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Treatment Effect of Edaravone in Patients With Amyotrophic Lateral Sclerosis (ALS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03272802
Recruitment Status : Active, not recruiting
First Posted : September 6, 2017
Last Update Posted : March 27, 2019
Sponsor:
Information provided by (Responsible Party):
Alireza Eishi Oskouei, Isfahan University of Medical Sciences

Brief Summary:
Amyotrophic Lateral Sclerosis (ALS) is a neurodegenerative disease that causes the death of 30,000 affected individual every year. Complex nature and unknown pathogenesis of this disease are 2 major reasons for failure of therapeutic interventions. Edaravone is a free radical scavenger that slows down functional decline and prevents from disease progression in ALS patients. FDA newly approved this drug in these patients (2017/5/5). In this study, investigators aimed to assess the treatment effect of this newly approved drug in patients with ALS in a representative Iranian population.

Condition or disease Intervention/treatment Phase
Neuromuscular Diseases Drug: Edaravone Drug: Riluzole Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment Effect of Edaravone in Patients With Amyotrophic Lateral Sclerosis (ALS) in a Representative Iranian Population
Actual Study Start Date : March 16, 2017
Estimated Primary Completion Date : March 16, 2019
Estimated Study Completion Date : September 16, 2019


Arm Intervention/treatment
Experimental: Case group

ALS patients who receive the usual treatment option (Riluzole) for this disease and Edaravone. Instructions:

  1. Tab. Rilutek 50 mg PO q12hr on empty stomach.
  2. Amp. Edaravone 60 mg per day IV infusion (in normal saline during 1 hour) for 14 days in the first 28 day cycle.
  3. Amp. Edaravone 60 mg per day IV infusion (in normal saline during 1 hour) for 10 days in the following 28 day cycles after the first cycle (for 11 cycles).
Drug: Edaravone
Edaravone is a free radical scavenger. this drug showed desirable effects like slowing decline of physical function by 33 percent in previous studies.
Other Names:
  • Radicut
  • RADICAVA

Drug: Riluzole
Riluzole is a treatment option for amyotrophic lateral sclerosis. The occurrence of ventilator-dependence or tracheostomy is delayed in selected patients who treated with this drug.
Other Names:
  • Rilutek
  • Teglutik

Active Comparator: Control group

ALS patients who receive the usual treatment option (Riluzole) for this disease.

Instructions:

1. Tab. Rilutek 50 mg PO q12hr on empty stomach.

Drug: Riluzole
Riluzole is a treatment option for amyotrophic lateral sclerosis. The occurrence of ventilator-dependence or tracheostomy is delayed in selected patients who treated with this drug.
Other Names:
  • Rilutek
  • Teglutik




Primary Outcome Measures :
  1. 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. ]
    Manual Muscle Testing (MMT) will be used to evaluate functional muscle strength. This procedure evaluates the strength of some proximal and distal muscles of each limb and also the neck region.

  2. 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. ]
    Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R) will be used to evaluate functional status of the patient.

  3. 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. ]
    Amyotrophic Lateral Sclerosis Assessment Questionnaire (ALSAQ-40) will be used to assess Quality of life in the patients. The Persian version of this questionare will be used in this study.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03272802


Locations
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Iran, Islamic Republic of
EMG Department, Alzahra Hospital
Isfahan, Iran, Islamic Republic of
Sponsors and Collaborators
Isfahan University of Medical Sciences

Publications:
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Responsible Party: Alireza Eishi Oskouei, MD, Isfahan University of Medical Sciences
ClinicalTrials.gov Identifier: NCT03272802     History of Changes
Other Study ID Numbers: Isfahan ALS Registery
First Posted: September 6, 2017    Key Record Dates
Last Update Posted: March 27, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Alireza Eishi Oskouei, Isfahan University of Medical Sciences:
Amyotrophic Lateral Sclerosis
Edaravone

Additional relevant MeSH terms:
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Sclerosis
Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Neuromuscular Diseases
Pathologic Processes
Neurodegenerative Diseases
Nervous System Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases
Riluzole
Edaravone
Anticonvulsants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Neuroprotective Agents
Protective Agents
Free Radical Scavengers
Antioxidants