CLINICAL TRIALS PROFILE FOR SAVELLA

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.

Clinical Trial Conditions for Savella

Condition Name

Condition Name for Savella
Intervention	Trials
Fibromyalgia	11
Chronic Pain	3
Post Treatment Lyme Syndrome (PTLS)	2
Primary Fibromyalgia Syndrome	1

Condition MeSH

Condition MeSH for Savella
Intervention	Trials
Myofascial Pain Syndromes	12
Fibromyalgia	12
Syndrome	4
Chronic Pain	3

Clinical Trial Locations for Savella

Trials by Country

Trials by Country for Savella
Location	Trials
United States	63
Canada	1

Trials by US State

Trials by US State for Savella
Location	Trials
New York	7
North Carolina	5
California	5
Florida	4
Ohio	3

Clinical Trial Progress for Savella

Clinical Trial Phase

Clinical Trial Phase for Savella
Clinical Trial Phase	Trials
Phase 4	15
Phase 3	5
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for Savella
Clinical Trial Phase	Trials
Completed	18
Terminated	6
Withdrawn	2

Clinical Trial Sponsors for Savella

Sponsor Name

Sponsor Name for Savella
Sponsor	Trials
Forest Laboratories	21
Duke University	3
Cypress Bioscience, Inc.	2

Sponsor Type

Sponsor Type for Savella
Sponsor	Trials
Other	29
Industry	25
U.S. Fed	2