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FibromyalgiaPhase 3NCT00618956

A Study Of Milnacipran In Patients With Fibromyalgia: Effects On 24 Hour Ambulatory Blood Pressure Monitoring

A Phase 3 study testing Milnacipran hydrochloride in people with Fibromyalgia, run by Forest Laboratories at 38 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Fibromyalgia
What is being tested?
Milnacipran hydrochloride
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
321 participants
Where
38 sitesUnited States
Study dates
Oct 2007to Jul 2008
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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 judgment or based on an answer of 2 or 3 for question 9 of the Beck Depression Inventory (BDI) (regarding suicidal ideation) performed at Visit 1 (Screening) or Visit 2 (Baseline/Randomization)
  • Patients with a total BDI score greater than 25 at Visit 1 (Screening) or Visit 2 (Baseline/Randomization)
  • Patients testing positive for illegal substances prior to Visit 2 (Baseline/Randomization) as demonstrated by positive drug screening or based on the Investigator's judgment
  • Patients with any history or behavior that would, in the Investigator's judgment, prohibit compliance for the duration of the study
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  • Somatic Criteria
  • Patients with myocardial infarction and/or stroke within the past 12 months; active cardiac disease (American Heart Association Functional Class 2, 3, or 4); congestive heart failure; hemodynamically significant valvular heart disease (including patients with a prosthetic heart valve); hypertensive cardiovascular disease changes (heart, eyes or kidneys) that in the Investigator's judgment, would preclude patient participation; ischemic changes; and/or clinically significant cardiac rhythm or conduction abnormalities (including atrial fibrillation, left bundle branch block, second- or third-degree heart block)
  • Patients with a mean of two sitting systolic blood pressure (SBP) readings equal to or greater than 160 mm Hg or sitting diastolic blood pressure (DBP) equal to or greater than 100 mm Hg at Visits 1 (Screening) and 2 (Baseline/Randomization) using an automatic office blood pressure monitor
  • Patients with pacemakers
  • Patients with an upper arm circumference less than 24 cm or greater than 42 cm in their nondominant arm
  • Patients with evidence of active liver disease (levels of aspartate aminotransferase, alanine aminotransferase, and/or alkaline phosphatase > 1.5× the upper limit of the normal range for the clinical laboratory performing the test)
  • Patients with renal impairment (estimated creatinine clearance < 50 mL/min)
  • Patients with documented autoimmune disease. Patients diagnosed with Hashimoto or Grave disease that has been stable for 3 months prior to Visit 1 (Screening) will be allowed to enroll
  • Patients with current systemic infection (eg, human immunodeficiency virus, hepatitis)
  • Patients with active cancer, except basal cell carcinoma. Patients taking prophylactic tamoxifen (or other antiestrogen agents) because of a family history of breast cancer or patients taking tamoxifen (or other antiestrogen agents) but who are at least 1 year post-active treatment of breast cancer, may be enrolled
  • Patients with a current life expectancy of less than 1 year
  • Patients with active peptic ulcer disease or history of inflammatory bowel disease or celiac sprue
  • Patients with pulmonary dysfunction or severe chronic obstructive pulmonary disease that, in the Investigator's judgment, could interfere with study participation and completion
  • Patients with unstable endocrine disease, including unstable diabetes or thyroid disease. Disorders that have been stable for the preceding 3 months will be acceptable
  • Male patients with prostatic enlargement or other genitourinary disorders who might be at significant risk for dysuria and/or urinary retention while taking agents with noradrenaline-reuptake inhibition properties
  • Pregnant or breastfeeding patients
  • Any other conditions (such as epilepsy) that, in the Investigator's judgment, would indicate that the patient is unsuitable for the study (eg, might interfere with study conduct, confound the interpretation of study results, endanger the patient)
  • Treatment-Related Criteria
  • Patients who have received treatment with an experimental agent within the last 30 days prior to Visit 1 (Screening). Patients who have completed previous milnacipran studies (ie, all respective protocol-related study procedures have been completed by the patient) are eligible to participate. Any patients who failed screening in previous milnacipran studies may be re-evaluated, and eligible patients may enroll. Patients currently enrolled in Study MLN-MD-06 are not eligible to participate
  • Patients who are receiving concomitant therapy with digitalis (digoxin) preparations. (Note: Patients should not undergo washout of digoxin; therefore, patients on digoxin should not be enrolled in the study)
  • Patients who are receiving concomitant therapy with monoamine oxidase inhibitors, tricyclics, tetracyclics, SSRIs, noradrenaline or noradrenaline-serotonin (NSRI) reuptake inhibitors, SNRIs, St. John's Wort, and/or other agents marketed as antidepressants and are unable to washout or for whom washout is inadvisable*
  • Patients who are receiving concomitant therapy with pregabalin (Lyrica) or gabapentin (Neurontin) and are unable to washout or for whom washout is inadvisable*
  • Patients who are receiving concomitant therapy with 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) and are unable to washout or for whom washout is inadvisable*
  • Patients who are receiving concomitant therapy with anorectic agents such as diethylpropion , sibutramine (Meridia), and phentermine (Adipex) and are unable to washout or for whom washout is inadvisable*
  • Patients who require the use of agents affecting serotonin pharmacology, such as ondansetron (Zofran), granisetron (Kytril), and/or dolasetron (Anzemet)
  • Patients who require doses of guaifenesin greater than 2400 mg/d (approximately 24 teaspoons)
  • Occupational Criteria
  • 1. Patients whose occupation requires them to work nocturnal hours (eg, 11 PM to 7 AM)
  • ABPM Criteria
  • Patients whose ABPM results at Visit 2 (Baseline/Randomization) do not satisfy ABPM inclusion/exclusion criteria outlined in the ABPM training manual

