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Huntington Study Group and the European Huntington’s Disease Network Announce Results from the Phase 3 HORIZON Trial of Dimebon in Huntington Disease
-- Dimebon Did Not Meet Primary Efficacy Endpoints --
Rochester, NY, and Ulm, Germany, April 11, 2011 – The Huntington Study Group (HSG) and the European Huntington’s Disease Network (EHDN), under the leadership of Karl Kieburtz, MD, MPH (Principal Investigator) and Bernhard Landwehrmeyer, MD (co-Principal Investigator), announce the preliminary results of a large multi-center, randomized, placebo-controlled clinical trial of an investigational drug dimebon (Latrepirdine*), in people with Huntington disease (HD). The trial, called HORIZON, was sponsored by Medivation, Inc. in collaboration with Pfizer Inc.
Among study participants taking dimebon 60 mg/day, cognitive (thinking and memory) and global function did not differ significantly compared to study participants taking placebo as evaluated by the co-primary endpoint assessments of the Mini-Mental State Examination (MMSE) total score, which measures cognition , or the Clinician's Interview-Based Impression of Change, plus caregiver input (CIBIC-plus), which measures global function. Trial participation was associated with improved MMSE (cognitive assessment) scores and stable global function (CIBIC-plus) measures independent of treatment assignment. Consistent with results from previous trials in over 2000 research participants, dimebon was safe and well tolerated in the HORIZON trial.
“The HORIZON findings are disappointing news for the Huntington disease community as there are no medications currently approved to treat the thinking and memory impairment seen in this disease,” said Karl Kieburtz, MD, MPH, lead investigator of the HORIZON trial and Director of the Center for Human Experimental Therapeutics and Professor in the Department of Neurology at the University of Rochester Medical Center. “Loss of cognitive function eventually is a significant problem for nearly all people with Huntington disease and a key cause of disability.”
The HORIZON study was conducted in North America and Australia by the HSG and in Europe by the EHDN. Research investigators at 68 sites evaluated 403 participants in the 6-month study. “While dimebon did not improve cognition in HD as we had hoped, this study is still a major milestone for the HD community,” said Bernhard Landwehrmeyer, MD, co-lead investigator of the Horizon trial, Chair of the Executive Committee of EHDN and Professor of Neurology at the University of Ulm, Germany. “This was the first large clinical trial to focus on the cognitive aspects of HD and represents the first global study protocol in HD simultaneously reviewed and accepted by regulatory agencies in the United States and the European Union; the concordance of outcomes observed in North America, Australia and Europe speaks to the feasibility of conducting global clinical studies in HD. Notwithstanding the results of HORIZON, this study will therefore lay the foundation for future global investigations of promising new treatments for cognition and other aspects of HD.”
HD is an inherited neurodegenerative disease that affects about 60,000 people in both North America and Europe. The symptoms of HD usually begin between the ages of 30 to 50 and results in progressive motor, behavioral, and cognitive dysfunction. While there are medications to help relieve some of these symptoms, there is no known treatment to address the cognitive symptoms of HD.
The HSG and EHDN are not-for-profit groups of physicians and other clinical researchers who are experienced in the care of patients with HD and dedicated to finding treatments that make a difference for this condition.
*Latrepirdine is the generic (nonproprietary) name for dimebon.
Letter to investigators and coordinators
Letter to the participant (in several languages)
Please use this as a template to inform the study participants at your study site: