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Hi gang; Feb. 10th. marks one year since I volunteered for a clinical study of the drug tolcapone. It's been essentially a very smooth ride for me. The first month consisted of first testing on 100 mg. tablets to see if you could tolerate the drug. If you could (with minimal adverse side effects) and you perceived any benefit then you were encouraged to continue with double blind studies where you were given tablets but you did not know if you were getting 100 mg. or 200 mg. or a placebo. By documenting perceived benefit a drug dosage was selected and the study continued. After I think 9 mo. the double blind was lifted and my dosage was revealed - 200mg. tablet 3x aday at 6 hour intervals combined with Sinemet CR 50/200 also at 6 hour intervals. The study is essentially complete after 1 year and I have a small quantity of study supplied meds left. When they're gone I will have to purchase my meds and apply to my plan for reimbursement. I've been advised to keep all receipts (goes without saying) request a "special authorization form" from the insurance company, have it filled out by the neuro, and if approved I would then be reimbursed. I would imagine this advise might apply to any new drug until it is officialy on the formulary lists the claims adjudicators use to make reimbursement a "gimmee". TASMAR(R) (tolcapone) was approved for Europe Aug. 27/97 http://webster.syntex.com/roche/news/mrel97/e970827a.htm Received regulatory clearance from Health Canada Oct. 30th/97 and assigned an 8 digit DIN number. http://www.parkinson.ca/pnet84-3.html US Food and Drug Administration has cleared TASMAR(R) (tolcapone) for marketing in the US (See press release of Feb. 3rd. 98) http://www.pathfinder.com/money/latest/press/PW/1998Feb03/739.html Now we just have to cross our fingers and hope that it will soon be placed on the approved list for reimbursement by medical plans. Special thanks to Judith Richards and Anne Rutherford for assistance in ferreting out info. on approval processes. Good health..............Murray . [log in to unmask]