This trial is active, not recruiting.

Condition spastic paraplegia, hereditary
Treatments xenbilox, resveratrol, tahor
Phase phase 2
Sponsor Institut National de la Santé Et de la Recherche Médicale, France
Start date January 2015
End date June 2017
Trial size 12 participants
Trial identifier NCT02314208, C14-04


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model crossover assignment
Masking open label
Primary purpose treatment
(Active Comparator)
Xenbilox (chenodeoxycholic acid) 1000mg capsule by mouth every day for 2 months
xenbilox Chenodeoxycholic acid
(Active Comparator)
Resveratrol 80mg capsule by mouth every day for 2 months
(Active Comparator)
Tahor (atorvastatin) 40mg tablet by mouth every day for 2 months
tahor Atorvastatin

Primary Outcomes

Change of 27-hydroxycholesterol blood level after 2 months of treatment for each treatment
time frame: 2 months

Secondary Outcomes

Modification of the serum acid profile after a 2-month treatment measured in blood and urine samples
time frame: 2 months
Change of 25-hydroxycholesterol blood level after 2 months of treatment for each treatment
time frame: 2 months
Number of participants with adverse events related with digestive problems
time frame: 18 months
Number of partcipants with adverse events related with standard biological parameters
time frame: 18 months

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Therapeutic Metabolic Intervention in Patients With Spastic Paraplegia SPG5
Principal investigator Fanny MOCHEL, MD-PhD
Description The primary objective of the study is: - decrease the accumulation of metabolites which can have a negative impact on neurological and systemic function of patients with SPG5. The secondary objectives of the study are: - confirm the clinical and biological tolerance of the different candidate molecules under study - improve the serum bile acid profile of patients with SPG5
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Institut National de la Santé Et de la Recherche Médicale, France.