Clinical Study MCI-186-E04

• Research type

  Research Study

• Full title

  A Phase IIa, multi-centre, randomised, double-blind, placebo controlled, clinical study investigating the safety, tolerability and pharmacokinetics of two different infusion doses over 72 hours of a new regimen and new formulation of MCI-186 in subjects with acute ischemic stroke.

• IRAS ID

  30837

• Contact name

  Gary A Ford

• Sponsor organisation

  Mitsubishi Tanabe Pharma Corporation

• Eudract number

  2008-003397-17

• Clinicaltrials.gov Identifier

  NCT00821821

• Research summary

  This is a study of MCI-186, a drug that may reduce or even prevent further damage to brain cells from a stroke. During a stroke, particles called ??free radicals? are released in the brain. These particles cause damage to the brain cells. MCI-186 helps to remove these ??free radicals? and it may help to reduce brain cell death. The main aim of the study is to compare the safety, tolerability and local tolerance of two new different infusion (drip) doses and a new drug formulation of MCI-186, with a dummy infusion (placebo) to find out if it is a more acceptable and safe way of giving the MCI-186 drug. The study population are those who have had a recent acute ischaemic stroke i.e. due to a blocked artery in the brain. The current trial will be performed in up to 36 patients, divided into 2 groups, Group 1 and Group 2. About 70% (2/3rds) of patients will through random allocation receive MCI-186 by infusion into a vein for 72 hours and the remainder (1/3rd) will receive a dummy infusion that looks exactly the same as MCI-186 but is not ??active?. Blood samples will be taken from patients to determine the levels of drug achieved in stroke patients. Patients will be assessed for any adverse effects and the recovery from their stroke assessed at three months measuring the level of independence they have achieved. It is planned to use a different dose of MCI-186 in Groups 1 and 2. The dose for Group 2 will be decided depending on the blood results and review of patient outcomes from Group 1. Recruitment for this study is now closed.

• REC name

  East Midlands - Derby Research Ethics Committee

• REC reference

  09/H0405/55

• Date of REC Opinion

  5 Nov 2009

• REC opinion

  Further Information Favourable Opinion