This contract represents a Master Agreement Order (MAO) award under the general terms and conditions of Master Agreement for the Clinical Evaluation Of Investigational Antiepileptic Drugs. Independently and not as an agent of the Government, the Contractor shall furnish all necessary services, qualified personnel, materials, equipment and facilities, not otherwise provided by the Government, and shall participate in performance of a multi-center clinical trial to obtain information about the efficacy and safety of losigamone as a monotherapy regimen and to obtain information about the pharmacokinetics of the total drug and of the two enantiomers. Specifically the principal purpose of this project is the acquisition of information in accordance with the purpose of the ADD Program to promote the development of more effective and less toxic antiepileptic drugs. The Contractor shall: (1) obtain IRB approval during the Phase I period; (2) enroll a target estimate of twelve (12) patients within twelve months after the NINDS authorizes Phase Il performance. Assuming 75% of the enrolled patients will be randomized, each center should plan to enroll at least 12 patients to provide 9 patients who complete the trial. NIH policy requires that clinical studies include both genders in such a manner that results are applicable to the general population. A similar policy exists regarding the inclusion of minorities; and (3) cooperate with the NINDS Epilepsy Branch, drug sponsor, and the other trial participants to agree on uniform protocol interpretation, conduct the trial, and develop a comprehensive final report suitable for submission as a scientific publication.
