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A Study of PDC-1421 Treatment in Adult Patients With Attention-Deficit Hyperactivity Disorder (ADHD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02699086
Recruitment Status : Recruiting
First Posted : March 4, 2016
Last Update Posted : August 12, 2020
Sponsor:
Information provided by (Responsible Party):
BioLite, Inc.

Tracking Information
First Submitted Date  ICMJE March 1, 2016
First Posted Date  ICMJE March 4, 2016
Last Update Posted Date August 12, 2020
Actual Study Start Date  ICMJE December 1, 2019
Estimated Primary Completion Date August 10, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 1, 2019)
Attention-Deficit Hyperactivity Disorder-Rating Scale-IV (ADHD-RS-IV) [ Time Frame: 8 weeks ]
The primary endpoint is the change of ADHD Rating Scale-IV (ADHD-RS-IV) total score from baseline up to Week 8 of treatment.
Original Primary Outcome Measures  ICMJE
 (submitted: March 3, 2016)
ADHD Rating Scale-IV (ADHD-RS-IV) [ Time Frame: 8 weeks ]
The primary endpoint is the change of ADHD Rating Scale-IV (ADHD-RS-IV) total score from baseline to Week 8 compared to placebo.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 1, 2019)
  • Conners' Adult Attention- Deficit/Hyperactivity Disorder Rating Scale-Self Report: Short Version (CAARS-S:S) [ Time Frame: 8 weeks ]
    Change from baseline in the Conners' Adult Attention-Deficit/Hyperactivity Disorder Rating Scale-Self Report: Short Version (CAARS-S:S) 18-Item total ADHD symptom score up to 8 weeks treatment.
  • Clinical Global Impression-ADHD- Severity (CGI-ADHD-S) and Clinical Global Impression-ADHD- improvement (CGI-ADHD-I) [ Time Frame: 8 weeks ]
    Clinical Global Impression-ADHD- Severity (CGI-ADHD-S) and Clinical Global Impression-ADHD- improvement (CGI-ADHD-I) score of 2 or lower.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 3, 2016)
  • Conners' Adult Attention- Deficit/Hyperactivity Disorder Rating Scale-Self Report: Short Version (CAARS-S:S) [ Time Frame: 8 weeks ]
    Change from baseline in the Conners' Adult Attention-Deficit/Hyperactivity Disorder Rating Scale-Self Report: Short Version (CAARS-S:S) 18-Item total ADHD symptom score up to 8 weeks treatment.
  • Clinical Global Impression-ADHD- Severity (CGI-ADHD-S) and Clinical Global Impression-ADHD- improvement (CGI-ADHD-I) [ Time Frame: 8 weeks ]
    Clinical Global Impression-ADHD- Severity (CGI-ADHD-S) and Clinical Global Impression-ADHD- improvement (CGI-ADHD-I) score of 2 or lower.
  • CANTAB [ Time Frame: 8 weeks ]
    Difference from baseline to after drug administration in the three CANTAB scores were considered.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of PDC-1421 Treatment in Adult Patients With Attention-Deficit Hyperactivity Disorder (ADHD)
Official Title  ICMJE A Phase II Tolerability and Efficacy Study of PDC-1421 Treatment in Adult Patients With Attention-Deficit Hyperactivity Disorder (ADHD), Part I
Brief Summary

The primary objective of this trial was to determine the effective doses and treatment period of PDC-1421 Capsule in subjects with ADHD.

The secondary objective was to evaluate the safety of PDC-1421 Capsule in subjects receiving PDC-1421 at various dose levels.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Attention-Deficit Hyperactivity Disorder (ADHD)
Intervention  ICMJE Drug: PDC-1421 Capsule
PDC-1421 Capsule is a botanical investigational new drug containing the extract of Radix Polygalae (Polygala tenuifolia Willd.) as active ingredient.
Study Arms  ICMJE
  • Experimental: 1 PDC-1421 Capsule
    1 PDC-1421 Capsule, trice daily, p.o. after meal for 28 days
    Intervention: Drug: PDC-1421 Capsule
  • Experimental: 2 PDC-1421 Capsules
    2 PDC-1421 Capsules, trice daily, p.o. after meal for 28 days
    Intervention: Drug: PDC-1421 Capsule
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 1, 2019)
6
Original Estimated Enrollment  ICMJE
 (submitted: March 3, 2016)
105
Estimated Study Completion Date  ICMJE August 10, 2020
Estimated Primary Completion Date August 10, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  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 20 or higher on the 18-item total ADHD symptoms score of Conners' Adult Attention-Deficit/Hyperactivity Disorder Rating Scale-Self Report: Short Version (CAARS-S:S) at screening
  7. Have a moderate or severe symptom of ADHD with score of 4 or higher in Clinical Global Impression-ADHD-Severity (CGI-ADHD-S) at screening

Exclusion Criteria:

  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)
  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 Beck Scale for Suicidal Ideation (BSS)
  9. Have a history of jailing or imprisonment in the past 6 months due to worsening of symptoms of ADHD
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Hsien-Ming Wu, MS 886-3-657-9631 sonnywu@bioliteinc.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02699086
Other Study ID Numbers  ICMJE Phase II BLI-1008-001
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party BioLite, Inc.
Study Sponsor  ICMJE BioLite, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Keith R McBurnett, PhD University of California San Francisco, School of Medicine
PRS Account BioLite, Inc.
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP