Clinical trial NCT06348303: Study to Assess Drowsiness, Cognition, Fall Risk After Metaxalone 640 mg and Metaxalone 800 mg
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"
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Healthy Participants
Lead sponsor: Primus Pharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: ClinOhio Research Services, LLC
First posted: 2024-04-04
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 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 purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of participants unable to maintain Tandem Stand Position for more than 10 seconds (position 3 of the 4-Stage Balance Test).
timeFrame: Baseline, Visit 2 dosing (Day 1), Visit 3 dosing (Day 8)
measure: Change from baseline of gait during a stopwatch timed, stand, and walk activity from a seated position along a 30 foot path
timeFrame: Baseline, Visit 2 dosing (Day 1), Visit 3 dosing (Day 8)
measure: Change from baseline of correct number of steps taken on a fixed 4 inch wide, 9 feet long path
timeFrame: Baseline, Visit 2 dosing (Day 1), Visit 3 dosing (Day 8)
Secondary outcomes:
measure: Change from baseline of participants' subjective report of drowsiness on a 10-point scale
timeFrame: Baseline, Visit 2 dosing (Day 1), Visit 3 dosing (Day 8)
measure: Change from baseline of reaction to stimulus by computer generated visual prompts measured in milliseconds
timeFrame: Baseline, Visit 2 dosing (Day 1), Visit 3 dosing (Day 8)
measure: Change from baseline of participants' reasoning ability to recognize differences in six (6) computer generated shapes for 30 minutes
timeFrame: Baseline, Visit 2 dosing (Day 1), Visit 3 dosing (Day 8)
measure: The number of product related adverse events experienced by participants from Visit 2 through Visit 4
timeFrame: Visit 2 dosing (Day 1, Visit 3 dosing (Day 8), Visit 4 End of Study (Day 15)
Other outcomes:
Locations:
city: Columbus
country: United States
facility: ClinOhio Research Institute
state: Ohio
Study officials:
affiliation: Primus Pharmaceuticals, Inc.
name: J Lukban, DO
role: STUDY_DIRECTOR
References: