Phase 3
Completed N=321
A Study Of Milnacipran In Patients With Fibromyalgia: Effects On 24 Hour Ambulatory Blood Pressure Monitoring
Source: ClinicalTrials.gov NCT00618956 ↗Enrolled (actual)
321
Serious AEs
2.2%
Results posted
Sep 2009
Primary outcomePrimary: Change From Baseline in Mean Systolic Blood Pressure Following 12-hour Period Post-AM Dose at Visit 4 — -0.9; 4.0; 0.2; 3.7 mm Hg
Summary
The study is designed to accurately assess any changes in blood pressure and pulse at 100 and 200 mg daily dose of milnacipran in patients with fibromyalgia syndrome.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Mean Systolic Blood Pressure Following 12-hour Period Post-AM Dose at Visit 4 |
-0.9; 4.0; 0.2; 3.7 | — |
| PRIMARY Change From Baseline in Mean Systolic Blood Pressure Following 12-hour Period Post-AM Dose at Visit 6 |
0.1; 5.5; -0.9; 4.4 | — |
| SECONDARY Change From Baseline in Mean Systolic Blood Pressure /Diastolic Blood Pressure for 12-hour Period Post-AM Dose at Visit 4 |
-0.3; 3.8; -0.3; 4.2 | — |
| SECONDARY Change From Baseline in Mean SBP/DBP Following 12-hour Period Post-AM Dose at Visit 6 |
-0.4; 5.0; -0.5; 5.0 | — |
| SECONDARY Change From Baseline in Mean Heart Rate (HR) Following 24-hour Treatment at Visit 4 |
-1.0; 11.7 | — |
| SECONDARY Change From Baseline in Mean HR Following 24-hour Treatment at Visit 6 |
-1.6; 12.9 | — |
Eligibility Criteria
Inclusion Criteria
- To be eligible to participate in the study, patients must meet the following criteria:
- Patients may be male or female between the ages of 18 and 70 years, inclusive
- Patients must have been diagnosed of primary fibromyalgia, as defined by the 1990 ACR Criteria for the Classification of Fibromyalgia
- Females must be either postmenopausal (no menses for at least 1 year), posthysterectomy, postoophorectomy (bilateral), or, if of childbearing potential, must have a negative urine pregnancy test prior to randomization and be using a medically acceptable form of contraception (eg, hormonal birth control, IUD, double-barrier method [eg, simultaneous use of two of the following: male condom, female condom, diaphragm], or a barrier method plus a spermicidal agent [contraceptive foam, jelly, or cream])
- Patients must have the ability to give written informed consent
- Patients may have hypertension untreated or treated with a maximum of two antihypertensive medications. (Note: medications contributing to a combination product(s) will each be considered as a separate medication.) If untreated, the patient should be stable, with no expectation of initiating treatment during the study. If treated, the patient must have been on stable doses of antihypertensive medications for at least 2 months, with the expectation that dose adjustments will not be necessary for the duration of the study. A patient will be classified as hypertensive if the patient is taking antihypertensive medication, has a SBP equal to or greater than 130 mm Hg, or has a DBP equal to or greater than 85 mm Hg. A patient will be classified as normotensive if he/she is not on antihypertensive medication and has a SBP less than 130 mm Hg and DBP less than 85 mm Hg
- Patients must have a mean of two sitting SBP measurements of less than 160 mm Hg and sitting DBP less than 100 mm Hg at Visit 1 (Screening) and Visit 2 (Baseline/Randomization) using an automatic office blood pressure monitor
- Patients must have normal physical examination findings, clinical laboratory results, and electrocardiogram (ECG) results from Visit 1 (Screening) or abnormal findings judged not clinically significant by the Investigator and documented as such in the eCRF
- Patients must be willing to withdraw from CNS-active therapies marketed as antidepressants, including monoamine oxidase inhibitors, tricyclics, tetracyclics, selective-serotonin reuptake inhibitors (SSRIs), noradrenaline reuptake inhibitors (NARIs), noradrenaline-serotonin reuptake inhibitors (NSRI), serotonin-noradrenaline reuptake inhibitors (SNRIs), and St. John's Wort
- Patients must be willing to withdraw from pregabalin (Lyrica) or gabapentin (Neurontin).
- Patients must be willing to withdraw from stimulant medications such as those used to treat attention deficit disorder/attention deficit hyperactivity disorder (eg, amphetamine/dextroamphetamine [Adderall], methylphenidate, dextroamphetamine) or the fatigue associated with sleep apnea or shift work (eg, modafinil)
- Patients must be willing to withdraw from anorectic agents such as diethylpropion , sibutramine (Meridia), and phentermine (Adipex)
- Patients must be willing to withhold certain medications for the 24 hours before, as well as during, any ABPM assessment. These medications include phosphodiesterase type 5 inhibitors (eg, Viagra, Levitra, Cialis, Edex, Muse), decongestants (eg, pseudoephedrine, phenylephrine), and antimigraine therapies (eg, triptans such as Imitrex and Maxalt, ergotamines such as Cafergot and Midrin). If, for any reason, the patient takes any of these medications, the ABPM visit should be rescheduled so that at least 24 hours have transpired since the patient's last use
Exclusion Criteria
- Patients who meet any of the following criteria will not be eligible to participate in the study:
- Psychological/Psychiatric Criteria
- Patients with a significant risk of suicide, according to the Investigator's
Data sourced from ClinicalTrials.gov (NCT00618956). 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.