Galantamine begins phase II trial in U.S.

Clinical study of a drug called galantamine hydrobromide for treatment of CFIDS is beginning in the United States. The four-month trial is a placebo-controlled study and will be conducted at 12 sites with a total of 140 participants.

The sites, with doctor and contact information, are:

• Oceanside, Calif.; Dr. T. Chippendale, North County Neurology Assoc.; Tracy Sweet, 760/732-0557, ext. 7.
• Washington, D.C.; Dr. Gary Simon, George Washington University; Barbara Lewis, 202/994-2417.
• Fort Lauderdale, Fla.; Dr. Y. Sherrer, Centre for Rheumatology, Immunology and Arthritis; Karen Herr, 954/229-0524.
• Miami, Fla.; Dr. Nancy Klimas, VA Medical Center; Mack Smith, 305/324-3267.
• Lansing, Mich.; Dr. Robert Bielski, Institute for Health Studies; Recruitment Center, 800/682-6663.
• Ridgewood, N.J.; Dr. Kenneth Levin, Neurology Group of Bergen Co.; Joanne Blayman, 201/612-3089.
• New York, N.Y.; Dr. Alexander Mauskop, N.Y. Headache Center; Elizabeth Van Hook, 212/794-3550.
• Cincinnati, Ohio; Dr. B. Corser, Community Research Management Associates; Lisa Izzo, 513/721-3868.
• Portland, Ore.; Dr. W. Smith, Pacific Northwest Clinical Research; Michelle Manhart, 503/293-5039.
• Harrisburg, Pa.; Dr. Nelson Gantz, Pinnacle Health at Polyclinic Hosp.; Michele Marcus, 717/782-2986.
• Seattle, Wash.; Dr. P. Londborg, Seattle Clinical Research Center; Recruitment Center, 206/292-2273.
• Madison, Wis.; Dr. Leslie Taylor, Dean Foundation for Health Research; Lisa Jorgensen, 608/827-2340.

Recruitment ends in February. Patients with a diagnosis of CFIDS or fibromyalgia may be suitable. Entry criteria include: ages 18–65; no prescribed anti-depressants or medication for CFIDS during the study; no other physical of psychiatric illness; no history of CFIDS in excess of seven years.

The study involves: up to eight visits to the clinic over a four-month period; taking two tablets three times per day (this may be either the treatment or a placebo); completing questionnaires, performing simple computer tests, and having a small blood sample taken at each visit.

The manufacturer, Shire Laboratories of England, describes the drug as a reversible cholinesterase inhibitor. According to Taber’s Cyclopedic Medical Dictionary, cholinesterase is an enzyme that breaks down acetylcholine, which is believed to play a key role in the transmission of nerve impulses at brain synapses and at nerve endings in muscles.