CLINICAL TRIAL...Safety Study of Gene Transfer Therapy in People with PD
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Safety Study of Gene Transfer Therapy in People with Parkinson’s Disease
Official Study Title: A Phase 1 Open-label Safety Study of Intrastriatal Infusion of Adeno-Associated Virus Encoding Human Aromatic L-Amino Acid Decarboxylase (AAV-hAADC-2) in Subjects with Mid- to Late- Stage Parkinson’s Disease Sponsor: Genzyme Clinicaltrials.gov ID : NCT00229736 Study ID : AAV-hAADC-2-003 Last Updated Date: 02 Mar 2007 Trial Start Date: 01 Nov 2004 Trial Post date: 02 Mar 2007 Website URL: http://www.pdtrials.org/front/trial_...p?trial_id=139 Summary In people with Parkinson’s disease (PD), the part of the brain called the substantia nigra progressively loses the ability to send dopamine signals to the striatum, another part of the brain. As a result, dopamine levels are lacking in people diagnosed with PD. The purpose of this study is to determine the safety of an investigational drug, AAV-hAADC-2. This gene therapy drug works to provide an essential enzyme in the brain that will enable L-dopa – a drug commonly used to treat PD- to convert to dopamine in the brain. Participants for this study will receive a surgical injection of this drug into the brain, then undergo periodic clinical evaluations and brain scans. They will also continue to take L-dopa while taking part on this study. The primary objective of the study is to determine the safety of intrastriatal administration of AAV-hAADC-2. A secondary objective is to determine the effect of AAV-hAADC-2 on clinical status. Enrollment Expected Enrollment: 15 Trial Phase Study Phase: Phase 1 Symptoms #Trial does not specify symptoms Time Commitment Length of Time Commitment: More than six months Frequency of office visits: Every 2 weeks for the first 3 months, once a month for the next 9 months, then once every 3 months for the next 4 years. Eligibility Minimum Age: 40 Maximum Age: 75 Inclusion Criteria
Primary Contact Rowena Mah Study Coordinator University of California, San Francisco (UCSF) Phone : 415-476-0947 rowenam@itsa.ucsf.edu San Francisco, CA 94143 USA Attachment 1412 Full Details: PDTrials.org http://www.pdtrials.org/front/trial_...p?trial_id=161ClinicalTrials.gov http://clinicaltrials.gov/ct/show/NCT00427674?order=1[LIST][*]Complete list of PD trials Attachment 1412 Parkinson Pipeline Project www.pdpipeline.org Following theapies from pre-clinical development to approval in the Parkinson Pipeline Project Database (see homepage for link to database) Attachment 1412 |
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