NCT02314208

Therapeutic Metabolic Intervention in Patients With Spastic Paraplegia SPG5

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Institut National de la Santé Et de la Recherche Médicale, France · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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

Conditions

• Spastic Paraplegia, Hereditary

Interventions

Type	Name	Description
DRUG	Xenbilox
DIETARY_SUPPLEMENT	Resveratrol
DRUG	Tahor

Timeline

• Start date: 2015-01-08
• Primary completion: 2017-09-27
• Completion: 2018-01-01
• First posted: 2014-12-11
• Last updated: 2025-09-02

Locations

1 site across 1 country: France