Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as CTx-1301-Dexmethylphenidate
CTx-1301- Dexmethylphenidate · 2 trials · 6 indications
The Attention Deficit Hyperactivity Disorder Rating Scale Version 5 (ADHD-RS-5) overall scores range from 0-54; an improvement from Baseline is defined as a decrease in the overall score.
The Permanent Product Measure of Performance-Correct (PERMP-C) is an objective, validated, skill-adjusted 10-minute math test that measures attention and accuracy in ADHD. Performance is measured by the number of math problems answered correctly. The minimum possible score is 0. The highest possible score is 400, with higher scores mean higher performance and less severe ADHD symptoms.
| Arm | Type | Description |
|---|---|---|
| 18.75 mg CTx-1301 (dexmethylphenidate tablet) | ACTIVE_COMPARATOR | Subjects who are randomized to active drug (18.75 mg of CTx-1301) will be titrated (increased) weekly up to their assigned fixed dose. The starting dose at Day 0 is 12.5 mg; at week 1 they will be increased to their assigned dose of 18.75 mg. Subjects will remain on this assigned fixed dose for the remainder of the randomized study period. |
| 25 mg CTx-1301 (dexmethylphenidate tablet) | ACTIVE_COMPARATOR | Subjects who are randomized to active drug (25 mg of CTx-1301) will be titrated (increased) weekly up to their assigned fixed dose. The starting dose at Day 0 is 12.5 mg; at week 1 they will be increased to 18.75 mg; at week 2 they will be increased to their assigned dose of 25 mg. Subjects will remain on this assigned fixed dose for the remainder of the randomized study period. |
| 37.5 mg CTx-1301 (dexmethylphenidate tablet) | ACTIVE_COMPARATOR | Subjects who are randomized to active drug (37.5 mg of CTx-1301) will be titrated (increased) weekly up to their assigned fixed dose. The starting dose at Day 0 is 12.5 mg; at week 1 they will be increased to 18.75 mg; at week 2 they will be increased to 25 mg; at week 3 they will be increased to their assigned dose of 37.5 mg. Subjects will remain on this assigned fixed dose for the remainder of the randomized study period. |
| Placebo | PLACEBO_COMPARATOR | Subjects randomized to placebo will be on placebo for the full 5 weeks of the study. |
| 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. |
| Name | Type | Description |
|---|---|---|
| CTx-1301-Dexmethylphenidate 12.5 mg (titration only) | DRUG | Subjects will be randomized at Visit 2 to CTx-1301 to 12.5mg |
| CTx-1301-Dexmethylphenidate 18.75mg (randomized fixed dose) | DRUG | Subjects will be randomized at Visit 2 to CTx-1301 to 12.5mg, then week 1 to 18.75 mg |
| CTx-1301-Dexmethylphenidate 25mg (randomized fixed dose) | DRUG | Subjects will be randomized at Visit 2 to CTx-1301 to 12.5mg, then week 1 to 18.75 mg, then week 2 to 25 mg |
| CTx-1301-Dexmethylphenidate 37.5 mg (randomized fixed dose) | DRUG | Subjects will be randomized at Visit 2 to CTx-1301 to 12.5mg, then week 1 to 18.75 mg, then week 2 to 25 mg, then week 3 to 37.5 mg |
| Placebo | DRUG | Subjects will be randomized at Visit 2 to Placebo |
| 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) |
Inclusion Criteria: 1. Male or female subjects between 6 and 17 years of age (inclusive) at the time of Randomization (Visit 2). Subjects who are expected to turn 18 years of age during the trial will not be allowed. 2. Subject must have a body weight between the 5th and 95th percentile (≥5th perce...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Supernus Pharmaceuticals, Inc. | SUPN | 1 | PHASE3 | SPN-812 |
CTx-1301-Dexmethylphenidate is an investigational small molecule being developed for the treatment of attention deficit hyperactivity disorder (ADHD). It is being studied in both adult and pediatric patients with ADHD, including ADHD combined type. It has not been approved by the FDA and remains in clinical development.
CTx-1301-Dexmethylphenidate is being developed by Cingulate Inc., which trades on the Nasdaq under the ticker CING. The company is the sponsor of the clinical program evaluating this investigational ADHD candidate.
CTx-1301-Dexmethylphenidate is in Phase 3 clinical development. Two Phase 3 trials have been completed: one in adults with ADHD and one in pediatric patients aged 6 to 17 with ADHD. The drug is investigational and has not been approved by the FDA.
CTx-1301-Dexmethylphenidate has been evaluated in two completed Phase 3 trials. NCT05631626 was a Phase 3 efficacy and safety study in adults with ADHD that enrolled 26 participants. NCT05286762 was a Phase 3 fixed-dose efficacy and safety study in pediatric patients aged 6 to 17 with ADHD that enrolled 103 participants. Both were randomized, double-blind, and placebo-controlled.
Yes. CTx-1301-Dexmethylphenidate is also known as CTx-1301. The same investigational ADHD candidate has been referred to as CTx-1301-Dexmethylphenidate 25 mg and CTx-1301-Dexmethylphenidate 12.5 mg (titration only), reflecting different dose strengths studied in the clinical program.