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Study identifier: NCT07185347 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

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

Condition: Spinocerebellar Ataxia 27B (SCA27B)  ·  Sponsor: Assistance Publique - Hôpitaux de Paris

PhasePhase 3
Planned participants70
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

Spinocerebellar ataxias 27B (SCA27B) is caused by an expansion of ≥ 250 GAA triplets in the FGF14 gene and accounts for 15% of cerebellar ataxias (around 500 patients in France). It is a late-onset form often presenting paroxysmal episodes of ataxia and/or diplopia. The disease progresses slowly, with an average increase of 0.10 points/year on the Friedreich's Ataxia Rating Scale (FARS) - Functional Staging and by 0.23 points/year on the Scale for the Assessment and Rating of Ataxia (SARA). To date, no treatment has been proven to be effective in these patients. Three open-label studies using 4-aminopyridine, have shown improvements in visual symptoms and gait in a total of 36 out of 44 patients, although these improvements were evaluated through diverse methodologies. In a subgroup of patients (n=7), administration of 4-aminopyridine resulted in a reduction in FARS - Functional Staging, ranging from 0.5 to 2 points. Notably, this beneficial effect rapidly disappearing in all patients stopping the drug. 4-aminopyridine, a potassium channel blocker, may involve restoration of cerebellar Purkinje cell rhythmic firing property, impaired with the loss of FGF14 function. Although these results appear very promising, the positive effect of 4-aminopyridine is reported only in restricted sample sizes and open-label experiences. Therefore, a robust clinical trial is necessary to provide the level of evidence required for a definitive conclusion on the benefit-risk of fampridine and be…

This description comes directly from the study's public registry record.

Talk to the study team

Giulia COARELLI  ·  + 33 (0)1 57 27 46 82  ·  giulia.coarelli@aphp.fr

Alexandra DURR  ·  alexandra.durr@icm-institute.org

Always discuss trial participation with your own doctor first.

Locations (9)

Neurology Department, CHU d'AngersAngers, FranceNot Yet Recruiting
Genetics Department, CHU de BordeauxBordeaux, FranceRecruiting
Neurology and Gentics Department, CHU de DijonDijon, FranceRecruiting
Neurology Department, Hôpital Pierre Wertheimer HospitalLyon, FranceNot Yet Recruiting
Neurology Department, Gui De Chauliac HospitalMontpellier, FranceRecruiting
Genetics Department, Pitié-Salpêtrière University HospitalParis, FranceRecruiting
Genetics Department, CHU de RouenRouen, FranceNot Yet Recruiting
Neurology Department, CHRU de StrasbourgStrasbourg, FranceNot Yet Recruiting
Neurology Department, CHU de ToulouseToulouse, FranceNot Yet Recruiting

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Source record: clinicaltrials.gov/study/NCT07185347