Phase 4
Completed N=340
Discontinuation Study of the Durability of Effect of Milnacipran for the Treatment of Fibromyalgia
Source: ClinicalTrials.gov NCT01014585 ↗Enrolled (actual)
340
Serious AEs
1.5%
Results posted
Sep 2011
Primary outcomePrimary: Time to Loss of Therapeutic Response (LTR) — 56; NA Days — p=0.0004
Summary
The purpose of this study is to evaluate the durability of effect of milnacipran for the treatment of fibromyalgia in patients receiving long-term milnacipran treatment and to characterize the effects of milnacipran on multiple symptoms of fibromyalgia, as demonstrated by changes in symptoms following the discontinuation of milnacipran.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Loss of Therapeutic Response (LTR) |
56; NA | 0.0004 sig |
| SECONDARY Time to Worsening in Patient Global Impression of Change (PGIC) |
86; NA | 0.0002 sig |
| SECONDARY Time to Worsening in Multidimensional Assessment of Fatigue (MAF) |
NA; NA | 0.4104 |
Eligibility Criteria
Inclusion Criteria
- Currently participating in Study MLN-MD-06
- Receiving a stable dosage of milnacipran (50-200 mg/d) at Screening/Enrollment (Visit 1)
Exclusion Criteria
- Significant risk of suicide
- History of mania, bipolar disorder, psychotic disorder, schizophrenia, or a current episode of major depressive disorder
- Myocardial infarction and/or stroke within the prior 12 months
- Mean systolic blood pressure > 180 mm Hg or mean diastolic blood pressure > 110 mm Hg at Screening (Visit 1)
- Active liver disease
- Severe renal impairment
- Platelet and bleeding disorders
- Female patients who are pregnant or breastfeeding
Data sourced from ClinicalTrials.gov (NCT01014585). 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.