Trial Outcomes & Findings for A Study in Attention Deficit Hyperactivity Disorder in Children and Adolescents (NCT NCT01127646)

NCT ID: NCT01127646

Last Updated: 2012-11-28

Results Overview

Parent-completed 11-item questionnaire; measures difficulty level of and 8 common evening behaviors (such as, sit through dinner) and 3 common morning behaviors (such as, get out of bed). Each item is scored on a 4-point Likert scale ranging from 0 (no difficulty) to 3 (a lot of difficulty). Total score (evening+morning) range is 0 to 33. Higher scores indicate greater difficulty in evening and morning behavior. DPREMB-R total score between days without missing doses (on-days) and days with missing doses (off-days) was not analyzed due to the insufficient sample size.

• Recruitment status: TERMINATED
• Study phase: PHASE4
• Target enrollment: 23 participants
• Primary outcome timeframe: Baseline through 4 weeks
• Results posted on: 2012-11-28

Participant Flow

Participant milestones

Measure	Atomoxetine Participants received 25-80 milligrams (mg) of atomoxetine orally, once daily for 4 weeks (on/off period), except for the off-days, where participants received 1 or 2 oral once daily placebo doses per week, with 6 nonconsecutive, double-blinded placebo doses in total over the 4-week on/off period.	Osmotic-Release Oral System (OROS) Methylphenidate Participants received 18-54 mg of OROS methylphenidate orally, once daily for 4 weeks (on/off period), except for the off-days, where participants received 1 or 2 oral once daily placebo doses per week, with 6 nonconsecutive, double-blinded placebo doses in total over the 4-week on/off period.
Overall Study STARTED	15	8
Overall Study COMPLETED	14	7
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Measure	Atomoxetine Participants received 25-80 milligrams (mg) of atomoxetine orally, once daily for 4 weeks (on/off period), except for the off-days, where participants received 1 or 2 oral once daily placebo doses per week, with 6 nonconsecutive, double-blinded placebo doses in total over the 4-week on/off period.	Osmotic-Release Oral System (OROS) Methylphenidate Participants received 18-54 mg of OROS methylphenidate orally, once daily for 4 weeks (on/off period), except for the off-days, where participants received 1 or 2 oral once daily placebo doses per week, with 6 nonconsecutive, double-blinded placebo doses in total over the 4-week on/off period.
Overall Study Entry Criteria Not Met	1	0
Overall Study Protocol Violation	0	1

Baseline Characteristics

A Study in Attention Deficit Hyperactivity Disorder in Children and Adolescents

Baseline characteristics by cohort

Measure	Atomoxetine n=15 Participants Participants received 25-80 milligrams (mg) of atomoxetine orally, once daily for 4 weeks (on/off period), except for the off-days, where participants received 1 or 2 oral once daily placebo doses per week, with 6 nonconsecutive, double-blinded placebo doses in total over the 4-week on/off period.	Osmotic-Release Oral System (OROS) Methylphenidate n=8 Participants Participants received 18-54 mg of OROS methylphenidate orally, once daily for 4 weeks (on/off period), except for the off-days, where participants received 1 or 2 oral once daily placebo doses per week, with 6 nonconsecutive, double-blinded placebo doses in total over the 4-week on/off period.	Total n=23 Participants Total of all reporting groups
Age Continuous	10.8 years STANDARD_DEVIATION 2.65 • n=5 Participants	10.9 years STANDARD_DEVIATION 2.80 • n=7 Participants	10.8 years STANDARD_DEVIATION 2.64 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants	6 Participants n=7 Participants	18 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	15 Participants n=5 Participants	7 Participants n=7 Participants	22 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Netherlands	1 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants
Region of Enrollment Spain	12 participants n=5 Participants	8 participants n=7 Participants	20 participants n=5 Participants
Region of Enrollment Sweden	2 participants n=5 Participants	0 participants n=7 Participants	2 participants n=5 Participants
Attention-Deficit/Hyperactivity Disorder (ADHD) Subtype: Current Episode Combined	7 participants n=5 Participants	4 participants n=7 Participants	11 participants n=5 Participants
Attention-Deficit/Hyperactivity Disorder (ADHD) Subtype: Current Episode Hyperactive/Impulsive	0 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants
Attention-Deficit/Hyperactivity Disorder (ADHD) Subtype: Current Episode Inattentive	1 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants
Attention-Deficit/Hyperactivity Disorder (ADHD) Subtype: Current Episode Subtype not present	6 participants n=5 Participants	3 participants n=7 Participants	9 participants n=5 Participants
Attention-Deficit/Hyperactivity Disorder (ADHD) Subtype: Current Episode Missing	1 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants
Attention-Deficit/Hyperactivity Disorder (ADHD) Subtype: Lifetime Episode Combined	8 participants n=5 Participants	7 participants n=7 Participants	15 participants n=5 Participants
Attention-Deficit/Hyperactivity Disorder (ADHD) Subtype: Lifetime Episode Hyperactive/Impulsive	0 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants
Attention-Deficit/Hyperactivity Disorder (ADHD) Subtype: Lifetime Episode Inattentive	5 participants n=5 Participants	0 participants n=7 Participants	5 participants n=5 Participants
Attention-Deficit/Hyperactivity Disorder (ADHD) Subtype: Lifetime Episode Subtype not present	1 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants
Attention-Deficit/Hyperactivity Disorder (ADHD) Subtype: Lifetime Episode Missing	1 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline through 4 weeks

