Novel Use of (Oral) Ketotifen for the Treatment of Fibromyalgia: A Pilot Study
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Interventional
Phase: Phase 3

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.
    

Detailed description: 
      Approximately 46 subjects will be participating in this research. Each subject will be
      randomized (like flipping a coin) to one of two groups; approximately 23 volunteers will be
      randomized to receive the active medication and 23 will receive the placebo. Both groups will
      be "blinded" (will not know) to which group they have been assigned.

      The study will be conducted at the Indiana University Clinical Research Center for Pain
      (CRCP), located on the IUPUI campus in the National Institute of Fitness and Sport
      building,at 250 University Blvd.,Suite 118 Indianapolis, Indiana, 46202.

      To summarize: The subject will be asked to visit the CRCP on four separate occasions: Initial
      Screening, Week 1, Week 2, and Week 10. This study also includes, answering questionnaires,
      taking study medication, maintaining a written medication diary and agreeing to remain in
      weekly contact with the study team to answer a short side effect questionnaire. The side
      effect questionnaire will be conducted from week 1-4 and then once every 2 weeks from week
      4-10.

      Study Overview:

      Week 0 (clinic visit 1):

        1. Informed consent and initial screening questionnaire,

        2. Review of all current medications

        3. Light physical assessment, e.g. blood pressure, height, weight

        4. The investigators will obtain a urine sample for a urine pregnancy test (UPT)

        5. Complete short thumb pressure testing in order to set the testing parameters for futures
           tests (week 1 and week 10)

        6. Receive 'pain score' wrist monitor with instructions to record his/her pain level three
           times each day for one week

        7. Receive a one-week medication packet along with instructions to take one tablet twice a
           day for seven days along with entering dosing information in a medication diary.

      Week 1 (clinic visit 2):

        1. Submit his/her pain score wrist monitor

        2. Submit his/her medication diary for review and return any unused medication

        3. Complete the self-assessment questionnaires via computer

        4. Undergo a thumb pressures pain sensitivity test

        5. If qualified to continue, the subject will receive the next 7-day supply of either a
           placebo or the active medication, ketotifen 1 mg. along with verbal and written
           instructions and a medication diary.

      Week 2 (visit 3):

        1. The investigators will assess the subject's willingness to continue study participation.

        2. Review medication diary and medication side-effect/benefit checklist along with any
           unused study medication. If the subject has not experienced any bothersome side effect
           and agree to continue,he/she will be issued the next level of either the placebo or the
           active medication Ketotifen (2 mg.).

        3. To assure the subjects' safety, the project coordinator or a member of the research team
           will complete a medication side-effect questionnaire. The subject will be asked to
           schedule a weekly check-in call for week 3 and 4 and once every 2 weeks from week 4 to
           week 10 (weeks 6, 8, and 10)

      Week 10 (visit 4):

        1. One week prior to this visit, the subject will receive a 'pain score' wrist monitor via
           an express delivery service (e.g., FedEx) and will be asked to enter his/her pain level
           three times a day for one week. Then return it during this visit.

        2. Review medication side effect/benefit checklist, medication diary and return any unused
           medication.

        3. Completion of self-assessment questionnaires via computer

        4. Undergo a thumb pressures pain sensitivity test.
    

Intervention name(s): Ketotifen; Placebo (Sugar Pill)
Intervention type(s): Drug; Drug
Intervention description(s): 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.
Other intervention name(s): Zaditor; Placebo; Sugar Pill
Intervention MeSH terms: Ketotifen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
Keywords: Fibromyalgia; FMS