Trial Outcomes & Findings for Forced-dose Titration of SPD489 in Adults With Binge Eating Disorder (NCT NCT01291173)
NCT ID: NCT01291173
Last Updated: 2021-06-10
Results Overview
Binge day is defined as a day during which at least 1 binge episode occurs.
COMPLETED
PHASE2
271 participants
Baseline and week 11
2021-06-10
Participant Flow
A site with 11 enrolled subjects was excluded from study. An external investigation was initiated for reasons unrelated to the respective study. Lacking information on the purpose or scope of the investigation, it was deemed prudent to exclude data from subjects enrolled at site from the primary analyses of efficacy and safety.
Participant milestones
| Measure |
Placebo
Placebo capsule taken once daily for up to 11 weeks
|
Lisdexamfetamine Dimesylate (SPD489) 30 mg
SPD489-30mg capsules taken once daily for up to 11 weeks
|
Lisdexamfetamine Dimesylate (SPD489) 50 mg
SPD489 50mg capsules taken once-daily for up to 11 weeks
|
Lisdexamfetamine Dimesylate (SPD489) 70 mg
SPD489 70mg capsule taken once-daily for up to 11 weeks
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
64
|
66
|
65
|
65
|
|
Overall Study
COMPLETED
|
47
|
51
|
52
|
52
|
|
Overall Study
NOT COMPLETED
|
17
|
15
|
13
|
13
|
Reasons for withdrawal
| Measure |
Placebo
Placebo capsule taken once daily for up to 11 weeks
|
Lisdexamfetamine Dimesylate (SPD489) 30 mg
SPD489-30mg capsules taken once daily for up to 11 weeks
|
Lisdexamfetamine Dimesylate (SPD489) 50 mg
SPD489 50mg capsules taken once-daily for up to 11 weeks
|
Lisdexamfetamine Dimesylate (SPD489) 70 mg
SPD489 70mg capsule taken once-daily for up to 11 weeks
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
3
|
1
|
3
|
|
Overall Study
Protocol Violation
|
7
|
2
|
2
|
5
|
|
Overall Study
Withdrawal by Subject
|
6
|
4
|
4
|
2
|
|
Overall Study
Lost to Follow-up
|
4
|
6
|
3
|
2
|
|
Overall Study
Unable to meet visit schedule
|
0
|
0
|
1
|
0
|
|
Overall Study
Lack of compliance
|
0
|
0
|
0
|
1
|
|
Overall Study
Subject was unblinded
|
0
|
0
|
1
|
0
|
|
Overall Study
Excluded therapy
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Forced-dose Titration of SPD489 in Adults With Binge Eating Disorder
Baseline characteristics by cohort
| Measure |
Placebo
n=63 Participants
Placebo capsule taken once daily for up to 11 weeks
|
Lisdexamfetamine Dimesylate (SPD489) 30 mg
n=66 Participants
SPD489-30mg capsules taken once daily for up to 11 weeks
|
Lisdexamfetamine Dimesylate (SPD489) 50 mg
n=65 Participants
SPD489 50mg capsules taken once-daily for up to 11 weeks
|
Lisdexamfetamine Dimesylate (SPD489) 70 mg
n=65 Participants
SPD489 70mg capsule taken once-daily for up to 11 weeks
|
Total
n=259 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
38.0 years
STANDARD_DEVIATION 10.30 • n=5 Participants
|
38.4 years
STANDARD_DEVIATION 11.14 • n=7 Participants
|
39.6 years
STANDARD_DEVIATION 9.32 • n=5 Participants
|
38.6 years
STANDARD_DEVIATION 10.01 • n=4 Participants
|
38.7 years
STANDARD_DEVIATION 10.17 • n=21 Participants
|
|
Age, Customized
18-39 years
|
35 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
34 Participants
n=4 Participants
|
134 Participants
n=21 Participants
|
|
Age, Customized
40-55 years
|
28 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
31 Participants
n=4 Participants
|
125 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
49 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
55 Participants
n=4 Participants
|
211 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
48 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
63 Participants
n=5 Participants
|
66 Participants
n=7 Participants
|
65 Participants
n=5 Participants
|
65 Participants
n=4 Participants
|
259 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline and week 11Population: Full Analysis Set defined as all subjects who had taken at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment.
