Trial Outcomes & Findings for Efficacy and Safety of Methylphenidate HCl ER Capsules in Children and Adolescents With ADHD (NCT NCT01239030)
NCT ID: NCT01239030
Last Updated: 2023-02-22
Results Overview
Change in ADHD-RS-IV Total Score from Baseline (Visit 2) to end of Double Blind Phase (Visit 3); \[Calculations of baseline values (Visit 2) minus end of Double Blind values (Visit 3), higher differences means better outcomes\]. Attention Deficit Hyperactivity Disorder Rating Scale-IV (ADHD-RS-IV): The home version of the ADHD-RS-IV comprising symptoms of ADHD was used. This 18-item scale incorporates each of the ADHD symptoms regardless of assigned subtype. Trained clinicians administered questionnaire to parents. Scoring was based on symptom severity on a 4-point scale: 0=never or rarely, 1=sometimes, 2=often, and 3=very often. The Total Score is the sum of the scores for all 18 items, and could range from 0 (no impairment) to 54 (maximal impairment).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
230 participants
Primary outcome timeframe
From baseline (visit 2) to end of of Double-Blind phase (visit 3)
Results posted on
2023-02-22
Participant Flow
23 December 2010 (First subject screened) 09 November 2011 (Last subject visit in Open-Label Phase)
This study planned to randomize approximately 225 subjects to the Double-Blind phase of the study with the goal of approximately 200 subjects completing the double-blind parallel treatment
Participant milestones
| Measure |
10 mg (Double-Blind) Then Methylphenidate HCl ER Capsules 10, 15, 20, 40, 50 or 60 mg (Open Label)
Subjects randomized to 10 mg Methylphenidate HCl ER Capsules for 1 week of Double-Blind phase, then entered an 11-week Open Label phase where subject doses were optimized to either Methylphenidate HCl ER Capsules 10, 15, 20, 40, 50 or 60 mg via titration
Methylphenidate Hydrochloride Extended Release Capsules 10 mg then Methylphenidate Hydrochloride Extended Release Capsules 10, 15, 20, 40, 50 or 60 mg
Once-A-Day Capsules
|
15 mg (Double-Blind) Then Methylphenidate HCl ER Capsules 10, 15, 20, 40, 50 or 60 mg (Open Label)
Subjects randomized to 15 mg Methylphenidate HCl ER Capsules for 1 week of Double-Blind phase, then entered an 11-week Open Label phase where subject doses were optimized to either Methylphenidate HCl ER Capsules 10, 15, 20, 40, 50 or 60 mg via titration
Methylphenidate Hydrochloride Extended Release Capsules 15 mg then Methylphenidate Hydrochloride Extended Release Capsules 10, 15, 20, 40, 50 or 60 mg
Once-A-Day Capsules
|
20 mg (Double-Blind) Then Methylphenidate HCl ER Capsules 10, 15, 20, 40, 50 or 60 mg (Open Label)
Subjects randomized to 20 mg Methylphenidate HCl ER Capsules for 1 week of Double-Blind phase, then entered an 11-week Open Label phase where subject doses were optimized to either Methylphenidate HCl ER Capsules 10, 15, 20, 40, 50 or 60 mg via titration
Methylphenidate Hydrochloride Extended Release Capsules 20 mg then Methylphenidate Hydrochloride Extended Release Capsules 10, 15, 20, 40, 50 or 60 mg
Once-A-Day Capsules
|
40 mg (Double Blind) Then Methylphenidate HCl ER Capsules 10, 15, 20, 40, 50 or 60 mg (Open Label)
Subjects randomized to 40 mg Methylphenidate HCl ER Capsules for 1 week of Double-Blind phase, then entered an 11-week Open Label phase where subject doses were optimized to either Methylphenidate HCl ER Capsules 10, 15, 20, 40, 50 or 60 mg via titration
Methylphenidate Hydrochloride Extended Release Capsules 40 mg then Methylphenidate Hydrochloride Extended Release Capsules 10, 15, 20, 40, 50 or 60 mg
Once-A-Day Capsules
|
Placebo (Double Blind) Then Methylphenidate HCl ER Capsules 10, 15, 20, 40, 50 or 60 mg (Open Label)
Subjects randomized Placebo Capsules for 1 week of Double-Blind phase, then entered an 11-week Open Label phase where subject doses were optimized to either Methylphenidate HCl ER Capsules 10, 15, 20, 40, 50 or 60 mg via titration
Placebo Capsules then Methylphenidate Hydrochloride Extended Release Capsules 10, 15, 20, 40, 50 or 60 mg
Once-A-Day Capsules
|
|---|---|---|---|---|---|
|
Double Blind
STARTED
|
49
|
44
|
45
|
45
|
47
|
|
Double Blind
COMPLETED
|
48
|
40
|
44
|
43
|
46
|
|
Double Blind
NOT COMPLETED
|
1
|
4
|
1
|
2
|
1
|
|
Dose Optimization (Open Label)
STARTED
|
48
|
40
|
44
|
43
|
46
|
|
Dose Optimization (Open Label)
COMPLETED
|
41
|
38
|
42
|
40
|
39
|
|
Dose Optimization (Open Label)
NOT COMPLETED
|
7
|
2
|
2
|
3
|
7
|
Reasons for withdrawal
| Measure |
10 mg (Double-Blind) Then Methylphenidate HCl ER Capsules 10, 15, 20, 40, 50 or 60 mg (Open Label)
Subjects randomized to 10 mg Methylphenidate HCl ER Capsules for 1 week of Double-Blind phase, then entered an 11-week Open Label phase where subject doses were optimized to either Methylphenidate HCl ER Capsules 10, 15, 20, 40, 50 or 60 mg via titration
