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

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ClinicalTrials.gov Identifier: NCT01955616
Recruitment Status : Terminated
First Posted : October 7, 2013
Last Update Posted : September 23, 2016
Michael J. Fox Foundation for Parkinson's Research
Information provided by (Responsible Party):
Motus Therapeutics, Inc.

Brief Summary:
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 or disease Intervention/treatment Phase
Parkinson's Disease Drug: RM-131 Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : September 2013
Actual Primary Completion Date : May 2015
Actual Study Completion Date : September 2015

Arm Intervention/treatment
Active Comparator: RM-131
RM-131 100 µg by subcutaneous injection daily in the morning
Drug: RM-131
Other Names:
  • Ghrelin receptor agonist
  • relamorelin

Placebo Comparator: Placebo
by subcutaneous injection daily in the morning
Drug: Placebo

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. Assess symptoms of Parkinson's disease using the Unified Parkinson Disease Rating Scale (UPDRS) [ Time Frame: Screening through Day 28 ]

Other Outcome Measures:
  1. Assess the effect of RM-131 on gastroparesis symptoms [ Time Frame: Screening through Day 28 ]
  2. Time to first bowel movement (BM) [ Time Frame: Screening through Day 28 ]
  3. Area under the concentration versus time curve of RM-131 will be measured [ Time Frame: Screening through Day 28 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01955616

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United States, California
University of Southern California
Los Angeles, California, United States
United States, Colorado
Colorado Neurological Institute
Englewood, Colorado, United States
United States, Florida
University of Florida Ctr for Movement Disorders & Neurorestoration
Gainesville, Florida, United States
United States, Georgia
Emory University, Wesley Woods Health Center
Atlanta, Georgia, United States
Georgia Regents University
Augusta, Georgia, United States
United States, Iowa
University of Iowa Hospitals, Movement Disorders Div, Dept of Neurology
Iowa City, Iowa, United States
United States, Michigan
Michigan State University
East Lansing, Michigan, United States
Henry Ford West Bloomfield Hospital
West Bloomfield, Michigan, United States
United States, New Jersey
Atlantic Neuroscience
Summit, New Jersey, United States
United States, New York
University of Rochester
Rochester, New York, United States
United States, Ohio
University of Toledo Medical Center
Toledo, Ohio, United States
United States, Oregon
Movement Disorders Program & The Parkinson's Center of Oregon
Portland, Oregon, United States
United States, Pennsylvania
University of Pennsylvania, Penn Neurological Institute
Philadelphia, Pennsylvania, United States
Sponsors and Collaborators
Motus Therapeutics, Inc.
Michael J. Fox Foundation for Parkinson's Research
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Principal Investigator: Ronald Pfeiffer, MD Parkinson's Study Group
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Responsible Party: Motus Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT01955616    
Other Study ID Numbers: RM-131-007
First Posted: October 7, 2013    Key Record Dates
Last Update Posted: September 23, 2016
Last Verified: September 2016
Keywords provided by Motus Therapeutics, Inc.:
Parkinson's disease, chronic constipation
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Signs and Symptoms, Digestive