Binge day is defined as a day during which at least 1 binge episode occurs.
Outcome measures
| Measure |
Placebo
n=62 Participants
Placebo capsule taken once daily for up to 11 weeks
|
Lisdexamfetamine Dimesylate (SPD489) 30 mg
n=66 Participants
SPD489-30mg capsules taken once daily for up to 11 weeks
|
Lisdexamfetamine Dimesylate (SPD489) 50 mg
n=64 Participants
SPD489 50mg capsules taken once-daily for up to 11 weeks
|
Lisdexamfetamine Dimesylate (SPD489) 70 mg
n=63 Participants
SPD489 70mg capsule taken once-daily for up to 11 weeks
|
|---|---|---|---|---|
|
Change From Baseline in Log Transformed Binge Days Per Week at Week 11
|
-1.23 Log days
Standard Error 0.069
|
-1.24 Log days
Standard Error 0.067
|
-1.49 Log days
Standard Error 0.066
|
-1.57 Log days
Standard Error 0.067
|
SECONDARY outcome
Timeframe: Baseline and up to 11 weeksPopulation: Full Analysis Set defined as all subjects who had taken at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment.
The number of binge episodes per week as assessed by clinical interview based on subject diary.
Outcome measures
| Measure |
Placebo
n=62 Participants
Placebo capsule taken once daily for up to 11 weeks
|
Lisdexamfetamine Dimesylate (SPD489) 30 mg
n=66 Participants
SPD489-30mg capsules taken once daily for up to 11 weeks
|
Lisdexamfetamine Dimesylate (SPD489) 50 mg
n=64 Participants
SPD489 50mg capsules taken once-daily for up to 11 weeks
|
Lisdexamfetamine Dimesylate (SPD489) 70 mg
n=63 Participants
SPD489 70mg capsule taken once-daily for up to 11 weeks
|
|---|---|---|---|---|
|
Change From Baseline in the Number of Binge Episodes Per Week at Up to 11 Weeks
|
-4.07 Binge Episodes
Standard Deviation 2.718
|
-4.57 Binge Episodes
Standard Deviation 3.266
|
-5.10 Binge Episodes
Standard Deviation 3.026
|
-5.09 Binge Episodes
Standard Deviation 2.586
|
SECONDARY outcome
Timeframe: Last 7 days on studyPopulation: Full Analysis Set defined as all subjects who had taken at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment.
The 1-week binge response was defined as either a 1-week remission (a 100% reduction of binge episodes from baseline \[ie, a cessation of binge eating behavior\]), or a marked response (75 to \<100% reduction in binge episodes from baseline), or a moderate response (50 to \<75% reduction in binge episodes from baseline), or a negative/minimal response (\<50% reduction in binge episodes from baseline). The 1-week response was determined at the end of the study utilizing a LOCF approach.
Outcome measures
| Measure |
Placebo
n=62 Participants
Placebo capsule taken once daily for up to 11 weeks
|
Lisdexamfetamine Dimesylate (SPD489) 30 mg
n=66 Participants
SPD489-30mg capsules taken once daily for up to 11 weeks
|
Lisdexamfetamine Dimesylate (SPD489) 50 mg
n=64 Participants
SPD489 50mg capsules taken once-daily for up to 11 weeks
|
Lisdexamfetamine Dimesylate (SPD489) 70 mg
n=63 Participants
SPD489 70mg capsule taken once-daily for up to 11 weeks
|
|---|---|---|---|---|
|
1-Week Binge Response, Last Observation Carried Forward (LOCF)
Moderate response
|
13 Participants
|
8 Participants
|
4 Participants
|
1 Participants
|
|
1-Week Binge Response, Last Observation Carried Forward (LOCF)
Negative/Minimal response
|
11 Participants
|
10 Participants
|
3 Participants
|
4 Participants
|
|
1-Week Binge Response, Last Observation Carried Forward (LOCF)
1 week remission
|
23 Participants
|
28 Participants
|
33 Participants
|
35 Participants
|
|
1-Week Binge Response, Last Observation Carried Forward (LOCF)
Marked response
|
15 Participants
|
20 Participants
|
24 Participants
|
23 Participants
|
SECONDARY outcome
Timeframe: Last 28 days on studyPopulation: Full Analysis Set defined as all subjects who had taken at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment.
Subjects are free from binge episodes for 4 weeks.
Outcome measures
| Measure |
Placebo
n=61 Participants
Placebo capsule taken once daily for up to 11 weeks
|
Lisdexamfetamine Dimesylate (SPD489) 30 mg
n=63 Participants
SPD489-30mg capsules taken once daily for up to 11 weeks
|
Lisdexamfetamine Dimesylate (SPD489) 50 mg
n=64 Participants
SPD489 50mg capsules taken once-daily for up to 11 weeks
|
Lisdexamfetamine Dimesylate (SPD489) 70 mg
n=62 Participants
SPD489 70mg capsule taken once-daily for up to 11 weeks
|
|---|---|---|---|---|
|
4-Week Binge Response
|
13 Participants
|
22 Participants
|
27 Participants
|
31 Participants
|
SECONDARY outcome
Timeframe: BaselinePopulation: Full Analysis Set defined as all subjects who had taken at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment. (Not all subjects in the FAS had an assessment for this outcome.)
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 |
Placebo
n=62 Participants
Placebo capsule taken once daily for up to 11 weeks
|
Lisdexamfetamine Dimesylate (SPD489) 30 mg
n=66 Participants
SPD489-30mg capsules taken once daily for up to 11 weeks
|
Lisdexamfetamine Dimesylate (SPD489) 50 mg
n=64 Participants
SPD489 50mg capsules taken once-daily for up to 11 weeks
|
Lisdexamfetamine Dimesylate (SPD489) 70 mg
n=63 Participants
SPD489 70mg capsule taken once-daily for up to 11 weeks
|
|---|---|---|---|---|
|
Percent of Participants With Clinical Global Impression - Severity of Illness (CGI-S) at Baseline
Normal, not at all ill
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percent of Participants With Clinical Global Impression - Severity of Illness (CGI-S) at Baseline
Mildly ill
|
1.6 Percentage of participants
|
0 Percentage of participants
|
3.1 Percentage of participants
|
1.6 Percentage of participants
|
|
Percent of Participants With Clinical Global Impression - Severity of Illness (CGI-S) at Baseline
Moderately ill
|
56.5 Percentage of participants
|
54.5 Percentage of participants
|
59.4 Percentage of participants
|
42.9 Percentage of participants
|
|
Percent of Participants With Clinical Global Impression - Severity of Illness (CGI-S) at Baseline
Markedly ill
|
29.0 Percentage of participants
|
30.3 Percentage of participants
|
29.7 Percentage of participants
|
47.6 Percentage of participants
|
|
Percent of Participants With Clinical Global Impression - Severity of Illness (CGI-S) at Baseline
Borderline mentally ill
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
1.6 Percentage of participants
|
|
Percent of Participants With Clinical Global Impression - Severity of Illness (CGI-S) at Baseline
Severely ill
|
11.3 Percentage of participants
|
12.1 Percentage of participants
|
6.3 Percentage of participants
|
6.3 Percentage of participants
|
|
Percent of Participants With Clinical Global Impression - Severity of Illness (CGI-S) at Baseline
Among the most extremely ill
|
1.6 Percentage of participants
|
3.0 Percentage of participants
|
1.6 Percentage of participants
|
0 Percentage of participants
|
SECONDARY outcome
Timeframe: up to 11 weeksPopulation: Full Analysis Set defined as all subjects who had taken at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment. (Not all subjects in the FAS had an assessment for this outcome.)
