ALIAS II/III Trial:Albumin Therapy in Ischemic Stroke

Project: Research project

Description

DESCRIPTION: (Provided by applicant). The objective of this Planning Grant is to provide support to carry out the organizational and grant-writing activities needed to prepare an NIH application for a major Phase II/III Randomized, Multi-center Clinical Trial of Human Serum Albumin (HSAIb) Therapy for Neuroprotection in Acute Ischemic Stroke - the ALIAS Trial. This grant mechanism provides for early peer review of the rationale and design of the proposed trial. Funding is requested to support the following activities: Identification and recruitment of study sites; identification of Steering Committee members, independent medical monitors, and a central pharmacy; finalization of the protocol and case report forms; development of the Manual of Operations and the Data Management Plan; development of innovative alternative statistical-design and -analysis methods; design of a Magnetic Resonance Imaging (MRI) substudy; and preparation of the Phase II/lll ALIAS Trial grant. The multi-functional properties of the albumin molecule render it uniquely suited as a neuroprotective agent, and our pre-clinical investigations have shown consistent high-grade neuroprotection in focal cerebral ischemia. Our NIH-supported Phase I, dose-escalation and safety trial of albumin in acute ischemic stroke (NS 40406), has established the safety of HSAIb at the1 g./kg. i.v. dose (a pre-clinically efficacious dose level) in patients with acute ischemic stroke, and has given us experience in implementing standard assessment measures as a prelude to the Phase II/III ALIAS Trial. The ALIAS Trial consists of a single-arm Phase II futility study; and subsequently, if futility is rejected, a two-arm Phase III efficacy study. Both studies are designed as double-blind, placebo-controlled, randomized, multi-center trials. Two cohorts of subjects will be studied in parallel: A tPA-treated cohort receiving HSAIb within 3 h, and a non-tPA cohort receiving HSAIb within 4.5 h. of stroke onset. At a minimum clinical effect size of 10%, a total of approximately 410 patients is required for the futility trial, and -1,950 for the efficacy trial. The primary outcome measure is the modified Rankin score at 3 months.
StatusFinished
Effective start/end date4/1/043/31/06

Funding

  • National Institutes of Health: $204,145.00

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Medical Futility
Organized Financing
Albumins
Stroke
Personnel Selection
Committee Membership
Safety
Peer Review
Neuroprotective Agents
Therapeutics
Brain Ischemia
Serum Albumin
Placebos
Magnetic Resonance Imaging
Outcome Assessment (Health Care)
Clinical Trials
Neuroprotection

ASJC

  • Medicine(all)
  • Neuroscience(all)