TPTX » Topics » Clinical Trial Design

This excerpt taken from the TPTX 8-K filed Oct 22, 2007.

Clinical Trial Design

 

This Phase IIb trial was an in-clinic evaluation of tezampanel in patients suffering a single migraine attack, with or without aura. The clinical trial was designed as a randomized, double-blind, placebo-controlled, parallel-group, multi-center trial. A total of 306 patients were enrolled at 23 centers in the United States. Patients were equally randomized at each center to one of four treatment arms and received 40 mg, 70 mg, or 100 mg of tezampanel or placebo as a single, subcutaneous dose.

 

The primary purpose of the trial was to identify a dose that could be used in a Phase III development program for tezampanel in acute migraine. The primary efficacy endpoint was headache pain response at two hours post-dose. Secondary efficacy endpoints included the traditional endpoints associated with acute migraine trials. Safety and tolerability data were collected throughout the clinical trial period. Additionally, pharmacokinetic evaluations were completed in a subset of patients through 24 hours post-dose.

 

"Clinical Trial Design" elsewhere:

Molecular Templates, Inc. (THLD)
Wikinvest © 2006, 2007, 2008, 2009, 2010, 2011, 2012. Use of this site is subject to express Terms of Service, Privacy Policy, and Disclaimer. By continuing past this page, you agree to abide by these terms. Any information provided by Wikinvest, including but not limited to company data, competitors, business analysis, market share, sales revenues and other operating metrics, earnings call analysis, conference call transcripts, industry information, or price targets should not be construed as research, trading tips or recommendations, or investment advice and is provided with no warrants as to its accuracy. Stock market data, including US and International equity symbols, stock quotes, share prices, earnings ratios, and other fundamental data is provided by data partners. Stock market quotes delayed at least 15 minutes for NASDAQ, 20 mins for NYSE and AMEX. Market data by Xignite. See data providers for more details. Company names, products, services and branding cited herein may be trademarks or registered trademarks of their respective owners. The use of trademarks or service marks of another is not a representation that the other is affiliated with, sponsors, is sponsored by, endorses, or is endorsed by Wikinvest.
Powered by MediaWiki