Approval Probability
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Adjusted LOA
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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 for the treatment of idiopathic hypersomnia, a neurological disorder characterized by excessive daytime sleepiness despite adequate or prolonged sleep. It is currently in Phase 2 clinical development and has not been approved by regulatory authorities.
Serdexmethylphenidate is being developed by Zevra Therapeutics, Inc., a biopharmaceutical company traded on the Nasdaq under the ticker symbol ZVRA. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with idiopathic hypersomnia.
Serdexmethylphenidate is in Phase 2 clinical development. A Phase 2 clinical trial has been completed, and the drug remains investigational. It has not received FDA approval and is still undergoing clinical evaluation for the treatment of idiopathic hypersomnia.
Serdexmethylphenidate has one completed Phase 2 clinical trial registered under NCT05668754, titled 'Study of SDX in Patients With Idiopathic Hypersomnia (IH)'. This randomized, double-blind, placebo-controlled trial enrolled 66 participants in the United States, with a minimum age of 18 years.
Yes, Serdexmethylphenidate is also known as SDX. The clinical trial NCT05668754 uses the abbreviation SDX in its title, referring to the same investigational drug being developed by Zevra Therapeutics for idiopathic hypersomnia.