FibromyalgiaPhase 3NCT01418651
Efficacy and Safety of Milnacipran in the Treatment of Fibromyalgia in an Elderly Population
A Phase 3 study testing Savella in people with Fibromyalgia, run by Banner Health at 1 site in United States.
Trial summary
Participants will undertake a 12-week, open-label study of milnacipran in a well-characterized cohort of patients with fibromyalgia syndrome (FMS) who are 65 years and older to investigate the short-term efficacy and safety of this drug in the elderly population. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Savella
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2011to Aug 2011
- Phase
- Phase 3
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Male or female patients.
- Age 65 years or older.
- Fibromyalgia diagnosed according to ACR 1990 criteria.
- Pain Score ≥ 10 on Gracely scale at screening and baseline assessments.
- Discontinuation of other dual-acting antidepressant medications, including duloxetine, venlafaxine, and tricyclic antidepressants for a period not less than 4.5 times the drug half-life as of the baseline evaluation.
Who cannot join
- Uncontrolled hypertension (BP ≥ 140/90) at screening or baseline evaluations.
- Baseline orthostasis (documented drop in SBP ≥ 20 mmHg or in DBP ≥ 10 mmHg within 3 minutes after standing) at screening or baseline evaluations.
- Psychosis, active suicidality, current episode of major depression or other severe psychiatric illness, or current alcohol/substance abuse or dependence as assessed by the MINI.
- Significant cardiovascular disease, including atrial fibrillation or other dysrhythmia, congestive heart failure, valvular heart disease, or QTc prolongation on baseline EKG (> 450 msec).
- Uncontrolled narrow angle glaucoma.
- History of seizures.
Show all 10Show fewer
- Use of MAO inhibitor drugs within the last 14 days.
- Abnormal baseline liver or renal function tests.
- Dementia or other syndrome of cognitive impairment that could interfere with the subject's ability to participate fully in the assessment protocol.
- Obstructive uropathy in males.
Trial locations and contacts
1 site in 1 country.
United States1 site
Banner Sun Health Research Institute
Sun City, Arizona, 85351
About this study
Official title: Efficacy and Safety of Milnacipran in the Treatment of Fibromyalgia in an Elderly Population: an Open-label Study
Participants will undertake a 12-week, open-label study of milnacipran in a well-characterized cohort of patients with fibromyalgia syndrome (FMS) who are 65 years and older to investigate the short-term efficacy and safety of this drug in the elderly population. The investigators hypothesize that milnacipran will be effective in treating fibromyalgia syndrome (FMS), and will be prove to be safe when patients are selected for the absence of pre-existing blood pressure abnormalities and other serious medical conditions.
- Conditions
- Fibromyalgia
- Being tested
- Savella
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SavellaDrug
milnacipran 25 to 200 mg daily, divided into two doses (morning and evening)
| Study group | Role | What they receive |
|---|---|---|
| Milnacipran | Experimental | Drug Receives: Drug: Savella |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in self-reported severity of pain over 12 weeks of treatment in persons aged 65 and older
Percent change in self-reported severity of pain (averaged Visual Analog Scale scores) over 12 weeks of treatment.
Rate of occurrence of adverse events necessitating drug discontinuation
Measured: 14 months
Secondary outcomes (1)
Determine the effects of milnacipran on cognition
Change in functional activity (FIQ), perceived health (SF-36), and severity of pain (Gracely scale).
Incidence and severity of treatment-emergent adverse events. Change in sleep quality and daytime sleepiness as measured by the Pittsburgh Sleep Quality Index and Epworth Sleepiness Scale.
Change in other sleep/wake parameters(actigraphy measures). Change in cognitive test scores from baseline to the 12 week visit. Patient global impression of change score.
Measured: 14 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2011 (estimated)
- Study startMar 2011
- Primary completionAug 2011 (estimated)
- Study completionAug 2011 (estimated)
Why it stopped: Lack of subjects
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Banner Health
- Sponsor type
- University, hospital or other
- Collaborators
- Forest Laboratories
- Investigators
- Sandra Jacobson, MD, Principal investigator, Banner Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01418651
- Sponsor's protocol ID
- 10-007
- Status last verified
- Jan 2011
- First submitted
- 28 Mar 2011
- Last updated
- 17 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Milnacipran in the Treatment of Fibromyalgia in an Elderly Population: an Open-label Study
- ClinicalTrials.gov ID
- NCT01418651
- Acronym / sponsor ID
- 10-007
- Conditions
- Fibromyalgia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of subjects
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Banner HealthUniversity, hospital or other
- Collaborators
- Forest Laboratories
- Study start
- Mar 2011
- Primary completion
- Aug 2011 (estimated)
- Study completion
- Aug 2011 (estimated)
- First posted
- 17 Aug 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.
Participants will undertake a 12-week, open-label study of milnacipran in a well-characterized cohort of patients with fibromyalgia syndrome (FMS) who are 65 years and older to investigate the short-term efficacy and safety of this drug in the elderly population. The investigators hypothesize that milnacipran will be effective in treating fibromyalgia syndrome (FMS), and will be prove to be safe when patients are selected for the absence of pre-existing blood pressure abnormalities and other serious medical conditions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Milnacipran | Experimental | Drug: SavellaDrug |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Male or female patients.
- Age 65 years or older.
- Fibromyalgia diagnosed according to ACR 1990 criteria.
- Pain Score ≥ 10 on Gracely scale at screening and baseline assessments.
- Discontinuation of other dual-acting antidepressant medications, including duloxetine, venlafaxine, and tricyclic antidepressants for a period not less than 4.5 times the drug half-life as of the baseline evaluation.
Key exclusion criteria (10 listed)
- Uncontrolled hypertension (BP ≥ 140/90) at screening or baseline evaluations.
- Baseline orthostasis (documented drop in SBP ≥ 20 mmHg or in DBP ≥ 10 mmHg within 3 minutes after standing) at screening or baseline evaluations.
- Psychosis, active suicidality, current episode of major depression or other severe psychiatric illness, or current alcohol/substance abuse or dependence as assessed by the MINI.
- Significant cardiovascular disease, including atrial fibrillation or other dysrhythmia, congestive heart failure, valvular heart disease, or QTc prolongation on baseline EKG (> 450 msec).
- Uncontrolled narrow angle glaucoma.
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 |
|---|---|---|
| Savellamilnacipran 25 to 200 mg daily, divided into two doses (morning and evening) | Drug | Milnacipran |
Primary outcome
Change in self-reported severity of pain over 12 weeks of treatment in persons aged 65 and older
Time frame: 14 months
Percent change in self-reported severity of pain (averaged Visual Analog Scale scores) over 12 weeks of treatment. Rate of occurrence of adverse events necessitating drug discontinuation
1 secondary outcome
Determine the effects of milnacipran on cognition
Time frame: 14 months
Results and safety
The study was stopped early (reason given: Lack of subjects). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2011.
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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.
Sandra Jacobson, MD principal investigator
Banner Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Savella in people with Fibromyalgia, run by Banner Health 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 10 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: stopped early, as of the sponsor's last update on 17 Aug 2011. 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 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?
The study was stopped early (reason given: Lack of subjects). Results are not available in the source record.
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 in self-reported severity of pain over 12 weeks of treatment in persons aged 65 and older (time frame: 14 months). 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 17 Aug 2011; AzTrials last refreshed its copy on 8 Nov 2026.