Trial Outcomes & Findings for Safety and Efficacy Workplace Environment Study of Lisdexamfetamine Dimesylate (LDX) in Adults With Attention-Deficit Hyperactivity Disorder (ADHD) (NCT NCT00697515)

NCT ID: NCT00697515

Last Updated: 2021-06-09

Results Overview

The Permanent Product Measure of Performance (PERMP) is a skill adjusted math test. The PERMP score is the sum of the number of math problems attempted plus the number of math problems answered correctly in a 10-minute session. The scores range from 0-800 with higher scores indicating better performance.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 142 participants
• Primary outcome timeframe: 2, 4, 8, 10, 12 and 14 hours post-dose on Day 7
• Results posted on: 2021-06-09

Participant Flow

The study consisted of a 4-week dose optimization phase (30, 50 or 70 mg SPD489 once-daily) and a 2-week crossover phase. Of the 142 subjects enrolled in the dose optimization phase, 15 discontinued prior to randomization.

Participant milestones

Measure	SPD489 First Lisdexamfetamine Dimesylate (LDX, SPD489) is dosed once-daily at 30, 50 or 70 mg for 1 week during the first intervention and placebo is administered once-daily for 1 week in the second intervention.	Placebo First Placebo is administered once-daily for 1 week in the first intervention and Lisdexamfetamine Dimesylate (LDX, SPD489)is dosed once-daily at 30, 50 or 70 mg for 1 week during the second intervention.
Dose Optimization Period STARTED	142	0
Dose Optimization Period COMPLETED	127	0
Dose Optimization Period NOT COMPLETED	15	0
First Intervention (Crossover Period) STARTED	63	64
First Intervention (Crossover Period) COMPLETED	53	52
First Intervention (Crossover Period) NOT COMPLETED	10	12
Second Intervention (Crossover Period) STARTED	53	52
Second Intervention (Crossover Period) COMPLETED	52	51
Second Intervention (Crossover Period) NOT COMPLETED	1	1

Reasons for withdrawal

Measure	SPD489 First Lisdexamfetamine Dimesylate (LDX, SPD489) is dosed once-daily at 30, 50 or 70 mg for 1 week during the first intervention and placebo is administered once-daily for 1 week in the second intervention.	Placebo First Placebo is administered once-daily for 1 week in the first intervention and Lisdexamfetamine Dimesylate (LDX, SPD489)is dosed once-daily at 30, 50 or 70 mg for 1 week during the second intervention.
Dose Optimization Period Adverse Event	4	0
Dose Optimization Period Withdrawal by Subject	5	0
Dose Optimization Period Lost to Follow-up	2	0
Dose Optimization Period sponsor request	2	0
Dose Optimization Period called to active duty	1	0
Dose Optimization Period elevated QTc	1	0
First Intervention (Crossover Period) Natural disaster	8	9
First Intervention (Crossover Period) Adverse Event	0	2
First Intervention (Crossover Period) Withdrawal by Subject	2	1
Second Intervention (Crossover Period) Withdrawal by Subject	1	1

Baseline Characteristics

Safety and Efficacy Workplace Environment Study of Lisdexamfetamine Dimesylate (LDX) in Adults With Attention-Deficit Hyperactivity Disorder (ADHD)

Baseline characteristics by cohort

Measure	Entire Study Population n=142 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	142 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	30.5 years STANDARD_DEVIATION 10.7 • n=5 Participants
Sex: Female, Male Female	54 Participants n=5 Participants
Sex: Female, Male Male	88 Participants n=5 Participants
Region of Enrollment United States	142 Participants n=5 Participants

PRIMARY outcome

Timeframe: 2, 4, 8, 10, 12 and 14 hours post-dose on Day 7

Population: Intent to Treat (ITT) population defined as all subjects who are randomized and have at least one post-dose primary efficacy assessment.

The Permanent Product Measure of Performance (PERMP) is a skill adjusted math test. The PERMP score is the sum of the number of math problems attempted plus the number of math problems answered correctly in a 10-minute session. The scores range from 0-800 with higher scores indicating better performance.