Methylphenidate Hydrochloride Extended Release Capsules 10 mg then Methylphenidate Hydrochloride Extended Release Capsules 10, 15, 20, 40, 50 or 60 mg
Once-A-Day Capsules
|
15 mg (Double-Blind) Then Methylphenidate HCl ER Capsules 10, 15, 20, 40, 50 or 60 mg (Open Label)
Subjects randomized to 15 mg Methylphenidate HCl ER Capsules for 1 week of Double-Blind phase, then entered an 11-week Open Label phase where subject doses were optimized to either Methylphenidate HCl ER Capsules 10, 15, 20, 40, 50 or 60 mg via titration
Methylphenidate Hydrochloride Extended Release Capsules 15 mg then Methylphenidate Hydrochloride Extended Release Capsules 10, 15, 20, 40, 50 or 60 mg
Once-A-Day Capsules
|
20 mg (Double-Blind) Then Methylphenidate HCl ER Capsules 10, 15, 20, 40, 50 or 60 mg (Open Label)
Subjects randomized to 20 mg Methylphenidate HCl ER Capsules for 1 week of Double-Blind phase, then entered an 11-week Open Label phase where subject doses were optimized to either Methylphenidate HCl ER Capsules 10, 15, 20, 40, 50 or 60 mg via titration
Methylphenidate Hydrochloride Extended Release Capsules 20 mg then Methylphenidate Hydrochloride Extended Release Capsules 10, 15, 20, 40, 50 or 60 mg
Once-A-Day Capsules
|
40 mg (Double Blind) Then Methylphenidate HCl ER Capsules 10, 15, 20, 40, 50 or 60 mg (Open Label)
Subjects randomized to 40 mg Methylphenidate HCl ER Capsules for 1 week of Double-Blind phase, then entered an 11-week Open Label phase where subject doses were optimized to either Methylphenidate HCl ER Capsules 10, 15, 20, 40, 50 or 60 mg via titration
Methylphenidate Hydrochloride Extended Release Capsules 40 mg then Methylphenidate Hydrochloride Extended Release Capsules 10, 15, 20, 40, 50 or 60 mg
Once-A-Day Capsules
|
Placebo (Double Blind) Then Methylphenidate HCl ER Capsules 10, 15, 20, 40, 50 or 60 mg (Open Label)
Subjects randomized Placebo Capsules for 1 week of Double-Blind phase, then entered an 11-week Open Label phase where subject doses were optimized to either Methylphenidate HCl ER Capsules 10, 15, 20, 40, 50 or 60 mg via titration
Placebo Capsules then Methylphenidate Hydrochloride Extended Release Capsules 10, 15, 20, 40, 50 or 60 mg
Once-A-Day Capsules
|
|---|---|---|---|---|---|
|
Double Blind
Adverse Event
|
0
|
1
|
0
|
2
|
0
|
|
Double Blind
Withdrawal by Subject
|
0
|
1
|
1
|
0
|
1
|
|
Double Blind
Lost to Follow-up
|
1
|
1
|
0
|
0
|
0
|
|
Double Blind
Physician Decision
|
0
|
1
|
0
|
0
|
0
|
|
Dose Optimization (Open Label)
Adverse Event
|
2
|
0
|
2
|
0
|
5
|
|
Dose Optimization (Open Label)
Withdrawal by Subject
|
4
|
1
|
0
|
2
|
1
|
|
Dose Optimization (Open Label)
Lost to Follow-up
|
1
|
1
|
0
|
0
|
1
|
|
Dose Optimization (Open Label)
Physician Decision
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Baseline analysis is based on efficacy population (N = 221).
Baseline characteristics by cohort
| Measure |
10 mg
n=49 Participants
Biphentin Methylphenidate Hydrochloride Extended Release Capsules 10 mg
Methylphenidate Hydrochloride Extended Release Capsules: Biphentin Methylphenidate ER Once-A-Day Capsules
|
15 mg
n=44 Participants
Biphentin Methylphenidate Hydrochloride Extended Release Capsules 15 mg
Methylphenidate Hydrochloride Extended Release Capsules: Biphentin Methylphenidate ER Once-A-Day Capsules
|
20 mg
n=45 Participants
Biphentin Methylphenidate Hydrochloride Extended Release Capsules 20 mg
Methylphenidate Hydrochloride Extended Release Capsules: Biphentin Methylphenidate ER Once-A-Day Capsules
|
40 mg
n=45 Participants
Biphentin Methylphenidate Hydrochloride Extended Release Capsules 40 mg
Methylphenidate Hydrochloride Extended Release Capsules: Biphentin Methylphenidate ER Once-A-Day Capsules
|
Placebo
n=47 Participants
Placebo capsules
Placebo: Placebo Capsules
|
Total
n=230 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
49 Participants
n=49 Participants
|
44 Participants
n=44 Participants
|
45 Participants
n=45 Participants
|
45 Participants
n=45 Participants
|
47 Participants
n=47 Participants
|
230 Participants
n=230 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=49 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=45 Participants
|
0 Participants
n=45 Participants
|
0 Participants
n=47 Participants
|
0 Participants
n=230 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=49 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=45 Participants
|
0 Participants
n=45 Participants
|
0 Participants
n=47 Participants
|
0 Participants
n=230 Participants
|
|
Age, Continuous
|
10.5 years
STANDARD_DEVIATION 2.89 • n=49 Participants
|
10.2 years
STANDARD_DEVIATION 3.08 • n=44 Participants
|
11.1 years
STANDARD_DEVIATION 3.51 • n=45 Participants
|
11.2 years
STANDARD_DEVIATION 2.49 • n=45 Participants
|
10.9 years
STANDARD_DEVIATION 3.05 • n=47 Participants
|
10.8 years
STANDARD_DEVIATION 3.02 • n=230 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=49 Participants
