Clinical trial NCT05202327: PDC-1421 Treatment in Adult Patients With ADHD
Official title: A Phase II Tolerability and Efficacy Study of PDC-1421 Treatment in Adult Patients With Attention-Deficit Hyperactivity Disorder (ADHD), Part II
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Attention-Deficit Hyperactivity Disorder (ADHD)
Lead sponsor: BioLite, Inc.
Sponsor class: INDUSTRY
Collaborators: name: ABVC BioPharma, Inc
First posted: 2022-01-21
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are assigned to one of three groups in parallel for the duration of the study
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Number of Participants With Improvement ≥ 40% in ADHD-RS-IV From Baseline up to 8 Weeks Treatment
timeFrame: 8 weeks
Secondary outcomes:
measure: 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.
timeFrame: 8 weeks
measure: Change From Baseline up to 8 Weeks in the Sluggish Cognitive Tempo (K-SCT) Score.
timeFrame: 8 weeks
measure: Change From Baseline up to 8 Weeks in the ADHD-RS-IV Inattention Subscale, Hyperactivity-impulsivity Subscale, and Total Scale Raw Score.
timeFrame: 8 weeks
measure: Number of Participants With Symptom Remission in ADHD-RS-IV From Baseline up to 8 Weeks Treatment
timeFrame: 8 weeks
measure: Number of Participants With a CGI Score of 2 or Lower From Baseline up to 8 Weeks Treatment
timeFrame: 8 weeks
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Chang Gung Memorial Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Cheng Hsin General Hospital
city: Taipei
country: Taiwan
facility: Taipei veterans General Hospital
city: Taoyuan
country: Taiwan
facility: Linkou chang Gung Memorial Hospital
Study officials:
References: