Trial Outcomes & Findings for A Study of PDC-1421 Treatment in Adult Patients With Attention-Deficit Hyperactivity Disorder (ADHD) (NCT NCT02699086)

Last Updated: 2021-12-01

Results Overview

The primary endpoint is the change of ADHD Rating Scale-IV (ADHD-RS-IV) total score from baseline up to Week 8 of treatment in ITT population. 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 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 8 by the investigator.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

6 participants

Primary outcome timeframe

8 weeks

Results posted on

2021-12-01

Participant Flow

Participant milestones

Participant milestones
Measure	Low Dose + Low Dose 1 PDC-1421 Capsule, trice daily, p.o. after meal for 28 + 28 days PDC-1421 Capsule: PDC-1421 Capsule is a botanical investigational new drug containing the extract of Radix Polygalae (Polygala tenuifolia Willd.) as active ingredient.	Low Dose + High Dose 1 PDC-1421 Capsule for 28 days + 2 PDC-1421 Capsules for 28 days, trice daily, p.o. after meals PDC-1421 Capsule: PDC-1421 Capsule is a botanical investigational new drug containing the extract of Radix Polygalae (Polygala tenuifolia Willd.) as active ingredient.
Overall Study STARTED	0	6
Overall Study COMPLETED	0	6
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Low Dose + High Dose n=6 Participants 1 PDC-1421 Capsule for 28 days + 2 PDC-1421 Capsules for 28 days, trice daily, p.o. after meals PDC-1421 Capsule: PDC-1421 Capsule is a botanical investigational new drug containing the extract of Radix Polygalae (Polygala tenuifolia Willd.) as active ingredient.
Age, Continuous	38.0 years n=6 Participants
Sex: Female, Male Female	2 Participants n=6 Participants
Sex: Female, Male Male	4 Participants n=6 Participants
Height	178.80 cm n=6 Participants
Weight	170.0 lb n=6 Participants
ADHD Rating Scale	41.8 units on a scale STANDARD_DEVIATION 6.6 • n=6 Participants
CAARS-S:S ADHD Index (T-score)	73.5 T-scale STANDARD_DEVIATION 8.3 • n=6 Participants
CGI-severity	5.3 score on a scale STANDARD_DEVIATION 0.5 • n=6 Participants

PRIMARY outcome

Timeframe: 8 weeks

Population: ITT population

Outcome measures

Outcome measures
Measure	Low Dose + High Dose (at Week 8) n=6 Participants 1 PDC-1421 Capsule for 28 days + 2 PDC-1421 Capsules for 28 days, trice daily, p.o. after meals PDC-1421 Capsule: PDC-1421 Capsule is a botanical investigational new drug containing the extract of Radix Polygalae (Polygala tenuifolia Willd.) as active ingredient.	Low Dose + High Dose (Week 0-8) 1 PDC-1421 Capsule for 28 days + 2 PDC-1421 Capsules for 28 days, trice daily, p.o. after meals PDC-1421 Capsule: PDC-1421 Capsule is a botanical investigational new drug containing the extract of Radix Polygalae (Polygala tenuifolia Willd.) as active ingredient. The score change is calculated from the score of week 8 comparing to week 0.
Number of Participants With Improvement ≥ 40% in ADHD-RS-IV From Baseline up to 8 Weeks Treatment	5 Participants	—

SECONDARY outcome

Timeframe: 8 weeks

Population: ITT population

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 QuikScore 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.

