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Dose Finding Study of MCI-186 in Acute Ischemic Stroke

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ClinicalTrials.gov Identifier: NCT03346538
Recruitment Status : Terminated (Business objectives have changed.)
First Posted : November 17, 2017
Last Update Posted : September 24, 2018
Sponsor:
Information provided by (Responsible Party):
Mitsubishi Tanabe Pharma Corporation

Brief Summary:
To investigate the efficacy and safety of MCI-186 (bolus followed by continuous infusion) in acute ischemic stroke patients through a double-blind, parallel-group comparison with the existing MCI-186 dosing regimen (administration twice daily for 14 days) as the control.

Condition or disease Intervention/treatment Phase
Acute Ischemic Stroke Drug: Continuous infusion high-dose MCI-186 Drug: Continuous infusion low-dose MCI-186 Drug: Continuous infusion placebo Drug: Approved dosing regimen MCI-186 Drug: Approved dosing regimen placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Dose Finding Study of MCI-186 in Acute Ischemic Stroke
Actual Study Start Date : November 17, 2017
Actual Primary Completion Date : May 14, 2018
Actual Study Completion Date : May 14, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Edaravone

Arm Intervention/treatment
Experimental: Continuous infusion high-dose group (Group H)
High-dose MCI-186 will be administered as a bolus, and then as a continuous infusion. In addition, a placebo will be administered as an intravenous infusion twice a day over 30 minutes.
Drug: Continuous infusion high-dose MCI-186
intravenous injection

Drug: Approved dosing regimen placebo
intravenous injection

Experimental: Continuous infusion low-dose group (Group L)
Low-dose MCI-186 will be administered as a bolus, and then as a continuous infusion. In addition, a placebo will be administered as an intravenous infusion twice a day over 30 minutes.
Drug: Continuous infusion low-dose MCI-186
intravenous injection

Drug: Approved dosing regimen placebo
intravenous injection

Experimental: Approved dosing regimen group (control group)
A placebo will be administered as a bolus, and then as a continuous infusion. In addition, MCI-186 30 mg will be administered as an intravenous infusion twice a day over 30 minutes.
Drug: Continuous infusion placebo
intravenous injection

Drug: Approved dosing regimen MCI-186
intravenous injection




Primary Outcome Measures :
  1. Number of participants with National Institutes of Health Stroke Scale (NIHSS) score improved. [ Time Frame: Baseline up to Day 7 ]

    NIHSS is a scale to objectively quantify the neurologic impairment caused by a stroke.

    Possible scores range from 0 (no stroke symptoms) to 40(severe stroke).



Secondary Outcome Measures :
  1. Comparison of National Institutes of Health Stroke Scale (NIHSS) [ Time Frame: Day 14, at discharge(from Day15 to after 3 months) and after 3 months ]

    NIHSS is a scale used to objectively quantify the neurologic impairment caused by a stroke.

    Possible scores range from 0 (no stroke symptoms) to 40 (severe stroke).


  2. Comparison of modified Rankin Scale (mRS) [ Time Frame: at discharge(from Day15 to after 3 months) and after 3 months ]
    mRS is a scale for measuring the degree of disability caused by a stroke. Possible scores range from Grade 0 (no symptoms) to Grade 6 (death).

  3. Comparison of Barthel Index (BI) [ Time Frame: at discharge(from Day15 to after 3 months) and after 3 months ]
    BI is a scale for measuring performance in Activities of Daily Living (ADL). Possible scores range from 0 (worst) to 100 (best).

  4. Comparison of Functional Independence Measure (FIM) [ Time Frame: at discharge(from Day15 to after 3 months) and after 3 months ]
    FIM is a scale used to evaluate the functional status. Possible scores range from 18 (worst) to 126 (best).



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Ages Eligible for Study:   20 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients from whom written consent to study participation has been obtained, either from the patient personally or from the patient's legal guardian
  • Patients with age at consent between 20 and 85 years, inclusive
  • Patients for whom study treatment can be initiated within 24 hours after onset
  • Patients with confirmed new ischemic area only in the supratentorial region on MRI
  • Patients with neurological signs equivalent to between 4 and 22, inclusive, on the NIHSS

Exclusion Criteria:

  • Patients with disability equivalent to an mRS score of 2 or more from before onset
  • Patients being treated with antibiotics for an infection at registration
  • Patients who have received or are planning to receive treatment for their primary disease with a prohibited concomitant medication (e.g., a thrombolytic drug) or with a prohibited concomitant therapy (e.g., intravascular therapy)
  • Patients for whom the (sub)investigator judges the efficacy endpoints (e.g., NIHSS, mRS, BI) that have been selected for this study can not be measured appropriately, such as patients who are not expected to achieve improvement of 4 or more on the NIHSS because of nerve symptoms that have been present since before the onset of cerebral infarction, Alzheimer's dementia patients, or Parkinson's disease patients
  • Patients with severe consciousness disturbances (Japan coma scale ≥ 100)
  • Patients with clear concurrent peripheral vascular disease or peripheral neuropathy for whom the (sub)investigator judges the neurological tests could not be performed properly
  • Patients with severe renal impairment (e.g., patients with eGFR < 30)
  • Patients with severe hepatic impairment (e.g., ALT, AST, or gamma-GTP > 2.5 X ULN)
  • Patients with platelet count < 100,000/mm3
  • Patients diagnosed by MRI on admission with a disease other than stroke (e.g., intracranial bleeding, subarachnoid bleeding, arteriovenous malformations, Moyamoya disease, brain tumor) or with cerebral aneurysm with a maximum diameter > 7 mm
  • Patients with prior or current drug abuse or alcohol dependence
  • Patients with prior (or current) malignant tumor within 5 years before stroke onset
  • Patients with a past history of hypersensitivity to edaravone drug products
  • Patients with concurrent heart disease severe enough to warrant admission and treatment (e.g., acute myocardial infarction, cardiac failure) and with problems with their overall condition judged by the (sub)investigator to be unsuitable for study participation
  • Patients for whom MRI tests cannot be performed
  • Male or female patients who do not consent to practice contraception from the date of consent until the day after the administration of the last dose of study drug
  • Patients who are pregnant or nursing, or who could be pregnant
  • Patients who have received other investigational drugs in the 12 weeks prior to consent acquisition
  • Patients with body weight ≥ 100 kg
  • Patients otherwise judged unsuitable for study participation by the (sub)investigator

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): NCT03346538


Locations
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Japan
Investigational site 13
Aichi, Japan
Investigational site 39
Aomori, Japan
Investigational site 19
Chiba, Japan
Investigational site 28
Chiba, Japan
Investigational site 33
Ehime, Japan
Investigational site 10
Fukui, Japan
Investigational site 05
Fukuoka, Japan
Investigational site 09
Fukuoka, Japan
Investigational site 11
Fukuoka, Japan
Investigational site 12
Fukuoka, Japan
Investigational site 18
Fukuoka, Japan
Investigational site 21
Fukuoka, Japan
Investigational site 32
Fukuoka, Japan
Investigational site 37
Fukuoka, Japan
Investigational site 07
Fukushima, Japan
Investigational site 08
Fukushima, Japan
Investigational site 15
Gifu, Japan
Investigational site 23
Gifu, Japan
Investigational site 02
Gunma, Japan
Investigational site 01
Hokkaido, Japan
Investigational site 22
Hokkaido, Japan
Investigational site 06
Hyogo, Japan
Investigational site 30
Hyogo, Japan
Investigational site 42
Hyogo, Japan
Investigational site 43
Ishikawa, Japan
Investigational site 27
Iwate, Japan
Investigational site 40
Kanagawa, Japan
Investigational site 24
Kochi, Japan
Investigational site 35
Miyagi, Japan
Investigational site 16
Nagano, Japan
Investigational site 20
Nagano, Japan
Investigational site 44
Okayama, Japan
Investigational site 41
Okinawa, Japan
Investigational site 03
Osaka, Japan
Investigational site 25
Osaka, Japan
Investigational site 38
Saga, Japan
Investigational site 31
Saitama, Japan
Investigational site 14
Shimane, Japan
Investigational site 29
Tochigi, Japan
Investigational site 36
Tochigi, Japan
Investigational site 17
Tokyo, Japan
Investigational site 45
Tokyo, Japan
Investigational site 34
Yamagata, Japan
Investigational site 04
Yamaguchi, Japan
Investigational site 26
Yamaguchi, Japan
Sponsors and Collaborators
Mitsubishi Tanabe Pharma Corporation
Investigators
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Study Director: General Manager Mitsubishi Tanabe Pharma Corporation

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Responsible Party: Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier: NCT03346538     History of Changes
Other Study ID Numbers: MCI-186-J20
First Posted: November 17, 2017    Key Record Dates
Last Update Posted: September 24, 2018
Last Verified: September 2018

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

Additional relevant MeSH terms:
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Stroke
Ischemia
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Brain Infarction
Brain Ischemia
Edaravone
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs