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

NCT00772525 | Completed Phase 2 DMC

• 1 other identifier: ACT10573
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis; Optic Nerve; Neuritis

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Visual Evoked Potential (P100) latency

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

Secondary Outcomes (3)

• 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)

Study Arms (6)

Sequence 1

EXPERIMENTAL

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

Drug: Nerispirdine; Drug: Placebo

Sequence 2

EXPERIMENTAL

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

Drug: Nerispirdine; Drug: Placebo

Sequence 3

EXPERIMENTAL

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

Drug: Nerispirdine; Drug: Placebo

Sequence 4

EXPERIMENTAL

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

Drug: Nerispirdine; Drug: Placebo

Sequence 5

EXPERIMENTAL

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

Drug: Nerispirdine; Drug: Placebo

Sequence 6

EXPERIMENTAL

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

Drug: Nerispirdine; Drug: Placebo

Interventions

Nerispirdine DRUG

form: tablet Route: oral

Also known as: HP184

Sequence 1; Sequence 2; Sequence 3; Sequence 4; Sequence 5; Sequence 6

Placebo DRUG

form: tablet Route: oral

Sequence 1; Sequence 2; Sequence 3; Sequence 4; Sequence 5; Sequence 6

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (1)

Sanofi-Aventis Administrave Office

Bridgewater, New Jersey, 08807, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis; Neuritis

Interventions

nerispirdine

Condition Hierarchy (Ancestors)

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

Study Officials

• Robert SERGOTT, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2008
• First Posted: October 15, 2008
• Study Start: September 1, 2008
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: February 26, 2016

Record last verified: 2016-01

Locations

US (1)