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Main
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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. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT02405403 |
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Date of registration:
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02/03/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Microglial Activation Role In ALS (MARIA)
MARIA |
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Scientific title:
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Microglial Activation Role In ALS (MARIA) |
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Date of first enrolment:
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March 2015 |
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Target sample size:
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0 |
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Recruitment status: |
Withdrawn |
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URL:
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https://clinicaltrials.gov/show/NCT02405403 |
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Study type:
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Interventional |
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Study design:
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Intervention model: Single Group Assignment. Primary purpose: Diagnostic. Masking: None (Open Label).
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Phase:
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Early Phase 1
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Countries of recruitment
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France
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Contacts
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Name:
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Philippe CORCIA, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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CHRU Tours |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Signed informed consent
- Age = 18 years old
- Patient with probable or definite sporadic Amyotrophic Lateral Sclerosis (ALS) form
according to the modified criteria of El Escorial
- Treated with riluzole 2 weeks
- Evolution less than 18 months
- Mini-Mental State Examination (MMS) score = 26 and Frontal Assessment Battery (FAB)
(normal)
- Affiliated to a social security system
Exclusion Criteria:
- Another unbalanced progressive pathology
- Vascular diseases (hypertension, diabetes, smoking, dyslipidemia) unbalanced
- Forced vital capacity <75%
- Weight loss> 10% of the weight before disease
- Status "low affinity binder" or "mixed affinity binder", the TSPO respect to the [18
F] DPA-714, which can interfere with the process of neuroinflammation: drugs with
anti-inflammatory drugs (NSAIDs, corticosteroids, azathioprine, anti-tumor necrosis
factor (TNF), antibiotics)
- Benzodiazepine in the week before the PET scan [18F] DPA-714 given the potential
consequences for TSPO receivers
- Contraindications to MRI in patients with:
1. Metallic foreign body eye.
2. Any implanted electronic medical irremovably (pacemaker, neurostimulator,
cochlear implants ...)
3. Metal heart valve,
4. Vascular clips formerly located on cranial aneurysm.
- Treatment in the month before the PET scan [18F] DPA-714 antagonist
N-methyl-D-aspartate (NMDA) (memantine)
- Pregnant women, lactating women, and women in age for procreation and without reliable
contraception or without history of hysterectomy
- ?Person under guardianship
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Amyotrophic Lateral Sclerosis
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Intervention(s)
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Drug: [18F]DPA-714 PET
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Primary Outcome(s)
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Concentration of cytokines in cerebrospinal fluid (pg/mL)
[Time Frame: 18 months]
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Secondary Outcome(s)
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Fixation and distribution of [18F]DPA-714 (Binding Potential BP)
[Time Frame: 18 months]
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Secondary ID(s)
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PHAO-13-PC/MARIA
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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