Outcome measures

Measure	SPD489 n=104 Participants Lisdexamfetamine Dimesylate (LDX, SPD489) is dosed once-daily at 30, 50 or 70 mg	Placebo n=104 Participants Placebo is administered once-daily
Permanent Product Measure of Performance (PERMP) Total Score Over the Treatment Day in the Crossover Phase	312.9 Units on a scale Standard Error 8.59	289.5 Units on a scale Standard Error 8.59

SECONDARY outcome

Timeframe: 2, 4, 8, 10, 12 and 14 hours post-dose on Day 7

Population: ITT

The Permanent Product Measure of Performance (PERMP) is a skill adjusted math test. The PERMP score is the sum of the number of math problems attempted plus the number of math problems answered correctly in a 10-minute session. The scores range from 0-800 with higher scores indicating better performance.

Outcome measures

Measure	SPD489 n=104 Participants Lisdexamfetamine Dimesylate (LDX, SPD489) is dosed once-daily at 30, 50 or 70 mg	Placebo n=104 Participants Placebo is administered once-daily
PERMP Total Score by Timepoint in the Crossover Phase 2.0 hours post-dose	301.5 Units on a scale Standard Error 8.78	285.9 Units on a scale Standard Error 8.78
PERMP Total Score by Timepoint in the Crossover Phase 4.0 hours post-dose	314.1 Units on a scale Standard Error 9.16	284.7 Units on a scale Standard Error 9.16
PERMP Total Score by Timepoint in the Crossover Phase 8.0 hours post-dose	311.4 Units on a scale Standard Error 9.07	287.1 Units on a scale Standard Error 9.07
PERMP Total Score by Timepoint in the Crossover Phase 10.0 hours post-dose	313.5 Units on a scale Standard Error 8.82	288.8 Units on a scale Standard Error 8.82
PERMP Total Score by Timepoint in the Crossover Phase 12.0 hours post-dose	318.7 Units on a scale Standard Error 8.77	293.1 Units on a scale Standard Error 8.77
PERMP Total Score by Timepoint in the Crossover Phase 14.0 hours post-dose	318.6 Units on a scale Standard Error 9.03	296.7 Units on a scale Standard Error 9.03

SECONDARY outcome

Timeframe: 2, 4, 8, 10, 12 and 14 hours post-dose on Day 7

Population: ITT

The Permanent Product Measure of Performance (PERMP) is a skill adjusted math test. The PERMP score is the sum of the number of math problems attempted plus the number of math problems answered correctly in a 10-minute session. The scores range from 0-800 with higher scores indicating better performance.

Outcome measures

Measure	SPD489 n=104 Participants Lisdexamfetamine Dimesylate (LDX, SPD489) is dosed once-daily at 30, 50 or 70 mg	Placebo n=104 Participants Placebo is administered once-daily
PERMP Score for the Number of Math Problems Attempted by Timepoint in the Crossover Phase Over the treatment day	158.6 Units on a scale Standard Error 4.33	146.6 Units on a scale Standard Error 4.33
PERMP Score for the Number of Math Problems Attempted by Timepoint in the Crossover Phase 2.0 hours post-dose	153.1 Units on a scale Standard Error 4.41	144.9 Units on a scale Standard Error 4.41
PERMP Score for the Number of Math Problems Attempted by Timepoint in the Crossover Phase 4.0 hours post-dose	159.3 Units on a scale Standard Error 4.60	144.2 Units on a scale Standard Error 4.60
PERMP Score for the Number of Math Problems Attempted by Timepoint in the Crossover Phase 8.0 hours post-dose	157.6 Units on a scale Standard Error 4.56	145.3 Units on a scale Standard Error 4.56
PERMP Score for the Number of Math Problems Attempted by Timepoint in the Crossover Phase 10.0 hours post-dose	158.6 Units on a scale Standard Error 4.44	146.1 Units on a scale Standard Error 4.44
PERMP Score for the Number of Math Problems Attempted by Timepoint in the Crossover Phase 12.0 hours post-dose	161.2 Units on a scale Standard Error 4.43	148.4 Units on a scale Standard Error 4.43
PERMP Score for the Number of Math Problems Attempted by Timepoint in the Crossover Phase 14.0 hours post-dose	161.5 Units on a scale Standard Error 4.57	150.4 Units on a scale Standard Error 4.57

SECONDARY outcome

Timeframe: 2, 4, 8, 10, 12 and 14 hours post-dose on Day 7

Population: ITT

The Permanent Product Measure of Performance (PERMP) is a skill adjusted math test. The PERMP score is the sum of the number of math problems attempted plus the number of math problems answered correctly in a 10-minute session. The scores range from 0-800 with higher scores indicating better performance.

