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DIMOND - New HSG study using Dimebon. Phase I has begun   Message List  
Reply | Forward Message #158 of 447 |
Only 111 people will be included in Phase I of this study so if you're interested, contact the HSG for the nearest location to you participating in the DIMOND study!
 
Study: DIMOND,
Phase I enrollment Starts:  October 2006
Eligibility: Adults 18 and older with mild-to-moderate HD who are independently ambulatory (walking) and self-sufficient [ADL's]
Phase I duration: approximately 4 months
Locations: approximately 12 in the United States
Cost:  None
Contact: 1-800-487-7671
 
HSG to Conduct Research Study in Adults with Mild to Moderate Huntington’s Disease
10 October 2006
 
The Huntington Study Group [HSG] has launched a new trial in Huntington’s disease sponsored by Medivation, Inc.
 
The study is called DIMOND, a Multi-Center, Phase 1-2A, Open-Label, Dosage-Escalation and Randomized, Double-Blinded, Placebo-Controlled Study of Dimebon in Subjects With Huntington’s Disease in persons 18 years of age or older who have mild to moderate Huntington’s disease (HD).
 
This DIMOND study is designed to determine safe and tolerable doses of Dimebon and also to determine the effect of Dimebon on cognitive (thinking) and motor (movement) signs and overall functioning of subjects with HD. Dimebon is a research (experimental) medication that is thought to improve learning and memory. This current study is designed to determine how safe and tolerable Dimebon is in people with HD after short term exposure. Also the study will assess whether or not there is an effect of Dimebon on HD symptoms, including cognitive (thinking abilities), motor (movement), and overall functioning.
 
DIMOND has two parts to the study. The first part of the study will last about 2 weeks and the second part will last about 4 months. Approximately 12 research centers in the United States will enroll up to 111 research subjects. The study will enroll research subjects with early to moderate signs of HD who are independently ambulatory (walking) and self-sufficient in activities of daily living, such as eating, dressing, and bathing.
 
Enrollment will begin in October 2006.  There is no cost to participate in the study. Individuals with mild to moderate Huntington’s disease are eligible to participate in this study. If you are interested in learning more about this study, please contact the Huntington Study Group toll free at 1-800-487-7671 or see the press release on this study and the below link or here: http://snipurl.com/ytcl [PDF document 1 page].
 
Please see hyperlink to the HSG web site for information and the HSG press release.
http://www.huntington-study-group.org/THERAPEUTIC%20TRIALS.html

Additional information on this study:
Right on target!
 
FDA Approved Clinical Trials
http://snipurl.com/ytd0
excerpts:

SAN FRANCISCO (September 28, 2006) – Medivation, Inc. (AMEX: MDV) today announced that on September 27, 2006 it received permission from the FDA to begin the Company’s U.S. Phase 1-2a clinical trial of Dimebon™ in patients with Huntington’s disease. Medivation expects patient dosing to begin in early October.

Dimebon™ has been shown to prevent the death of brain cells (neurons) in preclinical models of Alzheimer’s disease and Huntington’s disease, making it a novel potential treatment for many neurodegenerative diseases. Dimebon recently met all five efficacy endpoints in a six-month randomized, double-blinded, placebo-controlled trial of 183 patients with mild to moderate Alzheimer’s disease. Patients in the trial were tested for a full spectrum of problems typically caused by Alzheimer’s disease, including memory loss, behavioral disturbances, and inability to perform everyday activities such as bathing and dressing. After six months of treatment, patients on Dimebon got significantly better on all of these tests. Dimebon patients also scored significantly better on all of these tests than did placebo patients. Dimebon, which has a 20-year record of human use, also was very well tolerated in this study. Medivation and its advisors designed this study to match closely the design of pivotal registration studies previously accepted by the FDA to approve currently marketed Alzheimer’s disease drugs, including duration of treatment, clinical endpoints and patient inclusion/exclusion criteria.

Medivation is conducting the Huntington’s disease study in collaboration with the Huntington Study Group (HSG), a network of more than 250 experienced clinical trial investigators, coordinators and consultants from more than 60 academic and research institutions throughout the United States, Canada, Europe and Australia. The study will be performed at approximately 12 HSG sites in the United States, and the principal investigator is Karl Kieburtz, MD, MPH, Professor of Neurology at the University of Rochester and the Director of the HSG Clinical Trials Coordination Center.

The Huntington’s disease clinical study has two parts – the first part is to assess the safety of various doses of Dimebon, and the second part is a randomized, double-blinded, placebo-controlled phase to assess the preliminary efficacy of Dimebon as a treatment for Huntington’s disease. Medivation will submit additional animal studies to the FDA before beginning the second part of the clinical trial, and expects to report clinical trial results in the second half of 2007.



Thu Oct 12, 2006 8:59 am

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New HSG study using Dimebon has begunOnly 111 people will be included in Phase I of this study so if you're interested, contact the HSG for the nearest...
Jean E. Miller
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Oct 12, 2006
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