Phase 2 N=69 Randomized Quadruple-blind Treatment

PDC-1421 Treatment in Adult Patients With ADHD

Attention-Deficit Hyperactivity Disorder (ADHD)

Bottom Line

View on ClinicalTrials.gov: NCT05202327 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2026

Primary outcome: Primary: Number of Participants With Improvement ≥ 40% in ADHD-RS-IV From Baseline up to 8 Weeks Treatment — 11; 9; 10 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: PDC-1421 Capsule (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: BioLite, Inc.
Primary completion: Dec 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Improvement ≥ 40% in ADHD-RS-IV From Baseline up to 8 Weeks Treatment	11; 9; 10	—
SECONDARY Number of Participants With a CGI Score of 2 or Lower From Baseline up to 8 Weeks Treatment	6; 9; 9	—
SECONDARY Change From Baseline up to 8 Weeks in the Sluggish Cognitive Tempo (K-SCT) Score.	-5.05; -6.04; -6.54	—
SECONDARY Change From Baseline up to 8 Weeks in the ADHD-RS-IV Total Scale.	-12.14; -13.61; -11.75	—
SECONDARY Number of Participants With Symptom Remission in ADHD-RS-IV From Baseline up to 8 Weeks Treatment	9; 4; 7	—
SECONDARY Change From Baseline up to 8 Weeks Treat in the Conners' Adult Attention-Deficit/Hyperactivity Disorder Rating Scale-Self Report: Short Version (CAARS-S:S) ADHD Index of T-score.	-10.68; -7.43; -7.67	—

Summary

Part II is a double-blind, randomized, parallel-group, placebo-controlled study. 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 is to evaluate the safety of PDC-1421 Capsule in subjects receiving PDC-1421 at various dose levels.

Eligibility Criteria

Inclusion 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, 5th Edition (DSM-5)
A total score of 28 or higher of ADHD Rating Scale-Investigator Rated (ADHD-RS-IV) at screening
Have a moderate or severe symptom of ADHD with score of 4 or higher in Clinical Global Impression- Severity (CGI-S) at screening

Exclusion Criteria

Have any clinically significant concurrent medical condition (endocrine, renal, respiratory, cardiovascular, hematological, immunological, cerebrovascular, neurological, anorexia, obesity or malignancy) that has become unstable and may interfere with the interpretation of safety and efficacy evaluations
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
Have known serological evidence of human immunodeficiency virus (HIV) antibody
Are pregnant as confirmed by a positive pregnancy test at screening
Have QTc values >450 msec at screening using Fridericia's QTc formula
Have current of bipolar and psychotic disorders
Have a current major depression disorder, obsessive-compulsive disorder, post-traumatic stress disorder, generalized anxiety disorder, panic disorder and eating disorder (also if treated but not currently symptomatic) NOTE: Comorbid diagnoses identified during screening and baseline are acceptable provided that ADHD is the primary diagnosis and the comorbid diagnoses will not confound study data or impair subject's ability to participate (per the Investigator's judgement and documented in source note).
Have any history of a significant suicide attempt, or possess a current risk of attempting suicide, in the investigator's opinion, based on clinical interview and responses provided on the Columbia-Suicide Severity Rating Scale (C-SSRS).
Have a history of jailing or imprisonment in the past 6 months due to worsening of symptoms of ADHD

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05202327). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.