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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Twice daily oral administration of milnacipran for 5 weeks, placebo for 2 weeks, and crossover to placebo for 5 weeks. |
|
| 2 | Experimental | Twice daily oral administration of placebo for 5 weeks, placebo for 2 weeks, and crossover to milnacipran for 5 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Milnacipran | Drug | Twice daily oral administration of Milnacipran for 5 weeks. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Week 0, 5, 7 and 12 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Allan Spera | Forest Research Institute, a subsidiary of Forest Laboratories Inc | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Forest Investigative Site | Ann Arbor | Michigan | 48106 | United States |
Of the five enrolled patients, only two received double-blind study medication due to equipment failure at the study site.
The recruitment period was from November 2008 to April 2009 at one university location.
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| ID | Title | Description |
|---|---|---|
| FG000 | Milnacipran to Placebo | Twice daily oral administration of milnacipran for 5 weeks, placebo for 2 weeks, and crossover to placebo for 5 weeks. |
| FG001 | Placebo to Placebo | Twice daily oral administration of placebo for 5 weeks, placebo for 2 weeks, and crossover to milnacipran for 5 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Milnacipran Crossover to Placebo |
|
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| Placebo |
| Drug |
Twice daily oral administration of placebo for 5 weeks. |
|
| Placebo | Drug | Twice daily oral administration of placebo for 5 weeks. |
|
| Milnacipran | Drug | Twice daily oral administration of Milnacipran for 5 weeks. |
|
| Weeks 0, 5, 7 and 12 |
| COMPLETED |
|
| NOT COMPLETED |
|
| Placebo Crossover to Milnacipran |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Milnacipran to Placebo | Twice daily oral administration of milnacipran for 5 weeks, placebo for 2 weeks, and crossover to placebo for 5 weeks. |
| BG001 | Placebo to Placebo | Twice daily oral administration of placebo for 5 weeks, placebo for 2 weeks, and crossover to milnacipran for 5 weeks. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Mean | 95% Confidence Interval | Pain Rating | Weeks 0, 5, 7 and 12 |
|
| ||||||||||||||||||||
| 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. | Posted | Mean | 95% Confidence Interval | Kg | Week 0, 5, 7 and 12 |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Milnacipran | Twice daily oral administration of milnacipran for 5 weeks, placebo for 2 weeks, and crossover to placebo for 5 weeks. | 0 | 1 | 1 | 1 | ||
| EG001 | Placebo | Twice daily oral administration of placebo for 5 weeks, placebo for 2 weeks, and crossover to milnacipran for 5 weeks. | 0 | 1 | 1 | 1 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Food poisoning | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Nightmares | Psychiatric disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
| |
| Fibromyalgia | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
|
Early termination leading to small numbers of subjects enrolled. Technical problems with MRI equipment resulted in early study termination. No analysis was performed.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Allan Spera | Forest Research Institute | 201-427-8399 | allan.spera@frx.com |
| ID | Term |
|---|---|
| D005356 | Fibromyalgia |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000078764 | Milnacipran |
| ID | Term |
|---|---|
| D003521 | Cyclopropanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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| >=65 years |
|
| Male |
|