Clinical Trials List
2022-01-01 - 2024-04-09
Phase II
Recruiting5
A Phase II Tolerability and Efficacy Study of PDC-1421 Treatment in Adult Patients with Attention-Deficit Hyperactivity Disorder (ADHD), Part II
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Trial Applicant
BioLite, Inc.
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Sponsor
BioLite, Inc.
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Trial scale
Multi-Regional Multi-Center
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Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
- 張鎔麒 無
- CHI-YUNG SHANG 無
- HUNG-KUANG SU 無
- 林海笛 無
- YI-LING CHIEN 無
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 鄭智銘 無
- W. C. LIN 無
- Mu-Hong Chen 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 陳麗淇 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
Endpoints
Inclution Criteria
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 (ADHDRS-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
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, posttraumatic 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
The Estimated Number of Participants
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Taiwan
74 participants
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Global
99 participants