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 |
Placebo
n=62 Participants
Placebo capsule taken once daily for up to 11 weeks
|
Lisdexamfetamine Dimesylate (SPD489) 30 mg
n=65 Participants
SPD489-30mg capsules taken once daily for up to 11 weeks
|
Lisdexamfetamine Dimesylate (SPD489) 50 mg
n=64 Participants
SPD489 50mg capsules taken once-daily for up to 11 weeks
|
Lisdexamfetamine Dimesylate (SPD489) 70 mg
n=63 Participants
SPD489 70mg capsule taken once-daily for up to 11 weeks
|
|---|---|---|---|---|
|
Percent of Participants With Clinical Global Impression - Severity of Illness (CGI-S) at Up to 11 Weeks
Borderline mentally ill
|
19.4 Percentage of participants
|
26.2 Percentage of participants
|
23.4 Percentage of participants
|
20.6 Percentage of participants
|
|
Percent of Participants With Clinical Global Impression - Severity of Illness (CGI-S) at Up to 11 Weeks
Normal, not at all ill
|
37.1 Percentage of participants
|
55.4 Percentage of participants
|
60.9 Percentage of participants
|
65.1 Percentage of participants
|
|
Percent of Participants With Clinical Global Impression - Severity of Illness (CGI-S) at Up to 11 Weeks
Mildly ill
|
12.9 Percentage of participants
|
1.5 Percentage of participants
|
6.3 Percentage of participants
|
11.1 Percentage of participants
|
|
Percent of Participants With Clinical Global Impression - Severity of Illness (CGI-S) at Up to 11 Weeks
Moderately ill
|
24.2 Percentage of participants
|
13.8 Percentage of participants
|
7.8 Percentage of participants
|
3.2 Percentage of participants
|
|
Percent of Participants With Clinical Global Impression - Severity of Illness (CGI-S) at Up to 11 Weeks
Markedly ill
|
6.5 Percentage of participants
|
1.5 Percentage of participants
|
1.6 Percentage of participants
|
0 Percentage of participants
|
|
Percent of Participants With Clinical Global Impression - Severity of Illness (CGI-S) at Up to 11 Weeks
Severely ill
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percent of Participants With Clinical Global Impression - Severity of Illness (CGI-S) at Up to 11 Weeks
Among the most extremely ill
|
0 Percentage of participants
|
1.5 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to 11 weeksPopulation: Full Analysis Set defined as all subjects who had taken at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment. (Not all subjects in the FAS had an assessment for this outcome.)
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=62 Participants
Placebo capsule taken once daily for up to 11 weeks
|
Lisdexamfetamine Dimesylate (SPD489) 30 mg
n=65 Participants
SPD489-30mg capsules taken once daily for up to 11 weeks
|
Lisdexamfetamine Dimesylate (SPD489) 50 mg
n=64 Participants
SPD489 50mg capsules taken once-daily for up to 11 weeks
|
Lisdexamfetamine Dimesylate (SPD489) 70 mg
n=63 Participants
SPD489 70mg capsule taken once-daily for up to 11 weeks
|
|---|---|---|---|---|
|
Percentage of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) at Up to 11 Weeks
|
64.5 Percentage of participants
|
84.6 Percentage of participants
|
90.6 Percentage of participants
|
93.7 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and week 11Population: Full Analysis Set defined as all subjects who had taken at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment.
The YBOCS-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. A score of 0-7 is sub-clinical; 8-15 is mild; 16-23 is moderate; 24-31 is severe; and 32-40 is extreme.
