Differential Study of Muscle Transcriptome

ALS Clinical Trial

— TRANE  

Official title:

Differential Study of Muscle Transcriptome in Patients With Neuromuscular Disease and Control Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01984957
• Other study ID #: P110401
• Status: Completed
• Phase: N/A
• First received: June 27, 2013
• Last updated: March 20, 2015
• Start date: January 2013
• Est. completion date: January 2015

Study information

• Verified date: June 2014
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

To isolate biomarkers of ALS in muscle

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion criteria :

• Patient with ALS, SMA, or SBMA

Exclusion criteria :

• Indication against biopsy (allergy to anesthetics local haemostasis disorders)

• Treatments that can affect muscle metabolism

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• ALS
• SBMA
• SMA

Intervention

Procedure:
• Muscle biopsy
open muscular biopsy of the deltoid under local anaesthesia

Locations

Country	Name	City	State
France	Centre d'évaluation Thérapeutique, Dr LACOMBLEZ	Paris

Sponsors (3)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	DGOS, Institut National de la Santé Et de la Recherche Médicale, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gene expression levels	Gene expression levels in muscle as determined By microarrays (transcriptome analysis)	day 1	No
Secondary	muscle denervation	Severity of muscle denervation as determined by histological analysis of muscle	day 1	No
Secondary	Functional evaluation	ALSFRS-R, Manual Muscle Testing and Slow Vital Capacity	day 1	No