NCT01984957

Brief Summary

To isolate biomarkers of ALS in muscle

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 27, 2013

Completed
5 months until next milestone

First Posted

Study publicly available on registry

November 15, 2013

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

March 23, 2015

Status Verified

June 1, 2014

Enrollment Period

2 years

First QC Date

June 27, 2013

Last Update Submit

March 20, 2015

Conditions

ALSSMASBMA

Keywords

ALSMotor neuron diseasesTranscriptome

Outcome Measures

Primary Outcomes (1)

  • Gene expression levels

    Gene expression levels in muscle as determined By microarrays (transcriptome analysis)

    day 1

Secondary Outcomes (2)

  • muscle denervation

    day 1

  • Functional evaluation

    day 1

Study Arms (1)

disease (ALS, SMA or SBMA)

OTHER

muscle biopsy

Procedure: Muscle biopsy

Interventions

Muscle biopsyPROCEDURE

open muscular biopsy of the deltoid under local anaesthesia

disease (ALS, SMA or SBMA)

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- Patient with ALS, SMA, or SBMA

You may not qualify if:

  • Indication against biopsy (allergy to anesthetics local haemostasis disorders)
  • Treatments that can affect muscle metabolism

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre d'évaluation Thérapeutique, Dr LACOMBLEZ

Paris, 75013, France

Location

MeSH Terms

Conditions

Motor Neuron Disease

Condition Hierarchy (Ancestors)

Neurodegenerative DiseasesNervous System DiseasesNeuromuscular Diseases

Study Officials

  • Pierre-Francois Pradat, MD, PhD

    APHP

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 27, 2013

First Posted

November 15, 2013

Study Start

January 1, 2013

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

March 23, 2015

Record last verified: 2014-06

Locations

FR(1)