|
14 Participants
n=44 Participants
|
14 Participants
n=45 Participants
|
12 Participants
n=45 Participants
|
17 Participants
n=47 Participants
|
76 Participants
n=230 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=49 Participants
|
30 Participants
n=44 Participants
|
31 Participants
n=45 Participants
|
33 Participants
n=45 Participants
|
30 Participants
n=47 Participants
|
154 Participants
n=230 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=49 Participants
|
8 Participants
n=44 Participants
|
7 Participants
n=45 Participants
|
4 Participants
n=45 Participants
|
3 Participants
n=47 Participants
|
26 Participants
n=230 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
45 Participants
n=49 Participants
|
36 Participants
n=44 Participants
|
38 Participants
n=45 Participants
|
41 Participants
n=45 Participants
|
44 Participants
n=47 Participants
|
204 Participants
n=230 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=49 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=45 Participants
|
0 Participants
n=45 Participants
|
0 Participants
n=47 Participants
|
0 Participants
n=230 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=49 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=45 Participants
|
1 Participants
n=45 Participants
|
1 Participants
n=47 Participants
|
2 Participants
n=230 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=49 Participants
|
2 Participants
n=44 Participants
|
0 Participants
n=45 Participants
|
0 Participants
n=45 Participants
|
1 Participants
n=47 Participants
|
3 Participants
n=230 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=49 Participants
|
2 Participants
n=44 Participants
|
0 Participants
n=45 Participants
|
0 Participants
n=45 Participants
|
0 Participants
n=47 Participants
|
2 Participants
n=230 Participants
|
|
Race (NIH/OMB)
Black or African American
|
13 Participants
n=49 Participants
|
11 Participants
n=44 Participants
|
9 Participants
n=45 Participants
|
11 Participants
n=45 Participants
|
9 Participants
n=47 Participants
|
53 Participants
n=230 Participants
|
|
Race (NIH/OMB)
White
|
34 Participants
n=49 Participants
|
26 Participants
n=44 Participants
|
33 Participants
n=45 Participants
|
32 Participants
n=45 Participants
|
33 Participants
n=47 Participants
|
158 Participants
n=230 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=49 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=45 Participants
|
0 Participants
n=45 Participants
|
0 Participants
n=47 Participants
|
0 Participants
n=230 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=49 Participants
|
3 Participants
n=44 Participants
|
3 Participants
n=45 Participants
|
1 Participants
n=45 Participants
|
3 Participants
n=47 Participants
|
12 Participants
n=230 Participants
|
|
Region of Enrollment
United States
|
49 participants
n=49 Participants
|
44 participants
n=44 Participants
|
45 participants
n=45 Participants
|
45 participants
n=45 Participants
|
47 participants
n=47 Participants
|
230 participants
n=230 Participants
|
|
ADHD-RS-IV
|
37.6 units on a scale
STANDARD_DEVIATION 8.32 • n=48 Participants • Baseline analysis is based on efficacy population (N = 221).
|
38.0 units on a scale
STANDARD_DEVIATION 8.64 • n=40 Participants • Baseline analysis is based on efficacy population (N = 221).
|
36.2 units on a scale
STANDARD_DEVIATION 8.46 • n=44 Participants • Baseline analysis is based on efficacy population (N = 221).
|
35.6 units on a scale
STANDARD_DEVIATION 9.16 • n=43 Participants • Baseline analysis is based on efficacy population (N = 221).
|
33.4 units on a scale
STANDARD_DEVIATION 11.01 • n=46 Participants • Baseline analysis is based on efficacy population (N = 221).
|
36.1 units on a scale
STANDARD_DEVIATION 9.25 • n=221 Participants • Baseline analysis is based on efficacy population (N = 221).
|
PRIMARY outcome
Timeframe: From baseline (visit 2) to end of of Double-Blind phase (visit 3)Population: Efficacy Population (N = 221) comprises subjects who completed ADHD-RS-IV assessments on Day 0 and Day 7.
Change in ADHD-RS-IV Total Score from Baseline (Visit 2) to end of Double Blind Phase (Visit 3); \[Calculations of baseline values (Visit 2) minus end of Double Blind values (Visit 3), higher differences means better outcomes\]. Attention Deficit Hyperactivity Disorder Rating Scale-IV (ADHD-RS-IV): The home version of the ADHD-RS-IV comprising symptoms of ADHD was used. This 18-item scale incorporates each of the ADHD symptoms regardless of assigned subtype. Trained clinicians administered questionnaire to parents. Scoring was based on symptom severity on a 4-point scale: 0=never or rarely, 1=sometimes, 2=often, and 3=very often. The Total Score is the sum of the scores for all 18 items, and could range from 0 (no impairment) to 54 (maximal impairment).
