Clinical Trials Resource Center

New Medical Therapies™

Brain Injury

March 31, 2008

ExonHit released positive results from a phase I trial of EHT 0202 for the treatment of scopolamine-induced brain impairments. This randomized, double-blind, placebo-controlled, crossover study enrolled twelve young healthy subjects who received single administrations of EHT 0202 (40mg, 80mg, and 120mg) or placebo. The effects of EHT 0202 on scopolamine-induced cognitive impairments were assessed by using EEG recordings (spectral analysis and Event Related Potentials - ERPs) at the following time points: 1 hour 15 minutes, 2 hours 45 minutes, 4 hours 15 minutes and 5 hours 45 minutes post dose. The results of the spectral analysis indicate that EHT 0202 is associated with an improvement of the vigilance level at 1 hour 15 minutes post-dose, as shown by the significant decrease of the power in Delta and Theta bands (p<0.01) in subjects dosed at 40 mg. Cognitive improvement, as assessed by the analysis of P300 (an ERP wave) amplitude, was shown at an 80mg dose of EHT 0202 regardless the time post-dose (p <0.04). Moreover, the maximum effect of EHT 0202 80mg occurred at 4 hours 15 minutes post-dose and was associated with the ability to restore working memory function, while the deleterious effect of scopolamine reached its peak (p<0.02). A phase II trial of EHT 0202 is currently underway.

May 21, 2007

Synthetic Blood International issued positive results from a phase IIa trial of Oxycyte for the treatment of traumatic brain injury. This open-label, proof of concept study enrolled 8 subjects with severe traumatic brain injury and a Glasgow Coma Scale score of 3-9, within 24 hours of the injury's occurrence. The first four subjects were stabilized with 50% oxygen for four hours before and 12 hours following Oxycyte administration. The remaining four subjects breathed 100% oxygen on the same schedule. The primary endpoint was the efficacy of the drug in increasing brain oxygen tension and improving brain chemistries impacting clinical outcome. Secondary measures included safety measures for the intravenous administration of the drug. Results confirmed that the primary endpoint was achieved when compared with baseline. In addition, data showed a decrease in patient glucose and lactate/pyruvate (LP) ratio, consistent with increased glucose metabolism. Both the 50% and 100% oxygen treatment arms were favorable. Based on the results the company plans to initiate phase IIb trials in the near future.

March 5, 2007

Novo Nordisk released negative results from a phase III trial of NovoSeven for the treatment of Intracerebral Hemorrhage (ICH). This international, randomized, double-blind, placebo-controlled trial enrolled 821 subjects who were suffering from spontaneous ICH as confirmed by a CT scan. Subjects received either NovoSeven or placebo within four hours of symptom onset, in addition to conventional treatment. Treatment was safe and well tolerated. Efficacy results revealed that NovoSeven significantly reduced intracerebral bleeding compared to placebo. In addition, improvements in functional independence and neurological impairment were observed on day 15. However the primary endpoint, improvement in mortality and severe disability at day 90, was not achieved. Based on the results, Novo Nordisk has decided not to seek FDA approval of NovoSeven for this indication.

March 20, 2006

Renovis and AstraZeneca announced preliminary results of a phase IIb trial, dubbed CHANT, of Cerovive (NXY-059) for the treatment of acute intracerebral hemorrhage (ICH). Safety and tolerability data were generally positive, with comparable overall mortality rates (roughly 20%) for subjects receiving the drug and placebo. Secondary outcomes yielded similar results, with no significant difference between the drug and placebo in stroke outcomes following ICH. This multi-center, double-blind, placebo-controlled, parallel group study enrolled 603 patients across 20 countries, who were randomized to receive a 72 hour infusion of NXY-509 or placebo, initiated within 6 hours of ICH onset.

July 5, 2004

Novo Nordisk has announced positive results of their phase IIb study of NovoSeven for the treatment of intracerebral hemorrhage (ICH). NovoSeven is currently approved as a treatment for acute bleeding in hemophilia. Results have shown that the drug led to a significant reduction in hematoma growth, compared to placebo, and significantly improved neurological and functional outcomes following an ICH incident. The double-blind, dose-response study enrolled a total of 400 subjects in 20 countries; subjects with spontaneous ICH confirmed by CT scan within three hours of symptom onset randomized to receive either NovoSeven or placebo, in addition to standard therapy. Follow-up CT scans, performed at 24 and 72 hours, found that NovoSeven significantly and dose-dependently reduced hematoma expansion, and observations at 15 and 90 days found significant improvement in severity score on neurological function tests in the NovoSeven group. Novo Nordisk announced plans to file supplementary regulatory submissions based upon this data.

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