Trial Outcomes & Findings for SPD489 in Adults Aged 18-55 Years With Moderate to Severe Binge Eating Disorder (NCT NCT01718509)

NCT ID: NCT01718509

Last Updated: 2021-07-16

Results Overview

Binge days defined as days during which at least 1 binge episode occurred. As assessed by clinical interview based on subject binge diary.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 390 participants
• Primary outcome timeframe: Baseline and Visit 8 Which Spans Weeks 11/12
• Results posted on: 2021-07-16

Participant Flow

Participant milestones

Measure	PLACEBO Administered once-daily, orally, for up to 12 weeks	SPD489 50 or 70 mg administered orally, once-daily for up to 12 weeks
Overall Study STARTED	195	195
Overall Study COMPLETED	147	147
Overall Study NOT COMPLETED	48	48

Reasons for withdrawal

Measure	PLACEBO Administered once-daily, orally, for up to 12 weeks	SPD489 50 or 70 mg administered orally, once-daily for up to 12 weeks
Overall Study Lost to Follow-up	18	15
Overall Study Withdrawal by Subject	7	13
Overall Study Adverse Event	5	7
Overall Study Other	13	11
Overall Study Protocol Violation	4	2
Overall Study Lack of Efficacy	1	0

Baseline Characteristics

SPD489 in Adults Aged 18-55 Years With Moderate to Severe Binge Eating Disorder

Baseline characteristics by cohort

Measure	PLACEBO n=185 Participants	SPD489 n=181 Participants	Total n=366 Participants Total of all reporting groups
Age, Continuous	38.7 Years STANDARD_DEVIATION 10.01 • n=5 Participants	37.1 Years STANDARD_DEVIATION 10.00 • n=7 Participants	37.9 Years STANDARD_DEVIATION 10.02 • n=5 Participants
Age, Customized < 40 years	90 Participants n=5 Participants	108 Participants n=7 Participants	198 Participants n=5 Participants
Age, Customized >= 40 years	95 Participants n=5 Participants	73 Participants n=7 Participants	168 Participants n=5 Participants
Sex: Female, Male Female	153 Participants n=5 Participants	159 Participants n=7 Participants	312 Participants n=5 Participants
Sex: Female, Male Male	32 Participants n=5 Participants	22 Participants n=7 Participants	54 Participants n=5 Participants
Region of Enrollment GERMANY	9 Participants n=5 Participants	11 Participants n=7 Participants	20 Participants n=5 Participants
Region of Enrollment UNITED STATES	176 Participants n=5 Participants	170 Participants n=7 Participants	346 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and Visit 8 Which Spans Weeks 11/12

Population: The Full Analysis Set was defined as all randomized subjects who took at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment (i.e., number of binge days per week calculated for at least 1 week).

Binge days defined as days during which at least 1 binge episode occurred. As assessed by clinical interview based on subject binge diary.

Outcome measures

Measure	PLACEBO n=176 Participants Administered once-daily, orally, for up to 12 weeks	SPD489 n=174 Participants 50 or 70 mg administered orally, once-daily for up to 12 weeks
Change From Baseline in the Number of Binge Days Per Week at Visit 8 Which Spans Weeks 11/12	-2.26 Binge days per week Standard Error 0.137	-3.92 Binge days per week Standard Error 0.135

SECONDARY outcome

Timeframe: Up to 12 weeks

Population: Full Analysis Set

Clinical Global Impression-Improvement (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	PLACEBO n=176 Participants Administered once-daily, orally, for up to 12 weeks	SPD489 n=174 Participants 50 or 70 mg administered orally, once-daily for up to 12 weeks
Percent of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) Scores	42.9 percentage of participants Interval 35.5 to 50.2	86.2 percentage of participants Interval 81.1 to 91.3

SECONDARY outcome

Timeframe: Up to 12 weeks

Population: Full Analysis Set

4-week cessation from binge eating is defined as no binge eating episodes for 28 consecutive days prior to the last study visit.

