Binge Eating DisorderPhase 3NCT01106053
Pramipexole for Binge Eating Disorder
A Phase 3 study testing Pramipexole in people with Binge Eating Disorder, run by Neuropsychiatric Research Institute, Fargo, North Dakota.
Trial summary
This study is being conducted to evaluate the effects that the drug pramipexole has on mood, food craving, and other behaviors that may be related to binge eating disorder. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Binge Eating Disorder
- What is being tested?
- Pramipexole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Apr 2010to Jul 2011
- Phase
- Phase 3
- 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 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male or female
- Age 18-50 years
- Women of child-bearing potential and males must agree to practice an accepted method of birth control. All women must have a negative pregnancy test at baseline.
- Good general health as demonstrated by history and physical examination.
- Body mass index of 30 kg/m2 or higher at the screening visit.
- Meet criteria for binge eating disorder as assessed through the SCID-1 and EDE.
Who cannot join
- Subjects with any unstable medical condition, or any current or past medical condition which in the opinion of the study physician and/or the principal investigator may increase the risks associated with pramipexole and study participation. Medical appropriateness will be determined through history and physical exam.
- Subjects with any current Axis I psychiatric diagnosis as determined through the Structured Clinical Interview for DSM-IV for Axis I disorders (SCID-1) interview (aside from BED).
- Subjects with a Hamilton Depression Rating Scale score greater than or equal to 12 at the screening visit.
- Subjects who report any history of hallucinations or delusions.
- Participants taking an antidepressant or other regularly used psychotropic medication which may confound the study results
- Subjects with any current or history of an impulse control spectrum disorder, other than binge eating disorder,(such as pathological gambling, compulsive shopping, etc.) at screening as determined by the Structured Clinical Interview for DSM-IV Impulse Control Module.
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- Subjects with any history of suicide attempts or current suicidal ideations.
- Subjects that have used tobacco products on a routine basis within the past six months.
- Subjects enrolled in any formal treatment programs or research protocols for binge eating disorder at present, or within the past 30 days.
- Subjects routinely taking any medication known to produce weight change (ex. olanzapine, amitriptyline, steroid medications, etc., other than oral contraceptives, stable thyroid replacement drugs, etc.), or medications with drug-drug interactions with pramipexole.
- Subjects who are currently breast-feeding.
- Subjects who have participated in an investigational drug trial in the past 30 days.
- Subjects who meet DSM IV-TR criteria for alcohol or drug abuse in the past year.
- Subjects with an allergy to pramipexole or tablet constituents.
- Subjects with hepatic dysfunction as determined through a hepatic panel obtained at the screening visit.
- Subjects with an elevated blood pressure or pulse at screening (140/90 mmHg or above or pulse of greater than 100 beats/minute after being seated and stationary for at least five minutes, or as determined at the discretion of the study physician and/or principal investigator) or history of serious cardiac events (myocardial infarction, arrhythmia, stroke, etc).
- Subjects with a history of renal dysfunction or with a creatinine clearance of less than 60 ml/min based upon a serum creatinine obtained during screening and as calculated with the Cockroft and Gault equation.
- Subjects with a positive urine drug screen.
- Any participant with Parkinson's disease or symptoms suggestive of probable Parkinson's disease.
- Subjects who have an Epworth Sleep Scale (ESS) score of >7 at screening. ESS scores > 7 have been associated with an increased risk of sleep attacks (Plowman et al., 2005).
- Any participant who demonstrates clinically significant orthostatic blood pressure changes or is symptomatic during the screening visit, as defined under "orthostatic blood pressure monitoring."
- History of bariatric surgery.
- Participants who report a history of obstructive sleep apnea, excessive fatigue, or any sleep disorder which in the opinion of the principal investigator or study medical personnel would increase the participant's risk of experiencing excessive somnolence with pramipexole.
- Participant has had a change in medication regimen in the last month (dose, starting a new medication, or stopping a medication).
- Participant is employed by, or has an immediate family member employed by NRI.
- Participant has participated in a formal weight loss program in the last month (e.g. Weight Watchers, Jenny Craig, etc.)
About this study
Official title: An Exploration of the Effects of the Dopamine Agonist Pramipexole on Binge Antecedants, Binge Frequency, and Weight in Binge Eating Disorder
This study is being conducted to evaluate the effects that the drug pramipexole has on mood, food craving, and other behaviors that may be related to binge eating disorder.
