Status:
COMPLETED
Study of Dopamine and Serotonin Transporters in Patients With Amyotrophic Lateral Sclerosis and Controls
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborating Sponsors:
Association Française contre les Myopathies (AFM), Paris
ARS (Association pour la Recherche sur la Sclérose Latérale Amyotrophique)
Conditions:
Amyotrophic Lateral Sclerosis
Eligibility:
All Genders
39-66 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to study the transporters of serotonin and dopamine in ALS patients in relation with the clinical phenotype, i.e., patients without stiffness, patients with pyramidal stif...
Detailed Description
Study design This study is a prospective cross-sectional controlled multicentric clinical study in 60 ALS patients and 20 controls. Three cohorts of 20 ALS patients(patients without stiffness, patien...
Eligibility Criteria
Inclusion
- Patients (men or women)
- between 39 (exclusive) and 66 (inclusive) years old
- with a sporadic ALS, defined, probable or laboratory possible
- with a disease duration between 3 months (inclusive) and 5 years (exclusive)
- treated with rilutek at 100 mg/ day since at least 1 month
- Patients will be assigned in three groups in relation with the clinical phenotypes:
- 20 patients without stiffness
- 20 patients with pyramidal stiffness (spasticity patients).
- 20 patients with mixed stiffness (both spasticity and rigidity).
- Patients have to be capable of thoroughly understanding the information given; have signed the informed consent form (signature of spouse or family relative or acceptable third party is acceptable if the patient is physically unable to sign).
- To have social insurance
Exclusion
- Patients with a FRONTO temporal dementia (according to NEARY' criteria)
- Patients with any concomitant life-threatening disease or any disease or impairment likely to interfere with functional assessment;
- Patients with any major evolving psychiatric disorder or major anxiety disorder according to DSM-IV criteria (APA, 1996)
- Patients receiving treatments which could interfere with the serotonin or dopamine metabolism
- Patients with contraindications for the dat-scan and /or ADAM scan
- Patients with contraindications for the MRI scan.
- Patients with previous vascular, traumatic or tumoral cerebral lesions making impossible the quantification of the tracer
- Patients with a cancer within the past 5
- Patients child bearing, breast feeding or in the second part of their cycle without any efficient contraceptive device or treatment
- Patients liable not to be co-operative or comply with the trial requirements (as assessed by the investigator), or unable to be reached in the event of an emergency;
Key Trial Info
Start Date :
October 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2014
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT01160263
Start Date
October 1 2012
End Date
October 1 2014
Last Update
May 13 2015
Active Locations (2)
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1
Salpêtrière Hospital
Paris, France, 75013
2
Bretonneau Hospital
Tours, France, 37044