Outcome measures

Outcome measures
Measure	Low Dose + High Dose (at Week 8) n=6 Participants 1 PDC-1421 Capsule for 28 days + 2 PDC-1421 Capsules for 28 days, trice daily, p.o. after meals PDC-1421 Capsule: PDC-1421 Capsule is a botanical investigational new drug containing the extract of Radix Polygalae (Polygala tenuifolia Willd.) as active ingredient.	Low Dose + High Dose (Week 0-8) n=6 Participants 1 PDC-1421 Capsule for 28 days + 2 PDC-1421 Capsules for 28 days, trice daily, p.o. after meals PDC-1421 Capsule: PDC-1421 Capsule is a botanical investigational new drug containing the extract of Radix Polygalae (Polygala tenuifolia Willd.) as active ingredient. The score change is calculated from the score of week 8 comparing to week 0.
Change in ITT Population From Baseline up to 4 and 8 Weeks Treatment in the Conners' Adult Attention-Deficit/Hyperactivity Disorder Rating Scale-Self Report: Short Version (CAARS-S:S) 5 Subscales T-score. Inattention/memory subscale	-10.0 T-score Standard Deviation 10.2	-10.5 T-score Standard Deviation 11.0
Change in ITT Population From Baseline up to 4 and 8 Weeks Treatment in the Conners' Adult Attention-Deficit/Hyperactivity Disorder Rating Scale-Self Report: Short Version (CAARS-S:S) 5 Subscales T-score. Hyperactivity subscale	-6.2 T-score Standard Deviation 7.1	-5.2 T-score Standard Deviation 5.9
Change in ITT Population From Baseline up to 4 and 8 Weeks Treatment in the Conners' Adult Attention-Deficit/Hyperactivity Disorder Rating Scale-Self Report: Short Version (CAARS-S:S) 5 Subscales T-score. Self-concept subscale	-5.7 T-score Standard Deviation 7.0	-4.7 T-score Standard Deviation 6.2
Change in ITT Population From Baseline up to 4 and 8 Weeks Treatment in the Conners' Adult Attention-Deficit/Hyperactivity Disorder Rating Scale-Self Report: Short Version (CAARS-S:S) 5 Subscales T-score. ADHD index subscale	-8.2 T-score Standard Deviation 7.4	-10.8 T-score Standard Deviation 6.2
Change in ITT Population From Baseline up to 4 and 8 Weeks Treatment in the Conners' Adult Attention-Deficit/Hyperactivity Disorder Rating Scale-Self Report: Short Version (CAARS-S:S) 5 Subscales T-score. Impulsivity subscale	-10.8 T-score Standard Deviation 7.1	-15.2 T-score Standard Deviation 7.9

SECONDARY outcome

Timeframe: 8 weeks

Population: ITT population

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).

Outcome measures

Outcome measures
Measure	Low Dose + High Dose (at Week 8) n=6 Participants 1 PDC-1421 Capsule for 28 days + 2 PDC-1421 Capsules for 28 days, trice daily, p.o. after meals PDC-1421 Capsule: PDC-1421 Capsule is a botanical investigational new drug containing the extract of Radix Polygalae (Polygala tenuifolia Willd.) as active ingredient.	Low Dose + High Dose (Week 0-8) n=6 Participants 1 PDC-1421 Capsule for 28 days + 2 PDC-1421 Capsules for 28 days, trice daily, p.o. after meals PDC-1421 Capsule: PDC-1421 Capsule is a botanical investigational new drug containing the extract of Radix Polygalae (Polygala tenuifolia Willd.) as active ingredient. The score change is calculated from the score of week 8 comparing to week 0.
Number of Participants With a CGI Score of 2 or Lower CGI-S	0 Participants	2 Participants
Number of Participants With a CGI Score of 2 or Lower CGI-I	1 Participants	6 Participants

SECONDARY outcome

Timeframe: 8 Weeks

Population: ITT population

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. . The ADHD-RS-IV was assessed from Visit 1 to Visit 8 by the investigator.