Population: No participants had data analyzed due to the termination of the trial and the insufficient sample size.

Parent-completed 11-item questionnaire; measures difficulty level of and 8 common evening behaviors (such as, sit through dinner) and 3 common morning behaviors (such as, get out of bed). Each item is scored on a 4-point Likert scale ranging from 0 (no difficulty) to 3 (a lot of difficulty). Total score (evening+morning) range is 0 to 33. Higher scores indicate greater difficulty in evening and morning behavior. DPREMB-R total score between days without missing doses (on-days) and days with missing doses (off-days) was not analyzed due to the insufficient sample size.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline through 4 weeks

Population: No participants had data analyzed due to the termination of the trial and the insufficient sample size.

Assesses attention-deficit/hyperactivity disorder (ADHD)-related difficulties (overall difficulties perceived in morning, during school, during homework, in evening, over entire day and night). Participant rates difficulties during past week on 7-point scale (1=normal, not difficult at all; 7=extremely difficult) for each of 5 items. Total score=sum of all subscores (items); range: 5 to 35. Higher scores=greater impairment. GIPD-Pat total score and item scores between days without missing doses (on-days) and days with missing doses (off-days) were not analyzed due to insufficient sample size.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline through 4 weeks

Population: No participants had data analyzed due to the termination of the trial and the insufficient sample size.

The teacher version of Conners' Global Index consists of 10 items with each item being scored on a 4-point scale ranging from 0 (not true at all, or never/seldom) to 3 (very much true, or very often/very frequent). The total score ranges from 0 to 30. Higher scores indicate greater impairment. The Conner's Global Index-Teacher Rating Scale total score between days without missing doses (on-days) and days with missing doses (off-days) was not analyzed due to the insufficient sample size.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline through 4 weeks

Population: No participants had data analyzed due to the termination of the trial and the insufficient sample size.

Assesses attention-deficit/hyperactivity disorder (ADHD)-related difficulties (overall difficulties perceived in morning, during school, during homework, in evening, over entire day and night). Difficulties during past week are rated by participant on a 7-point scale (1=normal, not difficult at all; 7=extremely difficult) for each of 5 items. Total score=sum of all subscores (items); range: 5 to 35. Higher scores=greater impairment. Mean GIPD-Pat total score and individual item scores for days with missing doses (off-days) between both groups were not analyzed due to insufficient sample size.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Weeks 2, 3, and 4

Population: No participants had data analyzed due to the termination of the trial and the insufficient sample size.

Assesses 18 Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision (DSM-IV-TR) ADHD diagnosis symptoms/severity in past week. Each item: 0 (none/never, rarely) to 3 (severe/very often). Total score ranges from 0 to 54. Higher total scores indicate greater illness severity. This outcome measure was not analyzed due to the insufficient sample size.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Weeks 2, 3, and 4

Population: No participants had data analyzed due to the termination of the trial and the insufficient sample size.