Outcome measures

Measure	SPD489 n=104 Participants Lisdexamfetamine Dimesylate (LDX, SPD489) is dosed once-daily at 30, 50 or 70 mg	Placebo n=104 Participants Placebo is administered once-daily
PERMP Score for the Number of Math Problems Answered Correctly by Timepoint in the Crossover Phase Over the treatment day	154.4 Units on a scale Standard Error 4.27	142.9 Units on a scale Standard Error 4.27
PERMP Score for the Number of Math Problems Answered Correctly by Timepoint in the Crossover Phase 2.0 hours post-dose	148.4 Units on a scale Standard Error 4.38	141.0 Units on a scale Standard Error 4.38
PERMP Score for the Number of Math Problems Answered Correctly by Timepoint in the Crossover Phase 4.0 hours post-dose	154.8 Units on a scale Standard Error 4.56	140.4 Units on a scale Standard Error 4.56
PERMP Score for the Number of Math Problems Answered Correctly by Timepoint in the Crossover Phase 8.0 hours post-dose	153.7 Units on a scale Standard Error 4.51	141.7 Units on a scale Standard Error 4.51
PERMP Score for the Number of Math Problems Answered Correctly by Timepoint in the Crossover Phase 10.0 hours post-dose	154.8 Units on a scale Standard Error 4.39	142.7 Units on a scale Standard Error 4.39
PERMP Score for the Number of Math Problems Answered Correctly by Timepoint in the Crossover Phase 12.0 hours post-dose	157.4 Units on a scale Standard Error 4.36	144.7 Units on a scale Standard Error 4.36
PERMP Score for the Number of Math Problems Answered Correctly by Timepoint in the Crossover Phase 14.0 hours post-dose	157.1 Units on a scale Standard Error 4.48	146.3 Units on a scale Standard Error 4.48

SECONDARY outcome

Timeframe: Baseline and 7, 14, 21 and 28 days

Population: Enrolled Efficacy Population (EEP) defined as all subjects who have taken one dose of study medication in the Dose Optimization Phase and had one post-Baseline efficacy assessment.

The Attention Deficit Hyperactivity Disorder Rating Scale with Prompts (ADHD-RS) consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54.

Outcome measures

Measure	SPD489 n=142 Participants Lisdexamfetamine Dimesylate (LDX, SPD489) is dosed once-daily at 30, 50 or 70 mg	Placebo Placebo is administered once-daily
Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale With Prompts (ADHD-RS) Total Score at up to 28 Days in the Dose Optimization Phase	-21.4 Units on a scale Standard Deviation 7.31	—

SECONDARY outcome

Timeframe: 7 days

Population: ITT

The Attention Deficit Hyperactivity Disorder Rating Scale with Prompts (ADHD-RS) consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54.

Outcome measures

Measure	SPD489 n=104 Participants Lisdexamfetamine Dimesylate (LDX, SPD489) is dosed once-daily at 30, 50 or 70 mg	Placebo n=104 Participants Placebo is administered once-daily
ADHD-RS With Prompts Total Score in the Crossover Phase	18.1 Units on a scale Standard Error 0.94	29.6 Units on a scale Standard Error 0.94

SECONDARY outcome

Timeframe: Baseline

Population: EEP

CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill)

Outcome measures

Measure	SPD489 n=142 Participants Lisdexamfetamine Dimesylate (LDX, SPD489) is dosed once-daily at 30, 50 or 70 mg	Placebo Placebo is administered once-daily
Assessment of Clinical Global Impression-Severity of Illness (CGI-S) in the Dose Optimization Phase Borderline mentally ill	0 Participants	—
Assessment of Clinical Global Impression-Severity of Illness (CGI-S) in the Dose Optimization Phase Mildly ill	0 Participants	—
Assessment of Clinical Global Impression-Severity of Illness (CGI-S) in the Dose Optimization Phase Moderately ill	92 Participants	—
Assessment of Clinical Global Impression-Severity of Illness (CGI-S) in the Dose Optimization Phase Markedly ill	46 Participants	—
Assessment of Clinical Global Impression-Severity of Illness (CGI-S) in the Dose Optimization Phase Normal, not at all ill	0 Participants	—
Assessment of Clinical Global Impression-Severity of Illness (CGI-S) in the Dose Optimization Phase Severely ill	4 Participants	—
Assessment of Clinical Global Impression-Severity of Illness (CGI-S) in the Dose Optimization Phase Among the most extremely ill subjects	0 Participants	—

SECONDARY outcome

Timeframe: 7, 14, 21 and 28 days

Population: EEP

CGI-I consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.