Outcome measures

Measure	PLACEBO n=176 Participants Administered once-daily, orally, for up to 12 weeks	SPD489 n=174 Participants 50 or 70 mg administered orally, once-daily for up to 12 weeks
Percent of Participants With a 4-Week Cessation From Binge Eating	13.1 percentage of participants Interval 8.1 to 18.0	36.2 percentage of participants Interval 29.1 to 43.3

SECONDARY outcome

Timeframe: Baseline and week 12

Population: Full Analysis Set.

Outcome measures

Measure	PLACEBO n=176 Participants Administered once-daily, orally, for up to 12 weeks	SPD489 n=174 Participants 50 or 70 mg administered orally, once-daily for up to 12 weeks
Percent Change From Baseline in Body Weight (kg) at Week 12	-0.15 percentage change Standard Error 0.353	-5.57 percentage change Standard Error 0.350

SECONDARY outcome

Timeframe: Baseline and week 12

Population: Full Analysis Set.

The Y-BOCS-BE measures the obsession of binge-eating thoughts and compulsiveness of binge-eating behaviors. The scale is a clinician-rated, 10-item scale, each item rated from 0 (no symptoms) to 4 (extreme symptoms). Total scores range from 0 to 40. Reduction in total score indicates improvement.

Outcome measures

Measure	PLACEBO n=176 Participants Administered once-daily, orally, for up to 12 weeks	SPD489 n=174 Participants 50 or 70 mg administered orally, once-daily for up to 12 weeks
Change From Baseline in Yale-Brown Obsessive Compulsive Scale Modified for Binge Eating (Y-BOCS-BE) Total Score at Week 12	-7.42 units on a scale Standard Error 0.571	-15.36 units on a scale Standard Error 0.563

SECONDARY outcome

Timeframe: Baseline and up to 12 weeks

Population: Full Analysis Set. Not all subjects had data for this outcome.

Outcome measures

Measure	PLACEBO n=153 Participants Administered once-daily, orally, for up to 12 weeks	SPD489 n=156 Participants 50 or 70 mg administered orally, once-daily for up to 12 weeks
Change From Baseline in Fasting Triglyceride Levels at Up to 12 Weeks	0.062 mmol/L Standard Error 0.0453	-0.133 mmol/L Standard Error 0.0449

SECONDARY outcome

Timeframe: Baseline and up to 12 weeks

Population: Full Analysis Set. Not all subjects had data for this outcome.

Outcome measures

Measure	PLACEBO n=153 Participants Administered once-daily, orally, for up to 12 weeks	SPD489 n=156 Participants 50 or 70 mg administered orally, once-daily for up to 12 weeks
Change From Baseline In Fasting Total Cholesterol Levels at Up to 12 Weeks	-0.126 mmol/L Standard Error 0.0460	-0.204 mmol/L Standard Error 0.0456

SECONDARY outcome

Timeframe: Baseline and up to 12 weeks

Population: Full Analysis Set. Not all subjects had data for this outcome.

Outcome measures

Measure	PLACEBO n=154 Participants Administered once-daily, orally, for up to 12 weeks	SPD489 n=156 Participants 50 or 70 mg administered orally, once-daily for up to 12 weeks
Change From Baseline in Hemoglobin A1c Levels at Up to 12 Weeks	-0.02 Percent Standard Error 0.017	0.01 Percent Standard Error 0.017

SECONDARY outcome

Timeframe: Up to 12 weeks

Population: Full Analysis Set. Not all subjects had data for this outcome.

Response is based on the reduction in the number of binge eating episodes. Responses were categorized as follows: -1-week Cessation = 100% reduction in binge episodes during the preceding 7 days -Marked Reduction = 99% to 75% reduction during the time since the previous visit -Moderate Reduction = 74% to 50% reduction during the time since the previous visit -Negative to Minimal Reduction = <50% reduction during the time since the previous visit

Outcome measures

Measure	PLACEBO n=142 Participants Administered once-daily, orally, for up to 12 weeks	SPD489 n=145 Participants 50 or 70 mg administered orally, once-daily for up to 12 weeks
Binge Eating Response 1-week cessation	23.9 percentage of participants	55.9 percentage of participants
Binge Eating Response Marked reduction	13.4 percentage of participants	22.8 percentage of participants
Binge Eating Response Moderate reduction	19.7 percentage of participants	16.6 percentage of participants
Binge Eating Response Negative to minimal reduction	43.0 percentage of participants	4.8 percentage of participants

SECONDARY outcome

Timeframe: Baseline and Visit 8 Which Spans Weeks 11/12

Population: Full Analysis Set.

