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SPATAX: Clinical and Genetic Analysis of Cerebellar Ataxias and Spastic Paraplegias

Study acronym: Spatax
StatusCompleted
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Amendment history

  1. Minor

    Study Status

    Re-verified, no change to tracked fields

    v14

  2. Notable

    Study completion date changed from estimate of Dec 2012 to Dec 30, 2020

    Start date: Jul 2003 to Feb 10, 2004; Trial status: Recruiting to Completed; Primary completion date: Dec 2020; and 2 more

    Show all 6 changes in this update
    • Notable Study completion date changed from estimate of Dec 2012 to Dec 30, 2020
    • Notable Start date: Jul 2003 to Feb 10, 2004
    • Minor Trial status: Recruiting to Completed
    • Minor Primary completion date: Dec 2020
    • Minor Site details revised at 27 of 27 sites
    • Minor Collaborators: 2 to 3
      Show what changed
      Paris Brain Institute (ICM)

    Study Status, Sponsor/Collaborators, Study Design, Outcome Measures, Contacts/Locationsv13

  3. Minor

    3 amendments

    3 re-verifications since 2011-04-26, no change to tracked fields

    v10-v12

  4. Minor

    Study sites: 18 to 27

    Completion date: Dec 2007 to Dec 2012; Collaborators: 1 to 2; Publications: 33 to 45

    Show what changed: Collaborators
    National Research Agency, France
    Show what changed: Publications
    Namekawa M, Muriel MP, Janer A, Latouche M, Dauphin A, Debeir T, Martin E, Duyckaerts C, Prigent A, Depienne C, Sittler A, Brice A, Ruberg M. Mutations in the SPG3A gene encoding the GTPase atlastin interfere with vesicle trafficking in the ER/Golgi interface and Golgi morphogenesis. Mol Cell Neuros [...]

    Study Identification, Study Status, Sponsor/Collaborators, Study Design, Eligibility, Contacts/Locations, Referencesv9

  5. Minor

    Completion date: Oct 2005 to Dec 2007

    Publications: 27 to 33

    Show what changed: Publications
    Stevanin G, Montagna G, Azzedine H, Valente EM, Durr A, Scarano V, Bouslam N, Cassandrini D, Denora PS, Criscuolo C, Belarbi S, Orlacchio A, Jonveaux P, Silvestri G, Hernandez AM, De Michele G, Tazir M, Mariotti C, Brockmann K, Malandrini A, van der Knapp MS, Neri M, Tonekaboni H, Melone MA, Tessa A [...]

    Study Status, Study Design, Referencesv8

Show 6 earlier versions

  1. Minor

    Publications: 29 to 27

    Show what changed: Publications
    Depienne C, Tallaksen C, Lephay JY, Bricka B, Poea-Guyon S, Fontaine B, Labauge P, Brice A, Durr A. Spastin mutations are frequent in sporadic spastic paraparesis and their spectrum is different from that observed in familial cases. J Med Genet. 2006 Mar;43(3):259-65. doi: 10.1136/jmg.2005.035311. E [...]

    Study Status, Referencesv7

  2. Minor

    Publications: 27 to 29

    Show what changed: Publications
    Le Ber I, Clot F, Vercueil L, Camuzat A, Viemont M, Benamar N, De Liege P, Ouvrard-Hernandez AM, Pollak P, Stevanin G, Brice A, Durr A. Predominant dystonia with marked cerebellar atrophy: a rare phenotype in familial dystonia. Neurology. 2006 Nov 28;67(10):1769-73. doi: 10.1212/01.wnl.0000244484.60 [...]

    Study Status, Referencesv6

  3. Minor

    Publications: 25 to 27

    Show what changed: Publications
    Namekawa M, Nelson I, Ribai P, Durr A, Denis E, Stevanin G, Ruberg M, Brice A. A founder effect and mutational hot spots may contribute to the most frequent mutations in the SPG3A gene. Neurogenetics. 2006 May;7(2):131-2. doi: 10.1007/s10048-006-0028-2. Epub 2006 Apr 13. No abstract available. Steva [...]

    Study Status, Referencesv5

  4. Minor

    Publications: 18 to 25

    Show what changed: Publications
    Namekawa M, Ribai P, Nelson I, Forlani S, Fellmann F, Goizet C, Depienne C, Stevanin G, Ruberg M, Durr A, Brice A. SPG3A is the most frequent cause of hereditary spastic paraplegia with onset before age 10 years. Neurology. 2006 Jan 10;66(1):112-4. doi: 10.1212/01.wnl.0000191390.20564.8e. van de War [...]

    Study Status, Referencesv4

  5. Minor

    Eligibility criteria shortened, about 2 words

    Study title expanded, about 10 words

    Show what changed: Eligibility criteria
    Inclusion Criteria: - progressiveProgressive ataxia or paraplegia Exclusion Criteria: - Lack of signed informed consent
    Show what changed: Study title
    SPATAX: Clinical and Genetic Analysis of Cerebellar Ataxias and Spastic Paraplegias

    Study Identification, Study Status, Study Description, Eligibilityv3

  6. Minor

    Publications: 12 to 18

    Show what changed: Publications
    Stevanin G, Durr A, Benammar N, Brice A. Spinocerebellar ataxia with mental retardation (SCA13). Cerebellum. 2005;4(1):43-6. doi: 10.1080/14734220510007923. Stevanin G, Broussolle E, Streichenberger N, Kopp N, Brice A, Durr A. Spinocerebellar ataxia with sensory neuropathy (SCA25). Cerebellum. 2005; [...]

    Study Status, Referencesv2

  1. Minor

    Study First Submitted

  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Cerebellar ataxias (CA) and spastic paraplegias (SP) are genetically and clinically very heterogeneous. More than 40 loci are already known but the number of phenotypes is even greater suggesting further genetic heterogeneity. These progressive disorders are often severe and fatal, due to the absence of specific therapy. The SPATAX network combines the experience of European clinicians and scientists working on these groups of diseases. Over the past year, they have assembled the largest collection of families and achieved a number of tasks (initiation of a clinical and genetic database, distribution of DNA to participating laboratories, mapping of three new loci, and refinement of several loci). In addition to clinicians from Europe and Mediterranean countries, who play a major role in collecting families according to evaluation tools developed and validated by the SPATAX members, the group includes major European laboratories devoted to the elucidation of the molecular basis of these disorders. Each laboratory will centralize all families with a subtype of autosomal recessive (AR) CA (n=116) or SP (n=207) in order to efficiently map and identify the responsible gene(s). Genome-wide scans are already underway in 61 families. Given the expertise of the participants, the researchers expect to map and identify several genes during the course of this project. The spectrum of mutations and phenotype/genotype correlations will be analysed thanks to this unique series of patients with various phenotypes. The knowledge gained will be immediately applicable to patients in terms of improved positive diagnosis, follow-up and appropriate genetic counselling. In the long term, models for genetic entity will be developed in order to understand the pathophysiology and to identify new targets for treatment. The series of patients assembled and the precise knowledge of natural history will facilitate the implantation of therapeutic trials based on rational approaches.
Trial Details
NCT Number NCT00140829
Lead Sponsor Institut National de la Santé Et de la Recherche Médicale, France
Collaborators: Institut des Maladies Rares, National Research Agency, France, Paris Brain Institute (ICM)
Conditions Cerebellar Ataxias, Spastic Paraplegias
Enrollment 6,000 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov