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

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ClinicalTrials.gov Identifier: NCT01160263
Recruitment Status : Completed
First Posted : July 12, 2010
Last Update Posted : May 13, 2015
Sponsor:
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
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Tracking Information
First Submitted Date  ICMJE July 9, 2010
First Posted Date  ICMJE July 12, 2010
Last Update Posted Date May 13, 2015
Study Start Date  ICMJE October 2012
Actual Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 9, 2010)
Dopamine transporter binding potential [ Time Frame: 1 month ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01160263 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 9, 2010)
  • Serotonin transporter binding potential [ Time Frame: 1 month ]
  • Relationships between transporter binding potential and the clinical scores [ Time Frame: 1 month ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Dopamine and Serotonin Transporters in Patients With Amyotrophic Lateral Sclerosis and Controls
Official Title  ICMJE 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
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

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Amyotrophic Lateral Sclerosis
Intervention  ICMJE 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.

Other Name: PECT : 123 I-FP-CIT (DATSCAN) and 123I-ADAM
Study Arms  ICMJE
  • patients without stiffness
    Intervention: Drug: SPECT : 123 I-FP-CIT (DATSCAN) and 123I-ADAM
  • patients with pyramidal stiffness
    Intervention: Drug: SPECT : 123 I-FP-CIT (DATSCAN) and 123I-ADAM
  • patients with mixed stiffness
    Intervention: Drug: SPECT : 123 I-FP-CIT (DATSCAN) and 123I-ADAM
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 12, 2015)
16
Original Estimated Enrollment  ICMJE
 (submitted: July 9, 2010)
80
Actual Study Completion Date  ICMJE October 2014
Actual Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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;
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 39 Years to 66 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01160263
Other Study ID Numbers  ICMJE P080402
P080402 ( Other Identifier: DRCD )
AOM 07225 ( Other Identifier: DRCD )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Assistance Publique - Hôpitaux de Paris
Study Sponsor  ICMJE Assistance Publique - Hôpitaux de Paris
Collaborators  ICMJE
  • 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
Investigators  ICMJE
Principal Investigator: Lucette Lacomblez, MD Pitié-Salpêtrière Hospital
PRS Account Assistance Publique - Hôpitaux de Paris
Verification Date May 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP