PDC-1421 Treatment in Adult Patients With ADHD

NCT05202327 | Completed Phase 2 Results FDA Drug

• 1 other identifier: BLI-1008-002
• Study Type: interventional
• Target: 99
• Locations: 2 countries
• Sites: 6

Brief 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.

Conditions

Attention-Deficit Hyperactivity Disorder (ADHD)

Outcome Measures

Primary Outcomes (1)

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

  The ADHD-RS-IV with Adult Prompts is an 18-item scale based on the DSM-IV-TR criteria for ADHD that provides a rating of the severity of symptoms. The adult prompts serve as a guide to explore more fully the extent and severity of ADHD symptoms and create a framework to ascertain impairment. The odd-numbered 9 items assess inattentive symptoms and the even-numbered 9 items assess hyperactive-impulsive symptoms. Scoring is based on a 4-point, yielding a possible total score of 0-54. Likert-type severity scale: 0 = Never or Rarely, 1 = Sometimes, 2 = Often, 3 = Very Often. Clinicians should score the highest score that is generated for the prompts for each item. The ADHD-RS-IV was assessed from Visit 1 to Visit 7 by the investigator.

  8 weeks

Secondary Outcomes (5)

• Number of Participants With a CGI Score of 2 or Lower From Baseline up to 8 Weeks Treatment

  8 weeks

• Change From Baseline up to 8 Weeks in the Sluggish Cognitive Tempo (K-SCT) Score.

  8 weeks

• Change From Baseline up to 8 Weeks in the ADHD-RS-IV Total Scale.

  8 weeks

• Number of Participants With Symptom Remission in ADHD-RS-IV From Baseline up to 8 Weeks Treatment

  8 weeks

• 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.

  8 weeks

Study Arms (3)

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Low-dose

EXPERIMENTAL

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

Drug: PDC-1421 Capsule; Drug: Placebo

High-dose

EXPERIMENTAL

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

Drug: PDC-1421 Capsule

Interventions

PDC-1421 Capsule DRUG

PDC-1421 Capsule is a botanical investigational new drug containing the extract of Radix Polygalae (Polygala tenuifolia Willd.) as the active ingredient.

Also known as: Extract of Radix Polygalae

High-dose; Low-dose

Placebo DRUG

The placebo contained corn starch.

Also known as: Corn Starch

Low-dose; Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• BioLite, Inc.: lead
• ABVC BioPharma, Inc.: collaborator

Study Sites (6)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, 83301, Taiwan

Location

National Taiwan University Hospital

Taipei, 10002, Taiwan

Location

Cheng Hsin General Hospital

Taipei, 112, Taiwan

Location

Taipei veterans General Hospital

Taipei, 112, Taiwan

Location

Linkou chang Gung Memorial Hospital

Taoyuan, 33425, Taiwan

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Starch

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Glucans; Biopolymers; Polymers; Macromolecular Substances; Dietary Carbohydrates; Carbohydrates; Polysaccharides

Results Point of Contact

• Title: Project Manager
• Organization: BioLite, Inc.

sonnywu@bioliteinc.com

886-36579631

Study Officials

• Hsien-Ming Wu, M.S.

  BioLite, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants are assigned to one of three groups in parallel for the duration of the study

Study Record Dates

• First Submitted: January 10, 2022
• First Posted: January 21, 2022
• Study Start: April 7, 2022
• Primary Completion: December 6, 2023
• Study Completion: April 8, 2024
• Last Updated: May 6, 2026
• Results First Posted: May 6, 2026

Record last verified: 2026-04

Locations

US (1); TW (5)