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

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-16

Study Completion Date

2024-10-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Safety and Efficacy of THN102 on Sleepiness in Narcoleptic Patients

NCT02821715

Narcolepsy

COMPLETED PHASE2

Modafinil Versus Amphetamines for the Treatment of Narcolepsy Type 2 and Idiopathic Hypersomnia

NCT03772314

Idiopathic Hypersomnia Narcolepsy Without Cataplexy

COMPLETED PHASE2

Phase IV Trial With Pramipexole to Evaluate Safety and Efficacy in Patients With RLS Associated With Mood Disturbances

NCT00356096

Restless Legs Syndrome Depression

COMPLETED PHASE4

Placebo-Controlled, Double-Blind, Study to Determine the Safety and Efficacy of SDX in Patients With IH

NCT05668754

Idiopathic Hypersomnia

COMPLETED PHASE2

A Study of the Safety and Effectiveness of ADX-N05 in the Treatment of Excessive Daytime Sleepiness

NCT01485770

Narcolepsy

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The Screening-Baseline Visit will include vital signs and urine testing, and a discussion of medications and current medical history. Participants 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.

Visit 2 approximately one to two (1 to 2) week(s) later will be the first dosing day (Arm 1) after eating the high fat meal. The testing from Baseline will be repeated four (4) hours after the medication dose is taken.

Visit 3 approximately one (1) week later will be the second dosing day (Arm 2) after eating the high fat meal. The testing from Baseline will be repeated four (4) hours after the medication dose is taken.

The End of Study safety visit will take place one (1) week after Visit 3 by phone with a discussion of any side effects from the drug, recent medications, and any illness or injury experienced since the previous visit. Participants will be given end of study and discharge instructions.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy Participants

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Each participant will be enrolled to two (2), single dose, study treatment arms in a crossover design. The treatments will occur consecutively with seven (7) days separating days of dosing.

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Single mask of participants. Participants will be prevented from knowing product dose.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Active 640 mg

Metaxalone (M640) 640 mg tablet, a single-dose at visit 2 of 4 visits.

Group Type ACTIVE_COMPARATOR

Metaxalone m640 mg oral tablet

Intervention Type DRUG

Metaxalone partially micronized 640 mg tablet

Active 800 mg

Metaxalone 800 mg tablet, a single-dose at Visit 3 of 4 visits.

Group Type ACTIVE_COMPARATOR

Metaxalone 800 mg oral tablet

Intervention Type DRUG

Metaxalone non-micronized 800 mg oral tablet

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Metaxalone m640 mg oral tablet

Metaxalone partially micronized 640 mg tablet

Intervention Type DRUG

Metaxalone 800 mg oral tablet

Metaxalone non-micronized 800 mg oral tablet

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

m640 Skelaxin

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Weigh at least 120 pounds at Screening
* Medically healthy with no clinically significant medical co-morbidities impact endpoints

Exclusion Criteria

* Current use of any medications known to affect sleep-wake cycle.
* Known sleep disorder.
* Current use of cimetidine.
* 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).
* Positive urine test for amphetamines, barbiturates, cocaine, opiates, benzodiazepines, or cannabinoids.
* Participants taking skeletal muscle relaxants or sedative hypnotics.
* Participants with gastrointestinal disease affecting absorption.
* Participants with severe hepatic or renal impairment.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes