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

What Was Tested

This registered phase 2 trial tested Relamorelin for parkinson's disease.

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.

It had two arms (groups): RM-131 (active comparator) and Placebo (placebo comparator).

By subcutaneous injection daily in the morning.

The registry classes the interventions as drug.

Who Took Part

18 actual participants took part.

It was open to people of any sex aged from 18 years up to 80 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Able to provide written informed consent and be willing and able to comply with study procedures. Diagnosis of chronic constipation (CC), including experiencing constipation for \~12 or more weeks in the preceding 12 months. 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.

The full record lists 14 inclusion and 23 exclusion criteria; among the exclusions: unable or unwilling to provide informed consent or to comply with study procedures; 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):.

How the Study Was Run

The set-up was randomized, parallel-group and quadruple-blind.

Because people in this Relamorelin study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Groups ran in parallel: each of the parkinson's disease participants stayed in one arm throughout.

Blinding on both sides kept the parkinson's disease participants and researchers unaware of who received Relamorelin.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2013-09 with completion listed for 2015-05.

It ran at 13 sites in United States (13).

Its stated primary purpose is treatment.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Relamorelin in 18 people with parkinson's disease.

Its size is small, so on its own it can only give an early look.

It ended early (terminated); no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Relamorelin compound page, Parkinson's disease research.