Novel Use of (Oral) Ketotifen for the Treatment of Fibromyalgia: A Pilot Study

• Status: Completed
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Indiana University
• Treatments: Ketotifen

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