Outcome measures
| Measure |
10 mg
n=48 Participants
Biphentin Methylphenidate Hydrochloride Extended Release Capsules 10 mg
Methylphenidate Hydrochloride Extended Release Capsules: Biphentin Methylphenidate ER Once-A-Day Capsules
Placebo: Placebo Capsules
|
15 mg
n=40 Participants
Biphentin Methylphenidate Hydrochloride Extended Release Capsules 15 mg
Methylphenidate Hydrochloride Extended Release Capsules: Biphentin Methylphenidate ER Once-A-Day Capsules
Placebo: Placebo Capsules
|
20 mg
n=44 Participants
Biphentin Methylphenidate Hydrochloride Extended Release Capsules 20 mg
Methylphenidate Hydrochloride Extended Release Capsules: Biphentin Methylphenidate ER Once-A-Day Capsules
Placebo: Placebo Capsules
|
40 mg
n=43 Participants
Biphentin Methylphenidate Hydrochloride Extended Release Capsules 40 mg
Methylphenidate Hydrochloride Extended Release Capsules: Biphentin Methylphenidate ER Once-A-Day Capsules
Placebo: Placebo Capsules
|
Placebo
n=46 Participants
Placebo capsules
Methylphenidate Hydrochloride Extended Release Capsules: Biphentin Methylphenidate ER Once-A-Day Capsules
Placebo: Placebo Capsules
|
|---|---|---|---|---|---|
|
Change in ADHD-RS-IV Total Score From Baseline (Visit 2) to the End of the Double-Blind Phase (Visit 3)
|
9.3 units on a scale
Standard Deviation 8.86
|
11.2 units on a scale
Standard Deviation 12.06
|
12.3 units on a scale
Standard Deviation 9.84
|
13.2 units on a scale
Standard Deviation 10.29
|
5.1 units on a scale
Standard Deviation 10.29
|
Adverse Events
Double Blind Phase - Biphentin 10 mg
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Double Blind Phase - Biphentin 15 mg
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
Double Blind Phase - Biphentin 20 mg
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Double Blind Phase - Biphentin 40 mg
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Double Blind Phase - Placebo
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Open Label Phase - Biphentin (10, 15, 20, 30, 40, 50 or 60 mg)
Serious events: 1 serious events
Other events: 116 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Double Blind Phase - Biphentin 10 mg
n=49 participants at risk
Double Blind Phase (Week 1) - Biphentin 10 mg: Methylphenidate Hydrochloride Extended Release Capsules 10 mg. Once-A-Day Capsules
|
Double Blind Phase - Biphentin 15 mg
n=44 participants at risk
Double Blind Phase (Week 1) - Biphentin 15 mg: Methylphenidate Hydrochloride Extended Release Capsules 15 mg. Once-A-Day Capsules
|
Double Blind Phase - Biphentin 20 mg
n=45 participants at risk
Double Blind Phase (Week 1) - Biphentin 20 mg: Methylphenidate Hydrochloride Extended Release Capsules 20 mg. Once-A-Day Capsules
|
Double Blind Phase - Biphentin 40 mg
n=45 participants at risk
Double Blind Phase (Week 1) - Biphentin 40 mg: Methylphenidate Hydrochloride Extended Release Capsules 40 mg. Once-A-Day Capsules
|
Double Blind Phase - Placebo
n=47 participants at risk
Double Blind Phase (Week 1) - Placebo capsules Once daily
|
Open Label Phase - Biphentin (10, 15, 20, 30, 40, 50 or 60 mg)
n=221 participants at risk
Open Label Phase (Week 2-Week 12) - Biphentin Methylphenidate Hydrochloride Extended Release Capsules (10, 15, 20, 30, 40, 50, or 60 mg as directed by Clinician). Once daily
|
|---|---|---|---|---|---|---|
|
Psychiatric disorders
Adjustment disorder with mixed disturbance or emotion and conduct
|
0.00%
0/49 • Treatment-Related Adverse event data during the 12 week study by phase of study. Double Blind phase (one week duration) followed by Open Label phase (11 week duration).
Treatment-Related AEs for Safety Population. Since subjects received multiple dose levels during the open label phase and a subject may have experienced an adverse event which started on one dose level and was ongoing at subsequent dose level(s), the adverse events are presented for all dose levels combined.
|
2.3%
1/44 • Treatment-Related Adverse event data during the 12 week study by phase of study. Double Blind phase (one week duration) followed by Open Label phase (11 week duration).
Treatment-Related AEs for Safety Population. Since subjects received multiple dose levels during the open label phase and a subject may have experienced an adverse event which started on one dose level and was ongoing at subsequent dose level(s), the adverse events are presented for all dose levels combined.
|
0.00%
0/45 • Treatment-Related Adverse event data during the 12 week study by phase of study. Double Blind phase (one week duration) followed by Open Label phase (11 week duration).
Treatment-Related AEs for Safety Population. Since subjects received multiple dose levels during the open label phase and a subject may have experienced an adverse event which started on one dose level and was ongoing at subsequent dose level(s), the adverse events are presented for all dose levels combined.
|
0.00%
0/45 • Treatment-Related Adverse event data during the 12 week study by phase of study. Double Blind phase (one week duration) followed by Open Label phase (11 week duration).
Treatment-Related AEs for Safety Population. Since subjects received multiple dose levels during the open label phase and a subject may have experienced an adverse event which started on one dose level and was ongoing at subsequent dose level(s), the adverse events are presented for all dose levels combined.
|
0.00%
0/47 • Treatment-Related Adverse event data during the 12 week study by phase of study. Double Blind phase (one week duration) followed by Open Label phase (11 week duration).
