbH

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-04-29
Study Completion Date2025-03-06

Study Record Updates

Study Start Date2024-04-29
Study Completion Date2025-03-06

Terms related to this study

Keywords Provided by Researchers

  • Impaired driving

Additional Relevant MeSH Terms

  • Cognitive Impairment