- Conditions
- Binge Eating Disorder
- Being tested
- Pramipexole
- Keywords
- Binge eating disorder, Food craving, Obesity, Pramipexole, Mirapex, Binge
- Medical subject headings
- Binge-Eating Disorder, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PramipexoleDrug
Also called Mirapex
Pramipexole tablet titrated up to a maximum dosage of 0.5 mg three times daily (1.5 mg/day).
| Study group | Role | What they receive |
|---|---|---|
| Pramipexole | Experimental | Open-label trial of pramipexole. Receives: Drug: Pramipexole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of binge eating
Measured: Baseline followed by weekly during the seven week protocol
Secondary outcomes (3)
Body weight
Measured: Baseline followed by weekly during the seven week protocol
Frequency and extent of craving for food using validated instruments
Measured: Baseline followed by weekly during the seven week protocol
Assessment of mood ratings using a validated instrument
Measured: Baseline followed by weekly during the seven week protocol
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2010 (estimated)
- Study startApr 2010
- Primary completionJul 2011
Why it stopped: No participants were recruited and study has been closed.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neuropsychiatric Research Institute, Fargo, North Dakota
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kristine Steffen, Neuropsychiatric Research Institute, Fargo, North Dakota
- Investigators
- Kristine J Steffen, PharmD, PhD, Principal investigator, Neuropsychiatric Research Institute, Fargo, ND
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01106053
- Sponsor's protocol ID
- NEDA-Pramipexole
- Status last verified
- May 2013
- First submitted
- 15 Apr 2010
- Last updated
- 6 May 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploration of the Effects of the Dopamine Agonist Pramipexole on Binge Antecedants, Binge Frequency, and Weight in Binge Eating Disorder
- ClinicalTrials.gov ID
- NCT01106053
- Acronym / sponsor ID
- NEDA-Pramipexole
- Conditions
- Binge Eating Disorder
- Keywords
- Binge eating disorder, Food craving, Obesity, Pramipexole, Mirapex, Binge
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No participants were recruited and study has been closed.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Neuropsychiatric Research Institute, Fargo, North DakotaUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Jul 2011 (actual)
- First posted
- 19 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.
This study is being conducted to evaluate the effects that the drug pramipexole has on mood, food craving, and other behaviors that may be related to binge eating disorder.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pramipexole | Experimental | Drug: PramipexoleOpen-label trial of pramipexole. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Male or female
- Age 18-50 years
- Women of child-bearing potential and males must agree to practice an accepted method of birth control. All women must have a negative pregnancy test at baseline.
- Good general health as demonstrated by history and physical examination.
- Body mass index of 30 kg/m2 or higher at the screening visit.
Key exclusion criteria (26 listed)
- Subjects with any unstable medical condition, or any current or past medical condition which in the opinion of the study physician and/or the principal investigator may increase the risks associated with pramipexole and study participation. Medical appropriateness will be determined through history and physical exam.
- Subjects with any current Axis I psychiatric diagnosis as determined through the Structured Clinical Interview for DSM-IV for Axis I disorders (SCID-1) interview (aside from BED).
- Subjects with a Hamilton Depression Rating Scale score greater than or equal to 12 at the screening visit.
- Subjects who report any history of hallucinations or delusions.
- Participants taking an antidepressant or other regularly used psychotropic medication which may confound the study results
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 |
|---|---|---|
| PramipexoleAlso: MirapexPramipexole tablet titrated up to a maximum dosage of 0.5 mg three times daily (1.5 mg/day). | Drug | Pramipexole |
Primary outcome
Frequency of binge eating
Time frame: Baseline followed by weekly during the seven week protocol
3 secondary outcomes
Body weight
Time frame: Baseline followed by weekly during the seven week protocol
Frequency and extent of craving for food using validated instruments
Time frame: Baseline followed by weekly during the seven week protocol
Assessment of mood ratings using a validated instrument
Time frame: Baseline followed by weekly during the seven week protocol
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2013.
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Naltrexone Neuroimaging in Teens With Eating Disorders
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A Neuropsychobiological Approach to Optimize Patient Selection for GLP-1-based Pharmacotherapy for Weight Management Across the Binge Eating Spectrum
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Targeting Transdiagnostic Self-regulatory Factors and Eating Disorder Pathology Among Adults With BInge-spectrum Eating disOrders: A mHEALTH Interoceptive Exposure Intervention (the Bio-HEALTH Study)
Eating Disorders
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.
Kristine J Steffen, PharmD, PhD principal investigator
Neuropsychiatric Research Institute, Fargo, ND
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Pramipexole in people with Binge Eating Disorder, run by Neuropsychiatric Research Institute, Fargo, North Dakota.
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 6 inclusion and 26 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: withdrawn, as of the sponsor's last update on 6 May 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 was withdrawn before enrolling participants, so there are no results.
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?
Frequency of binge eating (time frame: Baseline followed by weekly during the seven week protocol). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 May 2013.