PDC-1421 for ADHD

No longer recruiting at 8 trial locations

Overseen By Shirley Chiu, Ph.D.

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: BioLite, Inc.

Must not be taking: Psychotropics

Disqualifiers: Bipolar, Major depression, HIV, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 4

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new capsule treatment called PDC-1421 for individuals with ADHD, a condition affecting attention and focus. The main goal is to determine the optimal dose and treatment duration while assessing the capsule's safety. Participants will receive either a placebo (a pill with no active medicine), a low dose, or a high dose of PDC-1421. Suitable candidates for this trial have moderate to severe ADHD symptoms, including difficulties with daily focus and task management, and are not currently on any ADHD medication. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to the development of new ADHD therapies.

Will I have to stop taking my current medications?

Yes, you will need to stop taking any psychotropic medications (drugs that affect mood, perception, or behavior) for the treatment of ADHD symptoms before joining the study.

Is there any evidence suggesting that PDC-1421 Capsule is likely to be safe for humans?

Research has shown that PDC-1421 is generally safe and well-tolerated. Earlier studies found it safe for adults with ADHD, with participants experiencing no major side effects. Specifically, a small group of six adult patients described the PDC-1421 capsule as both safe and effective.

While these results are encouraging, they come from a limited number of participants. The treatment is now undergoing a phase 2 trial, where researchers are gathering more information on its safety in a larger group. This stage of testing helps confirm the initial safety results and checks for any rare side effects. When considering joining a trial, these points can help evaluate the safety of PDC-1421. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for ADHD?

Researchers are excited about PDC-1421 for ADHD because it offers a potentially new approach compared to typical stimulant medications like methylphenidate and amphetamines. PDC-1421 is derived from a natural plant extract, which may provide a different mechanism of action that could lead to fewer side effects and a lower risk of dependency. This treatment is administered in capsule form and has both low-dose and high-dose options, offering flexibility in managing symptoms. These unique features make PDC-1421 a promising candidate in advancing ADHD treatment.

What evidence suggests that PDC-1421 Capsule might be an effective treatment for ADHD?

Research has shown that PDC-1421 may help treat ADHD (Attention-Deficit/Hyperactivity Disorder). An earlier study found the capsule to be safe and well-tolerated by adults, effectively reducing ADHD symptoms in those who took it. This trial will evaluate different dosages of PDC-1421 to determine the optimal dose for these results. This suggests that PDC-1421 could help manage ADHD symptoms. ^{1 3 4 5 6}

Who Is on the Research Team?

Keith McBurnett, Ph.D.

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

My ADHD symptoms are moderate to severe, scoring 4 or higher on the CGI-S.

I am not pregnant and will use birth control during and 15 days after the study.

You have a score of 28 or higher on the ADHD Rating Scale completed by the investigator.

Exclusion 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.

You currently have bipolar disorder or psychotic disorders.

Have any clinically significant abnormal laboratory, vital sign, physical examination, or electrocardiogram (ECG) findings at screening that, in the opinion of the investigator, may interfere with the interpretation of safety or efficacy evaluations

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either PDC-1421 or placebo capsules thrice daily for 8 weeks

8 weeks

4 visits (in-person) every two weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• PDC-1421 Capsule

Trial Overview 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.

How Is the Trial Designed?

Group I: Low-dose Experimental Treatment 2 Interventions

One placebo capsule and 1 PDC-1421 Capsule, thrice daily for 56 days (8 weeks).

Group II: High-dose Experimental Treatment 1 Intervention

Two PDC-1421 Capsules thrice daily for 56 days (8 weeks).

Group III: Placebo Placebo Group 1 Intervention

Two placebo capsules thrice daily for 56 days (8 weeks).

Who Is Running the Clinical Trial?

BioLite, Inc.

Lead Sponsor

Trials

7

Recruited

290+

ABVC BioPharma, Inc

Collaborator

Trials

2

Recruited

110+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT02699086

NCT02699086 | A Study of PDC-1421 Treatment in Adult ... The primary objective of this trial was to determine the effective doses and treatment period of PDC-1421 Capsule in subjects with ADHD.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05202327

PDC-1421 Treatment in Adult Patients With ADHD The primary objective of this trial is to determine the effective doses and treatment period of PDC-1421 Capsule in subjects with ADHD. The secondary objective ...

3. ctv.veeva.com ctv.veeva.com/study/a-study-of-pdc-1421-treatment-in-adult-patients-with-attention-deficit-hyperactivity-disorder-adhd

A Study of PDC-1421 Treatment in Adult Patients With ... The primary objective of this trial was to determine the effective doses and treatment period of PDC-1421 Capsule in subjects with ADHD.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9713849/

Treatment of ADHD: Drugs, psychological therapies, devices ... It was found that the PDC-1421 capsule was safe, well-tolerated, and efficacious in six adult patients with ADHD (US National Library of ...

5. withpower.com withpower.com/trial/phase-2-hyperkinesis-3-2022-7faf7

PDC-1421 for ADHD · Info for Participants It aims to find the best and safest dose by giving different amounts to participants. The study will check how well the capsule works and if it is safe.

6. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05202327/pdc-1421-treatment-in-adult-patients-with-adhd?activelyRecruiting=false&page=31&id=499&slug=attention-deficit-hyperactivity-disorder-adhd-adults

PDC-1421 Treatment in Adult Patients With ADHD The primary objective of this trial is to determine the effective doses and treatment period of PDC-1421 Capsule in subjects with ADHD. The ...