Clinical trial NCT03346538: Dose Finding Study of MCI-186 in Acute Ischemic Stroke
Official title: Dose Finding Study of MCI-186 in Acute Ischemic Stroke
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Acute Ischemic Stroke
Lead sponsor: Mitsubishi Tanabe Pharma Corporation
Sponsor class: INDUSTRY
First posted: 2017-11-17
Enrollment: 17
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Number of Participants With National Institutes of Health Stroke Scale (NIHSS) Score Improved.
timeFrame: Baseline up to Day 7
Secondary outcomes:
measure: Comparison of National Institutes of Health Stroke Scale (NIHSS)
timeFrame: Day 14, at discharge(from Day15 to after 3 months) and after 3 months
measure: Number of Participants With Modified Rankin Scale (mRS) 0-1 at Each Evaluations
timeFrame: at discharge(from Day15 to after 3 months) and after 3 months
measure: Comparison of Barthel Index (BI)
timeFrame: at discharge(from Day15 to after 3 months) and after 3 months
measure: Comparison of Functional Independence Measure (FIM)
timeFrame: at discharge(from Day15 to after 3 months) and after 3 months
Other outcomes:
Locations:
city: Aichi
country: Japan
facility: Investigational site 13
city: Aomori
country: Japan
facility: Investigational site 39
city: Chiba
country: Japan
facility: Investigational site 19
city: Chiba
country: Japan
facility: Investigational site 28
city: Ehime
country: Japan
facility: Investigational site 33
city: Fukui
country: Japan
facility: Investigational site 10
city: Fukuoka
country: Japan
facility: Investigational site 05
city: Fukuoka
country: Japan
facility: Investigational site 09
city: Fukuoka
country: Japan
facility: Investigational site 11
city: Fukuoka
country: Japan
facility: Investigational site 12
city: Fukuoka
country: Japan
facility: Investigational site 18
city: Fukuoka
country: Japan
facility: Investigational site 21
city: Fukuoka
country: Japan
facility: Investigational site 32
city: Fukuoka
country: Japan
facility: Investigational site 37
city: Fukushima
country: Japan
facility: Investigational site 07
city: Fukushima
country: Japan
facility: Investigational site 08
city: Gifu
country: Japan
facility: Investigational site 15
city: Gifu
country: Japan
facility: Investigational site 23
city: Gunma
country: Japan
facility: Investigational site 02
city: Hokkaido
country: Japan
facility: Investigational site 01
city: Hokkaido
country: Japan
facility: Investigational site 22
city: Hyogo
country: Japan
facility: Investigational site 06
city: Hyogo
country: Japan
facility: Investigational site 30
city: Hyogo
country: Japan
facility: Investigational site 42
city: Ishikawa
country: Japan
facility: Investigational site 43
city: Iwate
country: Japan
facility: Investigational site 27
city: Kanagawa
country: Japan
facility: Investigational site 40
city: Kochi
country: Japan
facility: Investigational site 24
city: Miyagi
country: Japan
facility: Investigational site 35
city: Nagano
country: Japan
facility: Investigational site 16
city: Nagano
country: Japan
facility: Investigational site 20
city: Okayama
country: Japan
facility: Investigational site 44
city: Okinawa
country: Japan
facility: Investigational site 41
city: Osaka
country: Japan
facility: Investigational site 03
city: Osaka
country: Japan
facility: Investigational site 25
city: Saga
country: Japan
facility: Investigational site 38
city: Saitama
country: Japan
facility: Investigational site 31
city: Shimane
country: Japan
facility: Investigational site 14
city: Tochigi
country: Japan
facility: Investigational site 29
city: Tochigi
country: Japan
facility: Investigational site 36
city: Tokyo
country: Japan
facility: Investigational site 17
city: Tokyo
country: Japan
facility: Investigational site 45
city: Yamagata
country: Japan
facility: Investigational site 34
city: Yamaguchi
country: Japan
facility: Investigational site 04
city: Yamaguchi
country: Japan
facility: Investigational site 26
Study officials:
affiliation: Mitsubishi Tanabe Pharma Corporation
name: General Manager
role: STUDY_DIRECTOR
References: