Binge Eating DisorderPhase 2NCT01098435
ALK33-101: A Study of RDC-0313 (ALKS 33) in Adults With Binge Eating Disorder
A Phase 2 study testing RDC-0313 (ALKS 33) in people with Binge Eating Disorder, run by Alkermes, Inc. at 6 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Binge Eating Disorder
- What is being tested?
- RDC-0313 (ALKS 33)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 69 participants
- Where
- 6 sitesUnited States
- Study dates
- May 2010to Jun 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
- Display greater than or equal to 3 binge eating days per week
- Body mass index (BMI) greater than or equal to 30 kg/m2
- Age of 18 years or older
- Women of childbearing potential must agree to use an approved method of birth control for the duration of the study
Who cannot join
- Concurrent symptoms of bulimia nervosa or anorexia nervosa
- Suicidal ideation
- DSM-IV-TR diagnosis of substance abuse or dependence (except nicotine or caffeine) within 6 months prior to randomization
- Positive urine toxicological screen for benzodiazepines, opioids, amphetamine/methamphetamine, or cocaine at screening or randomization
- Women who are pregnant or breastfeeding
- Participation in a psychological or weight loss intervention for BED that was initiated within the 3 months prior to screening
Show all 12Show fewer
- Clinically unstable medical disease
- History of hepatitis B, hepatitis C, or human immunodeficiency virus (HIV)
- History of seizures, including clinically significant febrile seizures in childhood
- Current or anticipated need for prescribed opioid medication during the study period
- Use of any psychotropic medications (other than hypnotics)
- Participation in a clinical trial of a pharmacological agent within 30 days prior to screening
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Alkermes' Investigational Study Site
Manlius, New York, 13104
Alkermes' Investigational Study Site
Mason, Ohio, 45040
Alkermes' Investigational Study Site
Minneapolis, Minnesota, 55454
Alkermes' Investigational Study Site
Raleigh, North Carolina, 27612
Alkermes' Investigational Study Site
Toledo, Ohio, 43623
Alkermes' Investigational Study Site
Tucson, Arizona, 85712
About this study
Official title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Pilot Study of the Safety and Efficacy of RDC-0313 in Adults With Binge Eating Disorder
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.
Read the detailed description
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.
- Conditions
- Binge Eating Disorder
- Being tested
- RDC-0313 (ALKS 33), Placebo
- Keywords
- Binge eating disorder, RDC-0313
- Medical subject headings
- Binge-Eating Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RDC-0313 (ALKS 33)Drug
Capsules for daily oral administration
PlaceboDrug
Capsules containing lactose and no active drug for daily oral administration
| Study group | Role | What they receive |
|---|---|---|
| RDC-0313 (ALKS 33) | Experimental | 2-capsules taken orally Receives: Drug: RDC-0313 (ALKS 33) |
| Placebo | Placebo comparator | 2-capsules taken orally Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants in each dose group reporting at least 1 treatment-emergent adverse event (TEAE)
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.
Measured: 6 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2010 (estimated)
- Study startMay 2010
- Primary completionMay 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Binge Eating DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alkermes, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Marc deSomer, MD, Study director, Alkermes, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01098435
- Sponsor's protocol ID
- ALK33-101
- Status last verified
- Aug 2011
- First submitted
- 1 Apr 2010
- Last updated
- 23 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 23381803
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Pilot Study of the Safety and Efficacy of RDC-0313 in Adults With Binge Eating Disorder
- ClinicalTrials.gov ID
- NCT01098435
- Acronym / sponsor ID
- ALK33-101
- Conditions
- Binge Eating Disorder
- Keywords
- Binge eating disorder, RDC-0313
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Alkermes, Inc.Industry (pharma, biotech, devices)
- Study start
- May 2010
- Primary completion
- May 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 2 Apr 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RDC-0313 (ALKS 33) | Experimental | Drug: RDC-0313 (ALKS 33)2-capsules taken orally |
| Placebo | Placebo comparator | Drug: Placebo2-capsules taken orally |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
- Display greater than or equal to 3 binge eating days per week
- Body mass index (BMI) greater than or equal to 30 kg/m2
- Age of 18 years or older
- Women of childbearing potential must agree to use an approved method of birth control for the duration of the study
Key exclusion criteria (12 listed)
- Concurrent symptoms of bulimia nervosa or anorexia nervosa
- Suicidal ideation
- DSM-IV-TR diagnosis of substance abuse or dependence (except nicotine or caffeine) within 6 months prior to randomization
- Positive urine toxicological screen for benzodiazepines, opioids, amphetamine/methamphetamine, or cocaine at screening or randomization
- Women who are pregnant or breastfeeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RDC-0313 (ALKS 33)Capsules for daily oral administration | Drug | RDC-0313 (ALKS 33) |
| PlaceboCapsules containing lactose and no active drug for daily oral administration | Drug | Placebo |
Primary outcome
Number of participants in each dose group reporting at least 1 treatment-emergent adverse event (TEAE)
Time frame: 6 Weeks
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2011.
- Derived from this study: PubMed 23381803McElroy 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marc deSomer, MD study director
Alkermes, Inc.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing RDC-0313 (ALKS 33) in people with Binge Eating Disorder, run by Alkermes, Inc. at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants in each dose group reporting at least 1 treatment-emergent adverse event (TEAE) (time frame: 6 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01098435, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2011.