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

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ClinicalTrials.gov Identifier: NCT02699086
Recruitment Status : Not yet recruiting
First Posted : March 4, 2016
Last Update Posted : July 12, 2019
Sponsor:
Information provided by (Responsible Party):
BioLite, Inc.

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.


Condition or disease Intervention/treatment Phase
Attention-Deficit Hyperactivity Disorder (ADHD) Drug: PDC-1421 Capsule Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 6 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Tolerability and Efficacy Study of PDC-1421 Treatment in Adult Patients With Attention-Deficit Hyperactivity Disorder (ADHD), Part I
Estimated Study Start Date : October 2019
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 1 PDC-1421 Capsule
1 PDC-1421 Capsule, trice daily, p.o. after meal for 28 days
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.

Experimental: 2 PDC-1421 Capsules
2 PDC-1421 Capsules, trice daily, p.o. after meal for 28 days
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02699086


Contacts
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Contact: Frank C Liu, MD 886-3-668-5386 liu3763@bioliteinc.com

Locations
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United States, California
UCSF Medical Center Not yet recruiting
San Francisco, California, United States, 94143
Contact: Keith R McBurnett, PhD    415-476-7892    Keith.McBurnett@ucsf.edu   
Sponsors and Collaborators
BioLite, Inc.
Investigators
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Study Director: Keith R McBurnett, PhD University of California San Francisco, School of Medicine

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Responsible Party: BioLite, Inc.
ClinicalTrials.gov Identifier: NCT02699086     History of Changes
Other Study ID Numbers: Phase II BLI-1008-001
First Posted: March 4, 2016    Key Record Dates
Last Update Posted: July 12, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by BioLite, Inc.:
ADHD
Additional relevant MeSH terms:
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Hyperkinesis
Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms