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COMPLETED
NCT05202327
PHASE2

PDC-1421 Treatment in Adult Patients With ADHD

Sponsor: BioLite, Inc.

View on ClinicalTrials.gov

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.

Official title: A Phase II Tolerability and Efficacy Study of PDC-1421 Treatment in Adult Patients With Attention-Deficit Hyperactivity Disorder (ADHD), Part II

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

99

Start Date

2022-04-07

Completion Date

2024-04-08

Last Updated

2026-05-06

Healthy Volunteers

No

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.

Locations (6)

University of California, San Francisco

San Francisco, California, United States

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, Taiwan

National Taiwan University Hospital

Taipei, Taiwan

Cheng Hsin General Hospital

Taipei, Taiwan

Taipei veterans General Hospital

Taipei, Taiwan

Linkou chang Gung Memorial Hospital

Taoyuan, Taiwan