Therapeutic Metabolic Intervention in Patients With Spastic Paraplegia SPG5

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-08

Study Completion Date

2018-01-01

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Spastic Paraplegia, Hereditary

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Xenbilox

Xenbilox (chenodeoxycholic acid) 1000mg capsule by mouth every day for 2 months

Group Type ACTIVE_COMPARATOR

Xenbilox

Intervention Type DRUG

Resveratrol

Resveratrol 80mg capsule by mouth every day for 2 months

Group Type ACTIVE_COMPARATOR

Resveratrol

Intervention Type DIETARY_SUPPLEMENT

Tahor

Tahor (atorvastatin) 40mg tablet by mouth every day for 2 months

Group Type ACTIVE_COMPARATOR

Tahor

Intervention Type DRUG

Interventions

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Xenbilox

Intervention Type DRUG

Resveratrol

Intervention Type DIETARY_SUPPLEMENT

Tahor

Intervention Type DRUG

Other Intervention Names

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Chenodeoxycholic acid Atorvastatin

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No