Ignite Creation Date:
2024-05-06 @ 8:20 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06348303
Status:
RECRUITING
Last Update Posted:
2024-06-07
First Post:
2024-03-30
Brief Title:
Study to Assess Drowsiness Cognition Fall Risk After Metaxalone 640 mg and Metaxalone 800 mg
Sponsor:
Primus Pharmaceuticals
Organization:
Primus Pharmaceuticals
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 weeks 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
Visit 2 approximately one to two 1 to 2 weeks 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None