Summary

Eligibility
for people ages 18-70 (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
estimated completion
Principal Investigator
by Keith McBurnett, Ph.D.
Headshot of Keith McBurnett
Keith McBurnett

Description

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

Details

The screening phase is intended for diagnosing and assessing the patient for possible inclusion in the study and for providing an adequate washout period. At the first stage, a number of 69 subjects will be randomly assigned on a 1:1:1 basis to one of the three arms (1 PDC-1421 Capsule plus 1 placebo TID, 2 PDC-1421 Capsules TID, 2 placebo TID) for 8 weeks and evaluated the safety and efficacy every two weeks during the treatment period. An interim analysis will be conducted to evaluate the efficacy of PDC-1421 and to decide whether it is necessary to enter the second stage of the Part II study in which 30 subjects will be randomly assigned on a 1:1:1 basis to one of the three treatment arms and receive the same treatment. Simple descriptive statistics with a 95% confidence interval will be performed with data collected in this study wherever applicable. The safety and efficacy data will be analyzed using the non-parametric method wherever appropriate. The primary endpoint will be analyzed by chi-square test, while the secondary endpoints will be analyzed using the ANOVA or Kruskal-Wallis non-parametric ANOVA test for continuous endpoints and chi-square test for binary endpoints.

Keywords

Attention-Deficit Hyperactivity Disorder (ADHD) Hyperkinesis Attention Deficit Disorder with Hyperactivity PDC-1421 Capsule

Eligibility

You can join if…

Open to people ages 18-70

  1. Aged 18-70 years
  2. 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
  3. Subjects must be able to understand and willing to sign informed consent
  4. Able to discontinue the use of any psychotropic medications for the treatment of ADHD symptoms at screening
  5. Meet strict operational criteria for adult ADHD according to the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5)
  6. A total score of 28 or higher of ADHD Rating Scale-Investigator Rated (ADHD-RS-IV) at screening
  7. Have a moderate or severe symptom of ADHD with score of 4 or higher in Clinical Global Impression- Severity (CGI-S) at screening

You CAN'T join if...

  1. 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
  2. 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
  3. Have known serological evidence of human immunodeficiency virus (HIV) antibody
  4. Are pregnant as confirmed by a positive pregnancy test at screening
  5. Have QTc values >450 msec at screening using Fridericia's QTc formula
  6. Have current of bipolar and psychotic disorders
  7. 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).
  8. 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).
  9. Have a history of jailing or imprisonment in the past 6 months due to worsening of symptoms of ADHD

Locations

  • UCSF Medical Center not yet accepting patients
    San Francisco California 94143 United States
  • Kaohsiung Chang Gung Memorial Hospital accepting new patients
    Kaohsiung 83301 Taiwan
  • National Taiwan University Hospital accepting new patients
    Taipei 10002 Taiwan
  • Cheng Hsin General Hospital accepting new patients
    Taipei 112 Taiwan
  • Taipei veterans General Hospital not yet accepting patients
    Taipei 112 Taiwan
  • Linkou chang Gung Memorial Hospital accepting new patients
    Taoyuan 33425 Taiwan

Lead Scientist at UCSF

  • Keith McBurnett, Ph.D.
    Professor Emeritus, Psychiatry, School of Medicine. Authored (or co-authored) 85 research publications

Details

Status
accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
(estimated)
Sponsor
BioLite, Inc.
ID
NCT05202327
Phase
Phase 2 Attention-Deficit/Hyperactivity Disorder Research Study
Study Type
Interventional
Participants
Expecting 99 study participants
Last Updated