What side effects are associated with this type of intervention?

Common treatments for ADHD, such as stimulants (methylphenidate and amphetamines) and non-stimulants (atomoxetine and guanfacine), have well-documented side effects. Stimulants can cause increased heart rate, elevated blood pressure, sleep disturbances, decreased appetite, and potential for anxiety or jitteriness. Non-stimulants like atomoxetine may lead to gastrointestinal issues, fatigue, and somnolence, while guanfacine can cause drowsiness, low blood pressure, and dizziness. Both classes of medications require monitoring for cardiovascular effects and potential impacts on sleep quality.

What prior FDA approvals exist?

The FDA has approved several medications for the treatment of ADHD, including stimulants like methylphenidate (e.g., Concerta, Ritalin) and amphetamines (e.g., Adderall XR), which are known for their efficacy in reducing core symptoms of ADHD. Non-stimulant options include atomoxetine (Strattera) and alpha-2 adrenergic agonists such as clonidine and guanfacine (Intuniv). These medications have been shown to be effective and generally well-tolerated, with long-term studies indicating sustained benefits. The trial for PDC-1421 Capsule is exploring a new treatment option, though its mechanism of action is not specified.

What other types of research exist?

Promising novel alternatives to PDC-1421 Capsule for ADHD treatment include: 1) PRC-063, a once-daily extended-release methylphenidate formulation that does not impact sleep, 2) MPH XR-ODT, an extended-release orally disintegrating tablet that provides consistent once-daily dosing, and 3) HLD200, a delayed-release and extended-release methylphenidate designed for evening dosing to provide efficacy from early morning through evening.

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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

All Individual Drugs Already Approved

Summary

This trial is testing a new capsule called PDC-1421 to help people with ADHD. 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.

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.

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.

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 below

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

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

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I am between 18 and 70 years old.

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of Participants With Improvement ≥ 40% in ADHD-RS-IV From Baseline up to 8 Weeks Treatment

Secondary study objectives

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 more

Side effects data

From 2019 Phase 2 trial • 72 Patients • NCT02395978

17%

Glaucoma

17%

Viral upper respirator tract infection

17%

Acne

100%

80%

60%

40%

20%

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

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

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

Starch, corn

FDA approved

PDC-1421 Capsule

2015

Completed Phase 2

~150

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for ADHD include stimulants like methylphenidate and amphetamines, which increase the levels of dopamine and norepinephrine in the brain by inhibiting their reuptake. This enhances neurotransmission in areas of the brain responsible for attention and behavior control. Non-stimulant options like atomoxetine work by selectively inhibiting the reuptake of norepinephrine, while guanfacine acts on alpha-2 adrenergic receptors to improve working memory and impulse control. These mechanisms are crucial for ADHD patients as they directly address the neurochemical imbalances that contribute to symptoms, thereby improving focus, reducing impulsivity, and enhancing overall daily functioning.

Evidence-based pharmacological treatment options for ADHD in children and adolescents.ADHD & Pharmacotherapy: Past, Present and Future: A Review of the Changing Landscape of Drug Therapy for Attention Deficit Hyperactivity Disorder.Methylphenidate and hospitalized adolescents with conduct disorder: Dose effects on classroom behavior, academic performance, and impulsivity.