Novel Use of (Oral) Ketotifen for the Treatment of Fibromyalgia: A Pilot Study
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Intervention: Ketotifen; Placebo (Sugar Pill)
Intervention description: After meeting the full eligibility requirement, participants will be randomized. From week 1 to 2, subjects will receive either ketotifen 1 mg by mouth, twice a day or the equivalent placebo. Thereafter, subjects will take ketotifen to 2 mg by mouth twice a day or the equivalent placebo.; After meeting the full eligibility requirement, participants will be randomized. From week 1 to 2, subjects will receive either ketotifen 1 mg BID or the equivalent placebo. Thereafter, subjects will take ketotifen to 2 mg BID or the equivalent placebo.
Intervention MeSH terms: Ketotifen
Phase: Phase 3
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 51.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Fibromyalgia; FMS

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.
    

Eligibility criteria:

        Inclusion Criteria:

        In order to qualify the subject:

          1. must have been diagnosed with fibromyalgia by a medical doctor

          2. must be between the ages of 18 to 65 years of age

          3. must have a weekly overall body pain average score ≥ 4

          4. must pass a screening questionnaire that calculates a physical impairment of ≥ 10

          5. must be on stable doses of his/her current medication for at least past four weeks

          6. must limit any changes in his/her medication(s) (e.g., dose change, addition or
             discontinuation of any medication that effects the central nervous system, e.g.,
             benzodiazepines, sedative/hypnotic, etc. ) during the 10-week study period unless
             medically necessary

          7. must report all medication including herbal supplements and over-the-counter
             medications, e.g. cold medication, eye drops, etc. that he/she is currently taking to
             a member of the research team

          8. must be willing to maintain a medication diary provided to him/her during the 10-week
             study period

          9. must be willing to abstain (not take) any fibromyalgia related medication including
             over-the-counter for at least 8-hours prior to each of the two testing visits
             (Otherwise, he/she may take these medication(s) immediately after pain sensitivity
             testing has been completed and as prescribed in-between visits)

         10. must agree to use a proven method of contraception to prevent pregnancy throughout
             this study

        Exclusion Criteria:

        The subject will not be allowed to participate if:

          1. he/she has a history of seizures

          2. he/she has atopic dermatitis (also called eczema) or chronic urticaria (hives)

          3. he/she has chronic thrombocytopenia (a low blood platelet count)

          4. she is currently pregnant, are planning to become pregnant, or is breastfeeding

          5. he/she has been diagnosed by a psychiatrist with Schizophrenia or bipolar disorder

          6. he/she has been diagnosed with another major rheumatic conditions (i.e. rheumatoid
             arthritis, systemic lupus erythematosus, scleroderma and/or other connective tissue
             diseases)

          7. he/she plans to undergo an elective surgery within the study timeline

          8. he/she is in the process of filing, or plan to file for disability benefits within the
             study timeline

          9. his/her screening labs results are abnormal (i.e., elevated SGPT and low platelet
             count)

         10. he/she is currently using any anti-allergy drugs (ophthalmic or oral histamine
             antagonist), leukotriene inhibitors (e.g., montelukast) or prednisone