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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05631626 | Phase 3 Efficacy and Safety Study in Adults With ADHD Using CTx-1301. | PHASE3 | COMPLETED | 21 | — | — | Dec 29, 2022 | Jun 13, 2023 | Aug 14, 2025 | 1 | United States |
The Permanent Product Measure of Performance (PERMP) is an objective, validated, skill-adjusted math test that measures attention in ADHD. The PERMP total score comprises the sum number of math problems attempted and the number of math problems answered correctly. A higher PERMP score indicates lower impairment.
| Arm | Type | Description |
|---|---|---|
| 25mg CTx-1301 (Dexmethylphenidate tablet) | ACTIVE_COMPARATOR | All subjects will be titrated to their optimal dose during the dose-optimization phase. The starting dose for all subjects at Day 0 is 25mg. Each subject is expected to be on their optimal dose for 2 sequential weeks prior to the randomization phase. Subjects will be randomized (1:1) to their optimal dose or placebo in the 7-day, double-blind, randomization phase. |
| 37.5mg CTx-1301 (Dexmethylphenidate tablet) | ACTIVE_COMPARATOR | All subjects will be titrated to their optimal dose during the dose-optimization phase. Possible doses are 25mg, 37.5mg, or 50mg . Each subject is expected to be on their optimal dose for 2 sequential weeks prior to the randomization phase. Subjects will be randomized (1:1) to their optimal dose or placebo in the 7-day, double-blind, randomization phase. |
| 50mg CTx-1301 (Dexmethylphenidate tablet) | ACTIVE_COMPARATOR | All subjects will be titrated to their optimal dose during the dose-optimization phase. Possible doses are 25mg, 37.5mg, or 50mg . Each subject is expected to be on their optimal dose for 2 sequential weeks prior to the randomization phase. Subjects will be randomized (1:1) to their optimal dose or placebo in the 7-day, double-blind, randomization phase. |
| Placebo | PLACEBO_COMPARATOR | Subjects will be randomized (1:1) to their optimal dose or placebo in the 7-day, double-blind, randomization phase. |
| Name | Type | Description |
|---|---|---|
| CTx-1301 - Dexmethylphenidate 25mg | DRUG | 25mg CTx-1301 (Dexmethylphenidate tablet) |
| CTx-1301 - Dexmethylphenidate 37.5mg | DRUG | 37.5mg CTx-1301 (Dexmethylphenidate tablet) |
| CTx-1301 - Dexmethylphenidate 50mg | DRUG | 50mg CTx-1301 (Dexmethylphenidate tablet) |
| Placebo | DRUG | Placebo |
Inclusion Criteria: 1. Male or female subjects between 18 and 55 years of age (inclusive) at the time of consent. 2. Subject must have a body mass index (BMI) ≥18.5 and ≤40. 3. Subject is unsatisfied with his/her current pharmacological therapy for treatment of ADHD or not currently receiving pharm...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Supernus Pharmaceuticals, Inc. | SUPN | 1 | PHASE3 | SPN-812 |