FibromyalgiaPhase 4NCT01125423
Study of Fibromyalgia Treated With Milnacipran
A Phase 4 study testing Milnacipran and Skin biopsy in people with Fibromyalgia, run by Albany Medical College at 1 site in United States.
Trial summary
The purpose of this study is to examine the characteristics of the nerves and the small veins in the skin of people with fibromyalgia. This information will then be used to identify possible processes in the skin that may help explain why some people feel pain relief with the study drug (milnacipran) and others do… Read more about this study
- Who is it for?
- Ages 18 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Milnacipran and Skin biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- May 2010to Jan 2013
- Phase
- Phase 4
- 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 18 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Female age 18-70
- fulfill the ACR criteria for FMA (wide spread pain for a least 3 months and pain in at least 11 or 18 tender point sites.
- VAS score greater that 40mm at Screening and Randomization visits.
Who cannot join
- History of clinically significant liver disease, serious peripheral vascular disease, a blood clotting disorder, or any other medical condition felt to be exclusionary by the investigator.
- Allergy to lidocaine
- Unwillingness to sign informed consent or any other reasons for which the investigator feels the subject cannot complete the study
- Women who are pregnant, breastfeeding or trying to become pregnant
- Active cancer with the previous two years except treated basal cell carcinoma of the skin.
- presence of dermatological or neurological condition that could interfere with the interpretation of the skin biopsy or QST
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- Co-existing conditions that can produce chronic widespread pain
- Presence of uncontrolled or severe depression
- Patients with Worker's Compensation, pending Worker's Compensation,
- any ongoing litigation or disability claims due to fibromyalgia or any other source of pain, or currently receiving monetary compensation as a result of any of the above.
- presence of uncontrolled narrow-angle glaucoma
Trial locations and contacts
1 site in 1 country.
United States1 site
Upstate Clinical Research, LLC
Albany, New York, 12205
About this study
Official title: An Open-Label Pilot Study to Assess Potential Mechanisms for Fibromyalgia in Peripheral Tissue Innervation That Could Predict Therapeutic Responsiveness to Milnacipran
The purpose of this study is to examine the characteristics of the nerves and the small veins in the skin of people with fibromyalgia. This information will then be used to identify possible processes in the skin that may help explain why some people feel pain relief with the study drug (milnacipran) and others do not. The investigators expect to learn more about the pathophysiology of fibromyalgia and the way in which milnacipran acts on these patients. The investigators hypotheses are:
- The pathophysiologic basis of fibromyalgia in some patients may be due to a biochemical and/or morphological pathology among the sensory innervation.
- Fibromyalgia patients may have different sites of innervation.
- Milnacipran may have a therapeutic effect on some fibromyalgia patients.
- Abnormalities in fibromyalgia patients may predict the likelihood of a good response to milnacipran.
- Conditions
- Fibromyalgia
- Being tested
- Milnacipran, Skin biopsy
- Keywords
- Female, age 18 to 70
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MilnacipranDrug
Also called Savella
Subject with Fibromyalgia will then be titrated onto milnacipran over 8 days to subject reported optimal pain control or a maximal dose of 100mg/day per package insert. Subjects will be permitted to increase or decrease their dosing at any time during the study per MD discretion in order to maintain optimal pain control.
Skin biopsyProcedure or surgery
Subjects with Fibromyalgia will have 3 mm skin biopsies obtained from the dominant trapezius and the glabrous hypothenar area of the hand.
Skin BiopsyProcedure or surgery
Control Subjects will have 3 mm skin biopsies obtained from the dominant trapezius and the glabrous hypothenar area of the hand.
| Study group | Role | What they receive |
|---|---|---|
| Subjects with Fibromyalgia | Active comparator | Subjects with Fibromyalgia have skin biopsies taken from the dominant trapezius and palm. Subjects will receive an eight week supply of milnacipran to be titrated 12.5 mg x one day, 12.5 mg twice a day x 2 days, 25mg twice daily for 4 days, then 50mg twice a day x 7 weeks. Receives: Drug: Milnacipran; Procedure: Skin biopsy |
| Control subjects without Fibromyalgia | Other | Subjects without Fibromyalgia have skin biopsies taken from the dominant trapezius and palm. Receives: Procedure: Skin biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of milnacipran will be determined by neurological and pain assessments
Patients will be evaluated prior to being started on milnacipran and again after 8 weeks. We will use data from VAS scores, sleep diaries and quantitative sensory testing.