Trial locations and contacts

38 sites in 1 country.

38 sites in 1 country

United States38 sites

  • Site #021

    Albuquerque, New Mexico, 87108

  • Site #006

    Atlanta, Georgia, 30328

  • Site #015

    Bellingham, Washington, 98226

  • Site #032

    Birmingham, Alabama, 35205

  • Site #035

    Birmingham, Alabama, 35209

  • Site #027

    Bristol, Tennessee, 37620

  • Site #029

    Charlotte, North Carolina, 28209

  • Site #002

    Cleveland, Ohio, 44122

  • Site #037

    Delray Beach, Florida, 33484

  • Site #005

    East Syracuse, New York, 13057

  • Site #023

    Eugene, Oregon, 97401

  • Site #007

    Eugene, Oregon, 97404

  • Site #018

    Evansville, Indiana, 47713

  • Site #014

    Greer, South Carolina, 29651

  • Site #034

    Indianapolis, Indiana, 46254

  • Site #025

    Jacksonville, Florida, 32216

  • Site #030

    Libertyville, Illinois, 60048

  • Site #026

    Mechanicsburg, Pennsylvania, 17055

  • Site #001

    Medford, Oregon, 97501

  • Site #024

    Memphis, Tennessee, 38119

  • Site #031

    Nashville, Tennessee, 37203

  • Site #009

    Ocala, Florida, 34471

  • Site #011

    Orlando, Florida, 32806

  • Site #038

    Phoenix, Arizona, 85004

  • Site #019

    Pismo Beach, California, 93449

  • Site #033

    Racine, Wisconsin, 53406

  • Site #020

    Richmond, Virginia, 23294

  • Site #010

    Rochester, New York, 14618

  • Site #003

    Salt Lake City, Utah, 84102

  • Site #016

    San Diego, California, 92117

  • Site #013

    Springfield, Missouri, 65807

  • Site #028

    Sugarland, Texas, 77479

  • Site #036

    Tampa, Florida, 33614

  • Site #017

    Toledo, Ohio, 13623

  • Site #008

    Walnut Creek, California, 94598

  • Site #022

    Winston-Salem, North Carolina, 27103

  • Site #012

    Woodstock, Vermont, 05091

  • Site #004

    Worchester, Massachusetts, 01610

Other trials in United States

About this study

Official title: A Randomized, Double-Blind, Placebo-Controlled, Dose Escalation Study of Milnacipran 100 And 200 MG Daily in Patients With Fibromyalgia: Effects On 24 Hour Ambulatory Blood Pressure

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.

Read the detailed description

This study is double blind (neither you nor the physician will know if you are receiving active study drug or placebo, an inactive compound such as a sugar pill) and it is being conducted at various research centers in the United States.

If the study staff determines that you are eligible and you decide to participate, there will be approximately 11 study visits in about 3 months. During these visits, you will undergo routine health exams and complete different kinds of questionnaires.

This study requires that you wear a blood pressure cuff continuously for 24 hours on three separate occasions. You will also be required to make multiple same-day visits to the study site on three separate occasions for blood draws.

