Novel Use of (Oral) Ketotifen for the Treatment of Fibromyalgia: A Pilot Study (KetoforFMS)
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.
|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|
- 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.
- 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.
|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)|
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.
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.
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.
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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, a blood samples drawn on two separate occasions, 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.
Week 0 (clinic visit 1):
- Informed consent and initial screening questionnaire,
- Review of all current medications
- Light physical assessment, e.g. blood pressure, height, weight
- The investigators will obtain a urine sample for a urine pregnancy test (UPT) and screening blood samples (approximately 17.5 ml /3.3 teaspoonfuls) from a vein in the subject's arm
- Complete short thumb pressure testing in order to set the testing parameters for futures tests (week 1 and week 10)
- Receive 'pain score' wrist monitor with instructions to record his/her pain level three times each day for one week
- 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):
- Submit his/her pain score wrist monitor
- Submit his/her medication diary for review and return any unused medication
- Complete the self-assessment questionnaires via computer
- Undergo a thumb pressures pain sensitivity test
- 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):
- The investigators will assess the subject's willingness to continue study participation.
- 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.).
- 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):
- 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.
- Review medication side effect/benefit checklist, medication diary and return any unused medication.
- Completion of self-assessment questionnaires via computer
- Obtain exit blood samples (approximately 17.5 ml /3.3 teaspoonfuls) from a vein in his/her arm.
- Undergo a thumb pressures pain sensitivity test.
|United States, Indiana|
|IU Clincial Research Center for Pain and Fibromyalgia|
|Indianapolis, Indiana, United States, 46202|
|Principal Investigator:||Dennis C. Ang, MD||Indiana University|