Acute Ischemic Stroke — GD-11 for Injection in the Treatment of Acute Ischemic Stroke
Citation(s)
Cui L, Hung HM, Wang SJ Modification of sample size in group sequential clinical trials. Biometrics. 1999 Sep;55(3):853-7. doi: 10.1111/j.0006-341x.1999.00853.x.
Enlimomab Acute Stroke Trial Investigators Use of anti-ICAM-1 therapy in ischemic stroke: results of the Enlimomab Acute Stroke Trial. Neurology. 2001 Oct 23;57(8):1428-34. doi: 10.1212/wnl.57.8.1428.
Mehta CR, Pocock SJ Adaptive increase in sample size when interim results are promising: a practical guide with examples. Stat Med. 2011 Dec 10;30(28):3267-84. doi: 10.1002/sim.4102. Epub 2010 Nov 30.
Motwani JG, Lipworth BJ Clinical pharmacokinetics of drug administered buccally and sublingually. Clin Pharmacokinet. 1991 Aug;21(2):83-94. doi: 10.2165/00003088-199121020-00001. No abstract available.
Sato T, Mizuno K, Ishii F A novel administration route of edaravone--II: mucosal absorption of edaravone from edaravone/hydroxypropyl-beta-cyclodextrin complex solution including L-cysteine and sodium hydrogen sulfite. Pharmacology. 2010;85(2):88-94. doi
Phase III Clinical Trial of GD-11 for Injection in the Treatment of Acute Ischemic Stroke
Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.
Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.
Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.
Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.
Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.