Outcome measures

Measure	SPD489 n=132 Participants Lisdexamfetamine Dimesylate (LDX, SPD489) is dosed once-daily at 30, 50 or 70 mg	Placebo Placebo is administered once-daily
Number of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) in the Dose Optimization Phase	130 Participants	—

SECONDARY outcome

Timeframe: 7 days

Population: ITT

CGI-I consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.

Outcome measures

Measure	SPD489 n=103 Participants Lisdexamfetamine Dimesylate (LDX, SPD489) is dosed once-daily at 30, 50 or 70 mg	Placebo n=103 Participants Placebo is administered once-daily
Number of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) in the Crossover Phase	70 Participants	13 Participants

SECONDARY outcome

Timeframe: Baseline and 26 days

Population: EEP

The BADDS assessment consists of 40 items rated on a scale from 0 (never) to 3 (almost daily). The total score ranges from 0 to 120 with increasing scores indicating more severe impairment.

Outcome measures

Measure	SPD489 n=127 Participants Lisdexamfetamine Dimesylate (LDX, SPD489) is dosed once-daily at 30, 50 or 70 mg	Placebo Placebo is administered once-daily
Change From Baseline in the Brown Attention Deficit Disorder Scale (BADDS) Total Scores at 26 Days in the Dose Optimization Phase	-34.1 Units on a scale Standard Deviation 20.99	—

SECONDARY outcome

Timeframe: 26 days

Population: EEP

MSQ is a survey rating the subject's level of satisfaction with the study treatment medication.

Outcome measures

Measure	SPD489 n=127 Participants Lisdexamfetamine Dimesylate (LDX, SPD489) is dosed once-daily at 30, 50 or 70 mg	Placebo Placebo is administered once-daily
Level of Satisfaction With Study Treatment on Medication Satisfaction Questionnaire (MSQ) in the Dose Optimization Phase Very satisfied	79 Participants	—
Level of Satisfaction With Study Treatment on Medication Satisfaction Questionnaire (MSQ) in the Dose Optimization Phase Moderately satisfied	44 Participants	—
Level of Satisfaction With Study Treatment on Medication Satisfaction Questionnaire (MSQ) in the Dose Optimization Phase Not satisfied	2 Participants	—
Level of Satisfaction With Study Treatment on Medication Satisfaction Questionnaire (MSQ) in the Dose Optimization Phase Don't know	2 Participants	—

SECONDARY outcome

Timeframe: Baseline and 26 days

Population: EEP

AIM-A is a quality of life instrument. Question 1 is 'On a scale of 1 to 10, how would you rate the overall quality of life right now?' It is rated on a scale of 1 (worst) to 10 (best).

Outcome measures

Measure	SPD489 n=127 Participants Lisdexamfetamine Dimesylate (LDX, SPD489) is dosed once-daily at 30, 50 or 70 mg	Placebo Placebo is administered once-daily
Change From Baseline in Adult ADHD Impact Module (AIM-A) Question 1 Score at 26 Days in the Dose Optimization Phase	0.9 Units on a scale Standard Deviation 1.67	—

SECONDARY outcome

Timeframe: Baseline and 26 days

AIM-A is a quality of life instrument. Question 4 is 'How much do you agree with this statement: Over the past few weeks, I've had more good days than bad days?' This is rated on a scale of 1 (strongly agree) to 5 (strongly disagree).

Outcome measures

Measure	SPD489 n=127 Participants Lisdexamfetamine Dimesylate (LDX, SPD489) is dosed once-daily at 30, 50 or 70 mg	Placebo Placebo is administered once-daily
Change From Baseline in AIM-A Question 4 Score at 26 Days in the Dose Optimization Phase	-0.7 Units on a scale Standard Deviation 0.96	—

SECONDARY outcome

Timeframe: Baseline and 7, 14, 21 and 28 days

Population: Safety Population (SP) defined as all subjects who received at least one dose of study medication.