This instrument is a single-item expert rating of the severity of the participant's attention-deficit/hyperactivity disorder (ADHD) symptoms in relation to the assessor's total experience of participants with ADHD. Severity is rated on a 7-point scale (1=normal, not ill at all; 7=among the most extremely ill participants). Higher scores represent greater illness severity. This outcome measure was not analyzed due to the insufficient sample size.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to Week 5

Population: No participants had data analyzed due to the termination of the trial and the insufficient sample size.

29-item parent-reported measure used to monitor effect of attention-deficit/hyperactivity disorder (ADHD) medication; examines 3 aspects of emotion expression: positive emotions, emotional flatness, and emotional lability. Each item rated on 5-point Likert scale (1="not at all true" to 5="very much true"). Positive emotional subscale items reversed scored (6-raw score). Total score=transformed positive emotion + emotional flatness+ emotional lability subscales. Total scores range: 29 to 145. Higher scores=emotional impairment. This outcome measure not analyzed due to insufficient sample size.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline through 4 weeks

Population: No participants had data analyzed due to the termination of the trial and the insufficient sample size.

Parent-completed 11-item questionnaire; measures difficulty level of 8 common evening behaviors (such as, sit through dinner) and 3 common morning behaviors (such as, get out of bed) from 0 (no difficulty) to 3 (a lot of difficulty). Evening behavior total score range is 0 to 24. Morning behavior total score range is 0 to 9. Higher scores indicate greater difficulty in evening and morning behavior. DPREMB-R subscores between days without missing doses (on-days) and days with missing doses (off-days) not analyzed due to insufficient sample size.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline through 4 weeks

Population: No participants had data analyzed due to the termination of the trial and the insufficient sample size.

6-item questionnaire from attention-deficit/hyperactivity disorder (ADHD) advocacy group evaluates treatment outcomes ADHD participant's perspective. Parent completed on each day of on/off period. Each item ranged from 1 ("I totally agree") to 5 ("I totally disagree"). Items 1 and 2 pertain to sleeping and eating; high scores=better outcome. Items 3-6 pertain to behavior; high scores=worse outcome. The mean scores for analysis would have been created for each question across the days of each of the on and off phases; however, mean scores were not analyzed due to insufficient sample size.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline through 4 weeks

Population: No participants had data analyzed due to the termination of the trial and the insufficient sample size.

Parent-completed 11-item questionnaire; measures difficulty level of 3 common morning behaviors (such as, get out of bed) and 8 common evening behaviors (such as, sit through dinner) from 0 (no difficulty) to 3 (a lot of difficulty). Evening behavior total score range is 0 to 24. Morning behavior total score range is 0 to 9. Total score (evening+morning) range is 0 to 33. Higher scores indicate greater difficulty in evening and morning behavior. Mean DPREMB-R total score and subscores for days with missing doses (off-days) between both groups were not analyzed due to insufficient sample size.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline through 4 weeks

Population: No participants had data analyzed due to the termination of the trial and the insufficient sample size.

The teacher version of Conners' Global Index consists of 10 items with each item being scored on a 4-point scale ranging from 0 (not true at all, or never/seldom) to 3 (very much true, or very often/very frequent). The total score ranges from 0 to 30. Higher scores indicate greater impairment. The Conners' Global Index-Teacher Rating Scale total score for days with missing doses (off-days) between both groups were not analyzed due to insufficient sample size.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Weeks 2, 3, and 4

Population: No participants had data analyzed due to the termination of the trial and the insufficient sample size.

Assesses attention-deficit/hyperactivity disorder (ADHD)-related difficulties (overall difficulties perceived in morning, during school, during homework, in evening, and over entire day and night). Difficulties during past week are rated by investigator on a 7-point scale (1=normal, not difficult at all; 7=extremely difficult) for each of 5 items. Total score=sum of all subscores (items) and ranges from 5 to 35. Higher scores indicate greater impairment. This outcome measure was not analyzed due to the insufficient sample size.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, up to 5 weeks

Population: Safety population: all participants who entered the study and took at least 1 dose of study medication.