Treatment-Related AEs for Safety Population. Since subjects received multiple dose levels during the open label phase and a subject may have experienced an adverse event which started on one dose level and was ongoing at subsequent dose level(s), the adverse events are presented for all dose levels combined.
|
0.00%
0/221 • Treatment-Related Adverse event data during the 12 week study by phase of study. Double Blind phase (one week duration) followed by Open Label phase (11 week duration).
Treatment-Related AEs for Safety Population. Since subjects received multiple dose levels during the open label phase and a subject may have experienced an adverse event which started on one dose level and was ongoing at subsequent dose level(s), the adverse events are presented for all dose levels combined.
|
|
Nervous system disorders
Migraine
|
0.00%
0/49 • Treatment-Related Adverse event data during the 12 week study by phase of study. Double Blind phase (one week duration) followed by Open Label phase (11 week duration).
Treatment-Related AEs for Safety Population. Since subjects received multiple dose levels during the open label phase and a subject may have experienced an adverse event which started on one dose level and was ongoing at subsequent dose level(s), the adverse events are presented for all dose levels combined.
|
0.00%
0/44 • Treatment-Related Adverse event data during the 12 week study by phase of study. Double Blind phase (one week duration) followed by Open Label phase (11 week duration).
Treatment-Related AEs for Safety Population. Since subjects received multiple dose levels during the open label phase and a subject may have experienced an adverse event which started on one dose level and was ongoing at subsequent dose level(s), the adverse events are presented for all dose levels combined.
|
0.00%
0/45 • Treatment-Related Adverse event data during the 12 week study by phase of study. Double Blind phase (one week duration) followed by Open Label phase (11 week duration).
Treatment-Related AEs for Safety Population. Since subjects received multiple dose levels during the open label phase and a subject may have experienced an adverse event which started on one dose level and was ongoing at subsequent dose level(s), the adverse events are presented for all dose levels combined.
|
0.00%
0/45 • Treatment-Related Adverse event data during the 12 week study by phase of study. Double Blind phase (one week duration) followed by Open Label phase (11 week duration).
Treatment-Related AEs for Safety Population. Since subjects received multiple dose levels during the open label phase and a subject may have experienced an adverse event which started on one dose level and was ongoing at subsequent dose level(s), the adverse events are presented for all dose levels combined.
|
0.00%
0/47 • Treatment-Related Adverse event data during the 12 week study by phase of study. Double Blind phase (one week duration) followed by Open Label phase (11 week duration).
Treatment-Related AEs for Safety Population. Since subjects received multiple dose levels during the open label phase and a subject may have experienced an adverse event which started on one dose level and was ongoing at subsequent dose level(s), the adverse events are presented for all dose levels combined.
|
0.45%
1/221 • Treatment-Related Adverse event data during the 12 week study by phase of study. Double Blind phase (one week duration) followed by Open Label phase (11 week duration).
Treatment-Related AEs for Safety Population. Since subjects received multiple dose levels during the open label phase and a subject may have experienced an adverse event which started on one dose level and was ongoing at subsequent dose level(s), the adverse events are presented for all dose levels combined.
|
Other adverse events
| Measure |
Double Blind Phase - Biphentin 10 mg
n=49 participants at risk
Double Blind Phase (Week 1) - Biphentin 10 mg: Methylphenidate Hydrochloride Extended Release Capsules 10 mg. Once-A-Day Capsules
|
Double Blind Phase - Biphentin 15 mg
n=44 participants at risk
Double Blind Phase (Week 1) - Biphentin 15 mg: Methylphenidate Hydrochloride Extended Release Capsules 15 mg. Once-A-Day Capsules
|
Double Blind Phase - Biphentin 20 mg
n=45 participants at risk
Double Blind Phase (Week 1) - Biphentin 20 mg: Methylphenidate Hydrochloride Extended Release Capsules 20 mg. Once-A-Day Capsules
|
Double Blind Phase - Biphentin 40 mg
n=45 participants at risk
Double Blind Phase (Week 1) - Biphentin 40 mg: Methylphenidate Hydrochloride Extended Release Capsules 40 mg. Once-A-Day Capsules
|
Double Blind Phase - Placebo
n=47 participants at risk
Double Blind Phase (Week 1) - Placebo capsules Once daily
|
Open Label Phase - Biphentin (10, 15, 20, 30, 40, 50 or 60 mg)
n=221 participants at risk
Open Label Phase (Week 2-Week 12) - Biphentin Methylphenidate Hydrochloride Extended Release Capsules (10, 15, 20, 30, 40, 50, or 60 mg as directed by Clinician). Once daily
|
|---|---|---|---|---|---|---|
|
Nervous system disorders
headache
|
10.2%
5/49 • Treatment-Related Adverse event data during the 12 week study by phase of study. Double Blind phase (one week duration) followed by Open Label phase (11 week duration).
Treatment-Related AEs for Safety Population. Since subjects received multiple dose levels during the open label phase and a subject may have experienced an adverse event which started on one dose level and was ongoing at subsequent dose level(s), the adverse events are presented for all dose levels combined.
|
6.8%
3/44 • Treatment-Related Adverse event data during the 12 week study by phase of study. Double Blind phase (one week duration) followed by Open Label phase (11 week duration).
Treatment-Related AEs for Safety Population. Since subjects received multiple dose levels during the open label phase and a subject may have experienced an adverse event which started on one dose level and was ongoing at subsequent dose level(s), the adverse events are presented for all dose levels combined.
|
13.3%
6/45 • Treatment-Related Adverse event data during the 12 week study by phase of study. Double Blind phase (one week duration) followed by Open Label phase (11 week duration).
