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Nerispirdine

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

Ensayo de Sanofi en Multiple Sclerosis · Optic Nerve · Neuritis (del registro, en inglés).

Más ensayos de: Esclerosis múltiple.

Fase

Fase 2

Estado

Completado

Participantes

31

previstos

Centros

1

Fin del objetivo primario

jun 2009

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, triple ciego. Comenzó en sep 2008.

Qué mide

Visual Evoked Potential (P100) latency (pre-dose and post-dose of each treatment intake (3)) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThe 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.

Más ensayos de SNY

Todos los de SNY, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT00772525), actualizada en ene 2016.