Outcome measures

Measure	SPD489 n=142 Participants Lisdexamfetamine Dimesylate (LDX, SPD489) is dosed once-daily at 30, 50 or 70 mg	Placebo Placebo is administered once-daily
Change From Baseline in Systolic Blood Pressure at Up to 28 Days in the Dose Optimization Phase	-0.3 mmHg Standard Deviation 9.46	—

SECONDARY outcome

Timeframe: Baseline and 7, 14, 21 and 28 days

Population: SP

Outcome measures

Measure	SPD489 n=142 Participants Lisdexamfetamine Dimesylate (LDX, SPD489) is dosed once-daily at 30, 50 or 70 mg	Placebo Placebo is administered once-daily
Change From Baseline in Diastolic Blood Pressure at Up to 28 Days in the Dose Optimization Phase	-0.2 mmHg Standard Deviation 6.94	—

SECONDARY outcome

Timeframe: Baseline and 7, 14, 21 and 28 days

Population: SP

Outcome measures

Measure	SPD489 n=142 Participants Lisdexamfetamine Dimesylate (LDX, SPD489) is dosed once-daily at 30, 50 or 70 mg	Placebo Placebo is administered once-daily
Change From Baseline in Pulse Rate at Up to 28 Days in the Dose Optimization Phase	3.2 bpm Standard Deviation 11.55	—

SECONDARY outcome

Timeframe: Baseline and 7 days

Population: SP

QTcF is the QT interval using Fridericia's correction formula. QT interval is a measure of time between the start of the Q wave and the end of the T wave and is dependent on the heart rate(e.g., the faster the heart rate, the shorter the QT interval). The QT interval has to be corrected in order to aid interpretation.

Outcome measures

Measure	SPD489 n=115 Participants Lisdexamfetamine Dimesylate (LDX, SPD489) is dosed once-daily at 30, 50 or 70 mg	Placebo n=117 Participants Placebo is administered once-daily
Change From Baseline in Electrocardiogram Results (QTcF Interval) at 7 Days in the Crossover Phase	4.4 msec Standard Deviation 16.62	4.8 msec Standard Deviation 15.45

