Fibromyalgia Clinical Trial
Official title:
A Phase III Pivotal, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of Milnacipran for the Treatment of Fibromyalgia
| Verified date | December 2007 |
| Source | Forest Laboratories |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
Antidepressants of all varieties represent a common form of therapy for many chronic states including fibromyalgia. The majority of antidepressants increase the levels of serotonin or norepinephrine in the central nervous system. Milnacipran is a dual norepinephrine and serotonin reuptake inhibitor and may be effective in the treatment of fibromyalgia.
| Status | Completed |
| Enrollment | 1200 |
| Est. completion date | December 2006 |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 70 Years |
| Eligibility |
Inclusion Criteria: - Diagnosis of fibromyalgia defined by 1990 American College of Rheumatology (ACR) Criteria Exclusion Criteria: - Psychiatric illness - Depression - Suicidal risk - Substance abuse - Pulmonary dysfunction - Renal impairment - Active cardiac disease - Liver disease - Autoimmune disease - Cancer - Sleep apnea - Inflammatory bowel disease |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Forest Investigative Site | Austin | Texas |
| United States | Forest Investigative Site | Baltimore | Maryland |
| United States | Forest Investigative Site | Bellingham | Washington |
| United States | Forest Investigative Site | Bend | Oregon |
| United States | Forest Investigative Site | Beverly Hills | California |
| United States | Forest Investigative Site | Birmingham | Alabama |
| United States | Forest Investigative Site | Bismarck | North Dakota |
| United States | Forest Investigative Site | Bristol | Tennessee |
| United States | Forest Investigative Site | Charlotte | North Carolina |
| United States | Forest Investigative Site | Chattanooga | Tennessee |
| United States | Forest Investigative Site | Cherry Hill | New Jersey |
| United States | Forest Investigative Site | Chicago | Illinois |
| United States | Forest Investigative Site | Clearwater | Florida |
| United States | Forest Investigative Site | Clementon | New Jersey |
| United States | Forest Investigative Site | Colorado Springs | Colorado |
| United States | Forest Investigative Site | Colorado Springs | Colorado |
| United States | Forest Investigative Site | Columbia | Maryland |
| United States | Forest Investigative Site | Danbury | Connecticut |
| United States | Forest Investigative Site | Decatur | Georgia |
| United States | Forest Investigative Site | Deland | Florida |
| United States | Forest Investigative Site | Delray Beach | Florida |
| United States | Forest Investigative Site | Duncanville | Pennsylvania |
| United States | Forest Investigative Site | East Syracuse | New York |
| United States | Forest Investigative Site | Eugene | Oregon |
| United States | Forest Investigative Site | Evansville | Indiana |
| United States | Forest Investigative Site | Everett | Washington |
| United States | Forest Investigative Site | Fayetteville | North Carolina |
| United States | Forest Investigative Site | Flowood | Mississippi |
| United States | Forest Investigative Site | Frederick | Maryland |
| United States | Forest Investigative Site | Great Neck | New York |
| United States | Forest Investigative Site | Hickory | North Carolina |
| United States | Forest Investigative Site | Honolulu | Hawaii |
| United States | Forest Investigative Site | Jacksonville | Florida |
| United States | Forest Investigative Site | Kalamazoo | Michigan |
| United States | Forest Investigative Site | Lafayette | Indiana |
| United States | Forest Investigative Site | Lexington | Kentucky |
| United States | Forest Investigative Site | Libertyville | Illinois |
| United States | Forest Investigative Site | Marion | Ohio |
| United States | Forest Investigative Site | Medford | Oregon |
| United States | Forest Investigative Site | Memphis | Tennessee |
| United States | Forest Investigative Site | Meridian | Idaho |
| United States | Forest Investigative Site | Missoula | Montana |
| United States | Forest Investigative Site | Mobile | Alabama |
| United States | Forest Investigative Site | Montgomery | Alabama |
| United States | Forest Investigative Site | Newton | Massachusetts |
| United States | Forest Investigative Site | North Dartmouth | Massachusetts |
| United States | Forest Investigative Site | Ocala | Florida |
| United States | Forest Investigative Site | Oklahoma City | Oklahoma |
| United States | Forest Investigative Site | Orangeburg | South Carolina |
| United States | Forest Investigative Site | Ormond Beach | Florida |
