Skip to main content
OpenTrials
Completed

NCT Number: NCT01160263

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

39 year–66 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Salpêtrière Hospital, Paris, France

Loading trial locations.

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

SPECT : 123 I-FP-CIT (DATSCAN) and 123I-ADAM

Drug

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 names: PECT : 123 I-FP-CIT (DATSCAN) and 123I-ADAM

Primary outcomes

  1. Dopamine transporter binding potential

    Time frame: 1 month

Secondary outcomes

  1. Serotonin transporter binding potential

    Time frame: 1 month

  2. Relationships between transporter binding potential and the clinical scores

    Time frame: 1 month

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • ARS (Association pour la Recherche sur la Sclérose Latérale Amyotrophique)
  • Agence Générale des Equipements et Produits de Santé
  • Association Française contre les Myopathies (AFM), Paris

Registry information

Official study 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

Acronym: DOSERAL

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Jul 12, 2010
Registry last updated
May 13, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.