Outcome measures

Measure	Atomoxetine n=14 Participants Participants received 25-80 milligrams (mg) of atomoxetine orally, once daily for 4 weeks (on/off period), except for the off-days, where participants received 1 or 2 oral once daily placebo doses per week, with 6 nonconsecutive, double-blinded placebo doses in total over the 4-week on/off period.	Osmotic-Release Oral System (OROS) Methylphenidate n=7 Participants Participants received 18-54 mg of OROS methylphenidate orally, once daily for 4 weeks (on/off period), except for the off-days, where participants received 1 or 2 oral once daily placebo doses per week, with 6 nonconsecutive, double-blinded placebo doses in total over the 4-week on/off period.
Change From Baseline in Heart Rate up to 5 Weeks	-1.2 beats per minute (bpm) Standard Deviation 7.65	2.5 beats per minute (bpm) Standard Deviation 12.74

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, up to 5 weeks

Population: Safety population: all participants who entered the study and took at least 1 dose of study medication.

Outcome measures

Measure	Atomoxetine n=14 Participants Participants received 25-80 milligrams (mg) of atomoxetine orally, once daily for 4 weeks (on/off period), except for the off-days, where participants received 1 or 2 oral once daily placebo doses per week, with 6 nonconsecutive, double-blinded placebo doses in total over the 4-week on/off period.	Osmotic-Release Oral System (OROS) Methylphenidate n=7 Participants Participants received 18-54 mg of OROS methylphenidate orally, once daily for 4 weeks (on/off period), except for the off-days, where participants received 1 or 2 oral once daily placebo doses per week, with 6 nonconsecutive, double-blinded placebo doses in total over the 4-week on/off period.
Change From Baseline in Systolic and Diastolic Blood Pressure up to 5 Weeks Diastolic Blood Pressure	1.9 millimeters of mercury (mm Hg) Standard Deviation 6.14	-1.5 millimeters of mercury (mm Hg) Standard Deviation 4.67
Change From Baseline in Systolic and Diastolic Blood Pressure up to 5 Weeks Systolic Blood Pressure	-0.1 millimeters of mercury (mm Hg) Standard Deviation 9.00	-3.7 millimeters of mercury (mm Hg) Standard Deviation 3.75

Adverse Events

Atomoxetine

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Osmotic-Release Oral System (OROS) Methylphenidate