Outcome measures
| Measure |
Placebo
n=62 Participants
Placebo capsule taken once daily for up to 11 weeks
|
Lisdexamfetamine Dimesylate (SPD489) 30 mg
n=66 Participants
SPD489-30mg capsules taken once daily for up to 11 weeks
|
Lisdexamfetamine Dimesylate (SPD489) 50 mg
n=64 Participants
SPD489 50mg capsules taken once-daily for up to 11 weeks
|
Lisdexamfetamine Dimesylate (SPD489) 70 mg
n=63 Participants
SPD489 70mg capsule taken once-daily for up to 11 weeks
|
|---|---|---|---|---|
|
Change From Baseline in Yale-Brown Obsessive Compulsive Scale Modified for Binge Eating (YBOCS-BE) Total Score at Week 11
|
-12.0 units on a scale
Standard Error 0.87
|
-15.0 units on a scale
Standard Error 0.84
|
-15.3 units on a scale
Standard Error 0.83
|
-17.0 units on a scale
Standard Error 0.83
|
SECONDARY outcome
Timeframe: Baseline and week 11Population: Full Analysis Set defined as all subjects who had taken at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment.
MADRS is a validated, 10-item rating scale with each item being scored on a scale from 0-6 with a total score ranging from 0-60. Lower scores indicate a decreased severity of depression.
Outcome measures
| Measure |
Placebo
n=62 Participants
Placebo capsule taken once daily for up to 11 weeks
|
Lisdexamfetamine Dimesylate (SPD489) 30 mg
n=66 Participants
SPD489-30mg capsules taken once daily for up to 11 weeks
|
Lisdexamfetamine Dimesylate (SPD489) 50 mg
n=64 Participants
SPD489 50mg capsules taken once-daily for up to 11 weeks
|
Lisdexamfetamine Dimesylate (SPD489) 70 mg
n=63 Participants
SPD489 70mg capsule taken once-daily for up to 11 weeks
|
|---|---|---|---|---|
|
Change From Baseline in Montgomery-Ǻsberg Depression Rating Scale (MADRS) Score at Week 11
|
-1.7 units on a scale
Standard Error 0.35
|
-1.9 units on a scale
Standard Error 0.34
|
-1.3 units on a scale
Standard Error 0.33
|
-1.6 units on a scale
Standard Error 0.33
|
SECONDARY outcome
Timeframe: Baseline and week 11Population: Full Analysis Set defined as all subjects who had taken at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment.
The HAM-A is a rating scale developed to quantify the severity of anxiety symptomatology. It consists of 14 items, each defined by a series of symptoms. Each item is rated on a 5-point scale, ranging from 0 (not present) to 4 (severe) with a total score range of 0-56, where \<17 indicates mild severity, 18-24 mild to moderate severity, and 25-30 moderate to severe, and 31-56 severe anxiety.
Outcome measures
| Measure |
Placebo
n=62 Participants
Placebo capsule taken once daily for up to 11 weeks
|
Lisdexamfetamine Dimesylate (SPD489) 30 mg
n=66 Participants
SPD489-30mg capsules taken once daily for up to 11 weeks
|
Lisdexamfetamine Dimesylate (SPD489) 50 mg
n=64 Participants
SPD489 50mg capsules taken once-daily for up to 11 weeks
|
Lisdexamfetamine Dimesylate (SPD489) 70 mg
n=63 Participants
SPD489 70mg capsule taken once-daily for up to 11 weeks
|
|---|---|---|---|---|
|
Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Score at Week 11
|
-1.5 units on a scale
Standard Error 0.30
|
-0.9 units on a scale
Standard Error 0.29
|
-1.1 units on a scale
Standard Error 0.29
|
-0.6 units on a scale
Standard Error 0.29
|
SECONDARY outcome
Timeframe: Baseline and week 11Population: Full Analysis Set defined as all subjects who had taken at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment.
The Eating Inventory also known as the Three-Factor Eating Questionnaire is a 51-item self-reported questionnaire intended to assess 3 dimensions of eating behavior: cognitive restraint of eating, disinhibition, and hunger. Cognitive restraint of eating consists of 20 items, disinhibition consists of 16 items, and hunger consists of 15 items. Each item scores either 0 or 1 point for a total score of 0-20 for cognitive restraint of eating, 0-16 for disinhibition, and 0-15 for hunger. A higher score is better for cognitive restraint of eating and lower scores are better for disinhibition and hunger.
