Single Oral Doses Study of Nerispirdine on Visual Function in Patients With Multiple Sclerosis

A Double-blind, Placebo-controlled, Randomized Crossover, Activity Study of Single Oral Doses of 50 mg and 400 mg Nerispirdine on Visual Function in Patients With Multiple Sclerosis

The primary objective of the study was to evaluate the effect of Nerispirdine (50 mg or 400 mg) and placebo given orally as a single dose once a week in crossover design on latency of Visual Evoked Potentials (VEP) P100 in optic nerves.

Secondary objectives included evaluation of the effect of Nerispirdine on VEP amplitude and other visual parameters including visual acuity and contrast, as well as evaluation of the safety and tolerability of Nerispirdine in patients with Multiple Sclerosis (MS).

Contrast sensitivity and visual acuity examinations (in addition to Optical Coherence Tomography [OCT] and VEPs) were needed during the screening period for defining etiologic relationships (if non-MS related impairment) and for assessing the effect of treatment of age-related eye disease versus the MS-related vision impairment.

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis; Neuritis; Optic Nerve
• Intervention / Treatment: Drug: Nerispirdine; Drug: Placebo

Detailed Description

The crossover design included 3 treatment periods 1 week apart and 6 treatment sequences. Study participation were to be 5 weeks.

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Bridgewater, New Jersey, United States, 08807
      • Sanofi-Aventis Administrave Office

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Clinically definite MS (McDonald criteria), which includes patients with remitting-relapsing, secondary progressive, progressive-relapsing, or primary progressive MS who have had a past history of Optic Neuritis.

Exclusion Criteria:

• Multiple sclerosis exacerbation within 60 days of the Screening Visit and the relapse involved the visual fields or visual acuity
• No eye with appropriate degree of lesions for this study as defined by criteria based on degree of visual acuity deficit, refractive error, VEP P100 latency and average retinal nerve fiber layer thickness of as measured by Optical Coherence Tomography (OCT)
• Any MS-unrelated prior ophthalmological impairment (eg, compressive, ischemic, toxic, or nutritional optic neuropathies, Leber's hereditary optic atrophy)
• Previously exposed to 3,4-diaminopyridine or 4-aminopyridine

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sequence 1; placebo,1 day treatment period 1 50 mg Nerispirdine, 1 day treatment period 2 400 mg Nerispirdine, 1 day treatment period 3	Drug: Nerispirdine; form: tablet Route: oral; Other Names: HP184; Drug: Placebo; form: tablet Route: oral
Experimental: Sequence 2; placebo,1 day treatment period 1 400 mg Nerispirdine, 1 day treatment period 2 50 mg Nerispirdine, 1 day treatment period 3	Drug: Nerispirdine; form: tablet Route: oral; Other Names: HP184; Drug: Placebo; form: tablet Route: oral
Experimental: Sequence 3; 50 mg Nerispirdine, 1 day treatment period 1 placebo, 1 day treatment period 2 400 mg Nerispirdine, 1 day treatment period 3	Drug: Nerispirdine; form: tablet Route: oral; Other Names: HP184; Drug: Placebo; form: tablet Route: oral
Experimental: Sequence 4; 50 mg Nerispirdine, 1 day treatment period 1 400 mg Nerispirdine, 1 day treatment period 2 placebo, 1 day treatment period 3	Drug: Nerispirdine; form: tablet Route: oral; Other Names: HP184; Drug: Placebo; form: tablet Route: oral
Experimental: Sequence 5; 400 mg Nerispirdine, 1 day treatment period 1 placebo, 1 day treatment period 2 50 mg Nerispirdine, 1 day treatment period 3	Drug: Nerispirdine; form: tablet Route: oral; Other Names: HP184; Drug: Placebo; form: tablet Route: oral
Experimental: Sequence 6; 400 mg Nerispirdine, 1 day treatment period 1 50 mg Nerispirdine, 1 day treatment period 2 placebo, 1 day treatment period 3	Drug: Nerispirdine; form: tablet Route: oral; Other Names: HP184; Drug: Placebo; form: tablet Route: oral

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Visual Evoked Potential (P100) latency	pre-dose and post-dose of each treatment intake (3)

Secondary Outcome Measures

Outcome Measure	Time Frame
Pelli-Robson Contrast Sensitivity Score	pre-dose and post-dose of each treatment intake (3)
Early Treatment Diabetic Retinopathy Study (EDTRS) visual acuity score	pre-dose and post-dose of each treatment intake (3)
Visual Evoked Potential (VEP) amplitude	pre-dose and post-dose of each treatment intake (3)

Collaborators and Investigators

• Sponsor: Sanofi
• Investigators: Principal Investigator: Robert SERGOTT, MD, Wills Eye Institute, Thomas Jefferson University, Philadelphia Pennsylvania, USA

Study record dates

Study Major Dates

• Study Start: September 1, 2008
• Primary Completion (Actual): June 1, 2009
• Study Completion (Actual): June 1, 2009

Study Registration Dates

• First Submitted: October 13, 2008
• First Submitted That Met QC Criteria: October 13, 2008
• First Posted (Estimate): October 15, 2008

Study Record Updates

• Last Update Posted (Estimate): February 26, 2016
• Last Update Submitted That Met QC Criteria: January 28, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Keywords: Optical Coherence Tomography; Visual acuity; Visual Evoked Potentials; Contrast sensitivity
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Multiple Sclerosis; Sclerosis; Neuritis
• Other Study ID Numbers: ACT10573