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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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12 December 2020 |
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Main ID: |
NCT03272802 |
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Date of registration:
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02/09/2017 |
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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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Treatment Effect of Edaravone in Patients With Amyotrophic Lateral Sclerosis (ALS)
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Scientific title:
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Treatment Effect of Edaravone in Patients With Amyotrophic Lateral Sclerosis (ALS) in a Representative Iranian Population |
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Date of first enrolment:
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March 16, 2017 |
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Target sample size:
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20 |
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Recruitment status: |
Active, not recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT03272802 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 2/Phase 3
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Countries of recruitment
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Iran, Islamic Republic of
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Patients diagnosed as definite or probable ALS according to El Escorial Criteria.
2. ALS patients who are graded as mild or moderate according to ALS Health State Scale.
3. Forced vital capacity of at least 80%
4. Desire of the patient to participate in this study and Signing Written Informed
Consent.
Exclusion Criteria:
1. Incidence of drug's side effects that requires discontinuation of the drug
(Edaravone's side effects: Acute kidney injury, Acute allergic reactions, DIC,
Thrombocytopenia, Leukopenia).
2. Desire of the patient to discontinue participating in this study.
3. the patient starts another drug or herb for ALS during the study.
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Neuromuscular Diseases
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Intervention(s)
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Drug: Riluzole
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Drug: Edaravone
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Primary Outcome(s)
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functional status of the patient.
[Time Frame: At the time of enrolling the patient to study, and then every 3 moths in the following period of 1 year.]
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Functional evaluation of patient's muscle strength.
[Time Frame: At the time of enrolling the patient to study, and then every 3 moths in the following period of 1 year.]
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Quality of life in the patients
[Time Frame: At the time of enrolling the patient to study, and then every 3 moths in the following period of 1 year.]
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Secondary ID(s)
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Isfahan ALS Registery
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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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