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Atomoxetine n=15 participants at risk Participants received 25-80 milligrams (mg) of atomoxetine orally, once daily during the run-in period for up to 7 days. The run-in period was followed by the 4-week on/off period in which participants received 25-80 mg of atomoxetine orally, once daily for 4 weeks, except for the off-days, where participants received 1 or 2 oral once daily placebo doses per week, with 6 nonconsecutive, double-blinded placebo doses in total over the 4-week on/off period. The on/off period was followed by a run-out period in which participants received 25-80 mg of atomoxetine orally, once daily for 1-5 days.	Osmotic-Release Oral System (OROS) Methylphenidate n=8 participants at risk Participants received 18-54 mg of OROS methylphenidate orally, once daily during the run-in period for up to 7 days. The run-in period was followed by the 4-week on/off period in which participants received 18-54 mg of OROS methylphenidate orally, once daily for 4 weeks, except for the off-days, where participants received 1 or 2 oral once daily placebo doses per week, with 6 nonconsecutive, double-blinded placebo doses in total over the 4-week on/off period. The on/off period was followed by a run-out period in which participants received 18-54 mg of OROS methylphenidate orally, once daily for 1-5 days.
Gastrointestinal disorders Abdominal pain	6.7% 1/15 • Number of events 6 • Adverse event data were collected for the entire study period, which included the following: 3-14 day screening period, a run-in period of up to 7 days, a 4-week on/off period, and a 1-5 day run-out period for a maximum of 54 days.	12.5% 1/8 • Number of events 1 • Adverse event data were collected for the entire study period, which included the following: 3-14 day screening period, a run-in period of up to 7 days, a 4-week on/off period, and a 1-5 day run-out period for a maximum of 54 days.
Gastrointestinal disorders Abdominal pain upper	6.7% 1/15 • Number of events 1 • Adverse event data were collected for the entire study period, which included the following: 3-14 day screening period, a run-in period of up to 7 days, a 4-week on/off period, and a 1-5 day run-out period for a maximum of 54 days.	0.00% 0/8 • Adverse event data were collected for the entire study period, which included the following: 3-14 day screening period, a run-in period of up to 7 days, a 4-week on/off period, and a 1-5 day run-out period for a maximum of 54 days.
Gastrointestinal disorders Nausea	13.3% 2/15 • Number of events 3 • Adverse event data were collected for the entire study period, which included the following: 3-14 day screening period, a run-in period of up to 7 days, a 4-week on/off period, and a 1-5 day run-out period for a maximum of 54 days.	0.00% 0/8 • Adverse event data were collected for the entire study period, which included the following: 3-14 day screening period, a run-in period of up to 7 days, a 4-week on/off period, and a 1-5 day run-out period for a maximum of 54 days.
Gastrointestinal disorders Toothache	6.7% 1/15 • Number of events 1 • Adverse event data were collected for the entire study period, which included the following: 3-14 day screening period, a run-in period of up to 7 days, a 4-week on/off period, and a 1-5 day run-out period for a maximum of 54 days.	0.00% 0/8 • Adverse event data were collected for the entire study period, which included the following: 3-14 day screening period, a run-in period of up to 7 days, a 4-week on/off period, and a 1-5 day run-out period for a maximum of 54 days.
Gastrointestinal disorders Vomiting	13.3% 2/15 • Number of events 10 • Adverse event data were collected for the entire study period, which included the following: 3-14 day screening period, a run-in period of up to 7 days, a 4-week on/off period, and a 1-5 day run-out period for a maximum of 54 days.	0.00% 0/8 • Adverse event data were collected for the entire study period, which included the following: 3-14 day screening period, a run-in period of up to 7 days, a 4-week on/off period, and a 1-5 day run-out period for a maximum of 54 days.
General disorders Fatigue	6.7% 1/15 • Number of events 2 • Adverse event data were collected for the entire study period, which included the following: 3-14 day screening period, a run-in period of up to 7 days, a 4-week on/off period, and a 1-5 day run-out period for a maximum of 54 days.	0.00% 0/8 • Adverse event data were collected for the entire study period, which included the following: 3-14 day screening period, a run-in period of up to 7 days, a 4-week on/off period, and a 1-5 day run-out period for a maximum of 54 days.
General disorders Pyrexia	6.7% 1/15 • Number of events 1 • Adverse event data were collected for the entire study period, which included the following: 3-14 day screening period, a run-in period of up to 7 days, a 4-week on/off period, and a 1-5 day run-out period for a maximum of 54 days.	0.00% 0/8 • Adverse event data were collected for the entire study period, which included the following: 3-14 day screening period, a run-in period of up to 7 days, a 4-week on/off period, and a 1-5 day run-out period for a maximum of 54 days.
Infections and infestations Herpes zoster	6.7% 1/15 • Number of events 1 • Adverse event data were collected for the entire study period, which included the following: 3-14 day screening period, a run-in period of up to 7 days, a 4-week on/off period, and a 1-5 day run-out period for a maximum of 54 days.	0.00% 0/8 • Adverse event data were collected for the entire study period, which included the following: 3-14 day screening period, a run-in period of up to 7 days, a 4-week on/off period, and a 1-5 day run-out period for a maximum of 54 days.