Outcome measures

Measure	PLACEBO n=176 Participants Administered once-daily, orally, for up to 12 weeks	SPD489 n=174 Participants 50 or 70 mg administered orally, once-daily for up to 12 weeks
Change From Baseline in the Number of Binge Episodes Per Week at Visit 8 Which Spans Weeks 11/12	-3.31 Binge episodes per week Standard Error 0.194	-5.54 Binge episodes per week Standard Error 0.193

SECONDARY outcome

Timeframe: Baseline and week 12

Population: Full Analysis Set.

There are 36 true/false items, 14 items on a 4-point Likert scale (1=eat rarely to 4=always), and 1 item on a 6-point Likert scale (1=eat whatever you want to 6=constantly limiting food intake). Cognitive Restraint score ranges from 0-21. Hunger score ranges from 0-14. Disinhibition score ranges from 0-16. Higher scores denote higher levels of restrained eating, disinhibited eating and predisposition to hunger.

Outcome measures

Measure	PLACEBO n=176 Participants Administered once-daily, orally, for up to 12 weeks	SPD489 n=174 Participants 50 or 70 mg administered orally, once-daily for up to 12 weeks
Change From Baseline in Eating Inventory Scores at Week 12 Cognitive Restraint of Eating	2.44 units on a scale Standard Error 0.352	3.71 units on a scale Standard Error 0.347
Change From Baseline in Eating Inventory Scores at Week 12 Disinhibition of Eating	-2.01 units on a scale Standard Error 0.305	-5.61 units on a scale Standard Error 0.300
Change From Baseline in Eating Inventory Scores at Week 12 Perceived Hunger	-1.93 units on a scale Standard Error 0.318	-6.14 units on a scale Standard Error 0.313

SECONDARY outcome

Timeframe: Baseline and week 12

Population: Full Analysis Set.

The BES is a self-reported questionnaire containing 16 items designed to assess behavioral, affective, and attitudinal components of the subjective experience of binge eating. Each item is assessed based on 1 of 4 responses, with 1 denoting that a subject has greater control over eating behavior and 4 denoting that a subject had less control over eating behavior. A total score (sum of the 16 items) may range from 16-64. A lower score indicates greater control over eating behavior.

Outcome measures

Measure	PLACEBO n=176 Participants Administered once-daily, orally, for up to 12 weeks	SPD489 n=174 Participants 50 or 70 mg administered orally, once-daily for up to 12 weeks
Change From Baseline in Binge Eating Scale (BES) Score at Week 12	-8.24 units on a scale Standard Error 0.781	-17.52 units on a scale Standard Error 0.771

SECONDARY outcome

Timeframe: Baseline and up to 12 weeks

Population: Full Analysis Set. Not all subjects had data for this outcome.

The FrSBe is a 46-item self-rating scale designed to measure the neurobehavioral traits associated with the 3 primary regions of the prefrontal cortex. Subjects were asked to indicate the frequency with which they have engaged in certain behaviors using a rating scale from "1" (almost never) to "5" (almost always). Summary scores were calculated and converted to t-score. A decrease from baseline in FrSBe total score represents improvement.

Outcome measures

Measure	PLACEBO n=153 Participants Administered once-daily, orally, for up to 12 weeks	SPD489 n=158 Participants 50 or 70 mg administered orally, once-daily for up to 12 weeks
Change From Baseline in Frontal Systems Behavior (FrSBe) Total Score at Up to 12 Weeks	-3.09 t-scores Standard Error 0.655	-4.05 t-scores Standard Error 0.644

SECONDARY outcome

Timeframe: Up to 12 weeks

Population: Full Analysis Set. Not all subjects had data for this outcome.

