Phase 3
N=418
Evaluate the Maintenance of Efficacy of SPD489 in Adults Aged 18-55 Years With Moderate to Severe Binge Eating Disorder
Binge Eating Disorder
Bottom Line
View on ClinicalTrials.gov: NCT02009163 ↗Enrolled (actual)
418
Serious AEs
0.7%
Results posted
Apr 2016
Primary outcome: Primary: Time to Relapse From Date of Randomization to Endpoint of The Randomized-withdrawal Period — NA; NA days — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Lisdexamfetamine dimesylate (Drug); Placebo (Other)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Shire
- Primary completion
- Apr 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Relapse From Date of Randomization to Endpoint of The Randomized-withdrawal Period |
NA; NA | <0.001 sig |
| SECONDARY Change From Randomized-Withdrawal Baseline in The Number of Binge- Eating Days Per Week During The Randomized-withdrawal Period |
0.63; 0.02 | <0.001 sig |
| SECONDARY Percent of Participants Within Each Category of The Clinical Global Impression-Severity of Illness (CGI-S) Scale at Endpoint of The Randomized-withdrawal Period |
45.0; 81.6; 10.7; 11.8; 14.5; 2.2 | <0.001 sig |
| SECONDARY Change From Randomized-Withdrawal Baseline in The Total Score of The Yale-Brown Obsessive Compulsive Scale Modified for Binge Eating (Y-BOCS-BE) During The Randomized-withdrawal Period |
5.5; -0.0 | <0.001 sig |
| SECONDARY Percent of Participants Within Each Category of The EuroQuol Group 5-Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Mobility at Endpoint of The Open-label Period |
87.9; 9.8; 1.5; 0.8; 0 | — |
| SECONDARY Percent of Participants Within Each Category of The EuroQuol Group 5--Dimension 5--Level Self--Report Questionnaire (EQ--5D--5L) For Mobility at Endpoint of The Randomized-withdrawal Period |
83.6; 91.3; 14.7; 6.3; 1.7; 1.6 | — |
| SECONDARY Percent of Participants Within Each Category of The EuroQuol Group 5-Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Self Care at Endpoint of The Open-label Period |
98.7; 0.8; 0.3; 0.3; 0 | — |
| SECONDARY Percent of Participants Within Each Category of The EuroQuol Group 5-Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Self Care at Endpoint of The Randomized-withdrawal Period |
98.3; 98.4; 0.9; 0.8; 0.9; 0.8 | — |
| SECONDARY Percent of Participants Within Each Category of The EuroQuol Group 5-Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Usual Activities at Endpoint of The Open-label Period |
88.9; 8.1; 2.3; 0.8; 0 | — |
| SECONDARY Percent of Participants Within Each Category of The EuroQuol Group 5-Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Usual Activities at Endpoint of The Randomized-withdrawal Period |
79.3; 86.6; 16.4; 11.0; 2.6; 0.8 | — |
| SECONDARY Percent of Participants Within Each Category of The EuroQuol Group 5-Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Pain and Discomfort at Endpoint of The Open-label Period |
72.3; 20.9; 5.3; 1.3; 0.3 | — |
| SECONDARY Percent of Participants Within Each Category of The EuroQuol Group 5-Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Pain and Discomfort at Endpoint of The Randomized-withdrawal Period |
75.0; 71.7; 16.4; 18.1; 8.6; 8.7 | — |
| SECONDARY Percent of Participants Within Each Category of The EuroQuol Group 5-Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Anxiety And Depression at Endpoint of The Open-label Period |
80.9; 15.6; 2.3; 1.0; 0.3 | — |
| SECONDARY Percent of Participants Within Each Category of The EuroQuol Group 5-Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Anxiety And Depression at Endpoint of The Randomized-withdrawal Period |
66.4; 79.5; 26.7; 15.7; 4.3; 3.1 | — |
| SECONDARY Number of Participants With a Positive Response on The Columbia Suicide Severity Rating Scale (C-SSRS) at Endpoint of The Open-label Period |
0; 0; 2 | — |
| SECONDARY Number of Participants With a Positive Response on The Columbia Suicide Severity Rating Scale (C-SSRS) at Endpoint of The Randomized-withdrawal Period |
0; 0; 0; 0; 0; 1 | — |
| SECONDARY Total Scores For The Amphetamine Cessation Symptom Assessment (ACSA) Scale During Follow-up |
7.6; 4.9; 4.6; 5.3 | — |
Summary
To evaluate maintenance of efficacy based on time to relapse between SPD489 (50 or 70mg) and placebo, as measured by the number of binge days (defined as days during which at least 1 binge episode occurs) per week as assessed by clinical interview based on subject diary and Clinical Global Impression - Severity (CGI-S) scores for patients who responded to SPD489 by the end of the Open-label Treatment Phase.
Eligibility Criteria
Inclusion Criteria
- Subject is between 18-55 years of age, inclusive.
- Subject meets the following criteria for a diagnosis of BED:
- Recurrent episodes of binge eating. An episode of binge eating is characterized by both of the following: eating, in a discrete period of time (eg, within a 2-hour period) an amount of food that is definitely larger than most people would eat in a similar period of time under similar conditions, and a sense of lack of control over the eating (eg, a feeling that one cannot stop eating or control what or how much one is eating).
- The binge eating episodes are associated with at least 3 of the following: eating much more rapidly than normal; eating until uncomfortably full; eating large amounts of food when not feeling physically hungry; eating alone because of being embarrassed by how much one is eating; feeling disgusted with oneself, depressed, or feeling very guilty after overeating.
- Marked distress regarding binge eating.
- The binge eating occurs, on average, at least 2 days a week for 6 months.
- The episodes of binge eating do not occur exclusively during the course of bulimia nervosa or anorexia nervosa.
- Subject is consistently able to swallow a capsule.
Exclusion Criteria
- Subject has current diagnosis of bulimia nervosa or anorexia nervosa.
- Subject is receiving psychotherapy or weight loss support within the past 3 months.
- Subject has used psychostimulants to facilitate fasting or dieting within the past 6 months.
- Subject has known history of symptomatic cardiovascular disease, advanced arteriosclerosis, structural cardiac abnormality, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease.
- Subject has abnormal thyroid function.
- Subject initiated treatment with a lipid lowering medication within the past 3 months.
- Subject has a history of moderate or severe hypertension.
- Subject has a recent history (within the past 6 months) of suspected substance abuse or dependence disorder.
- Subject has glaucoma.
- Subject is female and pregnant or nursing.
- Subjects who have had bariatric surgery, lap bands, duodenal stents, or other procedures for weight loss.
Data sourced from ClinicalTrials.gov (NCT02009163). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.