Outcome measures

Outcome measures
Measure	Low Dose + High Dose (at Week 8) n=6 Participants 1 PDC-1421 Capsule for 28 days + 2 PDC-1421 Capsules for 28 days, trice daily, p.o. after meals PDC-1421 Capsule: PDC-1421 Capsule is a botanical investigational new drug containing the extract of Radix Polygalae (Polygala tenuifolia Willd.) as active ingredient.	Low Dose + High Dose (Week 0-8) n=6 Participants 1 PDC-1421 Capsule for 28 days + 2 PDC-1421 Capsules for 28 days, trice daily, p.o. after meals PDC-1421 Capsule: PDC-1421 Capsule is a botanical investigational new drug containing the extract of Radix Polygalae (Polygala tenuifolia Willd.) as active ingredient. The score change is calculated from the score of week 8 comparing to week 0.
Change in ITT Population From Baseline up to 4 and 8 Weeks in the ADHD-RS-IV Inattention Subscale, Hyperactivity-impulsivity Subscale, and Total Scale Raw Score. Inattention subscale	-10.5 score on a scale Standard Deviation 8.2	-12.2 score on a scale Standard Deviation 7.9
Change in ITT Population From Baseline up to 4 and 8 Weeks in the ADHD-RS-IV Inattention Subscale, Hyperactivity-impulsivity Subscale, and Total Scale Raw Score. Hyperactivity-impulsivity subscale	-7.2 score on a scale Standard Deviation 5.3	-10.5 score on a scale Standard Deviation 4.1
Change in ITT Population From Baseline up to 4 and 8 Weeks in the ADHD-RS-IV Inattention Subscale, Hyperactivity-impulsivity Subscale, and Total Scale Raw Score. Total scale	-17.7 score on a scale Standard Deviation 13.2	-25.7 score on a scale Standard Deviation 11.0

Adverse Events

Low Dose + High Dose

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Low Dose + High Dose n=6 participants at risk 1 PDC-1421 Capsule for 28 days + 2 PDC-1421 Capsules for 28 days, trice daily, p.o. after meals PDC-1421 Capsule: PDC-1421 Capsule is a botanical investigational new drug containing the extract of Radix Polygalae (Polygala tenuifolia Willd.) as active ingredient.
Eye disorders Eye pruritus	16.7% 1/6 • Number of events 1 • 9 weeks
Gastrointestinal disorders Abdominal discomfort	16.7% 1/6 • Number of events 1 • 9 weeks
Gastrointestinal disorders Abdominal distension	16.7% 1/6 • Number of events 1 • 9 weeks
Gastrointestinal disorders Abdominal pain upper	16.7% 1/6 • Number of events 1 • 9 weeks
Gastrointestinal disorders Coating in mouth	16.7% 1/6 • Number of events 1 • 9 weeks
Gastrointestinal disorders Dyspepsia	16.7% 1/6 • Number of events 1 • 9 weeks
Gastrointestinal disorders Flatulence	16.7% 1/6 • Number of events 1 • 9 weeks
Gastrointestinal disorders Gastrointestinal pain	16.7% 1/6 • Number of events 1 • 9 weeks
General disorders Lethargy	16.7% 1/6 • Number of events 1 • 9 weeks
Infections and infestations Sinusitis	16.7% 1/6 • Number of events 1 • 9 weeks
Musculoskeletal and connective tissue disorders Arthralgia	16.7% 1/6 • Number of events 1 • 9 weeks
Musculoskeletal and connective tissue disorders Muscle spasms	16.7% 1/6 • Number of events 1 • 9 weeks
Nervous system disorders Dizziness	16.7% 1/6 • Number of events 1 • 9 weeks
Psychiatric disorders Insomnia	16.7% 1/6 • Number of events 1 • 9 weeks
Psychiatric disorders Irritable bowel syndrome	16.7% 1/6 • Number of events 1 • 9 weeks
Respiratory, thoracic and mediastinal disorders Cough	16.7% 1/6 • Number of events 1 • 9 weeks
Respiratory, thoracic and mediastinal disorders Dyspnoea	16.7% 1/6 • Number of events 1 • 9 weeks
Respiratory, thoracic and mediastinal disorders Epistaxis	16.7% 1/6 • Number of events 1 • 9 weeks
Respiratory, thoracic and mediastinal disorders Nasal discomfort	16.7% 1/6 • Number of events 1 • 9 weeks
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	16.7% 1/6 • Number of events 1 • 9 weeks
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	16.7% 1/6 • Number of events 1 • 9 weeks
Respiratory, thoracic and mediastinal disorders Sneezing	16.7% 1/6 • Number of events 1 • 9 weeks

Additional Information

Hsien-Ming Wu

BioLite, Inc.

Phone: +886-6579631

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place