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PDC-1421 Treatment in Adult Patients With ADHD
Sponsor: BioLite, Inc.
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
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.
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