Abstract

This trial will evaluate the safety and efficacy of losigamone in the treatment of patients with complex partial seizures in whom: (1) an optimal losigamone dosage has been determined and (2) the previous antiepileptic drug (AED) has been discontinued (patients may present with simple partial seizures in addition to complex partial seizures). After an 8-week losigamone monotherapy baseline period, patients will be randomized under double-blind conditions to either: (1) continue their optimal losigamone dosage or (2) titrate to one-half the optimal losigamone dosage and will enter an 8-week treatment period. Efficacy will be assessed by the variable time-from-randomization-to-meeting-exit criteria. Safety will be evaluated by comparing the nature and duration of the adverse experiences. The trial will be conducted at multiple epilepsy centers.

  Funding Agency

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
5M01RR000079-38
Application #
6416990
Study Section
Project Start
2000-12-01
Project End
2001-11-30
Budget Start
Budget End
Support Year
38
Fiscal Year
2001
Total Cost
Indirect Cost

  Institution

Name
University of California San Francisco
Department
Type
DUNS #
073133571
City
San Francisco
State
CA
Country
United States
Zip Code
94143

  Publications

Kurtz, Theodore W; DiCarlo, Stephen E; Pravenec, Michal et al. (2018) Functional foods for augmenting nitric oxide activity and reducing the risk for salt-induced hypertension and cardiovascular disease in Japan. J Cardiol 72:42-49
Anderegg, Nanina; Johnson, Leigh F; Zaniewski, Elizabeth et al. (2017) All-cause mortality in HIV-positive adults starting combination antiretroviral therapy: correcting for loss to follow-up. AIDS 31 Suppl 1:S31-S40
Kurtz, Theodore W; DiCarlo, Stephen E; Morris Jr, R Curtis (2016) Logical Issues With the Pressure Natriuresis Theory of Chronic Hypertension. Am J Hypertens 29:1325-1331
Cruz, Giovanna I; Shao, Xiaorong; Quach, Hong et al. (2016) A Child's HLA-DRB1 genotype increases maternal risk of systemic lupus erythematosus. J Autoimmun 74:201-207
Morris Jr, R Curtis; Schmidlin, Olga; Sebastian, Anthony et al. (2016) Vasodysfunction That Involves Renal Vasodysfunction, Not Abnormally Increased Renal Retention of Sodium, Accounts for the Initiation of Salt-Induced Hypertension. Circulation 133:881-93
Kurtz, Theodore W; DiCarlo, Stephen E; Pravenec, Michal et al. (2016) An alternative hypothesis to the widely held view that renal excretion of sodium accounts for resistance to salt-induced hypertension. Kidney Int 90:965-973
Brambati, Simona Maria; Amici, Serena; Racine, Caroline A et al. (2015) Longitudinal gray matter contraction in three variants of primary progressive aphasia: A tenser-based morphometry study. Neuroimage Clin 8:345-55
Abraham, Alison G; Althoff, Keri N; Jing, Yuezhou et al. (2015) End-stage renal disease among HIV-infected adults in North America. Clin Infect Dis 60:941-9
Wang, Julie B; Pierce, John P; Ayala, Guadalupe X et al. (2015) Baseline Depressive Symptoms, Completion of Study Assessments, and Behavior Change in a Long-Term Dietary Intervention Among Breast Cancer Survivors. Ann Behav Med 49:819-27
Brehm, John M; Ramratnam, Sima K; Tse, Sze Man et al. (2015) Stress and Bronchodilator Response in Children with Asthma. Am J Respir Crit Care Med 192:47-56

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