Phase 3
Completed N=604
Open Label Extension in Adults With Binge Eating Disorder (BED)
Source: ClinicalTrials.gov NCT01657019 ↗Enrolled (actual)
604
Serious AEs
2.8%
Results posted
Dec 2015
Primary outcomePrimary: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) as a Measure of Safety — 84.5; 2.8 percentage of participants
Summary
To evaluate the safety and tolerability of SPD489 administered as a daily morning dose (50 or 70mg) in the treatment of moderate to severe binge eating disorder (BED) in adults
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) as a Measure of Safety |
84.5; 2.8 | — |
| PRIMARY Number of Participants With a Positive Response on The Columbia Suicide Severity Rating Scale (C-SSRS) |
0; 2; 3 | — |
| SECONDARY Percentage of Participants With an Improved Response on The Clinical Global Impressions of Improvement (CGI-I) Scale |
53.7; 88.5; 92.7; 95.4; 89.9 | — |
| SECONDARY Change From Baseline in The Global Score for The Eating Disorder Examination Questionnaire (EDE-Q) |
-1.66; -1.95; -1.95; -1.90 | — |
| SECONDARY Percentage of Participants With a Response to The EuroQoL Group 5 Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Mobility |
91.2; 6.8; 1.4; 0.4; 0.2 | — |
| SECONDARY Percentage of Participants With a Response to The EuroQoL Group 5 Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Self Care |
97.1; 1.8; 0.7; 0.2; 0.2 | — |
| SECONDARY Percentage of Participants With a Response to The EuroQoL Group 5 Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Usual Activities |
88.5; 8.3; 2.2; 0.9; 0.2 | — |
| SECONDARY Percentage of Participants With a Response to The EuroQoL Group 5 Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Pain and Discomfort |
71.2; 20.9; 7.0; 0.9; 0 | — |
| SECONDARY Percentage of Participants With a Response to The EuroQoL Group 5 Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Anxiety or Depression |
75.9; 18.7; 4.5; 0.9; 0 | — |
Eligibility Criteria
Inclusion criteria
- Completion of an antecedent SPD489 BED Double-blind Study
- Subject meets the following Diagnostic and Statistical Manual of Mental Disorders Fourth Edition - Text Revision (DSM-IV-TR) criteria for a diagnosis of BED
- Subject has a body mass index (BMI) of > or =18 and < or =45
Exclusion criteria
- Subject has concurrent symptoms of bulimia nervosa or anorexia nervosa.
- Subject is considered a suicide risk or risk to harm others
Data sourced from ClinicalTrials.gov (NCT01657019). 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. Informational only — not medical advice.