Trial Outcomes & Findings for Drug and Talk Therapy for Fibromyalgia (NCT NCT01038323)

NCT ID: NCT01038323

Last Updated: 2017-03-06

Results Overview

Change in weekly average pain intensity score from baseline to week 21 (scale from -10 to +10; the more negative the value, the better in terms of pain reduction)

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 58 participants
• Primary outcome timeframe: Baseline and Week 21clinic visits
• Results posted on: 2017-03-06

Participant Flow

Participant milestones

Measure	Combination Combination cognitive behavioral therapy (CBT) and milnacipran	Milnacipran Milnacipran (drug) only	Cognitive Behavioral Therapy Cognitive behavioral therapy (CBT) only
Overall Study STARTED	20	19	19
Overall Study COMPLETED	17	17	15
Overall Study NOT COMPLETED	3	2	4

Reasons for withdrawal

Measure	Combination Combination cognitive behavioral therapy (CBT) and milnacipran	Milnacipran Milnacipran (drug) only	Cognitive Behavioral Therapy Cognitive behavioral therapy (CBT) only
Overall Study Withdrawal by Subject	3	2	4

Baseline Characteristics

Drug and Talk Therapy for Fibromyalgia

Baseline characteristics by cohort

Measure	Combination n=20 Participants Combination cognitive behavioral therapy (CBT) and milnacipran	Milnacipran n=19 Participants Milnacipran (drug) only	Cognitive Behavioral Therapy n=19 Participants Cognitive behavioral therapy (CBT) only	Total n=58 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	20 Participants n=5 Participants	19 Participants n=7 Participants	19 Participants n=5 Participants	58 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Continuous	44.8 years STANDARD_DEVIATION 8.8 • n=5 Participants	47.8 years STANDARD_DEVIATION 10.6 • n=7 Participants	47.11 years STANDARD_DEVIATION 11.9 • n=5 Participants	46.5 years STANDARD_DEVIATION 10.3 • n=4 Participants
Sex: Female, Male Female	19 Participants n=5 Participants	19 Participants n=7 Participants	16 Participants n=5 Participants	54 Participants n=4 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants	4 Participants n=4 Participants
Region of Enrollment United States	20 participants n=5 Participants	19 participants n=7 Participants	19 participants n=5 Participants	58 participants n=4 Participants
Weekly average pain intensity score	6.2 units on a scale STANDARD_DEVIATION 1.2 • n=5 Participants	6.3 units on a scale STANDARD_DEVIATION 1.3 • n=7 Participants	6.3 units on a scale STANDARD_DEVIATION 1.3 • n=5 Participants	6.3 units on a scale STANDARD_DEVIATION 1.2 • n=4 Participants

PRIMARY outcome

Timeframe: Baseline and Week 21clinic visits

Change in weekly average pain intensity score from baseline to week 21 (scale from -10 to +10; the more negative the value, the better in terms of pain reduction)

Outcome measures

Measure	Combination n=17 Participants Combination cognitive behavioral therapy (CBT) and milnacipran	Milnacipran n=17 Participants Milnacipran (drug) only	Cognitive Behavioral Therapy n=15 Participants Cognitive behavioral therapy (CBT) only
Change in Weekly Average Pain Intensity	-2.1 units on a scale Standard Error .43	-0.97 units on a scale Standard Error 0.43	-1.67 units on a scale Standard Error 0.45

SECONDARY outcome

Timeframe: Baseline and Week 21 clinic visits

0 to 20 pain scale, with higher pain score representing greater sensitivity to pressure pain stimuli

Outcome measures

Measure	Combination n=17 Participants Combination cognitive behavioral therapy (CBT) and milnacipran	Milnacipran n=17 Participants Milnacipran (drug) only	Cognitive Behavioral Therapy n=15 Participants Cognitive behavioral therapy (CBT) only
Change in Evoked Pain Scores	-0.76 units on a scale Standard Error 1.2	-0.41 units on a scale Standard Error 1.2	0.78 units on a scale Standard Error 1.2

SECONDARY outcome

Timeframe: week 21

Population: Information not captured (unfortunately)

Subjects identifying group assignment correctly

Outcome measures

Measure	Combination n=17 Participants Combination cognitive behavioral therapy (CBT) and milnacipran	Milnacipran n=17 Participants Milnacipran (drug) only	Cognitive Behavioral Therapy n=15 Participants Cognitive behavioral therapy (CBT) only
Identification of Group Assignment	0 participants	0 participants	0 participants

Adverse Events

Combination

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Milnacipran

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Cognitive Behavioral Therapy

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Combination n=20 participants at risk Cognitive behavioral therapy + milnacipran	Milnacipran n=19 participants at risk milnacipran + education	Cognitive Behavioral Therapy n=19 participants at risk Cognitive behavioral therapy + placebo
Gastrointestinal disorders nausea	45.0% 9/20 • Number of events 9 • 21 weeks	42.1% 8/19 • Number of events 8 • 21 weeks	15.8% 3/19 • Number of events 3 • 21 weeks

Additional Information

dennis ang

Wake Forest

Phone: 336-716-4209

Email: dang@wakehealth.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place