Dose Finding Study of MCI-186 in Acute Ischemic Stroke

Acute Ischemic Stroke Clinical Trial

Official title:

Dose Finding Study of MCI-186 in Acute Ischemic Stroke

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03346538
• Other study ID #: MCI-186-J20
• Status: Terminated
• Phase: Phase 2
• Start date: November 17, 2017
• Est. completion date: May 14, 2018

Study information

• Verified date: September 2018
• Source: Mitsubishi Tanabe Pharma Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 17
• Est. completion date: May 14, 2018
• Est. primary completion date: May 14, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Ischemic Stroke
• Cerebral Infarction
• Ischemia
• Stroke

Intervention

Drug:
• Continuous infusion high-dose MCI-186
intravenous injection
• Continuous infusion low-dose MCI-186
intravenous injection
• Continuous infusion placebo
intravenous injection
• Approved dosing regimen MCI-186
intravenous injection
• Approved dosing regimen placebo
intravenous injection

Locations

Country	Name	City	State
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

Sponsors (1)

Lead Sponsor	Collaborator
Mitsubishi Tanabe Pharma Corporation

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with National Institutes of Health Stroke Scale (NIHSS) score improved.	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).	Baseline up to Day 7
Secondary	Comparison of National Institutes of Health Stroke Scale (NIHSS)	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).	Day 14, at discharge(from Day15 to after 3 months) and after 3 months
Secondary	Comparison of modified Rankin Scale (mRS)	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).	at discharge(from Day15 to after 3 months) and after 3 months
Secondary	Comparison of Barthel Index (BI)	BI is a scale for measuring performance in Activities of Daily Living (ADL). Possible scores range from 0 (worst) to 100 (best).	at discharge(from Day15 to after 3 months) and after 3 months
Secondary	Comparison of Functional Independence Measure (FIM)	FIM is a scale used to evaluate the functional status. Possible scores range from 18 (worst) to 126 (best).	at discharge(from Day15 to after 3 months) and after 3 months