Outcome measures
| Measure |
Placebo
n=62 Participants
Placebo capsule taken once daily for up to 11 weeks
|
Lisdexamfetamine Dimesylate (SPD489) 30 mg
n=66 Participants
SPD489-30mg capsules taken once daily for up to 11 weeks
|
Lisdexamfetamine Dimesylate (SPD489) 50 mg
n=64 Participants
SPD489 50mg capsules taken once-daily for up to 11 weeks
|
Lisdexamfetamine Dimesylate (SPD489) 70 mg
n=63 Participants
SPD489 70mg capsule taken once-daily for up to 11 weeks
|
|---|---|---|---|---|
|
Change From Baseline in Eating Inventory Score at Week 11
Hunger
|
-3.3 units on a scale
Standard Error 0.58
|
-5.3 units on a scale
Standard Error 0.56
|
-6.0 units on a scale
Standard Error 0.55
|
-7.8 units on a scale
Standard Error 0.56
|
|
Change From Baseline in Eating Inventory Score at Week 11
Cognitive restraint of eating
|
2.5 units on a scale
Standard Error 0.65
|
4.4 units on a scale
Standard Error 0.62
|
3.8 units on a scale
Standard Error 0.61
|
4.3 units on a scale
Standard Error 0.62
|
|
Change From Baseline in Eating Inventory Score at Week 11
Disinhibition
|
-3.8 units on a scale
Standard Error 0.58
|
-5.6 units on a scale
Standard Error 0.56
|
-6.3 units on a scale
Standard Error 0.55
|
-7.2 units on a scale
Standard Error 0.56
|
SECONDARY outcome
Timeframe: Baseline and week 11Population: Full Analysis Set defined as all subjects who had taken at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment.
The BES is a 16-item self-reported questionnaire that is designed to assess behavioral, affective, and attitudinal components of the subjective experience of binge eating. The items are summed, with possible scores ranging from 0 to 46. A score of 27 or higher indicates severe binge-eating problems, and a score of 17 or lower designates no binge-eating problems.
Outcome measures
| Measure |
Placebo
n=62 Participants
Placebo capsule taken once daily for up to 11 weeks
|
Lisdexamfetamine Dimesylate (SPD489) 30 mg
n=66 Participants
SPD489-30mg capsules taken once daily for up to 11 weeks
|
Lisdexamfetamine Dimesylate (SPD489) 50 mg
n=64 Participants
SPD489 50mg capsules taken once-daily for up to 11 weeks
|
Lisdexamfetamine Dimesylate (SPD489) 70 mg
n=63 Participants
SPD489 70mg capsule taken once-daily for up to 11 weeks
|
|---|---|---|---|---|
|
Change From Baseline in Binge Eating Scale (BES) Score at Week 11
|
-12.2 units on a scale
Standard Error 1.28
|
-16.1 units on a scale
Standard Error 1.25
|
-17.6 units on a scale
Standard Error 1.24
|
-20.6 units on a scale
Standard Error 1.24
|
SECONDARY outcome
Timeframe: Baseline and week 11Population: Full Analysis Set defined as all subjects who had taken at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment.
The BIS-11 is a self-reported 30-item questionnaire that measures impulsiveness using a 4-point Likert scale (rarely/never = 1, occasionally = 2, often = 3, almost always/always = 4). A Total Impulsivity score is calculated by summing the scores for each item. Possible scores range from 30 - 120. Higher scores indicate increased impulsiveness.
