Phase 4
Completed N=8
Effect of Milnacipran on Pain in Fibromyalgia
Source: ClinicalTrials.gov NCT01288807 ↗Enrolled (actual)
8
Serious AEs
0.0%
Results posted
Sep 2019
Primary outcomePrimary: Concentration of Substance P in Cerebrospinal Fluid in Response to Experiemental Pain Before and After Milnacipran Treatment. — 77.2; 126.7; 81.0 pg/mL — p=< 0.01
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
The investigators want to study the effects of milnacipran treatment on neurotransmitter release in fibromyalgia.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Concentration of Substance P in Cerebrospinal Fluid in Response to Experiemental Pain Before and After Milnacipran Treatment. |
77.2; 126.7; 81.0 | < 0.01 sig |
| SECONDARY Measure Sensory Threshold for Temperature Pain |
20.6; 8.8 | < 0.05 sig |
| SECONDARY Measure Sensory Thresholds for Pressure Pain |
15.9; 14.1 | > 0.05 |
| SECONDARY Measure Pain Ratings and Fibromyalgia Symptoms |
4.5; 3.2 | > 0.05 |
| SECONDARY Measure Concentrations of Serotonin and Norepinephrine Cerebrospinal Fluid and Plasma |
— | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01288807). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.