Study of Dopamine and Serotonin Transporters in Patients With Amyotrophic Lateral Sclerosis and Controls

Amyotrophic Lateral Sclerosis Clinical Trial

— DOSERAL  

Official title:

Study of Dopamine and Serotonin Transporters in Patients With Amyotrophic Lateral Sclerosis and Controls. Analysis With 123I-FP-CIT (Datscan) and 123I-ADAM Brain SPECT

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01160263
• Other study ID #: P080402
• Secondary ID: P080402AOM 07225
• Status: Completed
• Phase: Phase 3
• First received: July 9, 2010
• Last updated: May 12, 2015
• Start date: October 2012
• Est. completion date: October 2014

Study information

• Verified date: May 2015
• 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

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 stiffness, patients with mixed (pyramidal and extra pyramidal) stiffness.

For such a goal the investigators will use SPECT to compare the binding of two specific tracers in ALS patients and in matched healthy controls.

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, patients with pyramidal stiffness, patients with mixed pyramidal and extra pyramidal stiffness) and 20 healthy controls will be included in this study

Study centres 40 ALS patients and 13 controls will be included in the Paris ALS center, 20 ALS patients and 7 controls will be included in the Tours ALS center.

MRI will be performed at the Neuroradiology department of salpetriere hospital (Paris) and Bretonneau hospital (Tours) SPECT will be done in the nuclear medicine center of each hospital (Paris- Tours).

Study duration Per patient or control, the study will be lasted one month. The total study duration will be two years

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 39 Years to 66 Years

Eligibility

Inclusion Criteria:

1. 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

2. 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).

3. 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).

4. To have social insurance

Exclusion Criteria:

1. Patients with a FRONTO temporal dementia (according to NEARY' criteria)

2. Patients with any concomitant life-threatening disease or any disease or impairment likely to interfere with functional assessment;

3. Patients with any major evolving psychiatric disorder or major anxiety disorder according to DSM-IV criteria (APA, 1996)

4. Patients receiving treatments which could interfere with the serotonin or dopamine metabolism

5. Patients with contraindications for the dat-scan and /or ADAM scan

6. Patients with contraindications for the MRI scan.

7. Patients with previous vascular, traumatic or tumoral cerebral lesions making impossible the quantification of the tracer

8. Patients with a cancer within the past 5

9. Patients child bearing, breast feeding or in the second part of their cycle without any efficient contraceptive device or treatment

10. 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;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Amyotrophic Lateral Sclerosis
• Motor Neuron Disease
• Sclerosis

Intervention

Drug:
• SPECT : 123 I-FP-CIT (DATSCAN) and 123I-ADAM
123 I-FP-CIT (DATSCAN) : 185 MBq (5 mCi), 2,5 ml will be injected via an arm intravenous catheter. 123I-ADAM:185 MBq,5 ml will be injected via an arm intravenous catheter.

Locations

Country	Name	City	State
France	Salpêtrière Hospital	Paris
France	Bretonneau Hospital	Tours

Sponsors (4)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	Agence Générale des Equipements et Produits de Santé, ARS (Association pour la Recherche sur la Sclérose Latérale Amyotrophique), Association Française contre les Myopathies (AFM), Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dopamine transporter binding potential		1 month	No
Secondary	Serotonin transporter binding potential		1 month	No
Secondary	Relationships between transporter binding potential and the clinical scores		1 month	No