Ignite Creation Date:
2024-10-25 @ 7:57 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06590662
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-06
Brief Title:
Efficacy and Tolerance of Solriamfetol in Patients Affected with Idiopathic Hypersomnia
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Randomized Double-blind Placebo-controlled Trial Comparing the Efficacy and Tolerance of Solriamfetol in Patients Affected with Idiopathic Hypersomnia
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SOLR-IH
Brief Summary:
This Phase II clinical trial is a monocenter double-blind randomized placebo-controlled study aimed at evaluate the efficacy and safety of solriamfetol from 75 to 300 mg per day in IH patients
Patients will be randomized 11 to receive either solriamfetol or placebo with titration every morning upon awakening during all treatment periods Day 0 to Week 7
Patients will be randomized 11 to receive either solriamfetol or placebo with titration every morning upon awakening during all treatment periods Day 0 to Week 7
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None