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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by Indiana University.
Recruitment status was  Active, not recruiting
Information provided by (Responsible Party):
Indiana University Identifier:
First received: March 1, 2012
Last updated: October 11, 2012
Last verified: March 2012

The purpose of this 10-week study is to determine the effects of a medication called Ketotifen on inflammation (blood) markers; 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.

Condition Intervention Phase
Drug: Ketotifen
Drug: Placebo (Sugar Pill)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Basic Science
Official Title: Novel Use of Ketotifen (Mast Cell Stabilizer) in Fibromyalgia: A Pilot Study

Resource links provided by NLM:

Further study details as provided by Indiana University:

Primary Outcome Measures:
  • Pain Scores on the Visual Analog Scale [ Time Frame: 10-weeks ] [ Designated as safety issue: No ]
    The investigators need to establish the effects of ketotifen on three outcome measures: FM-related pain severity, blood chemokines (i.e., IL-8, MCP-1 and eotaxin) and pressure pain threshold and it is established by conducting a 10-week randomized placebo-controlled trial. The primary outcome measures include the changes from week 0 to week 10 of the following: weekly average pain severity, chemokine (i.e., IL-8, MCP-1 and eotaxin) levels and pressure pain threshold.

Secondary Outcome Measures:
  • Effect Sizes of Ketotifen on Outcome Measures [ Time Frame: 10-weeks ] [ Designated as safety issue: No ]
    The investigators will be able to estimate the number of subjects needed to test their hypothesis that ketotifen will have a greater beneficial effects than placebo in reducing the severity of FM-related pain and the levels of blood chemokines. As well as that ketotifen will have a greater effect than placebo in lowering sensitivity to pressure stimuli.The goal is to estimate effect sizes of ketotifen on each of the three outcome measures (i.e., FM-related pain severity, blood chemokines and pressure pain threshold).

  • Physical Impact Questionnaire [ Time Frame: 10-week ] [ Designated as safety issue: No ]
    Secondary outcome measure includes the change in the fibromyalgia impact questionnaire-physical impairment (FIQ-PI) score.

Estimated Enrollment: 46
Study Start Date: March 2012
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Active Ketotifen
After meeting the full eligibility requirement, participants will be randomized. Approximately 23 of the 46 participants will assigned to this arm of the study.
Drug: Ketotifen
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.
Other Name: Zaditor
Placebo Comparator: Placebo for Ketotifen
After meeting the full eligibility requirement, participants will be randomized. Approximately 23 of the 46 participants will assigned to this arm of the study. Subjects in this arm will receive the placebo drug.
Drug: Placebo (Sugar Pill)
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 Names:
  • Placebo
  • Sugar Pill

  Show Detailed Description


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01553318

United States, Indiana
IU Clincial Research Center for Pain and Fibromyalgia
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Indiana University
Principal Investigator: Dennis C. Ang, MD Indiana University
  More Information

Responsible Party: Indiana University Identifier: NCT01553318     History of Changes
Other Study ID Numbers: 1106005839 (1106-01) 
Study First Received: March 1, 2012
Last Updated: October 11, 2012
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Indiana University:

Additional relevant MeSH terms:
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Dermatologic Agents
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Allergic Agents processed this record on October 21, 2016