Open Label Extension in Adults With Binge Eating Disorder (BED)
This study is currently recruiting participants.
Verified February 2013 by Shire Development LLC
Sponsor:
Shire Development LLC
Information provided by (Responsible Party):
Shire Development LLC
ClinicalTrials.gov Identifier:
NCT01657019
First received: August 1, 2012
Last updated: February 7, 2013
Last verified: February 2013
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Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
|
Binge Eating Disorder |
Drug: Lisdexamfetamine dimesylate |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase 3, Multicenter, Open-label, 12 Month Extension Safety and Tolerability Study of SPD489 in the Treatment of Adults With Binge Eating Disorder |
Resource links provided by NLM:
Further study details as provided by Shire Development LLC:
Primary Outcome Measures:
- Occurrence of treatment-emergent adverse events (TEAEs) as a measure of safety [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]
- Columbia Suicide Severity Rating Scale (C-SSRS) [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Clinical Global Impressions of Improvement (CGI-I) scale [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
- Eating Disorder Examination Questionnaire (EDE-Q) [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
- EuroQoL Group 5 Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 530 |
| Study Start Date: | August 2012 |
| Estimated Study Completion Date: | May 2015 |
| Estimated Primary Completion Date: | May 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Lisdexamfetamine dimesylate |
Drug: Lisdexamfetamine dimesylate
50 or 70 mg administered orally, once a day for 52 weeks
Other Name: Vyvanse, SPD489, LDX
|
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01657019
Contacts
| Contact: Shire Call Center | 1-866-842-5335 |
Locations
| United States, Arkansas | |
| Clinical Study Centers, LLC | Recruiting |
| Little Rock, Arkansas, United States, 72211 | |
| Principal Investigator: John Giblin | |
| United States, California | |
| Southwestern Research, Inc. | Recruiting |
| Beverly Hills, California, United States, 90210 | |
| Principal Investigator: John Murphy | |
| Scripps Clinical Research Services | Recruiting |
| La Jolla, California, United States, 92037 | |
| Principal Investigator: Ken Fujioka | |
| Pharmacology Research Institute | Recruiting |
| Newport Beach, California, United States, 92660 | |
| Principal Investigator: Nader Oskooilar | |
| PCSD - Feighner Research | Recruiting |
| San Diego, California, United States, 92108 | |
| Principal Investigator: Michael McManus | |
| United States, Florida | |
| Andrew Cutler | Recruiting |
| Brandenton, Florida, United States, 34201 | |
| Gulfcoast Clinical Research | Recruiting |
| Fort Myers, Florida, United States, 33912 | |
| Principal Investigator: John Prater | |
| John Joyce | Recruiting |
| Jacksonville, Florida, United States, 32256 | |
| Linda Harper | Recruiting |
| Orlando, Florida, United States, 32806 | |
| United States, Georgia | |
| Atlanta Institute of Medicine and Research | Recruiting |
| Atlanta, Georgia, United States, 30328 | |
| Principal Investigator: Angela Sambunaris | |
| United States, Illinois | |
| Michael Greenbaum | Recruiting |
| Libertyville, Illinois, United States, 60048 | |
| United States, Kansas | |
| Thomas H. Mikel | Recruiting |
| Prairie Village, Kansas, United States, 66206 | |
| United States, Louisiana | |
| Michael Biunno | Recruiting |
| New Orleans, Louisiana, United States, 70114 | |
| United States, Massachusetts | |
| McLean Hospital | Recruiting |
| Belmont, Massachusetts, United States, 02478 | |
| Principal Investigator: James Hudson | |
| Irinia Mezhebovsky | Recruiting |
| Boston, Massachusetts, United States, 02135 | |
| United States, North Carolina | |
| Treva Tyson | Recruiting |
| Raleigh, North Carolina, United States, 27612 | |
| United States, Ohio | |
| Alfredo Rivera | Recruiting |
| Cincinnati, Ohio, United States, 45227 | |
| United States, Tennessee | |
| Valerie Arnold | Recruiting |
| Memphis, Tennessee, United States, 38119 | |
| United States, Texas | |
| Donald Garcia | Recruiting |
| Austin, Texas, United States, 78731 | |
| Shonna Piegari | Recruiting |
| Houston, Texas, United States, 77081 | |
| United States, Virginia | |
| Charlottesville Medical Research | Recruiting |
| Charlottesville, Virginia, United States, 22911 | |
| Principal Investigator: Joseph David | |
Sponsors and Collaborators
Shire Development LLC
Investigators
| Principal Investigator: | Susan McElroy | University of Cincinnati |
More Information
No publications provided
| Responsible Party: | Shire Development LLC |
| ClinicalTrials.gov Identifier: | NCT01657019 History of Changes |
| Other Study ID Numbers: | SPD489-345 |
| Study First Received: | August 1, 2012 |
| Last Updated: | February 7, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Binge-Eating Disorder Bulimia Eating Disorders Hyperphagia Signs and Symptoms, Digestive Signs and Symptoms Mental Disorders Dextroamphetamine Dopamine Uptake Inhibitors |
Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Neurotransmitter Uptake Inhibitors Physiological Effects of Drugs Central Nervous System Stimulants Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 21, 2013