Adverse Events

SPD489

Serious events: 0 serious events

Other events: 113 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 23 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	SPD489 n=142 participants at risk Lisdexamfetamine Dimesylate (LDX, SPD489) is dosed once-daily at 30, 50 or 70 mg for 1 week during the first intervention and placebo is administered once-daily for 1 week in the second intervention.	Placebo n=117 participants at risk Placebo is administered once-daily for 1 week in the first intervention and Lisdexamfetamine Dimesylate (LDX, SPD489)is dosed once-daily at 30, 50 or 70 mg for 1 week during the second intervention.
Gastrointestinal disorders Dry mouth	30.3% 43/142 Safety Population defined as all subjects who received at least one dose of study medication. All 142 subjects received at least one dose of study medication during the dose optimization phase. In the crossover phase, 64 subjects received placebo in the first intervention and 53 in the second intervention for a total of 117 for placebo.	0.00% 0/117 Safety Population defined as all subjects who received at least one dose of study medication. All 142 subjects received at least one dose of study medication during the dose optimization phase. In the crossover phase, 64 subjects received placebo in the first intervention and 53 in the second intervention for a total of 117 for placebo.
Gastrointestinal disorders Nausea	7.7% 11/142 Safety Population defined as all subjects who received at least one dose of study medication. All 142 subjects received at least one dose of study medication during the dose optimization phase. In the crossover phase, 64 subjects received placebo in the first intervention and 53 in the second intervention for a total of 117 for placebo.	0.00% 0/117 Safety Population defined as all subjects who received at least one dose of study medication. All 142 subjects received at least one dose of study medication during the dose optimization phase. In the crossover phase, 64 subjects received placebo in the first intervention and 53 in the second intervention for a total of 117 for placebo.
General disorders Feeling jittery	5.6% 8/142 Safety Population defined as all subjects who received at least one dose of study medication. All 142 subjects received at least one dose of study medication during the dose optimization phase. In the crossover phase, 64 subjects received placebo in the first intervention and 53 in the second intervention for a total of 117 for placebo.	0.00% 0/117 Safety Population defined as all subjects who received at least one dose of study medication. All 142 subjects received at least one dose of study medication during the dose optimization phase. In the crossover phase, 64 subjects received placebo in the first intervention and 53 in the second intervention for a total of 117 for placebo.
General disorders Irritability	8.5% 12/142 Safety Population defined as all subjects who received at least one dose of study medication. All 142 subjects received at least one dose of study medication during the dose optimization phase. In the crossover phase, 64 subjects received placebo in the first intervention and 53 in the second intervention for a total of 117 for placebo.	0.00% 0/117 Safety Population defined as all subjects who received at least one dose of study medication. All 142 subjects received at least one dose of study medication during the dose optimization phase. In the crossover phase, 64 subjects received placebo in the first intervention and 53 in the second intervention for a total of 117 for placebo.
Infections and infestations Upper respiratory tract infection	9.9% 14/142 Safety Population defined as all subjects who received at least one dose of study medication. All 142 subjects received at least one dose of study medication during the dose optimization phase. In the crossover phase, 64 subjects received placebo in the first intervention and 53 in the second intervention for a total of 117 for placebo.	7.7% 9/117 Safety Population defined as all subjects who received at least one dose of study medication. All 142 subjects received at least one dose of study medication during the dose optimization phase. In the crossover phase, 64 subjects received placebo in the first intervention and 53 in the second intervention for a total of 117 for placebo.
Metabolism and nutrition disorders Decreased appetite	36.6% 52/142 Safety Population defined as all subjects who received at least one dose of study medication. All 142 subjects received at least one dose of study medication during the dose optimization phase. In the crossover phase, 64 subjects received placebo in the first intervention and 53 in the second intervention for a total of 117 for placebo.	0.00% 0/117 Safety Population defined as all subjects who received at least one dose of study medication. All 142 subjects received at least one dose of study medication during the dose optimization phase. In the crossover phase, 64 subjects received placebo in the first intervention and 53 in the second intervention for a total of 117 for placebo.
Nervous system disorders Headache	19.7% 28/142 Safety Population defined as all subjects who received at least one dose of study medication. All 142 subjects received at least one dose of study medication during the dose optimization phase. In the crossover phase, 64 subjects received placebo in the first intervention and 53 in the second intervention for a total of 117 for placebo.	0.00% 0/117 Safety Population defined as all subjects who received at least one dose of study medication. All 142 subjects received at least one dose of study medication during the dose optimization phase. In the crossover phase, 64 subjects received placebo in the first intervention and 53 in the second intervention for a total of 117 for placebo.
Psychiatric disorders Anxiety	5.6% 8/142 Safety Population defined as all subjects who received at least one dose of study medication. All 142 subjects received at least one dose of study medication during the dose optimization phase. In the crossover phase, 64 subjects received placebo in the first intervention and 53 in the second intervention for a total of 117 for placebo.	0.00% 0/117 Safety Population defined as all subjects who received at least one dose of study medication. All 142 subjects received at least one dose of study medication during the dose optimization phase. In the crossover phase, 64 subjects received placebo in the first intervention and 53 in the second intervention for a total of 117 for placebo.
Psychiatric disorders Insomnia	18.3% 26/142 Safety Population defined as all subjects who received at least one dose of study medication. All 142 subjects received at least one dose of study medication during the dose optimization phase. In the crossover phase, 64 subjects received placebo in the first intervention and 53 in the second intervention for a total of 117 for placebo.	0.00% 0/117 Safety Population defined as all subjects who received at least one dose of study medication. All 142 subjects received at least one dose of study medication during the dose optimization phase. In the crossover phase, 64 subjects received placebo in the first intervention and 53 in the second intervention for a total of 117 for placebo.
General disorders Fatigue	0.00% 0/142 Safety Population defined as all subjects who received at least one dose of study medication. All 142 subjects received at least one dose of study medication during the dose optimization phase. In the crossover phase, 64 subjects received placebo in the first intervention and 53 in the second intervention for a total of 117 for placebo.	12.0% 14/117 Safety Population defined as all subjects who received at least one dose of study medication. All 142 subjects received at least one dose of study medication during the dose optimization phase. In the crossover phase, 64 subjects received placebo in the first intervention and 53 in the second intervention for a total of 117 for placebo.

Additional Information

Study Director

Shire

Phone: +1 866 842 5335

Email: ClinicalTransparency@shire.com

Results disclosure agreements

• Principal investigator is a sponsor employee If a multicenter publication is not submitted within twelve (12) months after conclusion, abandonment or termination of the Study at all sites, or after Sponsor confirms there shall be no multicenter Study publication, the Institution and/or such Principal Investigator may publish the results from the Institution site individually.
• Publication restrictions are in place

Restriction type: OTHER