Efficacy, Safety, and Tolerability of Nerispirdine in Patients With Multiple Sclerosis
What it found
We found no results in the registry or in papers.
This trial finished 16 years ago. We found no results in the registry or in any paper that cites it.
What was tested
Treatment tested
- Nerispirdine
Sodium channel alpha subunit blocker|Voltage-gated potassium channel blocker
Placebo or sham
- placebo
What it measured
Main measures
Responder criterion based on consistency of improved response in walking speed on the Timed 25-Foot Walk (T25-FWT)
14 weeks
Disability progressionWalking and mobility? Responder criterion, based on consistency of improved response in walking speed on the T25-FW
Walking and mobility
Other measures (1)
Change from baseline to endpoint in the 12-item MS Walking Scale (MSWS-12)
14 weeks
Walking and mobility
Who could take part
Relapsing and progressive · 18 and over
Inclusion Criteria: * Clinically definite MS (according to McDonald criteria), Exclusion Criteria: * Multiple sclerosis exacerbation or clinical relapse within 6-month prior to the screening visit. * Subject who is not able to complete two trials of a timed 25 foot walk, with or without an assisted device, * Patients without valid V1, V2, and V4 T25-FW measurements are not eligible for randomization. * Female patients who are either pregnant or breastfeeding. Other protocol-defined inclusion/exclusion criteria may apply.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
The primary objective is to assess the activity of nerispirdine in improving the ability to walk, in patients with multiple sclerosis (MS). Secondary objectives: * To assess other measures of walking ability, tiredness, and lower limb muscular strength, spasticity, clinical assessment by subject and clinical assessment of change by the Study Investigator * To assess the safety and tolerance of nerispirdine * To evaluate the pharmacokinetics (PK) parameters of nerispirdine
Papers
Loading reviews and guidelines…
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History
Started
Dec 2008
Main results due
Mar 2010
Finished
Mar 2010
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