Fibromyalgia
Conditions
Keywords
fibromyalgia, milnacipran, Forest Laboratories
Brief summary
The purpose of this study is to evaluate the effect of milnacipran on how the brain processes pain in patients with fibromyalgia and to assess the relationship between this effect and brain activation patterns during functional magnetic resonance imaging.
Interventions
DRUGMilnacipran
Twice daily oral administration of Milnacipran for 5 weeks.
DRUGPlacebo
Twice daily oral administration of placebo for 5 weeks.
Sponsors
Forest Laboratories
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of fibromyalgia defined by 1990 American College of Rheumatology (ACR) criteria * Visual analog pain score between 40 and 90 mm * Right-hand dominance
Exclusion criteria
* Suicidal risk * Substance Abuse * Pulmonary dysfunction * Renal impairment * Active cardiac disease * Autoimmune disease * Uncontrolled narrow-angle glaucoma * Active liver disease * Cancer * Active peptic ulcer disease or a history of inflammatory bowel disease or celiac sprue * Unstable endocrine disease * Prostatic enlargement
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Medium Pressure Pain Threshold From Baseline to End of Treatment. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Diffuse Noxious Inhibitory Control (DNIC) Effect From Baseline to End of Treatment. | 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 |
Countries
United States
Participant flow
Recruitment details
The recruitment period was from November 2008 to April 2009 at one university location.
Pre-assignment details
Of the five enrolled patients, only two received double-blind study medication due to equipment failure at the study site.
Participants by arm
| Arm | Count |
|---|---|
| Milnacipran to Placebo Twice daily oral administration of milnacipran for 5 weeks, placebo for 2 weeks, and crossover to placebo for 5 weeks. | 1 |
| Placebo to Placebo Twice daily oral administration of placebo for 5 weeks, placebo for 2 weeks, and crossover to milnacipran for 5 weeks. | 1 |
| Total | 2 |
Baseline characteristics
| Characteristic | Placebo to Placebo | Milnacipran to Placebo | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants | 1 Participants | 2 Participants |
| Age Continuous | 48 years | 37 years | 42.5 years STANDARD_DEVIATION 7.78 |
| Region of Enrollment United States | 1 participants | 1 participants | 2 participants |
| Sex: Female, Male Female | 1 Participants | 1 Participants | 2 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 1 / 1 | 1 / 1 |
| serious Total, serious adverse events | 0 / 1 | 0 / 1 |
Outcome results
Primary
Change in Medium Pressure Pain Threshold From Baseline to End of Treatment.
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.
Time frame: Week 0, 5, 7 and 12
Secondary
Change in Diffuse Noxious Inhibitory Control (DNIC) Effect From Baseline to End of Treatment.
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
Time frame: Weeks 0, 5, 7 and 12