ALS Clinical Trial
— TRANEOfficial title:
Differential Study of Muscle Transcriptome in Patients With Neuromuscular Disease and Control Subjects
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 |
To isolate biomarkers of ALS in muscle
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 |
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Country | Name | City | State |
---|---|---|---|
France | Centre d'évaluation Thérapeutique, Dr LACOMBLEZ | Paris |
Lead Sponsor | Collaborator |
---|---|
Assistance Publique - Hôpitaux de Paris | DGOS, Institut National de la Santé Et de la Recherche Médicale, France |
France,
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 |
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