Trials Sponsors Conditions Drugs Pricing

Conditions

Spastic Paraplegia, Hereditary

Keywords

spastic paraplegiametabolismoxysterolsneurogenetics

Outcome Measures

Primary Outcomes (1)

Change of 27-hydroxycholesterol blood level after 2 months of treatment for each treatment
27-hydroxycholesterol will be measured on fasten blood samples for the 12 patients included before and after the 2-month treatment period for each treatment
2 months

Secondary Outcomes (4)

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

Study Arms (3)

Xenbilox

ACTIVE COMPARATOR

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

Drug: Xenbilox

Resveratrol

ACTIVE COMPARATOR

Resveratrol 80mg capsule by mouth every day for 2 months

Dietary Supplement: Resveratrol

Tahor

ACTIVE COMPARATOR

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

Drug: Tahor

Interventions

XenbiloxDrug

Also known as: Chenodeoxycholic acid

Xenbilox

ResveratrolDietary supplement

Resveratrol

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

patients that have confirmed through genetic testing their status as carriers of 2 mutations in the CYP7B1 gene
age ≥ 18 years

Sponsors & Collaborators

Institut National de la Santé Et de la Recherche Médicale, France
Governmentlead

Study Sites (1)

Pitié-Salpêtrière Hospital

Paris, France

Related Publications (1)

Marelli C, Lamari F, Rainteau D, Lafourcade A, Banneau G, Humbert L, Monin ML, Petit E, Debs R, Castelnovo G, Ollagnon E, Lavie J, Pilliod J, Coupry I, Babin PJ, Guissart C, Benyounes I, Ullmann U, Lesca G, Thauvin-Robinet C, Labauge P, Odent S, Ewenczyk C, Wolf C, Stevanin G, Hajage D, Durr A, Goizet C, Mochel F. Plasma oxysterols: biomarkers for diagnosis and treatment in spastic paraplegia type 5. Brain. 2018 Jan 1;141(1):72-84. doi: 10.1093/brain/awx297.
PMID: 29228183RESULT

MeSH Terms

Conditions

Spastic Paraplegia, HereditaryParaplegia

Interventions

Chenodeoxycholic AcidResveratrolAtorvastatin

Condition Hierarchy (Ancestors)

Hereditary Sensory and Motor NeuropathyNervous System MalformationsNervous System DiseasesHeredodegenerative Disorders, Nervous SystemNeurodegenerative DiseasesPolyneuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesCongenital Abnormalities

Study Officials

Fanny MOCHEL, MD-PhD
Pitié-Salpêtrière Hospital
PRINCIPAL INVESTIGATOR

Enrollment

12 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 2
Allocation: RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: CROSSOVER
Sponsor Type: OTHER GOV
Responsible Party: SPONSOR

Study Record Dates

First Submitted

November 14, 2014

First Posted

December 11, 2014

Study Start

January 8, 2015

Actual (reported)

Therapeutic Metabolic Intervention in Patients With Spastic Paraplegia SPG5

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Study Arms (3)

Xenbilox

Resveratrol

Tahor

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Study Arms (3)

Xenbilox

Resveratrol

Tahor

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Source record

Locations