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Central Nervous System Stimulant

50mg CTx-1301 (Dexmethylphenidate tablet) for Attention Deficit Hyperactivity Disorder (ADHD)

Phase 3
Waitlist Available
Led By Ann Childress, MD
Research Sponsored by Cingulate Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (pre-dose) at visit 8 then post-dose at hours .5,1,3,6,9,12,13,14,15, and 16.
Awards & highlights

Summary

This trial tests CTx-1301, a medication for adults with ADHD, by finding the best dose. The goal is to see if CTx-1301 can effectively manage ADHD symptoms.

Eligible Conditions
  • Attention Deficit Hyperactivity Disorder (ADHD)

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (pre-dose) at visit 8 then post-dose at hours .5,1,3,6,9,12,13,14,15, and 16.
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (pre-dose) at visit 8 then post-dose at hours .5,1,3,6,9,12,13,14,15, and 16. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
The primary efficacy analysis will analyze the change in PERMP scores from Baseline (pre-dose) at Visit 8 to hour 16 at Visit 8.
Secondary study objectives
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.
Key secondary analysis will analyze the change in PERMP scores from baseline at each time point during the laboratory environment at Visit 8.
Other study objectives
Exploratory endpoints will evaluate the efficacy of CTx-1301 during the dose optimization phase.
Safety - incidence of TEAEs
Safety - incidence of changes in vital signs, BMI, blood labs, physical exams, Columbia-Suicide Severity Rating Scale (CSSR-S), and ECGs.
+1 more

Trial Design

4Treatment groups
Active Control
Placebo Group
Group I: 50mg CTx-1301 (Dexmethylphenidate tablet)Active Control1 Intervention
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.
Group II: 37.5mg CTx-1301 (Dexmethylphenidate tablet)Active Control1 Intervention
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.
Group III: 25mg CTx-1301 (Dexmethylphenidate tablet)Active Control1 Intervention
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.
Group IV: PlaceboPlacebo Group1 Intervention
Subjects will be randomized (1:1) to their optimal dose or placebo in the 7-day, double-blind, randomization phase.

Find a Location

Who is running the clinical trial?

Rho, Inc.Industry Sponsor
24 Previous Clinical Trials
5,742 Total Patients Enrolled
Cingulate TherapeuticsLead Sponsor
4 Previous Clinical Trials
220 Total Patients Enrolled
3 Trials studying Attention Deficit Hyperactivity Disorder (ADHD)
193 Patients Enrolled for Attention Deficit Hyperactivity Disorder (ADHD)
Ann Childress, MDPrincipal InvestigatorPrincipal Investigator
11 Previous Clinical Trials
1,841 Total Patients Enrolled
10 Trials studying Attention Deficit Hyperactivity Disorder (ADHD)
1,829 Patients Enrolled for Attention Deficit Hyperactivity Disorder (ADHD)
~8 spots leftby Sep 2025
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