Ignite Creation Date:
2024-05-06 @ 6:26 PM
Last Modification Date:
2024-10-26 @ 2:48 PM
Study NCT ID:
NCT05668754
Status:
COMPLETED
Last Update Posted:
2024-01-09
First Post:
2022-12-19
Brief Title:
Placebo-Controlled Double-Blind Study to Determine the Safety and Efficacy of SDX in Patients With IH
Sponsor:
Zevra Therapeutics
Organization:
Zevra Therapeutics
Study Overview
Official Title:
A Phase 2 Placebo-Controlled Double-Blind Randomized Withdrawal Study to Determine the Safety and Efficacy of Oral SDX in Patients With Idiopathic Hypersomnia IH
Status:
COMPLETED
Status Verified Date:
2024-07
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:
This is a study of the safety efficacy and pharmacokinetics PK of Serdexmethylphenidate SDX compared to placebo in subjects with Idiopathic Hypersomnia IH
Detailed Description:
SDX is a prodrug of dexmethylphenidate d-MPH SDX behaves as a prototypical prodrug that is devoid of pharmacological effects until metabolized to active d-MPH Central nervous system CNS stimulants including d-MPH products are being used off-label by patients with IH The potential advantage of SDX-derived d-MPH is its unique PK profile with rising d-MPH plasma concentrations at approximately 3 hours postdose followed by a broad peak from approximately 8 to 12 hours postdose without sharp exposure spikes and a gradual decline after the peak
The optimal dose of SDX will be determined for each participant by titration based on individual tolerability and response during the 5-week SDX-only Open-Label Titration period OLTP after which 23 of the participants will continue to receive SDX and 13 of the participants will receive placebo withdrawal design in the 2-week Double-Blind Withdrawal Period DBWP
The study will evaluate safety primary endpoint efficacy and PK in patients with IH after daily oral administration of SDX either once per day in the evening qd pm or twice per day morning and evening bid The study is expected to inform about the optimal SDX dose range and the best dose regimen nighttime dosing or twice-per-day for further studies in patients with IH and narcolepsy The evening dosing regimen just before bedtime is of interest since there is little or no exposure to d-MPH for the first several hours post-dose and the mean peak d-MPH concentration occurs at 10-12 hours post-dose ie in the morning after a nighttime dose
The optimal dose of SDX will be determined for each participant by titration based on individual tolerability and response during the 5-week SDX-only Open-Label Titration period OLTP after which 23 of the participants will continue to receive SDX and 13 of the participants will receive placebo withdrawal design in the 2-week Double-Blind Withdrawal Period DBWP
The study will evaluate safety primary endpoint efficacy and PK in patients with IH after daily oral administration of SDX either once per day in the evening qd pm or twice per day morning and evening bid The study is expected to inform about the optimal SDX dose range and the best dose regimen nighttime dosing or twice-per-day for further studies in patients with IH and narcolepsy The evening dosing regimen just before bedtime is of interest since there is little or no exposure to d-MPH for the first several hours post-dose and the mean peak d-MPH concentration occurs at 10-12 hours post-dose ie in the morning after a nighttime dose
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?:
None
Is an FDA AA801 Violation?:
None