Attention-Deficit Hyperactivity Disorder (ADHD)Phase 2NCT05202327
PDC-1421 Treatment in Adult Patients With ADHD
A Phase 2 study testing PDC-1421 Capsule in people with Attention-Deficit Hyperactivity Disorder (ADHD), run by BioLite, Inc. at 6 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Attention-Deficit Hyperactivity Disorder (ADHD)
- What is being tested?
- PDC-1421 Capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 99 participants
- Where
- 6 sitesin 2 countries
- Study dates
- 7 Apr 2022to 8 Apr 2024
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 28 or higher of ADHD Rating Scale-Investigator Rated (ADHD-RS-IV) at screening
- Have a moderate or severe symptom of ADHD with score of 4 or higher in Clinical Global Impression- Severity (CGI-S) at screening
Who cannot join
- 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
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- 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).
- 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).
- Have a history of jailing or imprisonment in the past 6 months due to worsening of symptoms of ADHD
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
Taiwan5 sites
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, 83301
National Taiwan University Hospital
Taipei, 10002
Cheng Hsin General Hospital
Taipei, 112
Taipei veterans General Hospital
Taipei, 112
Linkou chang Gung Memorial Hospital
Taoyuan, 33425
United States1 site
University of California, San Francisco
San Francisco, California, 94143
About this study
Official title: A Phase II Tolerability and Efficacy Study of PDC-1421 Treatment in Adult Patients With Attention-Deficit Hyperactivity Disorder (ADHD), Part II
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.
Read the 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.
- Being tested
- PDC-1421 Capsule, Placebo
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PDC-1421 CapsuleDrug
Also called Extract of Radix Polygalae
PDC-1421 Capsule is a botanical investigational new drug containing the extract of Radix Polygalae (Polygala tenuifolia Willd.) as the active ingredient.
PlaceboDrug
Also called Corn Starch
The placebo contained corn starch.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Two placebo capsules thrice daily for 56 days (8 weeks). Receives: Drug: Placebo |
| Low-dose | Experimental | One placebo capsule and 1 PDC-1421 Capsule, thrice daily for 56 days (8 weeks). Receives: Drug: PDC-1421 Capsule; Drug: Placebo |
| High-dose | Experimental | Two PDC-1421 Capsules thrice daily for 56 days (8 weeks). Receives: Drug: PDC-1421 Capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Improvement ≥ 40% in ADHD-RS-IV From Baseline up to 8 Weeks Treatment
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.
Measured: 8 weeks
Secondary outcomes (5)
Number of Participants With a CGI Score of 2 or Lower From Baseline up to 8 Weeks Treatment
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).
Measured: 8 weeks
Change From Baseline up to 8 Weeks in the Sluggish Cognitive Tempo (K-SCT) Score.
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.
Measured: 8 weeks
Change From Baseline up to 8 Weeks in the ADHD-RS-IV Total Scale.
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. 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.
Measured: 8 weeks
Number of Participants With Symptom Remission in ADHD-RS-IV From Baseline up to 8 Weeks Treatment
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.
Measured: 8 weeks
Change From Baseline up to 8 Weeks Treat in the Conners' Adult Attention-Deficit/Hyperactivity Disorder Rating Scale-Self Report: Short Version (CAARS-S:S) ADHD Index of T-score.
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. 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
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2022
- Study start7 Apr 2022
- Primary completion6 Dec 2023
- Study completion8 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Attention-Deficit Hyperactivity Disorder (ADHD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are assigned to one of three groups in parallel for the duration of the study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- BioLite, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- ABVC BioPharma, Inc.
- Responsible party
- Sponsor
- Investigators
- Hsien-Ming Wu, M.S., Study director, BioLite, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05202327
- Sponsor's protocol ID
- BLI-1008-002
- Status last verified
- Apr 2026
- First submitted
- 10 Jan 2022
- Last updated
- 6 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No