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

Parkinson's Disease Clinical Trial

— MOVE-PD  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01955616
• Other study ID #: RM-131-007
• Status: Terminated
• Phase: Phase 2
• First received: September 25, 2013
• Last updated: September 21, 2016
• Start date: September 2013
• Est. completion date: September 2015

Study information

• Verified date: September 2016
• Source: Motus Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 18
• Est. completion date: September 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Constipation
• Parkinson Disease
• Parkinson's Disease

Intervention

Drug:
• RM-131

• Placebo

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Motus Therapeutics, Inc.	Michael J. Fox Foundation for Parkinson's Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Assess the effect of RM-131 on gastroparesis symptoms		Screening through Day 28	No
Other	Time to first bowel movement (BM)		Screening through Day 28	No
Other	Area under the concentration versus time curve of RM-131 will be measured		Screening through Day 28	No
Primary	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	No
Secondary	Evaluate the safety and tolerability of multiple doses of RM-131 when administered to patients with PD and CC		Screening through Day 28	No
Secondary	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	No
Secondary	Assess symptoms of Parkinson's disease using the Unified Parkinson Disease Rating Scale (UPDRS)		Screening through Day 28	No