Outcome measures
| Measure |
Placebo
n=62 Participants
Placebo capsule taken once daily for up to 11 weeks
|
Lisdexamfetamine Dimesylate (SPD489) 30 mg
n=66 Participants
SPD489-30mg capsules taken once daily for up to 11 weeks
|
Lisdexamfetamine Dimesylate (SPD489) 50 mg
n=64 Participants
SPD489 50mg capsules taken once-daily for up to 11 weeks
|
Lisdexamfetamine Dimesylate (SPD489) 70 mg
n=63 Participants
SPD489 70mg capsule taken once-daily for up to 11 weeks
|
|---|---|---|---|---|
|
Change From Baseline in Barratt Impulsiveness Scale (BIS-11) Total Score at Week 11
|
-3.1 units on a scale
Standard Error 1.09
|
-5.8 units on a scale
Standard Error 1.05
|
-5.2 units on a scale
Standard Error 1.05
|
-6.9 units on a scale
Standard Error 1.05
|
SECONDARY outcome
Timeframe: Baseline and week 11Population: Full Analysis Set defined as all subjects who had taken at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment.
The SF-12 is a 12-item self-report questionnaire that is a subset of the SF-36 Health Survey. The survey captures physical and mental health. There are 8 subscales. Four of the subscales has one-item each; the other 4 have two-items each. For each subscale, a mean value was first computed and transformed to a position on a scale ranging from 0-100 (Z-transformation). The aggregate total scores are then transformed into a mean value ranging from 0 (lowest level of health) to 100 (highest level of health).
Outcome measures
| Measure |
Placebo
n=62 Participants
Placebo capsule taken once daily for up to 11 weeks
|
Lisdexamfetamine Dimesylate (SPD489) 30 mg
n=66 Participants
SPD489-30mg capsules taken once daily for up to 11 weeks
|
Lisdexamfetamine Dimesylate (SPD489) 50 mg
n=64 Participants
SPD489 50mg capsules taken once-daily for up to 11 weeks
|
Lisdexamfetamine Dimesylate (SPD489) 70 mg
n=63 Participants
SPD489 70mg capsule taken once-daily for up to 11 weeks
|
|---|---|---|---|---|
|
Change From Baseline in Short Form-12 Health Survey (SF-12) Score at Week 11
Aggregate Physical Score
|
1.3 units on a scale
Standard Error 0.78
|
2.6 units on a scale
Standard Error 0.75
|
2.4 units on a scale
Standard Error 0.74
|
3.9 units on a scale
Standard Error 0.75
|
|
Change From Baseline in Short Form-12 Health Survey (SF-12) Score at Week 11
Aggregate Mental Score
|
4.9 units on a scale
Standard Error 1.03
|
5.0 units on a scale
Standard Error 1.00
|
5.5 units on a scale
Standard Error 0.99
|
4.9 units on a scale
Standard Error 1.00
|
Adverse Events
Placebo
Lisdexamfetamine Dimesylate (SPD489) 30 mg
Lisdexamfetamine Dimesylate (SPD489) 50 mg
Lisdexamfetamine Dimesylate (SPD489) 70 mg
Serious adverse events
| Measure |
Placebo
n=63 participants at risk
Placebo capsule taken once daily for up to 11 weeks
|
Lisdexamfetamine Dimesylate (SPD489) 30 mg
n=66 participants at risk
SPD489-30mg capsules taken once daily for up to 11 weeks
|
Lisdexamfetamine Dimesylate (SPD489) 50 mg
n=65 participants at risk
SPD489 50mg capsules taken once-daily for up to 11 weeks
|
Lisdexamfetamine Dimesylate (SPD489) 70 mg
n=65 participants at risk
SPD489 70mg capsule taken once-daily for up to 11 weeks
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/63
|
1.5%
1/66
|
0.00%
0/65
|
0.00%
0/65
|
|
Infections and infestations
Appendicitis
|
0.00%
0/63
|
