NCT00123305

Brief Summary

The primary purpose of this study is to evaluate the safety and preliminary efficacy of microplasmin when administered intravenously to patients who have suffered an acute stroke within 12 hours before randomization.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Oct 2005

Geographic Reach
3 countries

16 active sites

Status
completed

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

First Submitted

Initial submission to the registry

July 21, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 22, 2005

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2005

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
Last Updated

November 7, 2014

Status Verified

November 1, 2014

Enrollment Period

2.6 years

First QC Date

July 21, 2005

Last Update Submit

November 6, 2014

Conditions

Stroke, Acute

Keywords

StrokeAcute Ischemic Stroke

Outcome Measures

Primary Outcomes (2)

  • Intracranial haemorrhage

    24 hours and Day-7

  • Change from Baseline in NIHSS

    Day7 and Day-90

Secondary Outcomes (2)

  • Barthel Index and modified Rankin scale

    Day-90

  • Markers of systemic lysis

    Baseline, end of treatment, 6, 12, 24, 72 and 96 hours

Study Arms (4)

1

EXPERIMENTAL
Drug: Microplasmin

2

EXPERIMENTAL
Drug: Microplasmin

3

EXPERIMENTAL
Drug: Microplasmin

4

PLACEBO COMPARATOR
Drug: Microplasmin

Interventions

MicroplasminDRUG

1mg/kg bolus of microplasmin solution followed by 1,2 or 3mg/kg infusion of mircroplasmin solution.

123

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Acute ischemic stroke with onset within 12 hours before randomization with baseline NIHSS \> 6 and \< 22

You may not qualify if:

  • Participation in another study with an investigational drug or device within the previous 30 days, prior participation in the present study, or planned participation in another trial within the time frame of the current trial
  • Symptoms suggestive of subarachnoid hemorrhage, even if CT scan or MRI is negative for hemorrhage
  • Women known to be pregnant, lactating, or having a positive or indeterminate pregnancy test
  • Neurological deficit that has led to stupor or coma (National Institutes of Health Stroke Scale \[NIHSS\] Level Of Consciousness Item 1a score \>or=2)
  • High clinical suspicion of septic embolus
  • Thrombosis involving cerebral veins
  • Rapidly improving neurological signs at any time before initiation of study drug administration
  • Hemorrhagic transformation or intracerebral hemorrhage observed on baseline CT of the brain or gradient recalled echo (GRE) magnetic resonance imaging
  • CT or MRI evidence of nonvascular cause for the neurological symptoms
  • Large hypodensity on CT involving \> 1/3 of the middle cerebral artery (MCA) territory
  • Baseline DWI volume \> 1/3 of the MCA territory
  • Signs of mass effect causing shift of midline structures on CT or MRI
  • Unable to undergo MRI (i.e., ferrous implants, cardiac pacemakers, agitation, claustrophobia or known sensitivity to MRI contrast agents)
  • Congenital or acquired coagulopathy causing either of the following
  • activated partial thromboplastin time prolongation greater than 2 seconds above the upper limit of normal (ULN) for local laboratory
  • +19 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

Universitatsklinik fur Neurologie

Graz, 8036, Austria

Location

Landesnervenklinik Wagner-Jauregg

Linz, 4020, Austria

Location

AKH Linz Neurolog Abt

Linz, A-4020, Austria

Location

Allgemeines Offentliches Krankenhaus der

Linz, A-4021, Austria

Location

Cliniques Universitaires St Luc

Brussels, 1200, Belgium

Location

Gasthuisburg Hospital

Leuven, B-3000, Belgium

Location

Universitätsklinikum Erlangen

Erlangen, 91054, Germany

Location

Universitatsklinikum Essen

Essen, 45122, Germany

Location

Klinikum der J.W Goethe Univeristy

Frankfurt, 60528, Germany

Location

Universitatsklinikum Freiburg

Freiburg im Breisgau, 79106, Germany

Location

Georg August Universitat Gottingen

Göttingen, 37075, Germany

Location

Universitatskrankenhaus Hamburg-Eppendorf

Hamburg, 20246, Germany

Location

Universitatsklinikum Leipzig

Leipzig, 04103, Germany

Location

Klinikum Minden, Chefarzt der Neurologischen Klinik

Minden, 32427, Germany

Location

Klinikum rechts der Isar der TU München

München, 81675, Germany

Location

HSK Dr. Horst Schmidt Hospital

Wiesbaden, 65199, Germany

Location

MeSH Terms

Conditions

StrokeIschemic Stroke

Interventions

microplasmin

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Vincent Thijs, MD PhD

    KU Leuven

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 21, 2005

First Posted

July 22, 2005

Study Start

October 1, 2005

Primary Completion

May 1, 2008

Study Completion

June 1, 2008

Last Updated

November 7, 2014

Record last verified: 2014-11

Locations

AU(4)BE(2)DE(10)