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

Phase 2

Terminated

Conditions: Parkinson's Disease

Interventions: Drug: RM-131
Drug: Placebo

Registration Number: NCT01955616

Lead Sponsor: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 18

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
RM-131	RM-131	RM-131 100 µg by subcutaneous injection daily in the morning
Placebo	Placebo	by subcutaneous injection daily in the morning

Primary Outcome Measures

Name	Time	Method
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)	Screening through Day 28

Secondary Outcome Measures

Name	Time	Method
Assess symptoms of Parkinson's disease using the Unified Parkinson Disease Rating Scale (UPDRS)	Screening through Day 28
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.	Screening through Day 28
Evaluate the safety and tolerability of multiple doses of RM-131 when administered to patients with PD and CC	Screening through Day 28

Trial Locations

Locations (13): Henry Ford West Bloomfield Hospital
🇺🇸
West Bloomfield, Michigan, United States
Atlantic Neuroscience
🇺🇸
Summit, New Jersey, United States
Michigan State University
🇺🇸
East Lansing, Michigan, United States
University of Southern California
🇺🇸
Los Angeles, California, United States
Colorado Neurological Institute
🇺🇸
Englewood, Colorado, United States
University of Rochester
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Rochester, New York, United States
University of Florida Ctr for Movement Disorders & Neurorestoration
🇺🇸
Gainesville, Florida, United States
Emory University, Wesley Woods Health Center
🇺🇸
Atlanta, Georgia, United States
Georgia Regents University
🇺🇸
Augusta, Georgia, United States
University of Toledo Medical Center
🇺🇸
Toledo, Ohio, United States
Movement Disorders Program & The Parkinson's Center of Oregon
🇺🇸
Portland, Oregon, United States
University of Pennsylvania, Penn Neurological Institute
🇺🇸
Philadelphia, Pennsylvania, United States
University of Iowa Hospitals, Movement Disorders Div, Dept of Neurology
🇺🇸
Iowa City, Iowa, United States