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

Motus Therapeutics, Inc.13 sites in 1 country18 target enrollmentSeptember 2013

ConditionsParkinson's Disease

InterventionsRM-131 Placebo

DrugsRM-131 Placebo

Overview

Phase: Phase 2
Intervention: RM-131
Conditions: Parkinson's Disease
Sponsor: Motus Therapeutics, Inc.
Enrollment: 18
Locations: 13
Primary Endpoint: 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)
Status: Terminated
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

September 2013

End Date

September 2015

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Motus Therapeutics, Inc.

Responsible Party

Sponsor

Eligibility 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:

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)

Arms & Interventions

RM-131

RM-131 100 µg by subcutaneous injection daily in the morning

Intervention: RM-131

Placebo

by subcutaneous injection daily in the morning

Intervention: Placebo

Outcomes

Primary Outcomes

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 Outcomes

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)