Trial Outcomes & Findings for Effect of Milnacipran on Pain Processing and Functional Magnetic Resonance Imaging (fMRI) Activation Patterns in Patients With Fibromyalgia (NCT NCT00793520)

Results Overview

Pain intensity is rated using the Gracely Box Scale, where 0 is no pain sensation and 20 is extremely intense. Painful blunt pressure is applied to the thumbnail of the patient's left hand. A software system will determine medium(rated as 7 or 8) and high pain (rated as 13 or 14) thresholds at baseline, week 5 and at a second baseline at week 7 and week 12.

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

2 participants

Primary outcome timeframe

Week 0, 5, 7 and 12

Results posted on

2010-07-01

Participant Flow

The recruitment period was from November 2008 to April 2009 at one university location.

Of the five enrolled patients, only two received double-blind study medication due to equipment failure at the study site.

Participant milestones

Participant milestones
Measure	Milnacipran to Placebo Twice daily oral administration of milnacipran for 5 weeks, placebo for 2 weeks, and crossover to placebo for 5 weeks.	Placebo to Placebo Twice daily oral administration of placebo for 5 weeks, placebo for 2 weeks, and crossover to milnacipran for 5 weeks.
Milnacipran Crossover to Placebo STARTED	1	0
Milnacipran Crossover to Placebo COMPLETED	0	0
Milnacipran Crossover to Placebo NOT COMPLETED	1	0
Placebo Crossover to Milnacipran STARTED	0	1
Placebo Crossover to Milnacipran COMPLETED	0	0
Placebo Crossover to Milnacipran NOT COMPLETED	0	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effect of Milnacipran on Pain Processing and Functional Magnetic Resonance Imaging (fMRI) Activation Patterns in Patients With Fibromyalgia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Milnacipran to Placebo n=1 Participants Twice daily oral administration of milnacipran for 5 weeks, placebo for 2 weeks, and crossover to placebo for 5 weeks.	Placebo to Placebo n=1 Participants Twice daily oral administration of placebo for 5 weeks, placebo for 2 weeks, and crossover to milnacipran for 5 weeks.	Total n=2 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
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age Continuous	37 years n=5 Participants	48 years n=7 Participants	42.5 years STANDARD_DEVIATION 7.78 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	1 participants n=5 Participants	1 participants n=7 Participants	2 participants n=5 Participants

PRIMARY outcome

Timeframe: Week 0, 5, 7 and 12

Pain intensity is rated using the Gracely Box Scale, where 0 is no pain sensation and 20 is extremely intense. Painful blunt pressure is applied to the thumbnail of the patient's left hand. A software system will determine medium(rated as 7 or 8) and high pain (rated as 13 or 14) thresholds at baseline, week 5 and at a second baseline at week 7 and week 12.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Weeks 0, 5, 7 and 12

DNIC is evaluated using a conditioning stimulus and a test stimulus. Painful blunt pressure is applied to the thumbnail of the patient's left hand for 30 sec. Patient rates pain experienced on numerical scale of 0(no pain) to 100(worst pain) at 10, 20 \& 30 sec. This is repeated 3 times and a mean pain score is calculated. 5 minutes following test stimulus, patient's right hand is immersed in 12C water at 30 sec test stimulus is reapplied and a 2nd mean pain score is calculated. The difference in mean pain rating before and after conditioning stimulus indicates presence and magnitude of DNIC

Outcome measures

Outcome data not reported

Adverse Events

Milnacipran

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Milnacipran n=1 participants at risk Twice daily oral administration of milnacipran for 5 weeks, placebo for 2 weeks, and crossover to placebo for 5 weeks.	Placebo n=1 participants at risk Twice daily oral administration of placebo for 5 weeks, placebo for 2 weeks, and crossover to milnacipran for 5 weeks.
Gastrointestinal disorders Food poisoning	100.0% 1/1	0.00% 0/1
Nervous system disorders Headache	100.0% 1/1	100.0% 1/1
Psychiatric disorders Nightmares	100.0% 1/1	0.00% 0/1
Gastrointestinal disorders Abdominal pain upper	100.0% 1/1	0.00% 0/1
Infections and infestations Gastroenteritis viral	100.0% 1/1	100.0% 1/1
Musculoskeletal and connective tissue disorders Fibromyalgia	0.00% 0/1	100.0% 1/1
Nervous system disorders Dizziness	100.0% 1/1	0.00% 0/1

Additional Information

Allan Spera

Forest Research Institute

Phone: 201-427-8399

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place