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PDC-1421 Treatment in Adult Patients With 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: NCT05202327
Recruitment Status : Recruiting
First Posted : January 21, 2022
Last Update Posted : April 28, 2022
Sponsor:
Information provided by (Responsible Party):
BioLite, Inc.

Brief 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.

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

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 99 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants are assigned to one of three groups in parallel for the duration of the study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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 II
Actual Study Start Date : April 7, 2022
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo
Two placebo capsules thrice daily for 56 days (8 weeks).
Drug: Placebo
The placebo contained corn starch.

Experimental: Low-dose
One placebo capsule and 1 PDC-1421 Capsule, thrice daily for 56 days (8 weeks).
Drug: 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.

Drug: Placebo
The placebo contained corn starch.

Experimental: High-dose
Two PDC-1421 Capsules thrice daily for 56 days (8 weeks).
Drug: 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.




Primary Outcome Measures :
  1. Number of Participants With Improvement ≥ 40% in ADHD-RS-IV From Baseline up to 8 Weeks Treatment [ Time Frame: 8 weeks ]
    The ADHD-RS-IV with Adult Prompts is an 18-item scale based 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 7 by the investigator.


Secondary Outcome Measures :
  1. Change From Baseline up to 8 Weeks Treatment in the Conners' Adult Attention-Deficit/Hyperactivity Disorder Rating Scale-Self Report: Short Version (CAARS-S:S) 5 Subscales T-score. [ Time Frame: 8 weeks ]
    Conners' Adult Attention-Deficit/Hyperactivity Disorder Rating Scale-Self Report: Short Version (CAARS-S:S) consists of 26 items rated from 0=not at all, never to 3=very much, very frequently. Four subscales each composed of 5 items (A: inattention/memory problems; B: hyperactivity/restlessness; C: impulsivity/emotional lability; and D: problems with self-concept) as well as a 12-item ADHD index can be computed. The raw scores were converted into standard T-scores by the SAS program which was designed according to the Profile form of CAARS Quik Score forms. The higher T-scores represent a better or worse outcome. A T-score is a standard score with a mean of 50 and a standard deviation of 10 in all samples and across all scales

  2. Change From Baseline up to 8 Weeks in the Sluggish Cognitive Tempo (K-SCT) Score. [ Time Frame: 8 weeks ]
    The K-SCT rating scale queries 15 Sluggish Cognitive Tempo symptoms rated from 0 = Never or Rarely, 1 = Sometimes, 2 = Often, 3 = Very Often, grouped into latent factors of daydreaming, working memory problems, and subjective sleepiness/tiredness. The range for the Total Score is 0-45. The higher values represent a worse outcome for the total score and subscore.

  3. Change From Baseline up to 8 Weeks in the ADHD-RS-IV Inattention Subscale, Hyperactivity-impulsivity Subscale, and Total Scale Raw Score. [ Time Frame: 8 weeks ]
    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 summed "total score" of 0-54, "inattentive subscore" of 0-27, and "hyperactive-impulsive subscore" of 0-27. The higher values represent a worse outcome for the total score and subscore. Likert-type severity scale: 0 = Never or Rarely, 1 = Sometimes, 2 = Often, 3 = Very Often.

  4. Number of Participants With Symptom Remission in ADHD-RS-IV From Baseline up to 8 Weeks Treatment [ Time Frame: 8 weeks ]
    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 summed "total score" of 0-54, "inattentive subscore" of 0-27, and "hyperactive-impulsive subscore" of 0-27. The higher values represent a worse outcome for the total score and subscore. Likert-type severity scale: 0 = Never or Rarely, 1 = Sometimes, 2 = Often, 3 = Very Often.

  5. Number of Participants With a CGI Score of 2 or Lower From Baseline up to 8 Weeks Treatment [ Time Frame: 8 weeks ]
    Clinical Global Impression-Severity (CGI-S) and Clinical Global Impression-Improvement (CGI-I) score of 2 or lower. The CGI-S is rated on a 7-point scale, with the severity of illness scale using a range of responses from 1 (normal) through to 7 (amongst the most severely ill patients). CGI-I scores range from 1 (very much improved) through to 7 (very much worse).



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 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

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) 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

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): NCT05202327


Contacts
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Contact: Hsien-Ming Wu, M.S. 886+36579631 sonnywu@bioliteinc.com
Contact: Richard King, Ph.D. richard.king@ambrivis.com

Locations
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United States, California
UCSF Medical Center Not yet recruiting
San Francisco, California, United States, 94143
Principal Investigator: Keith McBurnett, Ph.D.         
Taiwan
Kaohsiung Chang Gung Memorial Hospital Recruiting
Kaohsiung, Taiwan, 83301
Principal Investigator: Wen-Jiun Chou, M.D.         
National Taiwan University Hospital Recruiting
Taipei, Taiwan, 10002
Principal Investigator: Susan Shur-Fen Gau, M.D. Ph.D.         
Cheng Hsin General Hospital Recruiting
Taipei, Taiwan, 112
Principal Investigator: Tung-Ping Su, M.D.         
Taipei veterans General Hospital Not yet recruiting
Taipei, Taiwan, 112
Principal Investigator: Cheng-Ta Li, M.D. Ph.D.         
Linkou chang Gung Memorial Hospital Recruiting
Taoyuan, Taiwan, 33425
Principal Investigator: Hsing-Chang Ni, M.D. Ph.D.         
Sponsors and Collaborators
BioLite, Inc.
Investigators
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Principal Investigator: Keith McBurnett, Ph.D. University of California, San Francisco
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Responsible Party: BioLite, Inc.
ClinicalTrials.gov Identifier: NCT05202327    
Other Study ID Numbers: BLI-1008-002
First Posted: January 21, 2022    Key Record Dates
Last Update Posted: April 28, 2022
Last Verified: April 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
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