Fibromyalgia Clinical Trial
— ForestOfficial title:
Effects of a 12 Week Milnacipran 200 mg Treatment on Pain Perception and Pain Processing in Fibromyalgia - An Open Label Study
NCT number | NCT01288807 |
Other study ID # | 100686 |
Secondary ID | |
Status | Completed |
Phase | Phase 4 |
First received | |
Last updated | |
Start date | February 2011 |
Est. completion date | January 2015 |
Verified date | September 2019 |
Source | University of California, San Diego |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The investigators want to study the effects of milnacipran treatment on neurotransmitter release in fibromyalgia.
Status | Completed |
Enrollment | 8 |
Est. completion date | January 2015 |
Est. primary completion date | January 2015 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Female age 18 or older - Written informed consent and written release of health and research study information - Diagnosis of Fibromyalgia - Participant has pain greater than 4 on the NRS of 0 to 10 on average over the last week prior to initial evaluation that interferes with function most days per week - Pain duration greater than 6 months - Negative urine pregnancy test on experimental day 1 and 2 and on first day of treatment prior to administration of study medication and fluoroscopy - Ability to speak and understand English, to follow instructions, and fill out study questionnaires - Likely to complete all required visits - Must be ambulatory and able to lay prone for 30 minutes Exclusion Criteria: - Any condition or situation that in the investigator's opinion may put the participant at significant risk, confound the study results, or interfere significantly with the participant's participation in the study - Serious, unstable medical illness that could lead to hospitalization over the next three months; and/or a DSM-IV diagnosis(es) with active problems within the last six months, such as: schizophrenia, bipolar disorder, antisocial personality disorder, or substance use disorder - Known, uncontrolled, serious systemic disease, including: hypertension and/or tachyarrythmia - Females who are pregnant, breast feeding, or who plan to become pregnant, or who may potentially become pregnant - Allergy or sensitivity to any component of the study medication or to contrast dye - Patients on coumadin, heparin, or any other known increase risk of bleeding - Signs of increased intracranial pressure - Patients who are unable to continue current pain medication - Allergy or contraindication to acetaminophen - Use of monoamine oxidase inhibitors - Uncontrolled narrow-angle glaucoma |
Country | Name | City | State |
---|---|---|---|
United States | UCSD Medical Center, La Jolla | San Diego | California |
Lead Sponsor | Collaborator |
---|---|
University of California, San Diego | Forest Laboratories, US Department of Veterans Affairs |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Concentration of Substance P in Cerebrospinal Fluid in Response to Experiemental Pain Before and After Milnacipran Treatment. | Measure levels of Substance P present in serial samples of CSF and plasma collected over the course of 4 hours in response to application of a painful thermal stimulus at baseline ("before") and the end of 12 weeks of treatment with milnacipran 200mg daily ("after"). Substance P levels are presented. Presented data show the 10 minute and 40 minute timepoint for Substance P after pain challenge. Additional time points were not analyzed. |
12 weeks | |
Secondary | Measure Sensory Threshold for Temperature Pain | Investigators will utilize quantitative sensory testing to assess changes in sensory thresholds among patients with fibromyalgia before and after a twelve (12) week course of milnacipran. | 12 weeks | |
Secondary | Measure Sensory Thresholds for Pressure Pain | Investigator will utilize sensory testing to assess changes in sensory thresholds among patients with fibromyalgia before and after a twelve (12) week course of milnacipran. | 12 weeks | |
Secondary | Measure Pain Ratings and Fibromyalgia Symptoms | Fibromyalgia patients will be asked to keep a pain diary which assess spontaneous pain ratings daily, a subjective weekly assessment, as well as degree of improvement weekly during treatment period on a numeric rating scale. The Numeric Pain Rating Scale (NPRS) is assessing the patients pain on a 11-point rating scale from 0 - 10 with 0 corresponding to 'No Pain' and 10 corresponding to 'Worst Pain imaginable'. |
12 weeks | |
Secondary | Measure Concentrations of Serotonin and Norepinephrine Cerebrospinal Fluid and Plasma | The investigators will measure cerebrospinal fluid and plasma concentrations of serotonin and norepinephrine in CSF and plasma before and after twelve (12) weeks of treatment with milnacipran. Assays for these outcomes were not performed. |
12 weeks |
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