Quality of life was assessed using the EQ-5D-5L, which is one of the most widely used generic index measures of health-related quality of life. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.

Outcome measures

Measure	PLACEBO n=168 Participants Administered once-daily, orally, for up to 12 weeks	SPD489 n=169 Participants 50 or 70 mg administered orally, once-daily for up to 12 weeks
EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Mobility No problems in walking about	86.9 percentage of participants	91.7 percentage of participants
EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Mobility Slight problems in walking about	8.9 percentage of participants	7.1 percentage of participants
EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Mobility Moderate problems walking about	3.0 percentage of participants	0.6 percentage of participants
EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Mobility Severe problems walking about	1.2 percentage of participants	0.6 percentage of participants
EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Mobility Unable to walk about	0 percentage of participants	0 percentage of participants

SECONDARY outcome

Timeframe: Up to 12 weeks

Population: Full Analysis Set. Not all subjects had data for this outcome.

Outcome measures

Measure	PLACEBO n=168 Participants Administered once-daily, orally, for up to 12 weeks	SPD489 n=169 Participants 50 or 70 mg administered orally, once-daily for up to 12 weeks
EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Self-Care No problems washing or dressing	97.0 percentage of participants	97.0 percentage of participants
EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Self-Care Slight problems washing or dressing	2.4 percentage of participants	3.0 percentage of participants
EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Self-Care Moderate problems washing or dressing	0.6 percentage of participants	0 percentage of participants
EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Self-Care Severe problems washing or dressing	0 percentage of participants	0 percentage of participants
EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Self-Care Unable to wash or dress	0 percentage of participants	0 percentage of participants

SECONDARY outcome

Timeframe: Up to 12 weeks

Population: Full Analysis Set. Not all subjects had data for this outcome.

Outcome measures

Measure	PLACEBO n=168 Participants Administered once-daily, orally, for up to 12 weeks	SPD489 n=169 Participants 50 or 70 mg administered orally, once-daily for up to 12 weeks
EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Usual Activities No problems doing usual activities	82.1 percentage of participants	89.9 percentage of participants
EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Usual Activities Slight problems dosin usual activities	14.3 percentage of participants	8.3 percentage of participants
EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Usual Activities Moderate problems doing usual activities	3.0 percentage of participants	1.2 percentage of participants
EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Usual Activities Severe problems doing usual activities	0.6 percentage of participants	0.6 percentage of participants
EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Usual Activities Unable to do usual activities	0 percentage of participants	0 percentage of participants

SECONDARY outcome

Timeframe: Up to 12 weeks

Population: Full Analysis Set. Not all subjects had data for this outcome.

Outcome measures

Measure	PLACEBO n=168 Participants Administered once-daily, orally, for up to 12 weeks	SPD489 n=169 Participants 50 or 70 mg administered orally, once-daily for up to 12 weeks
EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Pain/Discomfort Slight pain or discomfort	18.5 percentage of participants	20.1 percentage of participants
EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Pain/Discomfort No pain or discomfort	75.6 percentage of participants	76.3 percentage of participants
EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Pain/Discomfort Moderate pain or discomfort	3.0 percentage of participants	3.0 percentage of participants
EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Pain/Discomfort Severe pain or discomfort	3.0 percentage of participants	0 percentage of participants
EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Pain/Discomfort Extreme pain or discomfort	0 percentage of participants	0.6 percentage of participants

SECONDARY outcome

Timeframe: Up to 12 weeks

Population: Full Analysis Set. Not all subjects had data for this outcome.