Metabolism and nutrition disorders Decreased appetite	6.7% 1/15 • Number of events 2 • Adverse event data were collected for the entire study period, which included the following: 3-14 day screening period, a run-in period of up to 7 days, a 4-week on/off period, and a 1-5 day run-out period for a maximum of 54 days.	0.00% 0/8 • Adverse event data were collected for the entire study period, which included the following: 3-14 day screening period, a run-in period of up to 7 days, a 4-week on/off period, and a 1-5 day run-out period for a maximum of 54 days.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/15 • Adverse event data were collected for the entire study period, which included the following: 3-14 day screening period, a run-in period of up to 7 days, a 4-week on/off period, and a 1-5 day run-out period for a maximum of 54 days.	12.5% 1/8 • Number of events 1 • Adverse event data were collected for the entire study period, which included the following: 3-14 day screening period, a run-in period of up to 7 days, a 4-week on/off period, and a 1-5 day run-out period for a maximum of 54 days.
Nervous system disorders Disturbance in attention	0.00% 0/15 • Adverse event data were collected for the entire study period, which included the following: 3-14 day screening period, a run-in period of up to 7 days, a 4-week on/off period, and a 1-5 day run-out period for a maximum of 54 days.	12.5% 1/8 • Number of events 1 • Adverse event data were collected for the entire study period, which included the following: 3-14 day screening period, a run-in period of up to 7 days, a 4-week on/off period, and a 1-5 day run-out period for a maximum of 54 days.
Nervous system disorders Dizziness	13.3% 2/15 • Number of events 2 • Adverse event data were collected for the entire study period, which included the following: 3-14 day screening period, a run-in period of up to 7 days, a 4-week on/off period, and a 1-5 day run-out period for a maximum of 54 days.	0.00% 0/8 • Adverse event data were collected for the entire study period, which included the following: 3-14 day screening period, a run-in period of up to 7 days, a 4-week on/off period, and a 1-5 day run-out period for a maximum of 54 days.
Nervous system disorders Headache	13.3% 2/15 • Number of events 8 • Adverse event data were collected for the entire study period, which included the following: 3-14 day screening period, a run-in period of up to 7 days, a 4-week on/off period, and a 1-5 day run-out period for a maximum of 54 days.	0.00% 0/8 • Adverse event data were collected for the entire study period, which included the following: 3-14 day screening period, a run-in period of up to 7 days, a 4-week on/off period, and a 1-5 day run-out period for a maximum of 54 days.
Nervous system disorders Somnolence	6.7% 1/15 • Number of events 3 • Adverse event data were collected for the entire study period, which included the following: 3-14 day screening period, a run-in period of up to 7 days, a 4-week on/off period, and a 1-5 day run-out period for a maximum of 54 days.	0.00% 0/8 • Adverse event data were collected for the entire study period, which included the following: 3-14 day screening period, a run-in period of up to 7 days, a 4-week on/off period, and a 1-5 day run-out period for a maximum of 54 days.
Psychiatric disorders Affect lability	6.7% 1/15 • Number of events 1 • Adverse event data were collected for the entire study period, which included the following: 3-14 day screening period, a run-in period of up to 7 days, a 4-week on/off period, and a 1-5 day run-out period for a maximum of 54 days.	0.00% 0/8 • Adverse event data were collected for the entire study period, which included the following: 3-14 day screening period, a run-in period of up to 7 days, a 4-week on/off period, and a 1-5 day run-out period for a maximum of 54 days.
Psychiatric disorders Impulsive behaviour	0.00% 0/15 • Adverse event data were collected for the entire study period, which included the following: 3-14 day screening period, a run-in period of up to 7 days, a 4-week on/off period, and a 1-5 day run-out period for a maximum of 54 days.	25.0% 2/8 • Number of events 2 • Adverse event data were collected for the entire study period, which included the following: 3-14 day screening period, a run-in period of up to 7 days, a 4-week on/off period, and a 1-5 day run-out period for a maximum of 54 days.
Psychiatric disorders Insomnia	0.00% 0/15 • Adverse event data were collected for the entire study period, which included the following: 3-14 day screening period, a run-in period of up to 7 days, a 4-week on/off period, and a 1-5 day run-out period for a maximum of 54 days.	12.5% 1/8 • Number of events 1 • Adverse event data were collected for the entire study period, which included the following: 3-14 day screening period, a run-in period of up to 7 days, a 4-week on/off period, and a 1-5 day run-out period for a maximum of 54 days.
Psychiatric disorders Nervousness	6.7% 1/15 • Number of events 1 • Adverse event data were collected for the entire study period, which included the following: 3-14 day screening period, a run-in period of up to 7 days, a 4-week on/off period, and a 1-5 day run-out period for a maximum of 54 days.	0.00% 0/8 • Adverse event data were collected for the entire study period, which included the following: 3-14 day screening period, a run-in period of up to 7 days, a 4-week on/off period, and a 1-5 day run-out period for a maximum of 54 days.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	6.7% 1/15 • Number of events 1 • Adverse event data were collected for the entire study period, which included the following: 3-14 day screening period, a run-in period of up to 7 days, a 4-week on/off period, and a 1-5 day run-out period for a maximum of 54 days.	0.00% 0/8 • Adverse event data were collected for the entire study period, which included the following: 3-14 day screening period, a run-in period of up to 7 days, a 4-week on/off period, and a 1-5 day run-out period for a maximum of 54 days.

Additional Information

Chief Medical Officer

Eli Lilly and Company

Phone: 800-545-5979

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: GT60