Ignite Creation Date:
2025-12-24 @ 10:30 PM
Ignite Modification Date:
2025-12-25 @ 8:03 PM
Study NCT ID:
NCT01098435
Status:
COMPLETED
Last Update Posted:
2011-08-23
First Post:
2010-04-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
ALK33-101: A Study of RDC-0313 (ALKS 33) in Adults With Binge Eating Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D056912', 'term': 'Binge-Eating Disorder'}], 'ancestors': [{'id': 'D001068', 'term': 'Feeding and Eating Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C583425', 'term': 'ALKS-33'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 69}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-08', 'dispFirstSubmitDate': '2011-08-18', 'completionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-08-18', 'studyFirstSubmitDate': '2010-04-01', 'dispFirstSubmitQcDate': '2011-08-18', 'studyFirstSubmitQcDate': '2010-04-01', 'dispFirstPostDateStruct': {'date': '2011-08-23', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2011-08-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-04-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants in each dose group reporting at least 1 treatment-emergent adverse event (TEAE)', 'timeFrame': '6 Weeks', 'description': "A TEAE is any adverse event (AE), regardless of causality, that either: begins after a participant's first dose of study drug, up to and including the final follow-up visit; or started before a participant's first dose of study drug but worsens in severity after the first dose of study drug, up to and including the final follow-up visit."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Binge eating disorder', 'RDC-0313'], 'conditions': ['Binge Eating Disorder']}, 'referencesModule': {'references': [{'pmid': '23381803', 'type': 'DERIVED', 'citation': 'McElroy SL, Guerdjikova AI, Blom TJ, Crow SJ, Memisoglu A, Silverman BL, Ehrich EW. A placebo-controlled pilot study of the novel opioid receptor antagonist ALKS-33 in binge eating disorder. Int J Eat Disord. 2013 Apr;46(3):239-45. doi: 10.1002/eat.22114. Epub 2013 Feb 5.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety of daily doses of RDC-0313 (ALKS 33) compared with placebo in adults with binge-eating disorder (BED). An additional objective is to explore the efficacy of RDC-0313 treatment in comparison with placebo in adults with binge-eating disorder.', 'detailedDescription': 'Following screening, eligible subjects will be randomized in a 1:1 ratio to RDC-0313 (ALKS 33) or matching placebo. Once-daily at-home dosing will begin at randomization and will continue for 6 weeks. There will be 8 study visits over a 12-week study period. On an ongoing basis, subjects will complete a take-home binge diary designed to record the number of binge-eating episodes (binge episodes) and binge-eating days (binge days, days during which at least 1 binge occurred), as well as snacks and meals consumed daily over each 7-day period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Meet the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, text revised (DSM-IV-TR) criteria for a diagnosis of binge eating disorder (BED)\n* Display greater than or equal to 3 binge eating days per week\n* Body mass index (BMI) greater than or equal to 30 kg/m2\n* Age of 18 years or older\n* Women of childbearing potential must agree to use an approved method of birth control for the duration of the study\n\nExclusion Criteria:\n\n* Concurrent symptoms of bulimia nervosa or anorexia nervosa\n* Suicidal ideation\n* DSM-IV-TR diagnosis of substance abuse or dependence (except nicotine or caffeine) within 6 months prior to randomization\n* Positive urine toxicological screen for benzodiazepines, opioids, amphetamine/methamphetamine, or cocaine at screening or randomization\n* Women who are pregnant or breastfeeding\n* Participation in a psychological or weight loss intervention for BED that was initiated within the 3 months prior to screening\n* Clinically unstable medical disease\n* History of hepatitis B, hepatitis C, or human immunodeficiency virus (HIV)\n* History of seizures, including clinically significant febrile seizures in childhood\n* Current or anticipated need for prescribed opioid medication during the study period\n* Use of any psychotropic medications (other than hypnotics)\n* Participation in a clinical trial of a pharmacological agent within 30 days prior to screening'}, 'identificationModule': {'nctId': 'NCT01098435', 'briefTitle': 'ALK33-101: A Study of RDC-0313 (ALKS 33) in Adults With Binge Eating Disorder', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alkermes, Inc.'}, 'officialTitle': 'A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Pilot Study of the Safety and Efficacy of RDC-0313 in Adults With Binge Eating Disorder', 'orgStudyIdInfo': {'id': 'ALK33-101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'RDC-0313 (ALKS 33)', 'description': '2-capsules taken orally', 'interventionNames': ['Drug: RDC-0313 (ALKS 33)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': '2-capsules taken orally', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'RDC-0313 (ALKS 33)', 'type': 'DRUG', 'description': 'Capsules for daily oral administration', 'armGroupLabels': ['RDC-0313 (ALKS 33)']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Capsules containing lactose and no active drug for daily oral administration', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85712', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': "Alkermes' Investigational Study Site", 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '55454', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': "Alkermes' Investigational Study Site", 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '13104', 'city': 'Manlius', 'state': 'New York', 'country': 'United States', 'facility': "Alkermes' Investigational Study Site", 'geoPoint': {'lat': 43.00201, 'lon': -75.97686}}, {'zip': '27612', 'city': 'Raleigh', 'state': 'North Carolina', 'country': 'United States', 'facility': "Alkermes' Investigational Study Site", 'geoPoint': {'lat': 35.7721, 'lon': -78.63861}}, {'zip': '45040', 'city': 'Mason', 'state': 'Ohio', 'country': 'United States', 'facility': "Alkermes' Investigational Study Site", 'geoPoint': {'lat': 39.36006, 'lon': -84.30994}}, {'zip': '43623', 'city': 'Toledo', 'state': 'Ohio', 'country': 'United States', 'facility': "Alkermes' Investigational Study Site", 'geoPoint': {'lat': 41.66394, 'lon': -83.55521}}], 'overallOfficials': [{'name': 'Marc deSomer, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Alkermes, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alkermes, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}