A Phase 2 Study to Evaluate the Safety and Efficacy of RM-131 in Patients With Parkinson's Disease & Chronic Constipation (MOVE-PD)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Rhythm Pharmaceuticals, Inc.
Sponsor:
Collaborator:
Michael J. Fox Foundation for Parkinson's Research
Information provided by (Responsible Party):
Rhythm Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01955616
First received: September 25, 2013
Last updated: March 11, 2014
Last verified: March 2014
  Purpose

The purpose of this study, called MOVE-PD, is to investigate how individuals with Parkinson's disease (PD) and chronic constipation (CC) respond to RM-131 as compared to placebo. The study will look at how well RM-131 affects the frequency of spontaneous bowel movements over a 14-day period. The study will also evaluate the safety and tolerability of the study drug and evaluate whether the study drug relieves the uncomfortable GI symptoms related to chronic constipation in patients who are unsatisfied with other therapies they have tried for constipation.


Condition Intervention Phase
Parkinson's Disease
Drug: RM-131
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2, Randomized, Double-blind, Placebo-controlled, Multiple Dose, Parallel Group Study to Evaluate the Pharmacodynamics, Efficacy and Safety of RM-131 Administered to Patients With Parkinson's Disease and Chronic Constipation Dissatisfied With Current Therapy

Resource links provided by NLM:


Further study details as provided by Rhythm Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • Investigate the effects of treatment with RM-131 for 14 days on the frequency of spontaneous bowel movements (SBMs) when administered to patients with Parkinson's Disease (PD) and Chronic Constipation (CC) [ Time Frame: Screening through Day 28 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Evaluate the safety and tolerability of multiple doses of RM-131 when administered to patients with PD and CC [ Time Frame: Screening through Day 28 ] [ Designated as safety issue: No ]
  • Effect of RM-131 on stool frequency as measured by complete spontaneous bowel movements, stool consistency, straining, completeness of evacuation, abdominal pain, and global patient reported outcomes of severity of constipation and overall relief. [ Time Frame: Screening through Day 28 ] [ Designated as safety issue: No ]
  • Assess symptoms of Parkinson's disease using the Unified Parkinson Disease Rating Scale (UPDRS) [ Time Frame: Screening through Day 28 ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Assess the effect of RM-131 on gastroparesis symptoms [ Time Frame: Screening through Day 28 ] [ Designated as safety issue: No ]
  • Time to first bowel movement (BM) [ Time Frame: Screening through Day 28 ] [ Designated as safety issue: No ]
  • Area under the concentration versus time curve of RM-131 will be measured [ Time Frame: Screening through Day 28 ] [ Designated as safety issue: No ]

Estimated Enrollment: 56
Study Start Date: September 2013
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: RM-131
RM-131 100 µg by subcutaneous injection daily in the morning
Drug: RM-131
Other Name: Ghrelin receptor agonist
Placebo Comparator: Placebo
by subcutaneous injection daily in the morning
Drug: Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Able to provide written informed consent and be willing and able to comply with study procedures.
  • Diagnosis of Parkinson's disease
  • Diagnosis of chronic constipation (CC), including experiencing constipation for ~12 or more weeks in the preceding 12 months.
  • Regular treatment for chronic constipation during the last 6 months, and dissatisfaction with current treatment for CC, after treatment with at least 2 regimens for constipation (see note at end of this section).
  • Stable medication history defined as no changes in regimen for at least 2 weeks prior to the baseline period
  • Body mass index of 18-40 kg/m2
  • Mini-mental status exam (at screening) ≥26
  • Female patients must have negative serum or urine pregnancy tests and must not be lactating. For females able to bear children, a hormonal (i.e., oral, implantable, or injectable) and single-barrier method, or a double-barrier method of birth control must be used throughout the study. A vasectomized partner will be allowed as one in conjunction with another single-barrier method.
  • Female patients unable to bear children must have this documented in the case report form(i.e., tubal ligation, hysterectomy, or post-menopausal [defined as a minimum of one year since the last menstrual period]). Post-menopausal status will be confirmed by follicle stimulating hormone (FSH) in women less than 60 years of age

Note the following medications are allowed:

  • Selective serotonin reuptake inhibitor (SSRI), SNRI, and tricyclic antidepressants are permissible at stable doses. All medications shall be reviewed and dis/approved by the investigator on a case-by-case basis.
  • Benzodiazepines are permissible at stable doses
  • Stable doses of antacids, NSAIDS, Cox-2 inhibitors, calcium supplements, thyroid replacement, estrogen replacements, low-dose aspirin for cardioprotection, and birth control (but with adequate back up contraception as drug interactions with birth control have not been conducted) are permissible
  • Dopamine agonists and amantadine allowed if on a stable dose
  • Deep brain stimulation is allowed.

