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PDC-1421 for ADHD
Phase 2
Waitlist Available
Led By Keith McBurnett, Ph.D.
Research Sponsored by BioLite, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Female subjects of child-bearing potential must test negative to pregnancy and use appropriate birth control method from the beginning of study to the 15 days later after ending of study
Have a moderate or severe symptom of ADHD with a score of 4 or higher in Clinical Global Impression-Severity (CGI-S) at screening
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 weeks
Awards & highlights
Study Summary
This trial is testing a new potential treatment for ADHD, to see if it is effective and safe.
Who is the study for?
Adults aged 18-70 with a confirmed diagnosis of ADHD, who score at least 28 on the ADHD-RS-IV and have moderate to severe symptoms. Participants must be able to stop taking other psychotropic medications for ADHD and use birth control if applicable. Those with unstable medical conditions or significant mental health disorders are excluded.Check my eligibility
What is being tested?
The trial is testing PDC-1421 Capsule's effectiveness in different doses compared to a placebo over a set period. It's designed as a double-blind study, meaning neither participants nor researchers know who receives the actual drug versus the placebo.See study design
What are the potential side effects?
While specific side effects are not listed here, generally, safety evaluations will monitor any adverse reactions from various dose levels of PDC-1421 Capsule during the trial.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am not pregnant and will use birth control during and 15 days after the study.
Select...
My ADHD symptoms are moderate to severe, scoring 4 or higher on the CGI-S.
Select...
I am between 18 and 70 years old.
Select...
I can stop taking ADHD medication for the study.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 8 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Participants With Improvement ≥ 40% in ADHD-RS-IV From Baseline up to 8 Weeks Treatment
Secondary outcome measures
Attention Deficit Disorder
Change From Baseline up to 8 Weeks in the ADHD-RS-IV Inattention Subscale, Hyperactivity-impulsivity Subscale, and Total Scale Raw Score.
Change From Baseline up to 8 Weeks in the Sluggish Cognitive Tempo (K-SCT) Score.
+2 moreSide effects data
From 2019 Phase 2 trial • 72 Patients • NCT0239597817%
Glaucoma
17%
Viral upper respirator tract infection
17%
Acne
100%
80%
60%
40%
20%
0%
Study treatment Arm
Part I: 1 PDC-1421 Capsule
Part I: 2 PDC-1421 Capsule
Part II: 2 PDC-1421 Capsule
Part II: 1 PDC-1421 Capsule Plus 1 Placebo
Part II: 2 Placebo
Trial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Low-doseExperimental Treatment2 Interventions
One placebo capsule and 1 PDC-1421 Capsule, thrice daily for 56 days (8 weeks).
Group II: High-doseExperimental Treatment1 Intervention
Two PDC-1421 Capsules thrice daily for 56 days (8 weeks).
Group III: PlaceboPlacebo Group1 Intervention
Two placebo capsules thrice daily for 56 days (8 weeks).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
PDC-1421 Capsule
2015
Completed Phase 2
~80
Starch, corn
FDA approved
Find a Location
Who is running the clinical trial?
BioLite, Inc.Lead Sponsor
6 Previous Clinical Trials
216 Total Patients Enrolled
1 Trials studying Attention Deficit Hyperactivity Disorder (ADHD)
6 Patients Enrolled for Attention Deficit Hyperactivity Disorder (ADHD)
ABVC BioPharma, IncUNKNOWN
1 Previous Clinical Trials
40 Total Patients Enrolled
Keith McBurnett, Ph.D.Principal InvestigatorUniversity of California, San Francisco
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have recently tried to harm yourself or are at risk of doing so, according to the doctor's evaluation and a specific questionnaire.My ADHD symptoms are moderate to severe, scoring 4 or higher on the CGI-S.You currently have bipolar disorder or psychotic disorders.I am not pregnant and will use birth control during and 15 days after the study.Your heart's electrical activity, measured by the QTc value, is longer than 450 milliseconds.I do not have any unstable health conditions that could affect the trial's safety or results.You have tested positive for HIV.You have a score of 28 or higher on the ADHD Rating Scale completed by the investigator.You meet specific guidelines for adult ADHD according to the DSM-5.You have been in jail or prison in the past 6 months because your ADHD symptoms got worse.I have or have had major depression, OCD, PTSD, anxiety, panic disorder, or an eating disorder.I am between 18 and 70 years old.I am not pregnant and will use birth control during and 15 days after the study.I can stop taking ADHD medication for the study.You have a high score on the ADHD Rating Scale-Investigator Rated (ADHD-RS-IV) test.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: Low-dose
- Group 3: High-dose
Awards:
This trial has 1 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Attention Deficit Hyperactivity Disorder (ADHD) Patient Testimony for trial: Trial Name: NCT05202327 — Phase 2
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Who would this clinical trial be appropriate for?
"This study is enrolling 99 patients with a diagnosis of attention deficit hyperactivity disorder (ADHD). To be eligible for the trial, patients must meet the following criteria: Aged 18-70 years, Female subjects of child-bearing potential must test negative to pregnancy and use appropriate birth control method from the beginning of study to the 15 days later after ending of study, Subjects must be able to understand and willing to sign informed consent, Able to discontinue the use of any psychotropic medications for the treatment of ADHD symptoms at screening, Meet strict operational criteria for adult ADHD according to the Diagnostic and Statistical Manual of Mental Disorders,"
Answered by AI
Does this research include individuals outside of the age range of 45 years old?
"112 different clinical trials are available for patients that do not meet the age requirements of this trial. If an applicant is over 65, there are 40 other trials they may be eligible for."
Answered by AI
What are the potential side effects of PDC-1421 Capsule?
"While there is some clinical data supporting the safety of PDC-1421 Capsule, it has not been shown to be effective. Therefore, it received a score of 2."
Answered by AI
Are there any available openings for patients who want to enroll in this clinical trial?
"That is correct, the trial mentioned is still actively recruiting patients according to information on clinicaltrials.gov. The posting date was April 7th, 2022 and the most recent update was July 18th, 2022. So far, 99 people have been enrolled at 1 location"
Answered by AI
How many people can join this clinical trial at most?
"Yes, that is accurate. The most recent update on clinicaltrials.gov shows that this study was posted on 4/7/2022 and updated as recently as 7/18/2022. They are looking for a total of 99 patients from 1 location."
Answered by AI
Who else is applying?
What state do they live in?
Minnesota
California
Colorado
Other
How old are they?
18 - 65
What site did they apply to?
University of California, San Francisco
UCSF Medical Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
2
Why did patients apply to this trial?
Tried many drugs and still struggle with direct and indirect symptoms. I've tried other drugs and means of therapy, but my executive dysfunction is getting out of hand.
PatientReceived 1 prior treatment
I'm very new to treatment.Diagnosed in 1978 and untreated.Only have been on Generic adderal 20mg.Very ineffective.
PatientReceived 1 prior treatment
I don't think there is enough research with adult ADHD, and when you actually have it, go through hours of tests, it's still difficult for some clinicians to accept. It's so weird I don't understand. And I want to learn more to live better for me, and my daughter. Thank you for your consideration.
PatientReceived 2+ prior treatments
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