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Blog Post on May 28, 2008 by Clinical Trials
NeuroSearch (CSE:NEUR) raised DKK84 million ($17.8 million) through the sale of 300,000 shares to institutional investors at DKK280 per share. The price is a 5% discount to NeuroSearch's close of DKK294 on May 20, the day before the offering was proposed. The company plans to use the cash to pay a SEK100 million ($17 million) milestone payment to the sellers of Carlsson Research, which NeuroSearch acquired in 2006. The milestone was triggered by the April start of a Phase III trial of dopamine stabilizer ACR16 to treat Huntington's disease (HD).
Blog Post on October 30, 2007 by Clinical Trials
"Prestwick Pharmaceuticals will present arguments to support FDA approval of tetrabenazine to the Peripheral and Central Nervous System Drug Advisory Committee on December 6, 2007. A portion of this critically important FDA meeting will be given to HD family members to publicly voice their views on this drug .
Many U.S. doctors already prescribe tetrabenazine to treat chorea in Huntington disease. Many patients use this drug with benefit at great personal expense. Many others who would wish to try it can not afford it, or have doctors unwilling to prescribe it.
At HDDW we fervently hope that the FDA will approve this drug for Huntingtons, and that Prestwick Pharmaceuticals and Huntington Study Group Physicians will educate general doctors and HD patients regarding its safest use.
I will attend the Dec. 6 meeting to represent my patients from the Northwest and those of you who have responded to HDDW requests for your tetrabenazine experiences and stories. All of us at HDDW encourage you to come to this FDA meeting and give your opinion."
Original Source @ http://hddrugworks.org/index.php?option=com_content&task=view&id=208&Itemid=30
Original Author: LaVonne Goodman
Blog Post on October 24, 2007 by Clinical Trials
This long-term observational study will initially take place at 40 North American and Australian Huntington Study Group (HSG) sites. The goal of COHORT is to collect information in order to learn more about HD, potential treatments, and to plan future research studies of experimental drugs aimed at postponing the onset or slowing the progression of HD. This study will recruit both adults and children who have clinically diagnosed HD and adults who are a part of an HD family. Individuals who choose to participate will have one study visit every year for as long as they are able and choose to participate. Please refer to the COHORT Participating Site List for sites in your area @ http://www.huntington-study-group.org/COHORTSites.htm
At each annual visit, all individuals participating in COHORT will be required to have a clinical evaluation. Those who are 18 years of age and older will have blood drawn for genetic testing of the CAG polymorphism and for other genetic changes, which may be important to Huntington?s disease. For those who are 18 years of age and older, there will be optional research procedures including the collection of family history and the collection and storage of blood and urine for future HD research.
Data from the COHORT study will be collected in databases designed to protect the privacy of all those who participate. The data and samples will provide researchers with a valuable resource to address a wide variety of research questions in Huntington?s disease.
Clinical Evaluation
Each year COHORT participants will undergo a medical and neurological evaluation. This evaluation will include standardized assessments of movement, thinking, memory, ability to perform daily activities, and behavior. Also, a medical and neurological examination will be conducted and the participant will provide information about medical history and current medications.
Collection of Blood for Genetic Testing
At the initial visit, all COHORT participants who are 18 years of age and older will have blood drawn for genetic testing of the CAG polymorphism and for other genetic changes, which may be important to Huntington?s disease. Since this testing will be experimental, neither the COHORT participants nor the site investigators will receive the results of this testing.
Collection of Family History Information (optional)
Family history data will be used to learn more about the natural history of the disease over several generations. This information may uncover new details about why there are differences in how HD affects different families and different members within a family. Any COHORT participant 18 years of age and older with a family history of HD will be asked to participate. This part of the COHORT study is optional. If the participant chooses not to provide family history information, he or she may still take part in the COHORT study.
The participant will be asked to complete a Family History Questionnaire (FHQ), which asks questions about the participant?s extended family, including:
? Family members? names, birthdates, sex, and, if applicable, date of death
? For any affected family members, age of HD diagnosis and whether a physician made the diagnosis will be collected.
Collection and Storage of Biological Samples for Future HD Research (optional)
Scientists have found that blood, urine, and other biological samples contain clues about HD that may be used to better understand the progression of the disease and to develop new therapies. Any COHORT participant 18 years of age and older will be given the option of having blood and urine collected and stored for future HD research. If a participant chooses not to participate, he or she may still take part in the COHORT study. These samples will be labeled with a unique identification code and stored in a research facility.
These stored samples will provide researchers with the resources necessary to study Huntington?s disease. Huntington?s disease researchers from institutions all over the world will be able to request samples for research in HD. All samples will be identified with a code, and researchers will not receive any personally identifying information about COHORT participants.
MORE @ http://www.huntingtonproject.org/ClinicalResearch/CurrentlyEnrolling/tabid/43/Default.aspx#dimond
GENE NEGATIVE INDIVIDUALS NEEDED! for PREDICT-HD: Neurobiological Predictors of Huntington's Disease
Blog Post on October 24, 2007 by Clinical Trials
GENE NEGATIVE INDIVIDUALS NEEDED!
In September 2001, the Huntington Study Group, under the direction of Jane Paulsen, Principal Investigator (University of Iowa), received funding from the National Institutes of Health (NIH) to study healthy persons who are known to have the CAG expansion in the HD gene.
As of September 27, 2006, the PREDICT-HD study has 907 participants who dedicate time from their busy lives to contribute to the study?nearing the anticipated enrollment figure of 925! In order to reach this goal, the study is seeking additional gene negative participants to enroll in this important project. Below we have included an additional study description along with contact information about how to become one of our valuable participants.
The PREDICT-HD study uses a variety of tests to examine the nature and pattern of neurobiological changes and neurobehavioral changes that occur in the period leading up to a diagnosis of HD. The intent of the study is to learn more about the beginning changes in thinking skills, emotional regulation, brain structure and brain function as a person begins the transition from health to HD.
If you are interested in learning more about this study, please contact the Huntington Study Group toll free at 800-487-7671. For a participating site near you, please go to the PREDICT-HD Participating Site List @ http://www.huntington-study-group.org/PREDICT%20SITES.html
For information about PREDICT-HD found on the ClinicalTrials.gov web site, please go to PREDICT-HD @ http://www.clinicaltrials.gov/ct/show/NCT00051324?order=1
Blog Post on October 24, 2007 by Clinical Trials
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
The Huntington Study Group (HSG) is conducting a study of the research medication Dimebon in persons 18 years of age or older who have mild to moderate Huntington?s disease (HD). DIMOND 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. Approximately 15 research centers in the United States and in the United Kingdom will enroll up to 90 research subjects and will last about 3 months. 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 the Summer of 2007. The study is sponsored by Medivation, Inc.
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 July 2007 DIMOND press release or the October 2006 DIMOND press release.
More @ http://www.huntingtonproject.org/ClinicalResearch/CurrentlyEnrolling/tabid/43/Default.aspx#dimond