Treatment-Related AEs for Safety Population. Since subjects received multiple dose levels during the open label phase and a subject may have experienced an adverse event which started on one dose level and was ongoing at subsequent dose level(s), the adverse events are presented for all dose levels combined.
|
11.1%
5/45 • Treatment-Related Adverse event data during the 12 week study by phase of study. Double Blind phase (one week duration) followed by Open Label phase (11 week duration).
Treatment-Related AEs for Safety Population. Since subjects received multiple dose levels during the open label phase and a subject may have experienced an adverse event which started on one dose level and was ongoing at subsequent dose level(s), the adverse events are presented for all dose levels combined.
|
2.1%
1/47 • Treatment-Related Adverse event data during the 12 week study by phase of study. Double Blind phase (one week duration) followed by Open Label phase (11 week duration).
Treatment-Related AEs for Safety Population. Since subjects received multiple dose levels during the open label phase and a subject may have experienced an adverse event which started on one dose level and was ongoing at subsequent dose level(s), the adverse events are presented for all dose levels combined.
|
14.0%
31/221 • Treatment-Related Adverse event data during the 12 week study by phase of study. Double Blind phase (one week duration) followed by Open Label phase (11 week duration).
Treatment-Related AEs for Safety Population. Since subjects received multiple dose levels during the open label phase and a subject may have experienced an adverse event which started on one dose level and was ongoing at subsequent dose level(s), the adverse events are presented for all dose levels combined.
|
|
Nervous system disorders
Insomnia
|
8.2%
4/49 • Treatment-Related Adverse event data during the 12 week study by phase of study. Double Blind phase (one week duration) followed by Open Label phase (11 week duration).
Treatment-Related AEs for Safety Population. Since subjects received multiple dose levels during the open label phase and a subject may have experienced an adverse event which started on one dose level and was ongoing at subsequent dose level(s), the adverse events are presented for all dose levels combined.
|
4.5%
2/44 • Treatment-Related Adverse event data during the 12 week study by phase of study. Double Blind phase (one week duration) followed by Open Label phase (11 week duration).
Treatment-Related AEs for Safety Population. Since subjects received multiple dose levels during the open label phase and a subject may have experienced an adverse event which started on one dose level and was ongoing at subsequent dose level(s), the adverse events are presented for all dose levels combined.
|
13.3%
6/45 • Treatment-Related Adverse event data during the 12 week study by phase of study. Double Blind phase (one week duration) followed by Open Label phase (11 week duration).
Treatment-Related AEs for Safety Population. Since subjects received multiple dose levels during the open label phase and a subject may have experienced an adverse event which started on one dose level and was ongoing at subsequent dose level(s), the adverse events are presented for all dose levels combined.
|
11.1%
5/45 • Treatment-Related Adverse event data during the 12 week study by phase of study. Double Blind phase (one week duration) followed by Open Label phase (11 week duration).
Treatment-Related AEs for Safety Population. Since subjects received multiple dose levels during the open label phase and a subject may have experienced an adverse event which started on one dose level and was ongoing at subsequent dose level(s), the adverse events are presented for all dose levels combined.
|
2.1%
1/47 • Treatment-Related Adverse event data during the 12 week study by phase of study. Double Blind phase (one week duration) followed by Open Label phase (11 week duration).
Treatment-Related AEs for Safety Population. Since subjects received multiple dose levels during the open label phase and a subject may have experienced an adverse event which started on one dose level and was ongoing at subsequent dose level(s), the adverse events are presented for all dose levels combined.
|
11.8%
26/221 • Treatment-Related Adverse event data during the 12 week study by phase of study. Double Blind phase (one week duration) followed by Open Label phase (11 week duration).
Treatment-Related AEs for Safety Population. Since subjects received multiple dose levels during the open label phase and a subject may have experienced an adverse event which started on one dose level and was ongoing at subsequent dose level(s), the adverse events are presented for all dose levels combined.
|
|
Gastrointestinal disorders
abdominal pain upper
|
6.1%
3/49 • Treatment-Related Adverse event data during the 12 week study by phase of study. Double Blind phase (one week duration) followed by Open Label phase (11 week duration).
Treatment-Related AEs for Safety Population. Since subjects received multiple dose levels during the open label phase and a subject may have experienced an adverse event which started on one dose level and was ongoing at subsequent dose level(s), the adverse events are presented for all dose levels combined.
|
9.1%
4/44 • Treatment-Related Adverse event data during the 12 week study by phase of study. Double Blind phase (one week duration) followed by Open Label phase (11 week duration).
Treatment-Related AEs for Safety Population. Since subjects received multiple dose levels during the open label phase and a subject may have experienced an adverse event which started on one dose level and was ongoing at subsequent dose level(s), the adverse events are presented for all dose levels combined.
|
8.9%
4/45 • Treatment-Related Adverse event data during the 12 week study by phase of study. Double Blind phase (one week duration) followed by Open Label phase (11 week duration).
Treatment-Related AEs for Safety Population. Since subjects received multiple dose levels during the open label phase and a subject may have experienced an adverse event which started on one dose level and was ongoing at subsequent dose level(s), the adverse events are presented for all dose levels combined.
|
2.2%
1/45 • Treatment-Related Adverse event data during the 12 week study by phase of study. Double Blind phase (one week duration) followed by Open Label phase (11 week duration).
