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

NCT02699086 | Completed Phase 2 Results FDA Drug

• 1 other identifier: Phase II BLI-1008-001
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Attention-Deficit Hyperactivity Disorder (ADHD)

Keywords

ADHD

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Improvement ≥ 40% in ADHD-RS-IV From Baseline up to 8 Weeks Treatment

  The primary endpoint is the change of ADHD Rating Scale-IV (ADHD-RS-IV) total score from baseline up to Week 8 of treatment in ITT population. The ADHD-RS-IV with Adult Prompts is an 18-item scale base on the DSM-IV-TR criteria for ADHD that provides a rating of the severity of symptoms. The adult prompts serve as a guide to explore more fully the extent and severity of ADHD symptoms and create a framework to ascertain impairment. The odd-numbered 9 items assess inattentive symptoms and the even-numbered 9 items assess hyperactive-impulsive symptoms. Scoring is based on a 4-point, yielding a possible total score of 0-54. Likert-type severity scale: 0 = Never or Rarely, 1 = Sometimes, 2 = Often, 3 = Very Often. Clinicians should score the highest score that is generated for the prompts for each item. The ADHD-RS-IV was assessed from Visit 1 to Visit 8 by the investigator.

  8 weeks

Secondary Outcomes (3)

• Change in ITT Population From Baseline up to 4 and 8 Weeks Treatment in the Conners' Adult Attention-Deficit/Hyperactivity Disorder Rating Scale-Self Report: Short Version (CAARS-S:S) 5 Subscales T-score.

  8 weeks

• Number of Participants With a CGI Score of 2 or Lower

  8 weeks

• Change in ITT Population From Baseline up to 4 and 8 Weeks in the ADHD-RS-IV Inattention Subscale, Hyperactivity-impulsivity Subscale, and Total Scale Raw Score.

  8 Weeks

Study Arms (2)

Low dose + Low dose

EXPERIMENTAL

1 PDC-1421 Capsule, trice daily, p.o. after meal for 28 + 28 days

Drug: PDC-1421 Capsule

Low dose + High dose

EXPERIMENTAL

1 PDC-1421 Capsule for 28 days + 2 PDC-1421 Capsules for 28 days, trice daily, p.o. after meals

Drug: PDC-1421 Capsule

Interventions

PDC-1421 Capsule DRUG

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

Low dose + High dose; Low dose + Low dose

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18-70 years
• 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
• Subjects must be able to understand and willing to sign informed consent
• Able to discontinue the use of any psychotropic medications for the treatment of ADHD symptoms at screening
• Meet strict operational criteria for adult ADHD according to the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5)
• 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
• 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

You may not qualify if:

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

Sponsors & Collaborators

• BioLite, Inc.: lead

Study Sites (1)

UCSF Medical Center

San Francisco, California, 94143, United States

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Results Point of Contact

• Title: Hsien-Ming Wu
• Organization: BioLite, Inc.

sonnywu@bioliteinc.com

+886-6579631

Study Officials

• Keith R McBurnett, PhD

  University of California San Francisco, School of Medicine

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2016
• First Posted: March 4, 2016
• Study Start: December 1, 2019
• Primary Completion: July 15, 2020
• Study Completion: July 15, 2020
• Last Updated: December 1, 2021
• Results First Posted: November 5, 2021

Record last verified: 2021-11

Locations

US (1)