FibromyalgiaPhase 1NCT01294059
Effects of Milnacipran on Widespread Mechanical and Thermal Hyperalgesia of Fibromyalgia Patients
A Phase 1 study testing Milnacipran in people with Fibromyalgia, run by University of Florida at 1 site in United States.
Trial summary
Fibromyalgia syndrome (FM) shares many symptoms common to chronic neuropathic pain, including the characteristic hyperalgesia of the skin (thermal, mechanical) and muscles (mechanical) found in almost all FM patients. Read more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Milnacipran
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2009to Apr 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 30 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with diagnosis of chronic wide-spread pain for at least 3 months, who fulfill the 1990 ACR Criteria for FM.
- Patients with mean pain ratings ≥ 4.0 VAS units, at Screening and Baseline visits.
- Patients, who are able to comprehend and satisfactorily comply with protocol requirements.
- Patients who have not taken any pain medications except acetaminophen within 3 days prior to the Baseline Visit (these medications if taken prior to the Screening Visit must be discontinued at Screening Visit and the Baseline Visit may be scheduled at least 7 days past the last dose of these medications).
- All women of childbearing potential (WOCBP) must have a negative urine pregnancy test at the Screening Visit. All women of childbearing potential participating in the study must use a medically acceptable form of contraception
Who cannot join
- FM patients unwilling or unable to discontinue analgesics (except Tylenol) for at least 5 drug half-lives prior to enrollment.
- Patient has previously failed treatment with Milnacipran for FM pain.
- Patients who have been treated with MAO inhibitors within 30 days prior to the Baseline Visit.
- Patients who received ECT within 3 months prior to the Screening Visit.
- Women who are pregnant or nursing, or women of childbearing potential who do not use adequate contraception, or who are judged to be unreliable in their use of contraception.
- Patients who have participated in any clinical trial within one month prior to the Screening Visit.
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- Patients who have a medical condition that, in the Investigator's opinion, would expose them to an increased risk of a significant adverse event or interfere with assessments of safety and efficacy during the course of the trial.
- Patients with severe renal insufficiency (Creatinine clearance < 30 ml/min)
- Patient has a BDI score >29
- Patients with any current malignancy, or any clinically significant hematological, endocrine, cardiovascular, renal, hepatic, gastrointestinal or neurological disease (including any form of epilepsy). If there is a history of such disease but the condition has been stable for at least the past year and is judged by the investigator not to interfere with the patient's participation in the study, the patient may be included.
- Patients with systolic blood pressure greater than 180 mm Hg or less than 90 mm Hg or diastolic blood pressure greater than 105 mm Hg or less than 50 mm Hg at the Screening visit. Similarly, tachycardia of >110/min is exclusionary.
- Patients who require concomitant therapy with any prohibited prescription or over-the-counter medication, including aspirin (except 81 mg for heart disease) or antidepressant medications.
- Patients who are unable to speak, read, and understand English or are judged by the investigator to be unable or unlikely to follow the study protocol and complete all scheduled visits.
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Musculoskeletal Pain Research
Gainesville, Florida, 32610
About this study
Fibromyalgia syndrome (FM) shares many symptoms common to chronic neuropathic pain, including the characteristic hyperalgesia of the skin (thermal, mechanical) and muscles (mechanical) found in almost all FM patients. Milnacipran, a balance norepinephrine-serotonin re-uptake inhibitor, has been found to reduce pain and improve physical function of FM patients. However, little is known about the pain mechanisms that are affected by this medication. Therefore, the investigator wants to determine the efficacy of milnacipran in reducing pain as well as mechanical and thermal hyperalgesia of FM patients during a randomized, double-blind, placebo controlled trial. Because the investigator expects anti-hyperalgesic effects to coincide or precede with effects on clinical FM pain the proposed duration for this trial is 6 weeks.
