Therapeutic Metabolic Intervention in Patients With Spastic Paraplegia SPG5 (NCT02314208) | Clinical Trial Compass
CompletedPhase 2
Therapeutic Metabolic Intervention in Patients With Spastic Paraplegia SPG5
France12 participantsStarted 2015-01-08
Plain-language summary
The purpose of this project is to study the efficacy of three candidate molecules (Xenbilox, Tahor and Resveratrol) in order to decrease the production of oxysterols by reducing the synthesis of cholesterol and/or regulate the production of bile acids and/or enabling neuroprotective action within the motor neuron.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* patients that have confirmed through genetic testing their status as carriers of 2 mutations in the CYP7B1 gene
* age ≥ 18 years
* patients that have signed the informed consent form
* presence of health care coverage
Exclusion Criteria:
* known hypersensitvity to chenodeoxycholic acid, atorvastatin, resveratrol or to any of their byproducts
* cholesterol lowering medications other than the study treatment
* hepatic failure with transaminases \>3 times the normal level
* progressive biliary pathology
* chronic diarrhea
* serious mental illness
* significant comorbid neurological disorder
* incapacity to understand information about the protocol
* unwilling or unable to participate in any part of the study
* participation in another clinical trial during the study period
* person deprived of liberty by judicial or administrative decision
* adult subject under legal protection or unable to consent
* pregnant or breastfeeding women
* lack of health care coverage
* absence of a signed informed consent form
What they're measuring
1
Change of 27-hydroxycholesterol blood level after 2 months of treatment for each treatment