1.5%
1/66
|
0.00%
0/65
|
0.00%
0/65
|
|
Injury, poisoning and procedural complications
Drug toxicity
|
0.00%
0/63
|
0.00%
0/66
|
0.00%
0/65
|
1.5%
1/65
|
Other adverse events
| Measure |
Placebo
n=63 participants at risk
Placebo capsule taken once daily for up to 11 weeks
|
Lisdexamfetamine Dimesylate (SPD489) 30 mg
n=66 participants at risk
SPD489-30mg capsules taken once daily for up to 11 weeks
|
Lisdexamfetamine Dimesylate (SPD489) 50 mg
n=65 participants at risk
SPD489 50mg capsules taken once-daily for up to 11 weeks
|
Lisdexamfetamine Dimesylate (SPD489) 70 mg
n=65 participants at risk
SPD489 70mg capsule taken once-daily for up to 11 weeks
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Dry mouth
|
7.9%
5/63
|
33.3%
22/66
|
33.8%
22/65
|
41.5%
27/65
|
|
Metabolism and nutrition disorders
Decreased appetite
|
6.3%
4/63
|
25.8%
17/66
|
20.0%
13/65
|
18.5%
12/65
|
|
Psychiatric disorders
Insomnia
|
1.6%
1/63
|
10.6%
7/66
|
15.4%
10/65
|
13.8%
9/65
|
|
Nervous system disorders
Headache
|
9.5%
6/63
|
13.6%
9/66
|
13.8%
9/65
|
7.7%
5/65
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/63
|
7.6%
5/66
|
9.2%
6/65
|
6.2%
4/65
|
|
Gastrointestinal disorders
Constipation
|
1.6%
1/63
|
9.1%
6/66
|
4.6%
3/65
|
7.7%
5/65
|
|
Infections and infestations
Nasopharyngitis
|
3.2%
2/63
|
12.1%
8/66
|
1.5%
1/65
|
4.6%
3/65
|
|
Investigations
Weight decreased
|
1.6%
1/63
|
3.0%
2/66
|
6.2%
4/65
|
9.2%
6/65
|
|
General disorders
Irritability
|
6.3%
4/63
|
7.6%
5/66
|
4.6%
3/65
|
4.6%
3/65
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/63
|
6.1%
4/66
|
7.7%
5/65
|
1.5%
1/65
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/63
|
6.1%
4/66
|
6.2%
4/65
|
1.5%
1/65
|
|
General disorders
Feeling jittery
|
0.00%
0/63
|
1.5%
1/66
|
4.6%
3/65
|
7.7%
5/65
|
|
Cardiac disorders
Palpitations
|
0.00%
0/63
|
6.1%
4/66
|
3.1%
2/65
|
4.6%
3/65
|
|
Infections and infestations
Upper respiratory tract infection
|
6.3%
4/63
|
1.5%
1/66
|
4.6%
3/65
|
7.7%
5/65
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
3.2%
2/63
|
4.5%
3/66
|
4.6%
3/65
|
3.1%
2/65
|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/63
|
1.5%
1/66
|
4.6%
3/65
|
6.2%
4/65
|
|
General disorders
Fatigue
|
3.2%
2/63
|
3.0%
2/66
|
4.6%
3/65
|
3.1%
2/65
|
|
Psychiatric disorders
Initial insomnia
|
0.00%
0/63
|
3.0%
2/66
|
3.1%
2/65
|
4.6%
3/65
|
|
General disorders
Energy increased
|
0.00%
0/63
|
3.0%
2/66
|
3.1%
2/65
|
3.1%
2/65
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/63
|
1.5%
1/66
|
1.5%
1/65
|
4.6%
3/65
|
|
Nervous system disorders
Dizziness
|
0.00%
0/63
|
3.0%
2/66
|
1.5%
1/65
|
3.1%
2/65
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/63
|
0.00%
0/66
|
4.6%
3/65
|
3.1%
2/65
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
4.8%
3/63
|
0.00%
0/66
|
1.5%
1/65
|
1.5%
1/65
|
|
Gastrointestinal disorders
Abdominal pain
|
3.2%
2/63
|
0.00%
0/66
|
0.00%
0/65
|
0.00%
0/65
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.8%
3/63
|
0.00%
0/66
|
1.5%
1/65
|
0.00%
0/65
|
|
Injury, poisoning and procedural complications
Excoriation
|
3.2%
2/63
|
0.00%
0/66
|
0.00%
0/65
|
1.5%
1/65
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
3.2%
2/63
|
0.00%
0/66
|
0.00%
0/65
|
0.00%
0/65
|
Additional Information
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