CLINICAL TRIALS PROFILE FOR SAVELLA
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All Clinical Trials for Savella
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT01038323 ↗ | Drug and Talk Therapy for Fibromyalgia | Completed | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | Phase 4 | 2009-12-01 | Fibromyalgia Syndrome (FMS) afflicts 2% of the U.S. population and have huge individual and societal costs in terms of quality of life, social and work functioning, health care use, and lost productivity. Although single therapy approaches such as medication, graduated exercise, and Cognitive Behavioral Therapy (CBT) are well-established treatment approaches, the majority of FMS continue to report significant levels of pain and pain-related disability. Testing the efficacy of using combination therapies such and CBT with medication has considerable potential to maximize treatment response. Also, exploring the biological and psychological mechanisms underlying combination treatment may pave the way for developing new treatments for FMS sufferers. We chose to study drug and CBT for several reasons: 1) the scarcity of trials that manipulate medications along with CBT in FMS, 2) the prohibitive nature of adding an exercise treatment arm in a study that has both time and budgetary constraints, 3) the complexity in understanding the mechanism of actions of 3 different modes of intervention in one clinical trial, and 4) the desire to explore mechanisms in this program of research, in particular the potential effects of a biological intervention (drug) on what is traditionally considered a psychological outcome (pain-related attributions and cognition) and the potential effects of a psychological intervention (CBT) on what is traditionally considered a physiological outcome (pain sensitivity). |
| NCT01038323 ↗ | Drug and Talk Therapy for Fibromyalgia | Completed | Indiana University | Phase 4 | 2009-12-01 | Fibromyalgia Syndrome (FMS) afflicts 2% of the U.S. population and have huge individual and societal costs in terms of quality of life, social and work functioning, health care use, and lost productivity. Although single therapy approaches such as medication, graduated exercise, and Cognitive Behavioral Therapy (CBT) are well-established treatment approaches, the majority of FMS continue to report significant levels of pain and pain-related disability. Testing the efficacy of using combination therapies such and CBT with medication has considerable potential to maximize treatment response. Also, exploring the biological and psychological mechanisms underlying combination treatment may pave the way for developing new treatments for FMS sufferers. We chose to study drug and CBT for several reasons: 1) the scarcity of trials that manipulate medications along with CBT in FMS, 2) the prohibitive nature of adding an exercise treatment arm in a study that has both time and budgetary constraints, 3) the complexity in understanding the mechanism of actions of 3 different modes of intervention in one clinical trial, and 4) the desire to explore mechanisms in this program of research, in particular the potential effects of a biological intervention (drug) on what is traditionally considered a psychological outcome (pain-related attributions and cognition) and the potential effects of a psychological intervention (CBT) on what is traditionally considered a physiological outcome (pain sensitivity). |
| NCT01077375 ↗ | Study of Milnacipran in Patients With Inadequate Response to Duloxetine for the Treatment of Fibromyalgia | Completed | Cypress Bioscience, Inc. | Phase 4 | 2010-02-01 | The objective of this study is to evaluate the safety, tolerability and efficacy of milnacipran in patients with an inadequate response to duloxetine for the treatment of fibromyalgia. |
| NCT01077375 ↗ | Study of Milnacipran in Patients With Inadequate Response to Duloxetine for the Treatment of Fibromyalgia | Completed | Forest Laboratories | Phase 4 | 2010-02-01 | The objective of this study is to evaluate the safety, tolerability and efficacy of milnacipran in patients with an inadequate response to duloxetine for the treatment of fibromyalgia. |
| NCT01108731 ↗ | The Effect of Milnacipran in Patients With Fibromyalgia | Completed | Beth Israel Medical Center | Phase 2/Phase 3 | 2010-03-01 | Use of the drug Milnacipran will reduce ventricular lactate levels and processing time for completing complex tasks relative to placebo. |
| NCT01125423 ↗ | Study of Fibromyalgia Treated With Milnacipran | Completed | Forest Laboratories | Phase 4 | 2010-05-01 | 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: 1. The pathophysiologic basis of fibromyalgia in some patients may be due to a biochemical and/or morphological pathology among the sensory innervation. 2. Fibromyalgia patients may have different sites of innervation. 3. Milnacipran may have a therapeutic effect on some fibromyalgia patients. 4. Abnormalities in fibromyalgia patients may predict the likelihood of a good response to milnacipran. |
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