Clinical research on a neuroprotective effect of minocycline treatment in the acute stage of Ischemic Stroke

UMIN ID: UMIN000002332

Registered date:14/08/2009

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Brain Infarction
• Date of first enrollment: 2010/04/01
• Target sample size: 200
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

200 mg/day of Minocycline for 5 consecutive days
Placebo for 5 consecutive days

Outcome(s)

• Primary Outcome: Comparison of NIH Stroke Scale (NIHSS) scores on day 90 in subjects treated with 200 mg/day minocycline vs placebo.
• Secondary Outcome: Comparison of NIH Stroke Scale (NIHSS) scores on day 7 and day 30, as well as modified Rankin Scale (mRS) and Barthel Index (BI) scores on day 7, day 30, and day 90.

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: 1) Hemorrhagic Stroke patients 2) Patients with evidence of other disease of the CNS 3) JCS >= 10 4) mRS before the onset >= grade 3 5) Patients who have known allergic response to tetracyclines 6) Patients with serious liver or renal diseases 7) Patients who have swallowing difficulties 8) During pregnancy or lactation 9) Patients who have serious pre-existing diseases 10) Patients who weigh over 100 kg

Related Information

• Primary Sponsor: Takeshi Takahashi
• Source(s) of Monetary Support: Ministry of health, labour and welfare