NCT05884086

Brief Summary

Cerebellar ataxias of late onset are of undetermined etiology in many cases. A new cause of late-onset cerebellar ataxia was discovered in January 2023 corresponding to an expansion of GAA triplets in intron 1 of the FGF14 gene. However, this cerebellar ataxia is still poorly known and requires further investigations to know its clinical phenotype and its evolution in order to propose a diagnosis and a genetic counseling adapted to patients and families. The objective of our study will be to describe the clinical and genotypic phenotype of patients with GAA-FGF14

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
1mo left

Started May 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress98%
May 2023Jun 2026

Study Start

First participant enrolled

May 1, 2023

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

May 16, 2023

Completed
16 days until next milestone

First Posted

Study publicly available on registry

June 1, 2023

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Last Updated

June 1, 2023

Status Verified

May 1, 2023

Enrollment Period

3.1 years

First QC Date

May 16, 2023

Last Update Submit

May 30, 2023

Conditions

Keywords

ataxiaspinocerebellar ataxiagenetic ataxia

Outcome Measures

Primary Outcomes (2)

  • description of clinical symptoms

    description of clinical symptoms such as gait impairment, diplopia, vertigo, dizziness etc.

    through study completion, an average of 3 years

  • description of genotype

    genotypic characterization of the GAA expansion

    through study completion, an average of 3 years

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with a diagnosis of cerebellar ataxia of type GAA-FGF14 followed at the CHRU of Nancy

You may qualify if:

  • Patients with a diagnosis of cerebellar ataxia of type GAA-FGF14

You may not qualify if:

  • patients not wishing to be followed

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre hospitalier régional universitaire

Nancy, 54000, France

Location

Related Publications (1)

  • Pellerin D, Danzi MC, Wilke C, Renaud M, Fazal S, Dicaire MJ, Scriba CK, Ashton C, Yanick C, Beijer D, Rebelo A, Rocca C, Jaunmuktane Z, Sonnen JA, Lariviere R, Genis D, Molina Porcel L, Choquet K, Sakalla R, Provost S, Robertson R, Allard-Chamard X, Tetreault M, Reiling SJ, Nagy S, Nishadham V, Purushottam M, Vengalil S, Bardhan M, Nalini A, Chen Z, Mathieu J, Massie R, Chalk CH, Lafontaine AL, Evoy F, Rioux MF, Ragoussis J, Boycott KM, Dube MP, Duquette A, Houlden H, Ravenscroft G, Laing NG, Lamont PJ, Saporta MA, Schule R, Schols L, La Piana R, Synofzik M, Zuchner S, Brais B. Deep Intronic FGF14 GAA Repeat Expansion in Late-Onset Cerebellar Ataxia. N Engl J Med. 2023 Jan 12;388(2):128-141. doi: 10.1056/NEJMoa2207406. Epub 2022 Dec 14.

    PMID: 36516086BACKGROUND

MeSH Terms

Conditions

Gait AtaxiaAtaxiaSpinocerebellar Ataxias

Condition Hierarchy (Ancestors)

DyskinesiasNeurologic ManifestationsNervous System DiseasesGait Disorders, NeurologicSigns and SymptomsPathological Conditions, Signs and SymptomsCerebellar AtaxiaCerebellar DiseasesBrain DiseasesCentral Nervous System DiseasesSpinocerebellar DegenerationsSpinal Cord DiseasesHeredodegenerative Disorders, Nervous SystemNeurodegenerative DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD,PhD

Study Record Dates

First Submitted

May 16, 2023

First Posted

June 1, 2023

Study Start

May 1, 2023

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2026

Last Updated

June 1, 2023

Record last verified: 2023-05

Locations