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

Primary Purpose

Amyotrophic Lateral Sclerosis

Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
SPECT : 123 I-FP-CIT (DATSCAN) and 123I-ADAM
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Amyotrophic Lateral Sclerosis focused on measuring ALS, serotonin, dopamine

Eligibility Criteria

39 Years - 66 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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;

Sites / Locations

  • Salpêtrière Hospital
  • Bretonneau Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Other

Other

Arm Label

patients without stiffness

patients with pyramidal stiffness

patients with mixed stiffness

Arm Description

Outcomes

Primary Outcome Measures

Dopamine transporter binding potential

Secondary Outcome Measures

Serotonin transporter binding potential
Relationships between transporter binding potential and the clinical scores

Full Information

First Posted
July 9, 2010
Last Updated
May 12, 2015
Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Association Française contre les Myopathies (AFM), Paris, ARS (Association pour la Recherche sur la Sclérose Latérale Amyotrophique), Agence Générale des Equipements et Produits de Santé
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1. Study Identification

Unique Protocol Identification Number
NCT01160263
Brief Title
Study of Dopamine and Serotonin Transporters in Patients With Amyotrophic Lateral Sclerosis and Controls
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
October 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Association Française contre les Myopathies (AFM), Paris, ARS (Association pour la Recherche sur la Sclérose Latérale Amyotrophique), Agence Générale des Equipements et Produits de Santé

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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 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.
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, 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amyotrophic Lateral Sclerosis
Keywords
ALS, serotonin, dopamine

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
patients without stiffness
Arm Type
Other
Arm Title
patients with pyramidal stiffness
Arm Type
Other
Arm Title
patients with mixed stiffness
Arm Type
Other
Intervention Type
Drug
Intervention Name(s)
SPECT : 123 I-FP-CIT (DATSCAN) and 123I-ADAM
Other Intervention Name(s)
PECT : 123 I-FP-CIT (DATSCAN) and 123I-ADAM
Intervention Description
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.
Primary Outcome Measure Information:
Title
Dopamine transporter binding potential
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Serotonin transporter binding potential
Time Frame
1 month
Title
Relationships between transporter binding potential and the clinical scores
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
39 Years
Maximum Age & Unit of Time
66 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lucette Lacomblez, MD
Organizational Affiliation
Pitié-Salpêtrière Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Salpêtrière Hospital
City
Paris
ZIP/Postal Code
75013
Country
France
Facility Name
Bretonneau Hospital
City
Tours
ZIP/Postal Code
37044
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

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