PERTH IV MINOCYCLINE STROKE STUDY (PIMSS)

PERTH IV MINOCYCLINE STROKE STUDY (PIMSS) A phase II, multicentre prospective randomised open-label blinded endpoint evaluation (PROBE) pilot study of IV minocycline, 200mg daily for 2 days, for patients with ischaemic or haemorrhagic stroke, commencing within 24hours of symptom onset, compared with routine stroke care.

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12612000237886

Acronym

PIMSS

Enrollment

100

Registered

2012-02-24

Start date

2010-02-10

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

To test the hypothesis that acute stroke patients (both ischaemic and haemorrhagic) treated with IV minocycline within 24 hours of symptom onset have improved clinical outcomes compared with standard stroke care.

Interventions

Following randomisation, patients will be treated with either: Intravenous Minocycline 100mg at Baseline and then 12 hourly for a total of 5 dose; or routine stroke unit care.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1.Age 18 years or older 2.Onset of stroke < 24 hours. 3.Measurable neurological deficit on NHISS 4.Able to provide informed consent or Next of Kin waver of consent for patients unable to provide voluntary consent due to stroke disability.

Exclusion criteria

1.Evidence of other significant CNS disease that interferes with assessment (eg tumor, multiple sclerosis) 2.Known allergy to tetracyclines/intolerance of minocycline. 3.Known systemic lupus erythrematosis. 4.Idiopathic intracranial hypertension. 5.Concurrent treatment with Vitamin A or retinoids. 6.Participation in another clinical drug trial. 7.Known significant renal failure; CLcr < 30 mL/min by the Crockoft-Gault equation. 8.Known significantly abnormal liver function tests (ALT > x3 ULN) 9.Thrombocytopaenia < 100 10.Concurrent infection (at enrolment) requiring antibiotic treatment. 11.Pregnancy. 12.Severe stroke or other co-morbidities likely to result in the patient dying within a week. NB – thrombolytic therapy is NOT an exclusion criterion.

Outcome results