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

Primary Purpose

Multiple Sclerosis, Optic Nerve, Neuritis

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Nerispirdine

Placebo

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring Visual acuity, Contrast sensitivity, Visual Evoked Potentials, Optical Coherence Tomography

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Sanofi-Aventis Administrave Office

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Arm Label

Sequence 1

Sequence 2

Sequence 3

Sequence 4

Sequence 5

Sequence 6

Arm Description

placebo,1 day treatment period 1 50 mg Nerispirdine, 1 day treatment period 2 400 mg Nerispirdine, 1 day treatment period 3

placebo,1 day treatment period 1 400 mg Nerispirdine, 1 day treatment period 2 50 mg Nerispirdine, 1 day treatment period 3

50 mg Nerispirdine, 1 day treatment period 1 placebo, 1 day treatment period 2 400 mg Nerispirdine, 1 day treatment period 3

50 mg Nerispirdine, 1 day treatment period 1 400 mg Nerispirdine, 1 day treatment period 2 placebo, 1 day treatment period 3

400 mg Nerispirdine, 1 day treatment period 1 placebo, 1 day treatment period 2 50 mg Nerispirdine, 1 day treatment period 3

400 mg Nerispirdine, 1 day treatment period 1 50 mg Nerispirdine, 1 day treatment period 2 placebo, 1 day treatment period 3

Outcomes

Primary Outcome Measures

Visual Evoked Potential (P100) latency

Secondary Outcome Measures

Pelli-Robson Contrast Sensitivity Score

Early Treatment Diabetic Retinopathy Study (EDTRS) visual acuity score

Visual Evoked Potential (VEP) amplitude

Full Information

NCT ID

NCT00772525

First Posted

October 13, 2008

Last Updated

January 28, 2016

Sponsor

Sanofi

1. Study Identification

Unique Protocol Identification Number

NCT00772525

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2016

Overall Recruitment Status

Completed

Study Start Date

September 2008 (undefined)

Primary Completion Date

June 2009 (Actual)

Study Completion Date

June 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sanofi

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

Detailed Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Multiple Sclerosis, Optic Nerve, Neuritis

Keywords

Visual acuity, Contrast sensitivity, Visual Evoked Potentials, Optical Coherence Tomography

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

31 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Sequence 1

Arm Type

Experimental

Arm Description

placebo,1 day treatment period 1 50 mg Nerispirdine, 1 day treatment period 2 400 mg Nerispirdine, 1 day treatment period 3

Arm Title

Sequence 2

Arm Type

Experimental

Arm Description

placebo,1 day treatment period 1 400 mg Nerispirdine, 1 day treatment period 2 50 mg Nerispirdine, 1 day treatment period 3

Arm Title

Sequence 3

Arm Type

Experimental

Arm Description

50 mg Nerispirdine, 1 day treatment period 1 placebo, 1 day treatment period 2 400 mg Nerispirdine, 1 day treatment period 3

Arm Title

Sequence 4

Arm Type

Experimental

Arm Description

50 mg Nerispirdine, 1 day treatment period 1 400 mg Nerispirdine, 1 day treatment period 2 placebo, 1 day treatment period 3

Arm Title

Sequence 5

Arm Type

Experimental

Arm Description

400 mg Nerispirdine, 1 day treatment period 1 placebo, 1 day treatment period 2 50 mg Nerispirdine, 1 day treatment period 3

Arm Title

Sequence 6

Arm Type

Experimental

Arm Description

400 mg Nerispirdine, 1 day treatment period 1 50 mg Nerispirdine, 1 day treatment period 2 placebo, 1 day treatment period 3

Intervention Type

Drug

Intervention Name(s)

Nerispirdine

Other Intervention Name(s)

HP184

Intervention Description

form: tablet Route: oral

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

form: tablet Route: oral

Primary Outcome Measure Information:

Title

Visual Evoked Potential (P100) latency

Time Frame

pre-dose and post-dose of each treatment intake (3)

Secondary Outcome Measure Information:

Title

Pelli-Robson Contrast Sensitivity Score

Time Frame

pre-dose and post-dose of each treatment intake (3)

Title

Early Treatment Diabetic Retinopathy Study (EDTRS) visual acuity score

Time Frame

pre-dose and post-dose of each treatment intake (3)

Title

Visual Evoked Potential (VEP) amplitude

Time Frame

pre-dose and post-dose of each treatment intake (3)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Robert SERGOTT, MD

Organizational Affiliation

Wills Eye Institute, Thomas Jefferson University, Philadelphia Pennsylvania, USA

Official's Role

Principal Investigator

Facility Information:

Facility Name

Sanofi-Aventis Administrave Office

City

Bridgewater

State/Province

New Jersey

ZIP/Postal Code

08807

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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