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

• Register: ClinicalTrials.gov
• Last refreshed on: 3 October 2016
• Main ID: NCT01955616
• Date of registration: 25/09/2013
• Prospective Registration: No
• Primary sponsor: Motus Therapeutics, Inc.
• Public title: A Phase 2 Study to Evaluate the Safety and Efficacy of RM-131 in Patients With Parkinson's Disease & Chronic Constipation MOVE-PD
• Scientific 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
• Date of first enrolment: September 2013
• Target sample size: 18
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT01955616
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

United States

Contacts

• Name: Ronald Pfeiffer, MD
• Affiliation: Parkinson's Study Group

Key inclusion & exclusion 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:

- 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



Age minimum: 18 Years
Age maximum: 80 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Parkinson's Disease

Intervention(s)

Drug: Placebo

Drug: RM-131

Primary Outcome(s)

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(s)

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]

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

Secondary ID(s)

RM-131-007

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Michael J. Fox Foundation for Parkinson's Research