Spinocerebellar Ataxia Type 1 Clinical Trial
— BIOSCAOfficial title:
Identification of Biomarkers in Patients With Autosomal Dominant Cerebellar Ataxia
NCT number | NCT01470729 |
Other study ID # | P100125 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | November 2011 |
Est. completion date | December 2015 |
Verified date | June 2014 |
Source | Assistance Publique - Hôpitaux de Paris |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Autosomal dominant cerebellar ataxias (ADCA) are a group of neurodegenerative disorders that are clinically and genetically various. BIOSCA study aims to identify markers of the metabolism (energy production inside the cells) in the blood and the brain of ADCA 1,2,3 and 7 patients and control subjects, in the perspective of future therapeutic trials.
Status | Completed |
Enrollment | 102 |
Est. completion date | December 2015 |
Est. primary completion date | December 2015 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion criteria : - More than 18 years of age - Ability to tolerate MRI - Positive genetic test to SCA1, 2, 3 or 7 - Coverage by social insurance - Written informed consent must be obtained from the subject Exclusion criteria : - Less than 18 years of age - Concomitant significant neurological disorder - Unsuitability for MRI, e.g. claustrophobia, metal implants - History of significant head injury - Unability to receive an informed explanation about the protocol - Unability to complete the protocol - Non coverage by social insurance - No written informed consent obtained |
Country | Name | City | State |
---|---|---|---|
France | Groupe Hospitalier Pitié Salpêtrière | Paris |
Lead Sponsor | Collaborator |
---|---|
Assistance Publique - Hôpitaux de Paris |
France,
Adanyeguh IM, Henry PG, Nguyen TM, Rinaldi D, Jauffret C, Valabregue R, Emir UE, Deelchand DK, Brice A, Eberly LE, Öz G, Durr A, Mochel F. In vivo neurometabolic profiling in patients with spinocerebellar ataxia types 1, 2, 3, and 7. Mov Disord. 2015 Apr — View Citation
Adanyeguh IM, Perlbarg V, Henry PG, Rinaldi D, Petit E, Valabregue R, Brice A, Durr A, Mochel F. Autosomal dominant cerebellar ataxias: Imaging biomarkers with high effect sizes. Neuroimage Clin. 2018 Jun 14;19:858-867. doi: 10.1016/j.nicl.2018.06.011. eC — View Citation
Garali I, Adanyeguh IM, Ichou F, Perlbarg V, Seyer A, Colsch B, Moszer I, Guillemot V, Durr A, Mochel F, Tenenhaus A. A strategy for multimodal data integration: application to biomarkers identification in spinocerebellar ataxia. Brief Bioinform. 2018 Nov — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | metabolic biomarkers of SCA | 12 months or 24 months | ||
Secondary | imaging biomarkers of SCA | 24 months |
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