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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 16 December 2017
Main ID:  NCT02164253
Date of registration: 20/05/2014
Prospective Registration: No
Primary sponsor: University Hospital, Lille
Public title: Focal Accumulation of Iron in Cerebral Regions in Early ALS (Amyotrophic Lateral Sclerosis) Patients SAFEFAIRALS
Scientific title: Feasibility and Safety Pilot Therapeutic Study of the Iron Chelator Deferiprone in Amyotrophic Lateral Sclerosis
Date of first enrolment: September 2013
Target sample size: 23
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT02164253
Study type:  Interventional
Study design:  Intervention model: Single Group Assignment. Primary purpose: Supportive Care. Masking: None (Open Label).  
Phase:  Phase 2
Countries of recruitment
France
Contacts
Name:     Caroline Moreau, MD
Address: 
Telephone:
Email:
Affiliation:  UH Lille
Key inclusion & exclusion criteria

Inclusion Criteria:

- Amyotrophic lateral sclerosis defined in accordance to the El Escorial criteria
(possible, probable or defined)

- 18 to 85 years old patient, male or female

- Patient with social security cover

Exclusion Criteria:

- Achieved respiratory defined by a FVC <70%

- Evolution of more than 24 months

- Demented subject

- Severe malnutrition

- Patients with treatment potentially at risk of agranulocytosis and neutropenia

- Patients with a history of agranulocytosis or iatrogenic under haematological disease

- Incapable of giving consent

- Indication against MRI

- Indication against lumbar puncture

- Patient refused lumbar puncture

- Hypersensitivity to iron chelators

- Concomitant treatment with antacids containing aluminum

- Presence of another serious illness to life-threatening or disabling cons to the use
of the treatment mixture of oxygen and nitrous oxide equally



Age minimum: 18 Years
Age maximum: 85 Years
Gender: All
Health Condition(s) or Problem(s) studied
ALS (Amyotrophic Lateral Sclerosis)
Iron Overload
Intervention(s)
Drug: Deferiprone
Primary Outcome(s)
Evolution of Amyotrophic Lateral Sclerosis Functional Rating Scale [Time Frame: V3, V6, V9, V12, V15]
Secondary Outcome(s)
Number of patients with anemia at 12 months defined by a hemoglobin / dL Hb <12 g [Time Frame: V3, V6, V9, V12, V15]
Values of R2 * in MRI [Time Frame: V3, V6, V19]
The proportion of patients who become non-self-sufficient after 12 months with the appearance of a sub scores ALSFRS-R less than or equal to 2 on swallowing, cut food using utensils or walk. [Time Frame: SCREENING, V0, V3, V6, V9, V12, V15]
Progression of respiratory vital capacity tests [Time Frame: SCREENING, V0, V3, V6, V9, V12, V15]
Comparison of the progression of ALSFRS-R (Amyotrophic Lateral Sclerosis Functional Rating Scale ) score for 3 months without treatment (V0 to V3) in the period of the first three months under treatment (V3 to V6). [Time Frame: SCREENING, V0, V3, V6]
No alteration of energy metabolism in aerobic and anaerobic blood and cerebrospinal fluid [Time Frame: V3, V9]
Number of serious and non-serious adverse events [Time Frame: SCREENING, V0, V3, V6, V9, V12, V15]
Oxidative stress markers analyzed blindly in blood and cerebrospinal fluid [Time Frame: V3, V9]
Secondary ID(s)
2013-001228-21
2012_69
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
ApoPharma
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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