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

Healthy Participants Clinical Trial

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"

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06348303
• Other study ID #: PMMD-01
• Status: Recruiting
• Phase: Phase 4
• Start date: March 15, 2024
• Est. completion date: March 15, 2025

Study information

• Verified date: March 2024
• Source: Primus Pharmaceuticals
• Contact: H Green, MD
• Phone: (614) 683-4900
• Email: jsanders[@]clinohioresearch.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: March 15, 2025
• Est. primary completion date: March 15, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Participants
• Sleepiness

Intervention

Drug:
• Metaxalone m640 mg oral tablet
Metaxalone partially micronized 640 mg tablet
• Metaxalone 800 mg oral tablet
Metaxalone non-micronized 800 mg oral tablet

Locations

Country	Name	City	State
United States	ClinOhio Research Institute	Columbus	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Primus Pharmaceuticals	ClinOhio Research Services, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of participants unable to maintain Tandem Stand Position for more than 10 seconds (position 3 of the 4-Stage Balance Test).	Validated 4-Stage Balance Test after completion of an FDA standardized high-fat meal. Place one foot in front of the other, heel touching toes.	Baseline, Visit 2 dosing (Day 1), Visit 3 dosing (Day 8)
Primary	Change from baseline of gait during a stopwatch timed, stand, and walk activity from a seated position along a 30 foot path	Timed Up and Go with Triaxial Accelerometry	Baseline, Visit 2 dosing (Day 1), Visit 3 dosing (Day 8)
Primary	Change from baseline of correct number of steps taken on a fixed 4 inch wide, 9 feet long path	Tandem Walk Test	Baseline, Visit 2 dosing (Day 1), Visit 3 dosing (Day 8)
Secondary	Change from baseline of participants' subjective report of drowsiness on a 10-point scale	Karolinska Sleepiness Scale where 1 = extremely alert and 10 = extremely sleepy, can't keep awake	Baseline, Visit 2 dosing (Day 1), Visit 3 dosing (Day 8)
Secondary	Change from baseline of reaction to stimulus by computer generated visual prompts measured in milliseconds	Reaction Time Test (RTT)	Baseline, Visit 2 dosing (Day 1), Visit 3 dosing (Day 8)
Secondary	Change from baseline of participants' reasoning ability to recognize differences in six (6) computer generated shapes for 30 minutes	Creyos Cognitive Test	Baseline, Visit 2 dosing (Day 1), Visit 3 dosing (Day 8)
Secondary	The number of product related adverse events experienced by participants from Visit 2 through Visit 4	Adverse and Serious Adverse Events	Visit 2 dosing (Day 1, Visit 3 dosing (Day 8), Visit 4 End of Study (Day 15)