Trial Outcomes & Findings for Novel Use of (Oral) Ketotifen for the Treatment of Fibromyalgia: A Pilot Study (NCT NCT01553318)

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

51 participants

Primary outcome timeframe

baseline and week 10

Results posted on

2016-11-17

Participant Flow

Participant milestones

Participant milestones
Measure	Ketotifen ketotifen active group	Placebo Placebo medication
Overall Study STARTED	24	27
Overall Study COMPLETED	21	25
Overall Study NOT COMPLETED	3	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Ketotifen ketotifen active group	Placebo Placebo medication
Overall Study Protocol Violation	3	2

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ketotifen Group n=24 Participants Participants who received the active drug - ketotifen	Placebo n=27 Participants Participants who received the placebo	Total n=51 Participants Total of all reporting groups
Age, Continuous	51.1 years STANDARD_DEVIATION 8.5 • n=5 Participants	51.3 years STANDARD_DEVIATION 8.5 • n=7 Participants	51.2 years STANDARD_DEVIATION 8.4 • n=5 Participants
Sex: Female, Male Female	22 Participants n=5 Participants	23 Participants n=7 Participants	45 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Region of Enrollment United States	24 participants n=5 Participants	27 participants n=7 Participants	51 participants n=5 Participants
weekly average pain score	6.5 units on a scale STANDARD_DEVIATION 0.9 • n=5 Participants	6.2 units on a scale STANDARD_DEVIATION 1.3 • n=7 Participants	6.4 units on a scale STANDARD_DEVIATION 1.1 • n=5 Participants
Fibromyalgia impact questionnaire	66.9 units on a scale STANDARD_DEVIATION 16.2 • n=5 Participants	66.6 units on a scale STANDARD_DEVIATION 12.0 • n=7 Participants	66.8 units on a scale STANDARD_DEVIATION 14.0 • n=5 Participants
Evoked pain	10.3 units on a scale STANDARD_DEVIATION 0.4 • n=5 Participants	9.8 units on a scale STANDARD_DEVIATION 0.4 • n=7 Participants	10.0 units on a scale STANDARD_DEVIATION 0.6 • n=5 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Ketotifen n=24 Participants Ketotifen active drug	Placebo n=27 Participants received placebo
Change From Baseline in Weekly Average Pain Score on the Visual Analog Scale at Week 10	-1.33 units on a scale Standard Deviation 1.92	-1.54 units on a scale Standard Deviation 1.93

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Ketotifen n=24 Participants Ketotifen active drug	Placebo n=27 Participants received placebo
Change From Baseline in Evoked Pain Score at Week 10	-0.33 units on a scale Standard Deviation 0.36	-0.27 units on a scale Standard Deviation 0.34

SECONDARY outcome

Timeframe: baseline and week 10

Population: Indeed, fibromyalgia impact questionnaire is a secondary outcome.

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

Outcome measures

Outcome measures
Measure	Ketotifen n=24 Participants Ketotifen active drug	Placebo n=27 Participants received placebo
Fibromyalgia Impact Questionnaire	-12.13 units on a scale Standard Deviation 19.54	-12.27 units on a scale Standard Deviation 18.12

SECONDARY outcome

Timeframe: baseline and week10

Population: We do not have data on the chemokines because of the problems we had with the assays. Indeed, IL-8, MCP-1 and Eotaxin were all secondary outcomes.

Change in peripheral blood levels of IL-8, MCP-1 and Eotaxin from baseline to week 10

Outcome measures

Outcome data not reported

Adverse Events

Ketotifen

Serious events: 6 serious events

Other events: 3 other events

Deaths: 0 deaths

Placebo

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Ketotifen n=24 participants at risk Received ketotifen the active drug	Placebo n=27 participants at risk received placebo
Nervous system disorders transient drowsiness	25.0% 6/24 • Number of events 6	3.7% 1/27 • Number of events 1

Other adverse events

Other adverse events
Measure	Ketotifen n=24 participants at risk Received ketotifen the active drug	Placebo n=27 participants at risk received placebo
Psychiatric disorders Fatigue	12.5% 3/24 • Number of events 3	3.7% 1/27 • Number of events 1

Additional Information

dennis ang

Wake Forest Baptist

Phone: 336-716-4209

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place