Conditions
Fibromyalgia
Being tested
Milnacipran hydrochloride, Placebo
Keywords
NSRI, milnacipran, fibromyalgia, blood pressure, hypertension
Medical subject headings
Fibromyalgia, Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Milnacipran hydrochlorideDrug

    Also called Ixel (outside of United States)

    Milnacipran 100 to 200 mg/day tablet (administered in divided doses, twice daily [BID]), oral administration.

  • PlaceboDrug

    Placebo

Study groups in NCT00618956
Study groupRoleWhat they receive
1ExperimentalNot described
Receives: Drug: Milnacipran hydrochloride
2Placebo comparatorNot described
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change From Baseline in Mean Systolic Blood Pressure Following 12-hour Period Post-AM Dose at Visit 4

    Change from baseline to Visit 4 in mean systolic blood pressure (SBP) based on ambulatory blood pressure monitor (ABPM) is defined as the mean SBP value at Visit 4 minus the corresponding mean SBP value at baseline in the same 12-hour period post-AM dose.

    Measured: 4 weeks (1 week of dose-escalation, 3 weeks of 100 mg/d)

  2. Change From Baseline in Mean Systolic Blood Pressure Following 12-hour Period Post-AM Dose at Visit 6

    Change from baseline to Visit 6 in mean systolic blood pressure based on ABPM is defined as the mean SBP value at Visit 6 minus the corresponding mean SBP value at baseline in the same 12-hour period post-AM dose.

    Measured: 7 weeks (1 week of dose-escalation, 3 weeks of 100 mg/d, followed by 1 week at 150 mg/d and 2 weeks of 200 mg/d)

Secondary outcomes (4)

  1. Change From Baseline in Mean Systolic Blood Pressure /Diastolic Blood Pressure for 12-hour Period Post-AM Dose at Visit 4

    Change from baseline to Visit 4 in mean SBP/DBP based on ABPM is defined as the mean SBP/DBP values at Visit 4 minus the corresponding mean SBP/DBP values at baseline in the same 12-hour period post-AM dose.

    Measured: 4 weeks (1 week of dose-escalation, 3 weeks of 100 mg/d)

  2. Change From Baseline in Mean SBP/DBP Following 12-hour Period Post-AM Dose at Visit 6

    Change from baseline to Visit 6 in mean SBP/DBP based on ABPM is defined as the mean SBP/DBP value at Visit 6 minus the corresponding mean SBP/DBP value at baseline in the same 12-hour period post-AM dose.

    Measured: 7 weeks (1 week of dose-escalation, 3 weeks of 100 mg/d, followed by 1 week at 150 mg/d and 2 weeks of 200 mg/d)

  3. Change From Baseline in Mean Heart Rate (HR) Following 24-hour Treatment at Visit 4

    Change from baseline to Visit 4 in HR based on ABPM is defined as the mean HR value at Visit 4 minus the corresponding mean HR value at baseline in the same 24-hour period.

    Measured: 4 weeks (1 week of dose-escalation, 3 weeks of 100 mg/d)

  4. Change From Baseline in Mean HR Following 24-hour Treatment at Visit 6

    Change from baseline to Visit 6 in HR based on ABPM is defined as the mean HR value at Visit 6 minus the corresponding mean HR value at baseline in the same 24-hour period.

    Measured: 7 weeks (1 week of dose-escalation, 3 weeks of 100 mg/d, followed by 1 week at 150 mg/d and 2 weeks of 200 mg/d)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Feb 2008 (estimated)
  2. Study startOct 2007
  3. Primary completionJul 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
321 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00618956
Sponsor's protocol ID
MLN-MD-12
Status last verified
Nov 2009
First submitted
31 Jan 2008
Last updated
20 Nov 2009
Data monitoring committee
No

Publications

  • Trugman JM, Palmer RH, Ma Y. Milnacipran effects on 24-hour ambulatory blood pressure and heart rate in fibromyalgia patients: a randomized, placebo-controlled, dose-escalation study. Curr Med Res Opin. 2014 Apr;30(4):589-97. doi: 10.1185/03007995.2013.861812. Epub 2013 Nov 20.

    PubMed 24188161

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Milnacipran hydrochloride in people with Fibromyalgia, run by Forest Laboratories at 38 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 36 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Nov 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 38 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Sep 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Mean Systolic Blood Pressure Following 12-hour Period Post-AM Dose at Visit 4 (time frame: 4 weeks (1 week of dose-escalation, 3 weeks of 100 mg/d)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00618956, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2009.

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