- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01418651
Efficacy and Safety of Milnacipran in the Treatment of Fibromyalgia in an Elderly Population
Efficacy and Safety of Milnacipran in the Treatment of Fibromyalgia in an Elderly Population: an Open-label Study
Study Overview
Study Type
Enrollment (Anticipated)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
Arizona
-
Sun City, Arizona, United States, 85351
- Banner Sun Health Research Institute
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Milnacipran
Drug
|
milnacipran 25 to 200 mg daily, divided into two doses (morning and evening)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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 |
14 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Determine the effects of milnacipran on cognition
Time Frame: 14 months
|
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. |
14 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Sandra Jacobson, MD, Banner Health
Study record dates
Study Major Dates
Study Start
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Nervous System Diseases
- Musculoskeletal Diseases
- Rheumatic Diseases
- Muscular Diseases
- Neuromuscular Diseases
- Fibromyalgia
- Myofascial Pain Syndromes
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Analgesics, Non-Narcotic
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Serotonin and Noradrenaline Reuptake Inhibitors
- Milnacipran
Other Study ID Numbers
- 10-007
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Fibromyalgia
-
University of AberdeenCompletedFibromyalgia | Fibromyalgia, Primary | Fibromyalgia, SecondaryUnited Kingdom
-
Eli Lilly and CompanyCompletedFibromyalgia, Primary | Fibromyalgia, SecondaryMexico
-
Rasmia ElgoharyNot yet recruiting
-
Spaulding Rehabilitation HospitalNot yet recruiting
-
Cairo UniversityNot yet recruiting
-
Children's Hospital Medical Center, CincinnatiNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)Completed
-
University of UtahTerminated
-
State University of New York - Upstate Medical...CompletedFibromyalgia, PrimaryUnited States
-
University of Sao Paulo General HospitalFundação de Amparo à Pesquisa do Estado de São PauloCompleted
-
Tel-Aviv Sourasky Medical CenterCompletedFibromyalgia (FM)Israel
Clinical Trials on Savella
-
Brigham and Women's HospitalForest LaboratoriesWithdrawnBack PainUnited States
-
Beth Israel Medical CenterCompleted
-
Brigham and Women's HospitalNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) and other collaboratorsCompletedArthritis, RheumatoidUnited States
-
Northwestern UniversityForest Laboratories; Shirley Ryan AbilityLab; Best PracticeCompleted
-
Forest LaboratoriesCypress Bioscience, Inc.CompletedFibromyalgiaUnited States
-
University of California, San DiegoForest Laboratories; US Department of Veterans AffairsCompleted
-
Montefiore Medical CenterForest LaboratoriesCompletedAutism Spectrum Disorder | Asperger Syndrome | Aspergers SyndromeUnited States
-
Forest LaboratoriesCypress Bioscience, Inc.TerminatedPrimary FibromyalgiaUnited States
-
Spencer Dorn, MD, MPHForest LaboratoriesTerminated
-
University of TennesseeForest LaboratoriesCompleted