Novel Use of (Oral) Ketotifen for the Treatment of Fibromyalgia: A Pilot Study
Status:
Completed
Trial end date:
2012-12-01
Target enrollment:
Participant gender:
Summary
The purpose of this 10-week study is to determine the effects of a medication called
Ketotifen on pain sensitivity; and fibromyalgia-related pain.
Ketotifen works by inhibiting (to prevent or slow down) certain substances in the body that
are known to cause inflammation. It is an antihistamine that reduces the harmful effects of
histamine. The ophthalmic (eye drops) formulation of ketotifen has been approved by the Food
and Drug Administration (FDA) and has been available in the United States for more than a
decade. Oral (taken by mouth) ketotifen has been in available in other countries for several
decades. Commonly prescribed for the maintenance treatment of asthma and allergic rhinitis,
ketotifen has long track record of safety. To date, the oral form of ketotifen has not been
approved by the FDA, therefore this study is referred to as an "investigational drug study."
Prior to opening recruitment an "investigational new drug" (IND) application which included
scientific data and information regarding human safety plans was submitted to and approved by
the FDA.