Esclerosis Múltiple ______________ Multiple Sclerosis MedDRA version: 11.0 Level: LLT Classification code 10028245 Term:
Conditions
Interventions
Product Name: Nerispirdine hydrochloride
Product Code: HP184
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Nerispirdine hydrochloride
CAS Number: 119229-64-0
Current Sponsor code: HP184
Sponsors
sanofi-aventis Recherche & Développement
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Clinically definite MS (McDonald criteria), which includes patients with remitting-relapsing, secondary progressive, progressive-relapsing, or primary progressive MS AND walking disability due to MS (untreated or treated with a stable regimen of a marketed compound for treatment of MS, limited to beta interferons or glatiramer acetate). MS type (relapsing-remitting, secondary progressive, primary progressive, or progressive relapsing) will be determined by the Investigator based on the AAN Practice Guidelines and Tools (http://www.aan.com/go/practice/guidelines) and reference 1 provided in the protocol. 2. Signed Informed Consent form Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Methodology-related 1. Patient who is able to walk 25 feet in less than 8 seconds or subject who takes more than 45 seconds (for any of the 2 allowed trials) to walk 25 feet with or without an assistive device during the T25-FW assessment at V1-V4 (before randomization). Patients without valid V1, V2, and V4 T25-FW measurements are not eligible for randomization. 2. Multiple sclerosis exacerbation or clinical relapse within 6 months prior to the screening visit (V1) or change in regimen or type of MS treatment during the last 3 months, or start of MS disease-modifying therapies within the 3 months prior to screening. 3. Age 3 ULN and CPK normal) or creatinine clearance < 50 mL/min cannot be randomized (see Appendix L specifying criteria for discontinuation of IP). -Nerispirdine-related based on current knowledge on the compound 11. Criteria to reduce reproductive risk: Breastfeeding and pregnant females cannot be included in a clinical study testing nerispirdine. Male subjects who are sexually active with a pregnant female should not participate in the study. Also, patients wishing to breastfeed or parent a child during the course of the study must not participate. Women of childbearing potential (WOCBP) as defined in the protocol or male patients not using an effective contraceptive method as described in the protocol cannot be included in clinical studies testing nerispirdine. Women of childbearing potential, who are unwilling to or unable to be tested for pregnancy at study entry and at each clinic visit, or who experience an unexpected delay of menses cannot participate in the study. The pregnancy test to be used in this study is a serum pregnancy test (?-HCG), and not an urine pregnancy test. This test will be performed at each visit. If, during any nerispirdine study, a female subject becomes pregnant or decides to attempt to become pregnant or if a male subject decides to attempt to father a child, then she or he must stop the study drug immediately. If
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to assess the activity of nerispirdine in improving ability to walk, defined as a consistent improvement in walking speed as measured by the Timed 25-Foot Walk (T25-FW) in patients with MS.;Secondary Objective: ?To assess other measures of efficacy such as the MSWS-12, MFIS, LEMMT, MAS, SGI, and CGI ?To assess the safety and tolerability of nerispirdine ?To evaluate the pharmacokinetic (PK) parameters of nerispirdine and its active metabolite, HP183;Primary end point(s): ? Responder criterion, based on consistency of improved response in walking speed on the T25-FW A responder is defined as one whose last T25-FW measurement on-treatment and at least 2 other T25-FW measurement on-treatment are faster than the fastest speed recorded during any of the 3 ?off drug? visits V2 to V4 before double-blind treatment and the 1 at the end of the 2-week placebo run-out period. All other randomized patients are defined as non-responders. | — |
Countries
Finland, France, Germany, Spain
Outcome results
None listed