Treatment-Related AEs for Safety Population. Since subjects received multiple dose levels during the open label phase and a subject may have experienced an adverse event which started on one dose level and was ongoing at subsequent dose level(s), the adverse events are presented for all dose levels combined.
|
0.00%
0/47 • Treatment-Related Adverse event data during the 12 week study by phase of study. Double Blind phase (one week duration) followed by Open Label phase (11 week duration).
Treatment-Related AEs for Safety Population. Since subjects received multiple dose levels during the open label phase and a subject may have experienced an adverse event which started on one dose level and was ongoing at subsequent dose level(s), the adverse events are presented for all dose levels combined.
|
9.5%
21/221 • Treatment-Related Adverse event data during the 12 week study by phase of study. Double Blind phase (one week duration) followed by Open Label phase (11 week duration).
Treatment-Related AEs for Safety Population. Since subjects received multiple dose levels during the open label phase and a subject may have experienced an adverse event which started on one dose level and was ongoing at subsequent dose level(s), the adverse events are presented for all dose levels combined.
|
|
Metabolism and nutrition disorders
decreased appetite
|
2.0%
1/49 • Treatment-Related Adverse event data during the 12 week study by phase of study. Double Blind phase (one week duration) followed by Open Label phase (11 week duration).
Treatment-Related AEs for Safety Population. Since subjects received multiple dose levels during the open label phase and a subject may have experienced an adverse event which started on one dose level and was ongoing at subsequent dose level(s), the adverse events are presented for all dose levels combined.
|
4.5%
2/44 • Treatment-Related Adverse event data during the 12 week study by phase of study. Double Blind phase (one week duration) followed by Open Label phase (11 week duration).
Treatment-Related AEs for Safety Population. Since subjects received multiple dose levels during the open label phase and a subject may have experienced an adverse event which started on one dose level and was ongoing at subsequent dose level(s), the adverse events are presented for all dose levels combined.
|
8.9%
4/45 • Treatment-Related Adverse event data during the 12 week study by phase of study. Double Blind phase (one week duration) followed by Open Label phase (11 week duration).
Treatment-Related AEs for Safety Population. Since subjects received multiple dose levels during the open label phase and a subject may have experienced an adverse event which started on one dose level and was ongoing at subsequent dose level(s), the adverse events are presented for all dose levels combined.
|
4.4%
2/45 • Treatment-Related Adverse event data during the 12 week study by phase of study. Double Blind phase (one week duration) followed by Open Label phase (11 week duration).
Treatment-Related AEs for Safety Population. Since subjects received multiple dose levels during the open label phase and a subject may have experienced an adverse event which started on one dose level and was ongoing at subsequent dose level(s), the adverse events are presented for all dose levels combined.
|
0.00%
0/47 • Treatment-Related Adverse event data during the 12 week study by phase of study. Double Blind phase (one week duration) followed by Open Label phase (11 week duration).
Treatment-Related AEs for Safety Population. Since subjects received multiple dose levels during the open label phase and a subject may have experienced an adverse event which started on one dose level and was ongoing at subsequent dose level(s), the adverse events are presented for all dose levels combined.
|
19.0%
42/221 • Treatment-Related Adverse event data during the 12 week study by phase of study. Double Blind phase (one week duration) followed by Open Label phase (11 week duration).
Treatment-Related AEs for Safety Population. Since subjects received multiple dose levels during the open label phase and a subject may have experienced an adverse event which started on one dose level and was ongoing at subsequent dose level(s), the adverse events are presented for all dose levels combined.
|
|
General disorders
fatigue
|
4.1%
2/49 • Treatment-Related Adverse event data during the 12 week study by phase of study. Double Blind phase (one week duration) followed by Open Label phase (11 week duration).
Treatment-Related AEs for Safety Population. Since subjects received multiple dose levels during the open label phase and a subject may have experienced an adverse event which started on one dose level and was ongoing at subsequent dose level(s), the adverse events are presented for all dose levels combined.
|
0.00%
0/44 • Treatment-Related Adverse event data during the 12 week study by phase of study. Double Blind phase (one week duration) followed by Open Label phase (11 week duration).
Treatment-Related AEs for Safety Population. Since subjects received multiple dose levels during the open label phase and a subject may have experienced an adverse event which started on one dose level and was ongoing at subsequent dose level(s), the adverse events are presented for all dose levels combined.
|
0.00%
0/45 • Treatment-Related Adverse event data during the 12 week study by phase of study. Double Blind phase (one week duration) followed by Open Label phase (11 week duration).
Treatment-Related AEs for Safety Population. Since subjects received multiple dose levels during the open label phase and a subject may have experienced an adverse event which started on one dose level and was ongoing at subsequent dose level(s), the adverse events are presented for all dose levels combined.
|
0.00%
0/45 • Treatment-Related Adverse event data during the 12 week study by phase of study. Double Blind phase (one week duration) followed by Open Label phase (11 week duration).
Treatment-Related AEs for Safety Population. Since subjects received multiple dose levels during the open label phase and a subject may have experienced an adverse event which started on one dose level and was ongoing at subsequent dose level(s), the adverse events are presented for all dose levels combined.
|
2.1%
1/47 • Treatment-Related Adverse event data during the 12 week study by phase of study. Double Blind phase (one week duration) followed by Open Label phase (11 week duration).
Treatment-Related AEs for Safety Population. Since subjects received multiple dose levels during the open label phase and a subject may have experienced an adverse event which started on one dose level and was ongoing at subsequent dose level(s), the adverse events are presented for all dose levels combined.
|
4.5%
10/221 • Treatment-Related Adverse event data during the 12 week study by phase of study. Double Blind phase (one week duration) followed by Open Label phase (11 week duration).
