Hi Genisi,
Nope, not terifludomide. I meant this one: it's basically the same class of 4AP drug as Acorda's amprya. but Sanofi is basically touting that based on their MOA of blocking both Na and K channels, it will have lower seizure risk.
i'm still keeping my eye on this one: according to clinical trials, it says they're in P2 right now. but based on ppl i've spoken with, they're currently recruiting for P3 investigators in US right now. they will be annoucing Phase II results for this drug in 3Q, according to their spokesperson when i called last wk.
hope this helps.
Efficacy, Safety, and Tolerability of Nerispirdine in Patients With Multiple Sclerosis
This study has been completed.
First Received: December 18, 2008 Last Updated: March 22, 2010 History of Changes
Sponsor: Sanofi-Aventis
Information provided by: Sanofi-Aventis
ClinicalTrials.gov Identifier: NCT00811902
Purpose
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
Condition Intervention Phase
Multiple Sclerosis
Drug: Nerispirdine (HP184)
Drug: placebo
Phase II
Study Type: Interventional
Study Design: Allocation: Randomized
Control: Placebo Control
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A 14-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy, Safety, and Tolerability of Nerispirdine 50 mg, 100 mg, and 200 mg in Patients With Multiple Sclerosis.
Resource links provided by NLM:
MedlinePlus related topics: Multiple Sclerosis
Drug Information available for: HP 184
U.S. FDA Resources
Further study details as provided by Sanofi-Aventis:
Primary Outcome Measures:
Responder criterion based on consistency of improved response in walking speed on the Timed 25-Foot Walk (T25-FWT) [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
Change from baseline to endpoint in the 12-item MS Walking Scale (MSWS-12) [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
Estimated Enrollment: 368
Study Start Date: December 2008
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
50 mg
Drug: Nerispirdine (HP184)
oral administration
2: Experimental
100 mg
Drug: Nerispirdine (HP184)
oral administration
3: Experimental
200 mg
Drug: Nerispirdine (HP184)
oral administration
4: Placebo Comparator Drug: placebo
oral administration
Eligibility
Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
Criteria
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.
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