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PDC-1421 Treatment in Adult Patients With ADHD

NCT05202327 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 99

Last updated 2026-05-06

Study results available
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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)

Interventions

DRUG

PDC-1421 Capsule

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

DRUG

Placebo

The placebo contained corn starch.

Sponsors & Collaborators

  • ABVC BioPharma, Inc.

    collaborator INDUSTRY

  • BioLite, Inc.

    lead INDUSTRY

Principal Investigators

  • Hsien-Ming Wu, M.S. · BioLite, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-07
Primary Completion
2023-12-06
Completion
2024-04-08
FDA Drug
Yes

Countries

  • United States
  • Taiwan

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05202327 on ClinicalTrials.gov