TerminatedPhase 2

Intra-arterial Microplasmin Administration in Patients With Acute Intracranial Vertebrobasilar Artery Occlusion

Stopped: Sponsor's decision not to pursue development of uPLi for vascular conditions.

Germany2 participantsStarted 2006-12

Plain-language summary

The purpose of the trial is to evaluate the safety of microplasmin as well as its ability to open blocked arteries to the brain in patients with acute stroke when given into the artery at the site of the blockage.

Who can participate

Age range18 Years – 75 Years

SexALL

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Inclusion criteria

✓. Patients with angiographically documented vertebrobasilar artery occlusion
✓. Initiation of study drug treatment within 24 hours of the onset of neurological symptoms
✓. Age 18-75 (inclusive).

Exclusion criteria

✕. Patients with coma \> 6 hrs duration and complete loss of brain stem reflexes (corneal reflex, gag reflex, VOR, pupil reflexes) as measured at the last assessment before sedation/intubation
✕. Rapidly improving neurologic signs at any time before initiation of study drug administration.
✕. Known contrast agent-sensitivity
✕. Uncontrolled hypertension defined as a systolic blood pressure \> 180 mm Hg or a diastolic blood pressure \> 100 mm Hg on 3 separate occasions at least 10 minutes apart or requiring continuous IV therapy.
✕. History of stroke within the previous 6 weeks.

What they're measuring

Recanalization rate

Timeframe: Day-7, Day-30 and Day-90

Trial details

NCT IDNCT00123266

SponsorThromboGenics

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2007-07

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