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Also known as SDX
Serdexmethylphenidate · 1 trial · 1 indication
Scores level of daytime sleepiness ranging from 0 to 24, with a higher score indicating worsened sleepiness
| Arm | Type | Description |
|---|---|---|
| Experimental: SDX | EXPERIMENTAL | SDX capsules at the optimized daily dose, once in the evening daily (qd pm) or twice per day (bid), for 2 weeks (Double-Blind Withdrawal Period) |
| Placebo Comparator | PLACEBO_COMPARATOR | Placebo capsules once in the evening daily (qd pm) or twice per day (bid), for 2 weeks (Double-Blind Withdrawal Period) |
| Name | Type | Description |
|---|---|---|
| Serdexmethylphenidate | DRUG | Participants randomized to active drug will receive their optimized dose according to a dosing regimen set by randomization at the start of the OLTP. The 4 possible oral SDX doses are 80, 160, 240, or 320 mg/day. The optimal SDX dose will be determined during the 5-week OLTP preceding the 2-week DBWP. |
| Placebo | OTHER | Participants randomized to placebo will receive matching placebo capsules to the optimized dose established at the end of the OLTP, according to a dosing regimen set by randomization at the start of the OLTP. |
Inclusion Criteria: 1. At least 18 years of age at the time of consent 2. Body Mass Index (BMI) ≤35 kg/m2 3. Documented primary diagnosis of IH according to the International Classification of Sleep Disorders (ICSD-3) criteria 4. At the Screening Visit and Baseline Visit (start of OLTP), Epworth Sl...
Serdexmethylphenidate is an investigational small molecule being developed by Zevra Therapeutics, Inc. for idiopathic hypersomnia, a neurological sleep disorder. It is a Phase 2 candidate and has been studied in a completed placebo-controlled trial. It is not approved for any indication.
Serdexmethylphenidate is being studied as a treatment for idiopathic hypersomnia, a condition characterized by excessive daytime sleepiness despite adequate sleep. The Phase 2 trial NCT05668754 evaluated it in adults with this disorder. It remains investigational and is not approved for idiopathic hypersomnia or any other use.
Serdexmethylphenidate targets the dopamine transporter SLC6A3 and the norepinephrine transporter SLC6A2. It acts as an inhibitor of these transporters. By inhibiting SLC6A3 and SLC6A2, it is designed to increase dopamine and norepinephrine signaling in the central nervous system.
Serdexmethylphenidate is being developed by Zevra Therapeutics, Inc., which trades on the Nasdaq under the ticker ZVRA. The company is advancing the candidate for idiopathic hypersomnia. Zevra is the sole developer named for this asset.
Serdexmethylphenidate is in Phase 2 development. The only listed trial, NCT05668754, is a completed Phase 2 study. There are no active trials for this drug. It is investigational and has not been approved by the FDA for any indication.
Serdexmethylphenidate has been studied in one completed clinical trial, NCT05668754, titled Study of SDX in Patients With Idiopathic Hypersomnia (IH). This Phase 2 trial enrolled 66 adults in the United States. It was randomized, double-blind, and placebo-controlled. No active trials are listed.