Exclusion Criteria:

  • Unable or unwilling to provide informed consent or to comply with study procedures
  • Diagnosis of secondary constipation beyond that of Parkinson's disease
  • Structural or metabolic diseases that affect the GI system
  • Unable to withdraw the following medications 48 hours prior to the baseline period and throughout the study (except as protocol defined rescue medications; see below):

    • Medications that alter GI transit including laxatives, prokinetics, erythromycin, narcotics, and anti-cholinergics (except as protocol defined rescue medications).
    • GABAergic agents
    • Drugs with a low therapeutic index, such as warfarin, digoxin, anti-seizure medications
    • NOTE: Parkinson's disease therapies are allowed. Exceptions for Parkinson's disease medications include:

      • Cogentin (benztopine), Artane (trihexyphenidyl), and apomorphone are excluded
  • History of recent major surgery (within 60 days of screening)
  • Acute or chronic illness or history of illness, which in the opinion of the Investigator, could pose a threat or harm to the patient or obscure interpretation of laboratory test results or interpretation of study data such as frequent angina, Class III or IV congestive heart failure, moderate impairment of renal or hepatic function, poorly controlled diabetes, etc.
  • History of symptomatic orthostatic hypotension or significant history of dizziness
  • History of hypersensitivity to mannitol which is an ingredient of both active and placebo study medications
  • Any clinically significant abnormalities on screening laboratories or physical examination as determined by the Investigator
  • Abnormal 12-lead electrocardiogram (ECG), including evidence of acute myocardial or subendocardial ischemia and clinically significant arrhythmias or conduction abnormalities (including prolonged QTc > 500 msec) or abnormal blood pressure at screening except minor deviations deemed to be of no clinical significance by the Investigator
  • Acute GI illness within 48 hours of the baseline period
  • History of major GI surgery, except that patients with uncomplicated appendectomy or cholecystectomy are allowed.
  • ALT or AST > 1.5 X upper limit of normal (ULN) during screening
  • Females who are pregnant or breastfeeding
  • History of excessive alcohol use or substance abuse
  • Patient or caregiver unable to administer daily SC injections
  • Participation in an investigational clinical study within the 30 days prior to dosing in the present study
  • Any other reason, which in the opinion of the Investigator, would confound proper interpretation of the study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01955616

Contacts
Contact: Elizabeth Stoner, MD 857-264-4280

Locations
United States, California
University of Southern California Recruiting
Los Angeles, California, United States
Contact: Mark F Lew, MD    323-442-5728      
Principal Investigator: Mark F Lew, MD         
United States, Colorado
Colorado Neurological Institute Recruiting
Englewood, Colorado, United States
Contact: Rajeev Kumar, MD    303-357-5445      
Principal Investigator: Rajeev Kumar, MD         
United States, Florida
University of Florida Ctr for Movement Disorders & Neurorestoration Recruiting
Gainesville, Florida, United States
Contact: Stacy Merritt, MA    352-273-5550      
Principal Investigator: Ramon Rodriguez, MD         
United States, Georgia
Emory University, Wesley Woods Health Center Recruiting
Atlanta, Georgia, United States
Contact: Alan Freeman, MD    404-728-4957      
Principal Investigator: Alan Freeman, MD         
Georgia Regents University Recruiting
Augusta, Georgia, United States
Contact: John C Morgan, MD PhD    706-721-2798      
Principal Investigator: John C Morgan, MD PhD         
United States, Iowa
University of Iowa Hospitals, Movement Disorders Div, Dept of Neurology Recruiting
Iowa City, Iowa, United States
Contact: Ergun UC, MD    319-356-8754      
Principal Investigator: Ergun Uc, MD         
United States, Maine
Port City Neurology Recruiting
Scarbourough, Maine, United States
Contact: Edward Drasby, DO    207-885-1400      
Principal Investigator: Edward Drasby, MD         
United States, Michigan
Michigan State University Recruiting
East Lansing, Michigan, United States
Contact: John L Goudreau, DO PhD    517-432-9277      
Principal Investigator: John L Goudreau, DO PhD         
Henry Ford West Bloomfield Hospital Recruiting
West Bloomfield, Michigan, United States
Contact: Peter Lewitt, MD    248-325-2452      
Principal Investigator: Peter Lewitt, MD         
United States, New Jersey
Atlantic Neuroscience Recruiting
Summit, New Jersey, United States
Contact: Roger Kurlan, MD    908-522-2089      
Principal Investigator: Roger Kurlan, MD         
United States, New York
University of Rochester Recruiting
Rochester, New York, United States
Contact: Michelle Burack, MD    585-273-1134      
Principal Investigator: Michelle Burack, MD         
United States, Ohio
University of Toledo Medical Center Recruiting
Toledo, Ohio, United States
Contact: Lawrence Elmer, MD PhD    419-383-3544      
Principal Investigator: Lawrence Elmer, MD PhD         
United States, Oregon
Movement Disorders Program & The Parkinson's Center of Oregon Recruiting
Portland, Oregon, United States
Contact: Matthew Brodsky, MD    503-494-9054      
Principal Investigator: Matthew Brodsky, MD         
United States, Pennsylvania
University of Pennsylvania, Penn Neurological Institute Recruiting
Philadelphia, Pennsylvania, United States
Contact: Matthew Stern, MD    215-829-3582      
Principal Investigator: Matthew Stern, MD         
United States, Virginia
Hunter Holmes McGuire Veterans Medical Center Not yet recruiting
Richmond, Virginia, United States
Contact: Peggy Roberge, RN    804-675-5931      
Principal Investigator: Mark Baron, MD         
Sponsors and Collaborators
Rhythm Pharmaceuticals, Inc.
Michael J. Fox Foundation for Parkinson's Research
Investigators
Principal Investigator: Ronald Pfeiffer, MD Parkinson's Study Group
  More Information

No publications provided

Responsible Party: Rhythm Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01955616     History of Changes
Other Study ID Numbers: RM-131-007
Study First Received: September 25, 2013
Last Updated: March 11, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Rhythm Pharmaceuticals, Inc.:
Parkinson's disease, chronic constipation

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Constipation
Signs and Symptoms, Digestive
Signs and Symptoms

ClinicalTrials.gov processed this record on September 16, 2014