NCT01160263

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Oct 2012

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 9, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 12, 2010

Completed
2.2 years until next milestone

Study Start

First participant enrolled

October 1, 2012

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

May 13, 2015

Status Verified

May 1, 2015

Enrollment Period

2 years

First QC Date

July 9, 2010

Last Update Submit

May 12, 2015

Conditions

Amyotrophic Lateral Sclerosis

Keywords

ALSserotonindopamine

Outcome Measures

Primary Outcomes (1)

  • Dopamine transporter binding potential

    1 month

Secondary Outcomes (2)

  • Serotonin transporter binding potential

    1 month

  • Relationships between transporter binding potential and the clinical scores

    1 month

Study Arms (3)

patients without stiffness

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

patients with pyramidal stiffness

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

patients with mixed stiffness

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

Interventions

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

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.

Also known as: PECT : 123 I-FP-CIT (DATSCAN) and 123I-ADAM
patients with mixed stiffnesspatients with pyramidal stiffnesspatients without stiffness

Eligibility Criteria

Age39 Years - 66 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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:
  • patients without stiffness
  • patients with pyramidal stiffness (spasticity patients).
  • 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

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Salpêtrière Hospital

Paris, 75013, France

Location

Bretonneau Hospital

Tours, 37044, France

Location

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

Interventions

ioflupane2-((2-((dimethylamino)methyl)phenyl)thio)-5-iodophenylamine

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesMotor Neuron DiseaseNeurodegenerative DiseasesTDP-43 ProteinopathiesNeuromuscular DiseasesProteostasis DeficienciesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Lucette Lacomblez, MD

    Pitié-Salpêtrière Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 9, 2010

First Posted

July 12, 2010

Study Start

October 1, 2012

Primary Completion

October 1, 2014

Study Completion

October 1, 2014

Last Updated

May 13, 2015

Record last verified: 2015-05

Locations

FR(2)