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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
Subject must have a body mass index (BMI) ≥18.5 and ≤40.
Male or female subjects between 18 and 55 years of age (inclusive) at the time of consent.
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

Study Summary

This trial tests if a new medicine is safe and helpful for adults with ADHD in a lab setting.

Eligible Conditions
  • Attention Deficit Hyperactivity Disorder (ADHD)

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
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 outcome measures
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
253 Total Patients Enrolled
3 Trials studying Attention Deficit Hyperactivity Disorder (ADHD)
226 Patients Enrolled for Attention Deficit Hyperactivity Disorder (ADHD)
Ann Childress, MDPrincipal InvestigatorPrincipal Investigator
11 Previous Clinical Trials
1,798 Total Patients Enrolled
10 Trials studying Attention Deficit Hyperactivity Disorder (ADHD)
1,786 Patients Enrolled for Attention Deficit Hyperactivity Disorder (ADHD)

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this medical experiment include individuals who are of a more advanced age?

"This research is open to patients that are between 18 and 55 years of age."

Answered by AI

Are there any specific criteria for qualifying to participate in this research?

"Prospective participants of this clinical trial must have an ADHD diagnosis and be between 18-55 years old to qualify. Approximately 25 people are being welcomed into the study."

Answered by AI

Are there adverse effects associated with the ingestion of 50mg CTx-1301 (Dexmethylphenidate tablet)?

"There is clinical evidence for the safety of 50mg CTx-1301 (Dexmethylphenidate tablet), so it was rated a 3 on our scale. This Phase 3 trial has yielded multiple rounds of data in support of its efficacy and security."

Answered by AI

Is enrollment currently open for this research endeavor?

"According to the information hosted on clinicaltrials.gov, recruitment for this experiment is ongoing. It was initially posted on December 29th 2022 and underwent a recent update on January 23rd 2023."

Answered by AI

What is the current enrollment capacity of this research endeavor?

"Affirmative. Information featured on clinicaltrials.gov suggests that recruitment is underway for this medical experiment, which was initially advertised on December 29th 2022 and last amended January 23rd 2023. Specifically, 25 individuals must be recruited from 1 particular location."

Answered by AI

Who else is applying?

What state do they live in?
Puerto Rico
Kansas
Other
Nevada
What site did they apply to?
Clinical Research of Southern Nevada, LLC
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
3+
0
2

What questions have other patients asked about this trial?

This is my first trial ever. Is there compensation? What happens after the trial if the drug works well for me?
PatientReceived 1 prior treatment

Why did patients apply to this trial?

Interested in new treatments as I am unsatisfied with my current one. Been on three other drugs. None of which have had satisfactory results.
PatientReceived 1 prior treatment
I have tried a few medicines but nothing seems to make me improve my quality of life.
PatientReceived 2+ prior treatments
I just need something that works. I lost my job due to ADHD being no meds because I can’t afford Vyvense. I need the economic relief and find something that really helps me since my past drugs haven’t or in Vyvense case is expensive and even if i was in the 70mg i felt wasn’t working how supposed to.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
Phase 3 Efficacy and Safety Study in Adults With ADHD Using CTx-1301.
2022. "Phase 3 Efficacy and Safety Study in Adults With ADHD Using CTx-1301.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05631626.
~9 spots leftby Apr 2025
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