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CTx-1301 - Dexmethylphenidate

Phase 3

ADHD | Small molecule | Psychiatry |Cingulate Inc.|Last Updated: Jul 2, 2026

Success Probability
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Market & Valuation
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment26
FDA Designations
No designations recorded
Clinical trial landscape

CTx-1301 - Dexmethylphenidate · 1 trial · 4 indications

Phase 3 1
NCT05631626Phase 3 Efficacy and Safety Study in Adults With ADHD Using CTx-1301.ADHD
COMPLETED26 Analytics
PHASE3COMPLETED
Phase 3 Efficacy and Safety Study in Adults With ADHD Using CTx-1301.
ADHD
NCT0563162626
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Study Endpoints
Primary Endpoints
The Primary Efficacy Analysis Will Analyze the Change in PERMP Scores From Baseline (Pre-dose) at Visit 8 to Hour 16 at Visit 8.
Average of the change of the PERMP-C scores from baseline defined as pre-dose score at Visit 8 which was at end of 7-day double-blind period to PERMP-C scores at hour 16 at Visit 8.

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.

Secondary Endpoints
Key Secondary Analysis Will Analyze the Change in PERMP Scores From Baseline at Each Time Point During the Laboratory Environment at Visit 8.
Average of the change of the PERMP-C scores from baseline defined as pre-dose score at Visit 8 which was at end of 7-day double-blind period to PERMP-C scores at hours .5,1,3,6,9,12,13,14,15, and 16.
Key Secondary Analysis Will Analyze the Change From Baseline (Pre-dose at Visit 2) of Clinical Global Impression - Severity (CGI-S) Scores to CGI-S at Visit 8.
Baseline (pre-dose at Visit 2) to Visit 8 (approximately 6 weeks).
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
25mg CTx-1301 (Dexmethylphenidate tablet)ACTIVE_COMPARATORAll 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_COMPARATORAll 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_COMPARATORAll 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.
PlaceboPLACEBO_COMPARATORSubjects will be randomized (1:1) to their optimal dose or placebo in the 7-day, double-blind, randomization phase.
Interventions
NameTypeDescription
CTx-1301 - Dexmethylphenidate 25mgDRUG25mg CTx-1301 (Dexmethylphenidate tablet)
CTx-1301 - Dexmethylphenidate 37.5mgDRUG37.5mg CTx-1301 (Dexmethylphenidate tablet)
CTx-1301 - Dexmethylphenidate 50mgDRUG50mg CTx-1301 (Dexmethylphenidate tablet)
PlaceboDRUGPlacebo
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Eligibility Criteria
Age Range18 Years to 55 Years
SexALL
Healthy VolunteersNo
Study Sites1

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...

Countries:United States
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Competitive Landscape -ADHD 3 trials
CompanyTickerTrialsLead PhaseDrugs
Supernus Pharmaceuticals, Inc.SUPN1PHASE3SPN-812
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