NCT07185347View on ClinicalTrials.gov

A Randomized, Parallel-arm, Double Blind, Placebo-controlled Study to Assess the Efficacy of Fampridine for Patients With Spinocerebellar Ataxia SCA27B Caused by a GAA Expansion in the FGF14 Gene

PHASE3Not yet recruitingINTERVENTIONAL
Enrollment

70

Participants

Timeline

Start Date

October 1, 2025

Primary Completion Date

May 1, 2027

Study Completion Date

May 1, 2027

Conditions
Spinocerebellar Ataxia 27B (SCA27B)
Interventions
DRUG

Fampridine 10 mg prolonged-release tablet (per os)

Patients randomized in the experimental arm will take 1 tablet twice a day, 12 hours apart, on an empty stomach, for 12 weeks.

DRUG

Placebo (tablets per os)

Patients randomized in the control arm will take 1 tablet twice a day, 12 hours apart, on an empty stomach, for 12 weeks.

Trial Locations (9)

Unknown

Neurology Department, CHU d'Angers, Angers

Genetics Department, CHU de Bordeaux, Bordeaux

Neurology and Gentics Department, CHU de Dijon, Dijon

Neurology Department, Hôpital Pierre Wertheimer Hospital, Lyon

Neurology Department, Gui De Chauliac Hospital, Montpellier

Genetics Department, Pitié-Salpêtrière University Hospital, Paris

Genetics Department, CHU de Rouen, Rouen

Neurology Department, CHRU de Strasbourg, Strasbourg

Neurology Department, CHU de Toulouse, Toulouse

All Listed Sponsors
lead

Assistance Publique - Hôpitaux de Paris

OTHER