A Phase 2 interventional study of PDC-1421 Capsule in Attention-Deficit Hyperactivity Disorder (ADHD), sponsored by BioLite, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2021-12-01.
Sponsored by BioLite, Inc. · Phase 2, Interventional, and Treatment
The primary objective of this trial was to determine the effective doses and treatment period of PDC-1421 Capsule in subjects with ADHD.
The secondary objective was to evaluate the safety of PDC-1421 Capsule in subjects receiving PDC-1421 at various dose levels.
This study was a Part I of Phase II study designed to evaluate the safety and efficacy in adult patients with ADHD. The Screening phase is intended for diagnosing and assessing the patient for possible inclusion in the study and for providing an adequate washout period. The targeted population of this Part I study is six subjects who met the intent-to-treat per-protocol basis.
Part I study is an open-label study, single-center, and dose escalation evaluation in six patients.
729 studies on the registry are indexed under Hyperkinesis; 25 are open to participants now.
This study's enrollment of 6 is below the median of 80 across 583 interventional studies indexed under Hyperkinesis.
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Exclusion Criteria:
1 PDC-1421 Capsule, trice daily, p.o. after meal for 28 + 28 days
Drug: PDC-1421 Capsule
1 PDC-1421 Capsule for 28 days + 2 PDC-1421 Capsules for 28 days, trice daily, p.o. after meals
Drug: PDC-1421 Capsule
PDC-1421 Capsule is a botanical investigational new drug containing the extract of Radix Polygalae (Polygala tenuifolia Willd.) as active ingredient.
Number of Participants With Improvement ≥ 40% in ADHD-RS-IV From Baseline up to 8 Weeks Treatment
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.
Time frame: 8 weeks
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.
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.
Time frame: 8 weeks
Number of Participants With a CGI Score of 2 or Lower
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).
Time frame: 8 weeks
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.
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.
Time frame: 8 Weeks
| Milestone | Low Dose + Low Dose | Low Dose + High Dose |
|---|---|---|
| Started | 0 | 6 |
| Completed | 0 | 6 |
| Not completed | 0 | 0 |
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.
| Participants | Low Dose + High Dose (at Week 8) |
|---|---|
| Number of Participants With Improvement ≥ 40% in ADHD-RS-IV From Baseline up to 8 Weeks Treatment | 5 |
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.
| T-score | Low Dose + High Dose (Week 0-4) | Low Dose + High Dose (Week 0-8) |
|---|---|---|
| Inattention/memory subscale | -10.0 ± 10.2 | -10.5 ± 11.0 |
| Hyperactivity subscale | -6.2 ± 7.1 | -5.2 ± 5.9 |
| Impulsivity subscale | -10.8 ± 7.1 | -15.2 ± 7.9 |
| Self-concept subscale | -5.7 ± 7.0 | -4.7 ± 6.2 |
| ADHD index subscale | -8.2 ± 7.4 | -10.8 ± 6.2 |
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).
| Participants | Low Dose + High Dose (at Week 4) | Low Dose + High Dose (at Week 8) |
|---|---|---|
| CGI-S | 0 | 2 |
| CGI-I | 1 | 6 |
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.
| score on a scale | Low Dose + High Dose (Week 0-4) | Low Dose + High Dose (Week 0-8) |
|---|---|---|
| Inattention subscale | -10.5 ± 8.2 | -12.2 ± 7.9 |
| Hyperactivity-impulsivity subscale | -7.2 ± 5.3 | -10.5 ± 4.1 |
| Total scale | -17.7 ± 13.2 | -25.7 ± 11.0 |
Collected over 9 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Low Dose + High Dose | 0/6 (0%) | 0/6 (0%) | 4/6 (66.7%) |
| Event | Low Dose + High Dose |
|---|---|
| Eye pruritusEye disorders | 1/6 |
| Abdominal discomfortGastrointestinal disorders | 1/6 |
| Abdominal distensionGastrointestinal disorders | 1/6 |
| Abdominal pain upperGastrointestinal disorders | 1/6 |
| Coating in mouthGastrointestinal disorders | 1/6 |
| DyspepsiaGastrointestinal disorders | 1/6 |
| FlatulenceGastrointestinal disorders | 1/6 |
| Gastrointestinal painGastrointestinal disorders | 1/6 |
| LethargyGeneral disorders | 1/6 |
| SinusitisInfections and infestations | 1/6 |
ITT
| Age, Continuous(years) | Low Dose + High Dose |
|---|---|
| Median | 38.0 (29 to 55) |
| Sex: Female, Male(Participants) | Low Dose + High Dose |
|---|---|
| Female | 2 |
| Male | 4 |
| Race and Ethnicity Not Collected(Participants) | Low Dose + High Dose |
|---|
| Height(cm) | Low Dose + High Dose |
|---|---|
| Median | 178.80 (155.4 to 182.8) |
| Weight(lb) | Low Dose + High Dose |
|---|---|
| Median | 170.0 (106.0 to 190.0) |
| ADHD Rating Scale(units on a scale) | Low Dose + High Dose |
|---|---|
| Mean | 41.8 ± 6.6 |
| CAARS-S:S ADHD Index (T-score)(T-scale) | Low Dose + High Dose |
|---|---|
| Mean | 73.5 ± 8.3 |
| CGI-severity(score on a scale) | Low Dose + High Dose |
|---|---|
| Mean | 5.3 ± 0.5 |
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BioLite, Inc.