Single Oral Doses Study of Nerispirdine on Visual Function in Patients With Multiple Sclerosis - Full Text View

Sponsor:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00772525

Purpose

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.

Condition	Intervention	Phase
Multiple Sclerosis Optic Nerve Neuritis	Drug: Nerispirdine (HP184) Drug: Placebo	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment
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

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:

Visual Evoked Potential (P100) latency [ Time Frame: pre-dose and post-dose of each treatment intake (3) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Pelli-Robson Contrast Sensitivity Score [ Time Frame: pre-dose and post-dose of each treatment intake (3) ] [ Designated as safety issue: Yes ]
Early Treatment Diabetic Retinopathy Study (EDTRS) visual acuity score [ Time Frame: pre-dose and post-dose of each treatment intake (3) ] [ Designated as safety issue: Yes ]
Visual Evoked Potential (VEP) amplitude [ Time Frame: pre-dose and post-dose of each treatment intake (3) ] [ Designated as safety issue: Yes ]

Enrollment:	31
Study Start Date:	September 2008
Study Completion Date:	June 2009
Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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 (HP184) form: tablet Route: oral 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 (HP184) form: tablet Route: oral 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 (HP184) form: tablet Route: oral 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 (HP184) form: tablet Route: oral 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 (HP184) form: tablet Route: oral 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 (HP184) form: tablet Route: oral Drug: Placebo form: tablet Route: oral

Detailed Description:

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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00772525

Locations

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

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Principal Investigator:

Robert SERGOTT, MD

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

More Information

No publications provided

Responsible Party:	ICD Study Director, sanofi-aventis
ClinicalTrials.gov Identifier:	NCT00772525 History of Changes
Other Study ID Numbers:	ACT10573
Study First Received:	October 13, 2008
Last Updated:	April 29, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Sanofi-Aventis:

Visual acuity
Contrast sensitivity
Visual Evoked Potentials
Optical Coherence Tomography

Additional relevant MeSH terms:

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

Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on February 09, 2012