Differential Study of Muscle Transcriptome

Not Applicable

Completed

• Conditions: ALS; SMA; SBMA
• Interventions: Procedure: Muscle biopsy

• Registration Number: NCT01984957
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

To isolate biomarkers of ALS in muscle

Detailed Description

At present, there is no validated biological diagnostic marker for amyotrophic lateral sclerosis (ALS). The main objective of the study is to isolate a set of genes that are specifically dysregulated in muscle from ALS patients.

Gene profiling in muscle will be compared between ALS patients and patients with other motor neuron diseases (SMA and SBMA)

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2013-06-27
• Study First Submitted QC: 2013-11-07
• Study First Posted: 2013-11-15
• Status Verified: 2014-06
• Primary Completion: 2015-01
• Study Completion: 2015-01
• Last Update Submitted: 2015-03-20
• Last Update Posted: 2015-03-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
disease (ALS, SMA or SBMA)	Muscle biopsy	muscle biopsy

Primary Outcome Measures

Name	Time	Method
Gene expression levels	day 1	Gene expression levels in muscle as determined By microarrays (transcriptome analysis)

Secondary Outcome Measures

Name	Time	Method
muscle denervation	day 1	Severity of muscle denervation as determined by histological analysis of muscle
Functional evaluation	day 1	ALSFRS-R, Manual Muscle Testing and Slow Vital Capacity

Trial Locations

Locations (1)

Centre d'évaluation Thérapeutique, Dr LACOMBLEZ; 🇫🇷 Paris, France