Novel Use of (Oral) Ketotifen for the Treatment of Fibromyalgia: A Pilot Study (KetoforFMS)
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|ClinicalTrials.gov Identifier: NCT01553318|
Recruitment Status : Completed
First Posted : March 14, 2012
Results First Posted : November 17, 2016
Last Update Posted : November 17, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Fibromyalgia||Drug: Ketotifen Drug: Placebo (Sugar Pill)||Phase 3|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||51 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Primary Purpose:||Basic Science|
|Official Title:||Novel Use of Ketotifen (Mast Cell Stabilizer) in Fibromyalgia: A Pilot Study|
|Study Start Date :||March 2012|
|Actual Primary Completion Date :||December 2012|
|Actual Study Completion Date :||December 2012|
Active Comparator: Active Ketotifen
After meeting the full eligibility requirement, participants will be randomized. Approximately 26 of the 51 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.
Other Name: Zaditor
Placebo Comparator: Placebo for Ketotifen
After meeting the full eligibility requirement, participants will be randomized. Approximately 25 of the 51 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.
- Change From Baseline in Weekly Average Pain Score on the Visual Analog Scale at Week 10 [ Time Frame: baseline and week 10 ]Change in weekly average pain score from baseline to week 10 (range from -10 to +10): interpretation= the more negative the value is, the larger reduction in pain severity at week 10 is
- Change From Baseline in Evoked Pain Score at Week 10 [ Time Frame: baseline and week 10 ]Change in evoked pain score from baseline to week 10 (scale range -20 to +20): interpretation= the more negative the value is, the larger the reduction in sensitivity to pressure pain stimuli
- Fibromyalgia Impact Questionnaire [ Time Frame: baseline and week 10 ]Change in global symptom severity [scale range from -100 to +100] = the more negative the value is, the greater the improvement in overall symptom severity
- Change From Baseline in the Blood Levels of IL-8, MCP-1 and Eotaxin at Week 10 [ Time Frame: baseline and week10 ]Change in peripheral blood levels of IL-8, MCP-1 and Eotaxin from baseline to week 10
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01553318
|United States, Indiana|
|IU Clincial Research Center for Pain and Fibromyalgia|
|Indianapolis, Indiana, United States, 46202|
|Principal Investigator:||Dennis C. Ang, MD||Wake Forest University|