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2010 (estimated)
- Study startMay 2010
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Albany Medical College
- Sponsor type
- University, hospital or other
- Collaborators
- Forest Laboratories
- Responsible party
- Principal investigator, Charles Argoff, Albany Medical College
- Investigators
- Charles E. Argoff, MD, Principal investigator, Neurosciences Institute, Albany Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01125423
- Sponsor's protocol ID
- MIL2009-FFMS
- Status last verified
- Jan 2020
- First submitted
- 17 May 2010
- Last updated
- 9 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Pilot Study to Assess Potential Mechanisms for Fibromyalgia in Peripheral Tissue Innervation That Could Predict Therapeutic Responsiveness to Milnacipran
- ClinicalTrials.gov ID
- NCT01125423
- Acronym / sponsor ID
- MIL2009-FFMS
- Conditions
- Fibromyalgia
- Keywords
- Female, age 18 to 70
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Albany Medical CollegeUniversity, hospital or other
- Collaborators
- Forest Laboratories
- Study start
- May 2010
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 18 May 2010 (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.
The purpose of this study is to examine the characteristics of the nerves and the small veins in the skin of people with fibromyalgia. This information will then be used to identify possible processes in the skin that may help explain why some people feel pain relief with the study drug (milnacipran) and others do not. The investigators expect to learn more about the pathophysiology of fibromyalgia and the way in which milnacipran acts on these patients. The investigators hypotheses are:
- The pathophysiologic basis of fibromyalgia in some patients may be due to a biochemical and/or morphological pathology among the sensory innervation.
- Fibromyalgia patients may have different sites of innervation.
- Milnacipran may have a therapeutic effect on some fibromyalgia patients.
- Abnormalities in fibromyalgia patients may predict the likelihood of a good response to milnacipran.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Subjects with Fibromyalgia | Active comparator | Drug: Milnacipran, Procedure: Skin biopsySubjects with Fibromyalgia have skin biopsies taken from the dominant trapezius and palm. Subjects will receive an eight week supply of milnacipran to be titrated 12.5 mg x one day, 12.5 mg twice a day x 2 days, 25mg twice daily for 4 days, then 50mg twice a day x 7 weeks. |
| Control subjects without Fibromyalgia | Other | Procedure: Skin biopsySubjects without Fibromyalgia have skin biopsies taken from the dominant trapezius and palm. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Female age 18-70
- fulfill the ACR criteria for FMA (wide spread pain for a least 3 months and pain in at least 11 or 18 tender point sites.
- VAS score greater that 40mm at Screening and Randomization visits.
Key exclusion criteria (11 listed)
- History of clinically significant liver disease, serious peripheral vascular disease, a blood clotting disorder, or any other medical condition felt to be exclusionary by the investigator.
- Allergy to lidocaine
- Unwillingness to sign informed consent or any other reasons for which the investigator feels the subject cannot complete the study
- Women who are pregnant, breastfeeding or trying to become pregnant
- Active cancer with the previous two years except treated basal cell carcinoma of the skin.
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: SavellaSubject with Fibromyalgia will then be titrated onto milnacipran over 8 days to subject reported optimal pain control or a maximal dose of 100mg/day per package insert. Subjects will be permitted to increase or decrease their dosing at any time during the study per MD discretion in order to maintain optimal pain control. | Drug | Subjects with Fibromyalgia |
| Skin biopsySubjects with Fibromyalgia will have 3 mm skin biopsies obtained from the dominant trapezius and the glabrous hypothenar area of the hand. | Procedure or surgery | Control subjects without Fibromyalgia, Subjects with Fibromyalgia |
| Skin BiopsyControl Subjects will have 3 mm skin biopsies obtained from the dominant trapezius and the glabrous hypothenar area of the hand. | Procedure or surgery | Control subjects without Fibromyalgia, Subjects with Fibromyalgia |
Primary outcome
Efficacy of milnacipran will be determined by neurological and pain assessments
Time frame: 10 weeks
Patients will be evaluated prior to being started on milnacipran and again after 8 weeks. We will use data from VAS scores, sleep diaries and quantitative sensory testing.
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 9 Jan 2020.
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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.
Charles E. Argoff, MD principal investigator
Neurosciences Institute, Albany Medical College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Milnacipran and Skin biopsy in people with Fibromyalgia, run by Albany Medical College 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 3 inclusion and 11 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 9 Jan 2020. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Efficacy of milnacipran will be determined by neurological and pain assessments (time frame: 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Jan 2020.