| United States | Forest Investigative Site | Palm Harbor | Florida |
| United States | Forest Investigative Site | Pembroke Pines | Florida |
| United States | Forest Investigative Site | Peoria | Arizona |
| United States | Forest Investigative Site | Peoria | Illinois |
| United States | Forest Investigative Site | Port Orange | Florida |
| United States | Forest Investigative Site | Portland | Oregon |
| United States | Forest Investigative Site | Racine | Wisconsin |
| United States | Forest Investigative Site | Raleigh | North Carolina |
| United States | Forest Investigative Site | Raleigh | North Carolina |
| United States | Forest Investigative Site | Richmond | Virginia |
| United States | Forest Investigative Site | Rochester | New York |
| United States | Forest Investigative Site | Sacramento | California |
| United States | Forest Investigative Site | San Antonio | Texas |
| United States | Forest Investigative Site | San Diego | California |
| United States | Forest Investigative Site | San Diego | California |
| United States | Forest Investigative Site | Santa Ana | California |
| United States | Forest Investigative Site | Santa Fe | New Mexico |
| United States | Forest Investigative Site | Seattle | Washington |
| United States | Forest Investigative Site | Spring Valley | California |
| United States | Forest Investigative Site | St. Louis | Missouri |
| United States | Forest Investigative Site | Stamford | Connecticut |
| United States | Forest Investigative Site | Sugarland | Texas |
| United States | Forest Investigative Site | Tamarac | Florida |
| United States | Forest Investigative Site | Torrance | California |
| United States | Forest Investigative Site | Trumball | Connecticut |
| United States | Forest Investigative Site | Virginia Beach | Virginia |
| United States | Forest Investigative Site | Warwick | Rhode Island |
| United States | Forest Investigative Site | Wenatchee | Washington |
| United States | Forest Investigative Site | Wichita | Kansas |
| United States | Forest Investigative Site | Winston-Salem | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| Forest Laboratories |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Composite responder analysis based on pain and patient global status, with or without physical function. | |||
| Secondary | Quality of Life | |||
| Secondary | Health Assessment Questionnaire (HAQ) Disability Index | |||
| Secondary | Fatigue, sleep and cognitive assessments |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT05659862 -
Digitally Assisted Behavioral Physical Activity Intervention in Fibromyalgia
|
N/A | |
| Recruiting |
NCT03207828 -
Testing Interventions for Patients With Fibromyalgia and Depression
|
N/A | |
| Completed |
NCT03042728 -
Impact of Inclusion of a Therapy Dog Visit as Part of the Fibromyalgia Treatment Program
|
N/A | |
| Recruiting |
NCT06097091 -
Effects and Mechanisms of Pain Neuroscience Education in Patients With Fibromyalgia
|
N/A | |
| Recruiting |
NCT04554784 -
Effectiveness of Bowen Therapy for Pain Management in Patients With Fibromyalgia
|
N/A | |
| Completed |
NCT03300635 -
Metabolism, Muscle Function and Psychological Factors in Fibromyalgia
|
N/A | |
| Recruiting |
NCT06166563 -
Exercise, Irritable Bowel Syndrome and Fibromyalgia
|
N/A | |
| Completed |
NCT03166995 -
Postural Exercises in Women With Fibromyalgia
|
N/A | |
| Completed |
NCT03227952 -
Sensory Stimulation in Fibromyalgia
|
N/A | |
| Recruiting |
NCT06237595 -
Vagus Nerve Stimulation in Fibromyalgia
|
N/A | |
| Completed |
NCT01888640 -
Fibromyalgia Activity Study With Transcutaneous Electrical Nerve Stimulation (FAST)
|
N/A | |
| Completed |
NCT03641495 -
Pain Education and Therapeutic Exercise for Fibromyalgia
|
N/A | |
| Recruiting |
NCT05581628 -
FREQUENCY OF FIBROMYALGIA IN PATIENTS WITH CELIAC DISEASE
|
||
| Active, not recruiting |
NCT05128162 -
Open-label Study to Assess the Safety and Efficacy of Psilocybin With Psychotherapy in Adult Participants With Fibromyalgia
|
Phase 2 | |
| Completed |
NCT04674878 -
Comparison of Muscle Energy Techniques and Breathing Exercises for Functional Improvement in Fibromyalgia
|
N/A | |
| Active, not recruiting |
NCT04084795 -
Augmentation of EMDR With tDCS in the Treatment of Fibromyalgia
|
N/A | |
| Completed |
NCT03129906 -
Impact of the Restriction of Sources of Gluten in Fibromyalgia Patients
|
N/A | |
| Completed |
NCT05058911 -
Exposure-based Cognitive Behavior Therapy vs Traditional Cognitive Behavior Therapy for Fibromyalgia
|
N/A | |
| Recruiting |
NCT04571853 -
New Educational Tool for FM
|
N/A | |
| Recruiting |
NCT04571528 -
Effectiveness of VIRTUAL FIBROWALK STUDY
|
N/A |