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

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Clinical Research of Southern Nevada, LLC, Las Vegas, NVAttention Deficit Hyperactivity Disorder (ADHD)+1 MoreCTx-1301 - Dexmethylphenidate 50mg - Drug
Eligibility
18 - 55
All Sexes
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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)

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Similar Trials

1
NRCT-101SR
1
Solriamfetol 75 MG
1
NB-001

Study Objectives

1 Primary · 2 Secondary · Reporting Duration: Baseline (pre-dose) at Visit 8 then post-dose at hours .5,1,3,6,9,12,13,14,15, and 16.

Hour 16
The primary efficacy analysis will analyze the change in PERMP scores from Baseline (pre-dose) at Visit 8 to hour 16 at Visit 8.
Week 6
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 8 then post-dose at hours .5,1,3,6,9,12,13,14,15, and 16.
Key secondary analysis will analyze the change in PERMP scores from baseline at each time point during the laboratory environment at Visit 8.
Week 10
Exploratory endpoints will evaluate the efficacy of CTx-1301 during the dose optimization phase.
Week 11
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.
The purpose of this study is to estimate the effect size of treatment on the PERMP instrument in an adult ADHD population as defined by the inclusion/exclusion criteria.

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Similar Trials

2
NRCT-101SR
2
Solriamfetol 75 MG
2
NB-001

Trial Design

4 Treatment Groups

50mg CTx-1301 (Dexmethylphenidate tablet)
1 of 4
37.5mg CTx-1301 (Dexmethylphenidate tablet)
1 of 4
25mg CTx-1301 (Dexmethylphenidate tablet)
1 of 4
Placebo
1 of 4

Active Control

Non-Treatment Group

25 Total Participants · 4 Treatment Groups

Primary Treatment: 50mg CTx-1301 (Dexmethylphenidate tablet) · Has Placebo Group · Phase 3

50mg CTx-1301 (Dexmethylphenidate tablet)
Drug
ActiveComparator Group · 1 Intervention: CTx-1301 - Dexmethylphenidate 50mg · Intervention Types: Drug
Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug
37.5mg CTx-1301 (Dexmethylphenidate tablet)
Drug
ActiveComparator Group · 1 Intervention: CTx-1301 - Dexmethylphenidate 37.5mg · Intervention Types: Drug
25mg CTx-1301 (Dexmethylphenidate tablet)
Drug
ActiveComparator Group · 1 Intervention: CTx-1301 - Dexmethylphenidate 25mg · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline (pre-dose) at visit 8 then post-dose at hours .5,1,3,6,9,12,13,14,15, and 16.

Who is running the clinical trial?

Rho, Inc.Industry Sponsor
22 Previous Clinical Trials
5,411 Total Patients Enrolled
Cingulate TherapeuticsLead Sponsor
3 Previous Clinical Trials
384 Total Patients Enrolled
2 Trials studying Attention Deficit Hyperactivity Disorder (ADHD)
357 Patients Enrolled for Attention Deficit Hyperactivity Disorder (ADHD)
Ann Childress, MDPrincipal InvestigatorPrincipal Investigator
10 Previous Clinical Trials
1,911 Total Patients Enrolled
10 Trials studying Attention Deficit Hyperactivity Disorder (ADHD)
1,911 Patients Enrolled for Attention Deficit Hyperactivity Disorder (ADHD)

Eligibility Criteria

Age 18 - 55 · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
References

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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