Outcome measures

Measure	PLACEBO n=168 Participants Administered once-daily, orally, for up to 12 weeks	SPD489 n=169 Participants 50 or 70 mg administered orally, once-daily for up to 12 weeks
EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Anxiety/Depression Not anxious or depressed	69.6 percentage of participants	76.3 percentage of participants
EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Anxiety/Depression Slightly anxious or depressed	23.2 percentage of participants	20.7 percentage of participants
EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Anxiety/Depression Moderately anxious or depressed	4.8 percentage of participants	2.4 percentage of participants
EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Anxiety/Depression Severely anxious or depressed	1.2 percentage of participants	0 percentage of participants
EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Anxiety/Depression Extremely anxious or depressed	1.2 percentage of participants	0.6 percentage of participants

SECONDARY outcome

Timeframe: Up to 12 weeks

Population: For this Outcome Measure the Safety Analysis Set is defined as all randomized subjects who took at least 1 dose of investigational product and who had at least 1 post-baseline safety assessment completed, and responded to the relevant questions for the C-SSRS. All subjects from Site 015 were excluded from the Safety Analysis Set.

C-SSRS is a semi-structured interview that captures the occurence, severity, and frequency of suicide-related thoughts and behaviors during the assessment period. The interview includes definitions and suggested questions to solicit the type of information needed to determine if a suicide-related thought or behaviour occurred. The assessment is done by the nature of the responses, not by a numbered scale.

Outcome measures

Measure	PLACEBO n=183 Participants Administered once-daily, orally, for up to 12 weeks	SPD489 n=179 Participants 50 or 70 mg administered orally, once-daily for up to 12 weeks
Columbia-Suicide Severity Rating Scale (C-SSRS) Suicidal ideation	0 participants	0 participants
Columbia-Suicide Severity Rating Scale (C-SSRS) Suicidal behavior	0 participants	0 participants

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: Safety Analysis Set who completed ACSC at Baseline \& Week 12 Visits.

ACSA scale has 16 symptom items rated on a scale from 0 (not at all) to 4 (extremely) with a possible total score range of 0 to 64. Higher scores indicate greater withdrawal symptom severity. Calculated as Baseline (Day 0) - Week 12 ACSA scores.

Outcome measures

Measure	PLACEBO n=142 Participants Administered once-daily, orally, for up to 12 weeks	SPD489 n=135 Participants 50 or 70 mg administered orally, once-daily for up to 12 weeks
Change in Amphetamine Cessation Symptom Assessment (ACSA) Total Score From Baseline to Week 12.	7.0 units on a scale Standard Deviation 7.69	4.6 units on a scale Standard Deviation 5.83

Adverse Events

PLACEBO

Serious events: 2 serious events

Other events: 43 other events

Deaths: 0 deaths

SPD489

Serious events: 1 serious events

Other events: 100 other events

Deaths: 0 deaths

Serious adverse events

Measure	PLACEBO n=185 participants at risk Administered once-daily, orally, for up to 12 weeks	SPD489 n=181 participants at risk 50 or 70 mg administered orally, once-daily for up to 12 weeks
Injury, poisoning and procedural complications Fibula fracture	0.54% 1/185 • Number of events 1 The Safety Analysis Set defined as all randomized subjects who took at least 1 dose of investigational product and had at least 1 follow-up safety assessment.	0.00% 0/181 The Safety Analysis Set defined as all randomized subjects who took at least 1 dose of investigational product and had at least 1 follow-up safety assessment.
Injury, poisoning and procedural complications Lumbar vertebral fracture	0.00% 0/185 The Safety Analysis Set defined as all randomized subjects who took at least 1 dose of investigational product and had at least 1 follow-up safety assessment.	0.55% 1/181 • Number of events 1 The Safety Analysis Set defined as all randomized subjects who took at least 1 dose of investigational product and had at least 1 follow-up safety assessment.
Nervous system disorders Syncope	0.54% 1/185 • Number of events 1 The Safety Analysis Set defined as all randomized subjects who took at least 1 dose of investigational product and had at least 1 follow-up safety assessment.	0.00% 0/181 The Safety Analysis Set defined as all randomized subjects who took at least 1 dose of investigational product and had at least 1 follow-up safety assessment.
Psychiatric disorders Agitation	0.54% 1/185 • Number of events 1 The Safety Analysis Set defined as all randomized subjects who took at least 1 dose of investigational product and had at least 1 follow-up safety assessment.	0.00% 0/181 The Safety Analysis Set defined as all randomized subjects who took at least 1 dose of investigational product and had at least 1 follow-up safety assessment.
Psychiatric disorders Anxiety	0.54% 1/185 • Number of events 1 The Safety Analysis Set defined as all randomized subjects who took at least 1 dose of investigational product and had at least 1 follow-up safety assessment.	0.00% 0/181 The Safety Analysis Set defined as all randomized subjects who took at least 1 dose of investigational product and had at least 1 follow-up safety assessment.

