NCT01388127

Brief Summary

The investigators will perform a double blind controlled study to investigate the efficacy of oral administration of 200 mg minocycline, on the neurological and functional outcome after acute hemorrhagic stroke and the effect on blood brain barrier permeability.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2011

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2011

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

July 3, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 6, 2011

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

July 6, 2011

Status Verified

June 1, 2011

Enrollment Period

1 year

First QC Date

July 3, 2011

Last Update Submit

July 5, 2011

Conditions

Poor Performance Status

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

150 patients after acute hemorrhagic stroke. Half treated with Minocycline.

You may qualify if:

  • Patients with acute hemorrhagic stroke
  • age \> 18
  • NIHSS score \> 5
  • onset of stroke 6 to 24 hours prior to beginning of treatment. Patients, who arrived within 0 to 6 hours post stroke, were treated with other medications according to the best accepted medical treatment guidelines.

You may not qualify if:

  • Evidence of other disease of the central nervous system, including brain tumor, demyelinating disease, inflammatory disease of the central nervous system, craniotomy in the past, severe brain injuries and benign intracranial hypertension
  • pre-existing neurological disability
  • known allergic response to tetracyclines
  • acute or chronic renal failure
  • pre-existing infectious disease requiring antibiotic therapy
  • swallowing difficulties

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Edith Wolfson Medical Center

Holon, Israel, 58100, Israel

Location

Study Officials

  • Yair Lampl, MD

    Edith Wolfson Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

July 3, 2011

First Posted

July 6, 2011

Study Start

July 1, 2011

Primary Completion

July 1, 2012

Study Completion

July 1, 2012

Last Updated

July 6, 2011

Record last verified: 2011-06

Locations

IL(1)