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

NCT01553318 | Completed Phase 3 Results DMC

• 1 other identifier: 1106005839 (1106-01)
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Fibromyalgia

Keywords

Fibromyalgia; FMS

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Weekly Average Pain Score on the Visual Analog Scale at 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

  baseline and week 10

Secondary Outcomes (3)

• Change From Baseline in Evoked Pain Score at Week 10

  baseline and week 10

• Fibromyalgia Impact Questionnaire

  baseline and week 10

• Change From Baseline in the Blood Levels of IL-8, MCP-1 and Eotaxin at Week 10

  baseline and week10

Study Arms (2)

Active Ketotifen

ACTIVE COMPARATOR

After meeting the full eligibility requirement, participants will be randomized. Approximately 26 of the 51 participants will assigned to this arm of the study.

Drug: Ketotifen

Placebo for Ketotifen

PLACEBO COMPARATOR

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)

Interventions

Ketotifen DRUG

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.

Also known as: Zaditor

Active Ketotifen

Placebo (Sugar Pill) DRUG

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.

Also known as: Placebo, Sugar Pill

Placebo for Ketotifen

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• In order to qualify the subject:
• must have been diagnosed with fibromyalgia by a medical doctor
• must be between the ages of 18 to 65 years of age
• must have a weekly overall body pain average score ≥ 4
• must pass a screening questionnaire that calculates a physical impairment of ≥ 10
• must be on stable doses of his/her current medication for at least past four weeks
• 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
• 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
• must be willing to maintain a medication diary provided to him/her during the 10-week study period
• 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)
• must agree to use a proven method of contraception to prevent pregnancy throughout this study

You may not qualify if:

• The subject will not be allowed to participate if:
• he/she has a history of seizures
• he/she has atopic dermatitis (also called eczema) or chronic urticaria (hives)
• he/she has chronic thrombocytopenia (a low blood platelet count)
• she is currently pregnant, are planning to become pregnant, or is breastfeeding
• he/she has been diagnosed by a psychiatrist with Schizophrenia or bipolar disorder
• he/she has been diagnosed with another major rheumatic conditions (i.e. rheumatoid arthritis, systemic lupus erythematosus, scleroderma and/or other connective tissue diseases)
• he/she plans to undergo an elective surgery within the study timeline
• he/she is in the process of filing, or plan to file for disability benefits within the study timeline
• his/her screening labs results are abnormal (i.e., elevated SGPT and low platelet count)
• he/she is currently using any anti-allergy drugs (ophthalmic or oral histamine antagonist), leukotriene inhibitors (e.g., montelukast) or prednisone

Sponsors & Collaborators

• Indiana University: lead

Study Sites (1)

IU Clincial Research Center for Pain and Fibromyalgia

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Fibromyalgia

Interventions

Ketotifen; ketotifen fumarate ophthalmic solution; Sugars

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Carbohydrates

Limitations and Caveats

Just tested one dose (low dose). Would be better if we tested higher dosages

Results Point of Contact

• Title: dennis ang
• Organization: Wake Forest Baptist

dang@wakehealth.edu

336-716-4209

Study Officials

• Dennis C. Ang, MD

  Wake Forest University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2012
• First Posted: March 14, 2012
• Study Start: March 1, 2012
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: November 17, 2016
• Results First Posted: November 17, 2016

Record last verified: 2016-09

Locations

US (1)