Treatment-Related AEs for Safety Population. Since subjects received multiple dose levels during the open label phase and a subject may have experienced an adverse event which started on one dose level and was ongoing at subsequent dose level(s), the adverse events are presented for all dose levels combined.
|
|
Psychiatric disorders
irritability
|
0.00%
0/49 • Treatment-Related Adverse event data during the 12 week study by phase of study. Double Blind phase (one week duration) followed by Open Label phase (11 week duration).
Treatment-Related AEs for Safety Population. Since subjects received multiple dose levels during the open label phase and a subject may have experienced an adverse event which started on one dose level and was ongoing at subsequent dose level(s), the adverse events are presented for all dose levels combined.
|
0.00%
0/44 • Treatment-Related Adverse event data during the 12 week study by phase of study. Double Blind phase (one week duration) followed by Open Label phase (11 week duration).
Treatment-Related AEs for Safety Population. Since subjects received multiple dose levels during the open label phase and a subject may have experienced an adverse event which started on one dose level and was ongoing at subsequent dose level(s), the adverse events are presented for all dose levels combined.
|
2.2%
1/45 • Treatment-Related Adverse event data during the 12 week study by phase of study. Double Blind phase (one week duration) followed by Open Label phase (11 week duration).
Treatment-Related AEs for Safety Population. Since subjects received multiple dose levels during the open label phase and a subject may have experienced an adverse event which started on one dose level and was ongoing at subsequent dose level(s), the adverse events are presented for all dose levels combined.
|
2.2%
1/45 • Treatment-Related Adverse event data during the 12 week study by phase of study. Double Blind phase (one week duration) followed by Open Label phase (11 week duration).
Treatment-Related AEs for Safety Population. Since subjects received multiple dose levels during the open label phase and a subject may have experienced an adverse event which started on one dose level and was ongoing at subsequent dose level(s), the adverse events are presented for all dose levels combined.
|
0.00%
0/47 • Treatment-Related Adverse event data during the 12 week study by phase of study. Double Blind phase (one week duration) followed by Open Label phase (11 week duration).
Treatment-Related AEs for Safety Population. Since subjects received multiple dose levels during the open label phase and a subject may have experienced an adverse event which started on one dose level and was ongoing at subsequent dose level(s), the adverse events are presented for all dose levels combined.
|
5.0%
11/221 • Treatment-Related Adverse event data during the 12 week study by phase of study. Double Blind phase (one week duration) followed by Open Label phase (11 week duration).
Treatment-Related AEs for Safety Population. Since subjects received multiple dose levels during the open label phase and a subject may have experienced an adverse event which started on one dose level and was ongoing at subsequent dose level(s), the adverse events are presented for all dose levels combined.
|
|
Psychiatric disorders
Affect Liability
|
0.00%
0/49 • Treatment-Related Adverse event data during the 12 week study by phase of study. Double Blind phase (one week duration) followed by Open Label phase (11 week duration).
Treatment-Related AEs for Safety Population. Since subjects received multiple dose levels during the open label phase and a subject may have experienced an adverse event which started on one dose level and was ongoing at subsequent dose level(s), the adverse events are presented for all dose levels combined.
|
0.00%
0/44 • Treatment-Related Adverse event data during the 12 week study by phase of study. Double Blind phase (one week duration) followed by Open Label phase (11 week duration).
Treatment-Related AEs for Safety Population. Since subjects received multiple dose levels during the open label phase and a subject may have experienced an adverse event which started on one dose level and was ongoing at subsequent dose level(s), the adverse events are presented for all dose levels combined.
|
0.00%
0/45 • Treatment-Related Adverse event data during the 12 week study by phase of study. Double Blind phase (one week duration) followed by Open Label phase (11 week duration).
Treatment-Related AEs for Safety Population. Since subjects received multiple dose levels during the open label phase and a subject may have experienced an adverse event which started on one dose level and was ongoing at subsequent dose level(s), the adverse events are presented for all dose levels combined.
|
0.00%
0/45 • Treatment-Related Adverse event data during the 12 week study by phase of study. Double Blind phase (one week duration) followed by Open Label phase (11 week duration).
Treatment-Related AEs for Safety Population. Since subjects received multiple dose levels during the open label phase and a subject may have experienced an adverse event which started on one dose level and was ongoing at subsequent dose level(s), the adverse events are presented for all dose levels combined.
|
0.00%
0/47 • Treatment-Related Adverse event data during the 12 week study by phase of study. Double Blind phase (one week duration) followed by Open Label phase (11 week duration).
Treatment-Related AEs for Safety Population. Since subjects received multiple dose levels during the open label phase and a subject may have experienced an adverse event which started on one dose level and was ongoing at subsequent dose level(s), the adverse events are presented for all dose levels combined.
|
4.5%
10/221 • Treatment-Related Adverse event data during the 12 week study by phase of study. Double Blind phase (one week duration) followed by Open Label phase (11 week duration).
Treatment-Related AEs for Safety Population. Since subjects received multiple dose levels during the open label phase and a subject may have experienced an adverse event which started on one dose level and was ongoing at subsequent dose level(s), the adverse events are presented for all dose levels combined.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee PI is restricted from using, disclosing, presenting, or publishing trial information without the prior written consent from the Sponsor
- Publication restrictions are in place
Restriction type: OTHER