Efficacy, Safety, and Tolerability of Nerispirdine in Patients With Multiple Sclerosis - Full Text View

Sponsored by:	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:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
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
Estimated Study Completion Date:	April 2010
Estimated Primary Completion Date:	April 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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00811902

Contacts

Contact: Public Registry ICD

GV-Contact-us@sanofi-aventis.com

Locations

United States, New Jersey
Sanofi-aventis Administrative Office	Recruiting
Bridgewater, New Jersey, United States, 08807
Canada
Sanofi-aventis Administrative Office	Recruiting
Laval, Canada
Finland
Sanofi-aventis Administrative Office	Recruiting
Helsinki, Finland
France
Sanofi-aventis Administrative Office	Recruiting
Paris, France
Germany
Sanofi-aventis Administrative Office	Recruiting
Berlin, Germany
Norway
Sanofi-aventis Administrative Office	Recruiting
Lysaker, Norway
Spain
Sanofi-aventis Administrative Office	Recruiting
Barcelona, Spain

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Study Director:

ICD CSD

Sanofi-Aventis

More Information

No publications provided

Responsible Party:	sanofi-aventis ( ICD Study Director )
Study ID Numbers:	DRI10566, EudraCT:2008-001999-67
Study First Received:	December 18, 2008
Last Updated:	August 24, 2009
ClinicalTrials.gov Identifier:	NCT00811902 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Sanofi-Aventis:

Multiple sclerosis

Study placed in the following topic categories:

Autoimmune Diseases
Multiple Sclerosis
Demyelinating Diseases

Demyelinating Autoimmune Diseases, CNS
Sclerosis
Autoimmune Diseases of the Nervous System

Additional relevant MeSH terms:

Pathologic Processes
Autoimmune Diseases
Multiple Sclerosis
Immune System Diseases
Demyelinating Diseases

Nervous System Diseases
Demyelinating Autoimmune Diseases, CNS
Sclerosis
Autoimmune Diseases of the Nervous System

ClinicalTrials.gov processed this record on September 03, 2009