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

Pivotal Trial

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 weeks3 visits

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.

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

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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

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.

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