A study of the safety and effects of baclofen er capsules (grs) in subjects with tightness, stiffness and pull of muscles due to multiple sclerosis
What it found
We found no results in the registry or in papers.
What was tested
What it measured
Main measures
The primary efficacy outcome is the proportion of subjects who become a treatment failure during double-blind randomized withdrawal (Part 3). Each subject's response will be determined after database lock, but prior to unblinding the data. A subject who meets the following criterion will be considered a treatment failure: A CGIC of ≥ 5 (“minimally worse” to “very much worse”) and at least one move
Spasticity
Other measures (1)
Subject Global Impression of Severity (SGIS)
Who could take part
MS (type not specified)
Inclusion: 1. Men and women age 18 years and older Exclusion: 1. History of hypersensitivity to baclofen
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
The primary objectives are to compare the continued treatment with Baclofen ER Capsules (GRS) versus down-titration to placebo in subjects stabilized on Baclofen ER Capsules (GRS) with respect to:
Loading reviews and guidelines…
Related trials
- ICE Trial
Phase 4 · Ongoing (inferred)
Still running
- A Study to Investigate Arbaclofen ER Tablets for the Trea…
Phase 3 · Not yet recruiting
Still running
- Cannabis (THC vs. CBD) in Multiple Sclerosis
Phase 2 · Recruiting
Still running
- ICE
Phase 4 · Recruiting
Still running
- Mechanisms of Cannabidiol in Persons With MS: the Role of…
Phase 2 · Recruiting
Still running
- AntibioBoNTA
Phase 3 · Ongoing
Still running
History
Started
Apr 2016
Assembled by software from public sources and not checked by people. Each record links to its source. Report an error