COMPLETED

Study to Assess Drowsiness, Cognition, Fall Risk After Metaxalone 640 mg and Metaxalone 800 mg

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Healthy Participants

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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 Metaxalone in two (2) stages, one week after the other. A single dose of each Metaxalone dose will be taken one (1) time after a high fat meal which must be eaten within 30 minutes. Every participant will be given written tests to measure drowsiness, reaction time and thinking process and will also be asked to take walking tests to assess fall risk. Participation in this study will last approximately 2-4 weeks.

Official Title

A Prospective, Randomized, Single-blind, Pilot Study to Assess Drowsiness, Cognition, and Fall Risk Following Oral Metaxalone 640 mg (M640) Versus Metaxalone 800 mg in Healthy Subjects"

Quick Facts

Study Start:2024-05-16
Study Completion:2024-10-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT06348303

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:18 Years to 55 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Weigh at least 120 pounds at Screening
  2. * Medically healthy with no clinically significant medical co-morbidities impact endpoints
  1. * Current use of any medications known to affect sleep-wake cycle.
  2. * Known sleep disorder.
  3. * Current use of cimetidine.
  4. * Current use of a monoamine oxidase Inhibitor (MAOI), selective serotonin reuptake inhibitor (SSRI), selective norepinephrine reuptake inhibitor (SNRI), 5- hydroxytryptamine (5-HT) agonist or any drug that has the potential to affect the serotonergic neurotransmitter system (e.g. mirtazapine, trazodone, tramadol).
  5. * Positive urine test for amphetamines, barbiturates, cocaine, opiates, benzodiazepines, or cannabinoids.
  6. * Participants taking skeletal muscle relaxants or sedative hypnotics.
  7. * Participants with gastrointestinal disease affecting absorption.
  8. * Participants with severe hepatic or renal impairment.

Contacts and Locations

Principal Investigator

J Lukban, DO
STUDY_DIRECTOR
Primus Pharmaceuticals, Inc.

Study Locations (Sites)

ClinOhio Research Institute
Columbus, Ohio, 43213
United States

Collaborators and Investigators

Sponsor: Primus Pharmaceuticals

  • J Lukban, DO, STUDY_DIRECTOR, Primus Pharmaceuticals, Inc.

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 Date2024-05-16
Study Completion Date2024-10-30

Study Record Updates

Study Start Date2024-05-16
Study Completion Date2024-10-30

Terms related to this study

Additional Relevant MeSH Terms

  • Healthy Participants