Other adverse events

Measure	PLACEBO n=185 participants at risk Administered once-daily, orally, for up to 12 weeks	SPD489 n=181 participants at risk 50 or 70 mg administered orally, once-daily for up to 12 weeks
Gastrointestinal disorders Constipation	0.54% 1/185 • Number of events 1 The Safety Analysis Set defined as all randomized subjects who took at least 1 dose of investigational product and had at least 1 follow-up safety assessment.	5.5% 10/181 • Number of events 10 The Safety Analysis Set defined as all randomized subjects who took at least 1 dose of investigational product and had at least 1 follow-up safety assessment.
Gastrointestinal disorders Diarrhoea	1.6% 3/185 • Number of events 3 The Safety Analysis Set defined as all randomized subjects who took at least 1 dose of investigational product and had at least 1 follow-up safety assessment.	6.1% 11/181 • Number of events 12 The Safety Analysis Set defined as all randomized subjects who took at least 1 dose of investigational product and had at least 1 follow-up safety assessment.
Gastrointestinal disorders Dry mouth	5.9% 11/185 • Number of events 11 The Safety Analysis Set defined as all randomized subjects who took at least 1 dose of investigational product and had at least 1 follow-up safety assessment.	33.1% 60/181 • Number of events 60 The Safety Analysis Set defined as all randomized subjects who took at least 1 dose of investigational product and had at least 1 follow-up safety assessment.
Gastrointestinal disorders Nausea	4.3% 8/185 • Number of events 9 The Safety Analysis Set defined as all randomized subjects who took at least 1 dose of investigational product and had at least 1 follow-up safety assessment.	8.8% 16/181 • Number of events 17 The Safety Analysis Set defined as all randomized subjects who took at least 1 dose of investigational product and had at least 1 follow-up safety assessment.
General disorders Fatigue	4.9% 9/185 • Number of events 12 The Safety Analysis Set defined as all randomized subjects who took at least 1 dose of investigational product and had at least 1 follow-up safety assessment.	9.4% 17/181 • Number of events 21 The Safety Analysis Set defined as all randomized subjects who took at least 1 dose of investigational product and had at least 1 follow-up safety assessment.
General disorders Feeling jittery	0.00% 0/185 The Safety Analysis Set defined as all randomized subjects who took at least 1 dose of investigational product and had at least 1 follow-up safety assessment.	5.5% 10/181 • Number of events 10 The Safety Analysis Set defined as all randomized subjects who took at least 1 dose of investigational product and had at least 1 follow-up safety assessment.
Metabolism and nutrition disorders Decreased appetite	1.6% 3/185 • Number of events 3 The Safety Analysis Set defined as all randomized subjects who took at least 1 dose of investigational product and had at least 1 follow-up safety assessment.	6.1% 11/181 • Number of events 11 The Safety Analysis Set defined as all randomized subjects who took at least 1 dose of investigational product and had at least 1 follow-up safety assessment.
Nervous system disorders Headache	8.6% 16/185 • Number of events 19 The Safety Analysis Set defined as all randomized subjects who took at least 1 dose of investigational product and had at least 1 follow-up safety assessment.	17.7% 32/181 • Number of events 37 The Safety Analysis Set defined as all randomized subjects who took at least 1 dose of investigational product and had at least 1 follow-up safety assessment.
Psychiatric disorders Insomnia	3.2% 6/185 • Number of events 6 The Safety Analysis Set defined as all randomized subjects who took at least 1 dose of investigational product and had at least 1 follow-up safety assessment.	10.5% 19/181 • Number of events 19 The Safety Analysis Set defined as all randomized subjects who took at least 1 dose of investigational product and had at least 1 follow-up safety assessment.

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