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Parkinson's DiseasePhase 2MOVE-PDNCT01955616

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

A Phase 2 study testing RM-131 in people with Parkinson's Disease, run by Motus Therapeutics, Inc. at 13 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Parkinson's Disease
What is being tested?
RM-131
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
18 participants
Where
13 sitesUnited States
Study dates
Sep 2013to Sep 2015
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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.

Who cannot join

  • 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
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  • 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

Trial locations and contacts

13 sites in 1 country.

13 sites in 1 country

United States13 sites

  • Emory University, Wesley Woods Health Center

    Atlanta, Georgia

  • Georgia Regents University

    Augusta, Georgia

  • Michigan State University

    East Lansing, Michigan

  • Colorado Neurological Institute

    Englewood, Colorado

  • University of Florida Ctr for Movement Disorders & Neurorestoration

    Gainesville, Florida

  • University of Iowa Hospitals, Movement Disorders Div, Dept of Neurology

    Iowa City, Iowa

  • University of Southern California

    Los Angeles, California

  • University of Pennsylvania, Penn Neurological Institute

    Philadelphia, Pennsylvania

  • Movement Disorders Program & The Parkinson's Center of Oregon

    Portland, Oregon

  • University of Rochester

    Rochester, New York

  • Atlantic Neuroscience

    Summit, New Jersey

  • University of Toledo Medical Center

    Toledo, Ohio

  • Henry Ford West Bloomfield Hospital

    West Bloomfield, Michigan

Other trials in United States

About this study

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

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.

Being tested
RM-131, Placebo
Keywords
Parkinson's disease, chronic constipation
Medical subject headings
Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RM-131Drug

    Also called Ghrelin receptor agonist, relamorelin

  • PlaceboDrug

Study groups in NCT01955616
Study groupRoleWhat they receive
RM-131Active comparatorRM-131 100 µg by subcutaneous injection daily in the morning
Receives: Drug: RM-131
PlaceboPlacebo comparatorby subcutaneous injection daily in the morning
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: Screening through Day 28

Secondary outcomes (3)

  1. Evaluate the safety and tolerability of multiple doses of RM-131 when administered to patients with PD and CC

    Measured: Screening through Day 28

  2. 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.

    Measured: Screening through Day 28

  3. Assess symptoms of Parkinson's disease using the Unified Parkinson Disease Rating Scale (UPDRS)

    Measured: Screening through Day 28

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Oct 2013 (estimated)
  2. Study startSep 2013
  3. Primary completionMay 2015
  4. Study completionSep 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
18 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01955616
Sponsor's protocol ID
RM-131-007
Acronym
MOVE-PD
Status last verified
Sep 2016
First submitted
25 Sep 2013
Last updated
23 Sep 2016
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing RM-131 in people with Parkinson's Disease, run by Motus Therapeutics, Inc. at 13 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 23 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early. Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01955616.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2016.

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