- Conditions
- Fibromyalgia
- Being tested
- Milnacipran
- Keywords
- Fibromyalgia, Hyperalgesia, Pain, Central Sensitization
- Medical subject headings
- Fibromyalgia, Hyperalgesia, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MilnacipranDrug
Also called Savella
50 mg BID Oral x 6 Weeks
| Study group | Role | What they receive |
|---|---|---|
| Sugar pill | Placebo comparator | One sugar pill twice daily over 6 weeks Receives: Drug: Milnacipran |
| Milnacipran | Active comparator | Milnacipran 50 mg bid over 6 weeks Receives: Drug: Milnacipran |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mechanical and Heat Hyperalgesia
Measured: 2 week intervals
Secondary outcomes (1)
Clinical Pain
Measured: daily
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2011 (estimated)
- Study startNov 2009
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- Forest Laboratories
- Responsible party
- Sponsor
- Investigators
- Roland Staud, MD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01294059
- Sponsor's protocol ID
- SAV-MD-06
- Status last verified
- Jul 2014
- First submitted
- 9 Feb 2011
- Last updated
- 31 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Staud R, Lucas YE, Price DD, Robinson ME. Effects of milnacipran on clinical pain and hyperalgesia of patients with fibromyalgia: results of a 6-week randomized controlled trial. J Pain. 2015 Aug;16(8):750-9. doi: 10.1016/j.jpain.2015.04.010. Epub 2015 May 19.
PubMed 25998206
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Milnacipran on Widespread Mechanical and Thermal Hyperalgesia of Fibromyalgia Patients
- ClinicalTrials.gov ID
- NCT01294059
- Acronym / sponsor ID
- SAV-MD-06
- Conditions
- Fibromyalgia
- Keywords
- Fibromyalgia, Hyperalgesia, Pain, Central Sensitization
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- Forest Laboratories
- Study start
- Nov 2009
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 11 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Fibromyalgia syndrome (FM) shares many symptoms common to chronic neuropathic pain, including the characteristic hyperalgesia of the skin (thermal, mechanical) and muscles (mechanical) found in almost all FM patients. Milnacipran, a balance norepinephrine-serotonin re-uptake inhibitor, has been found to reduce pain and improve physical function of FM patients. However, little is known about the pain mechanisms that are affected by this medication. Therefore, the investigator wants to determine the efficacy of milnacipran in reducing pain as well as mechanical and thermal hyperalgesia of FM patients during a randomized, double-blind, placebo controlled trial. Because the investigator expects anti-hyperalgesic effects to coincide or precede with effects on clinical FM pain the proposed duration for this trial is 6 weeks.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sugar pill | Placebo comparator | Drug: MilnacipranOne sugar pill twice daily over 6 weeks |
| Milnacipran | Active comparator | Drug: MilnacipranMilnacipran 50 mg bid over 6 weeks |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with diagnosis of chronic wide-spread pain for at least 3 months, who fulfill the 1990 ACR Criteria for FM.
- Patients with mean pain ratings ≥ 4.0 VAS units, at Screening and Baseline visits.
- Patients, who are able to comprehend and satisfactorily comply with protocol requirements.
- Patients who have not taken any pain medications except acetaminophen within 3 days prior to the Baseline Visit (these medications if taken prior to the Screening Visit must be discontinued at Screening Visit and the Baseline Visit may be scheduled at least 7 days past the last dose of these medications).
- All women of childbearing potential (WOCBP) must have a negative urine pregnancy test at the Screening Visit. All women of childbearing potential participating in the study must use a medically acceptable form of contraception
Key exclusion criteria (13 listed)
- FM patients unwilling or unable to discontinue analgesics (except Tylenol) for at least 5 drug half-lives prior to enrollment.
- Patient has previously failed treatment with Milnacipran for FM pain.
- Patients who have been treated with MAO inhibitors within 30 days prior to the Baseline Visit.
- Patients who received ECT within 3 months prior to the Screening Visit.
- Women who are pregnant or nursing, or women of childbearing potential who do not use adequate contraception, or who are judged to be unreliable in their use of contraception.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MilnacipranAlso: Savella50 mg BID Oral x 6 Weeks | Drug | Milnacipran, Sugar pill |
Primary outcome
Mechanical and Heat Hyperalgesia
Time frame: 2 week intervals
1 secondary outcome
Clinical Pain
Time frame: daily
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2014.
- Derived from this study: PubMed 25998206Staud R, Lucas YE, Price DD, Robinson ME. Effects of milnacipran on clinical pain and hyperalgesia of patients with fibromyalgia: results of a 6-week randomized controlled trial. J Pain. 2015 Aug;16(8):750-9. doi: 10.1016/j.jpain.2015.04.010. Epub 2015 May 19.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roland Staud, MD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Milnacipran in people with Fibromyalgia, run by University of Florida at 1 site 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 5 inclusion and 13 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 31 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Mechanical and Heat Hyperalgesia (time frame: 2 week intervals). 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 NCT01294059, 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 31 Jul 2014.