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

Motus Therapeutics

Status and phase

Terminated

Phase 2

Conditions

Parkinson's Disease

Treatments

Drug: RM-131

Drug: Placebo

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01955616

RM-131-007

Details and patient eligibility

About

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.

Enrollment

18 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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