Efficacy of 5 Weeks of Treatment With BGG492 in Patients With Spastici
A Multicenter, Randomized, Double-blind, Placebo Controlled, Parallel-group Study to Assess the Efficacy of 5 Weeks of Treatment With BGG492 in Patients With Spasticity Due to Multiple Sclerosis
What it found
The trial ended early for another reason (see below).
What was tested
Treatment tested
- Selurampanel
Glutamate receptor ionotropic AMPA antagonist|Glutamate receptor ionotropic kainate antagonist
Placebo
- Placebo
What it measured
Main measures
Change in spasticity NRS score from baseline to 5 weeks
5 weeks
SpasticityQuality of life (reported by participants)PGIC score at 5 weeks
5 weeks
Quality of life (reported by participants)
Other measures (2)
Change from baseline to 5 weeks in Ashworth spasticity score
5 weeks
SpasticitySafety and tolerability
average of 70 days, maximum from day -19 to day 52, i.e. from first baseline up to study completion visit
Safety
Who could take part
MS (type not specified) · 18 to 65
Show the full criteria
Inclusion criteria
Key Inclusion Criteria: * Diagnosis of multiple sclerosis (MS) of any type. * MS diagnosis at least 6 months prior to screening. * Stable MS with no relapse within 3 months prior to screening. * Treated or untreated spasticity due to MS for at least 3 months prior to screening, not wholly relieved with antispasticity medications. Key exclusion criteria: * Patients with symptoms of spasticity not due to MS. * Patients taking three or more different anti-spasticity medications. * Acute MS exacerbation requiring treatment within 3 months of the Screening Visit. * Initiation of, or the discontinuation of interferon beta or any other disease modifying therapy for MS within 3 months of the Screening Visit. * Use of baclofen pump at any time. * Wheelchair or bed-bound patients.
Exclusion criteria
Not separately supplied in the registry.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
To evaluate efficacy and safety of BGG492 versus placebo on moderate to severe spasticity due to multiple sclerosis
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History
Started
Oct 2016
Main results due
Mar 2018
Finished
Mar 2018