Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05668754 | Placebo-Controlled, Double-Blind, Study to Determine the Safety and Efficacy of SDX in Patients With IH | PHASE2 | COMPLETED | 50 | — | — | Dec 28, 2022 | Mar 21, 2024 | Feb 3, 2025 | 41 | United States |
Type and frequency of Treatment-Emergent Adverse Events
Change from baseline in heart rate (beats/minute).
Change from baseline in blood pressure (mmHg).
Clinical significant change from baseline in clinical laboratory tests.
Clinical significant change from baseline in electrocardiogram (ECG).
Change from baseline in Pittsburg Sleep Quality Index Question #6. Sleep quality score ranging from very good (0) to very bad (4).
| 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 (DBWP) |
| Active Comparator | PLACEBO_COMPARATOR | Placebo capsules once in the evening daily (qd pm) or twice per day (bid), for 2 weeks (DBWP) |
| 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...