A Phase 3 interventional study of Savella in Back Pain, sponsored by Brigham and Women's Hospital. Withdrawn at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-01-12.
Sponsored by Brigham and Women's Hospital · Phase 3, Interventional, and Treatment
Chronic pain is a costly syndrome that influences every aspect of a patient's life. Significant interference with sleep, employment, social functioning, and daily activities is common. Chronic pain patients frequently report depression, anxiety, irritability, sexual dysfunction, and decreased energy. Family roles are altered, and worries abound about financial limitations and future consequences of a restricted lifestyle. Epidemiological studies have independently documented that chronic pain is an immense international problem. Chronic pain symptoms afflict one third of the American population (more than 80 million people). Chronic pain accounts for 21% of emergency room visits and 25% of annual missed work days. When direct and indirect costs are considered, chronic pain imposes a greater economic burden than any other disease, with annual estimates up to $100 billion.
Patients will complete a number of questionnaires at baseline and undergo quantitative sensory testing (QST) as well as complete a handheld electronic diary PDA throughout the entire 10 weeks of the study. Patients will be evaluated by a physician and receive a complete history and physical. Radiological studies will be consulted to confirm diagnosis. All subjects who consent to participate in this study will be started on or converted to milnacipran if they are currently taking an SSRI, buproprion, or a TCA. This will be done over a 1 to 2 week period of gradually weaning the antidepressant and escalating milnacipran. All other adjuvant medication will remain constant through the course of the 10-week trial. Efforts will be made to recruit at least 40% of the patients (N= 24) who are not taking opioids for pain.
At the end of the study, all patients will repeat the baseline questionnaires listed above except the demographic questionnaire. They will also be asked to complete the Treatment Helpfulness Questionnaire. We will compare secondary outcome differences (treatment satisfaction and helpfulness) between patients either on or off of opioids.
2,373 studies on the registry are indexed under Back Pain; 284 are open to participants now.
Browse Back Pain studies →Brigham and Women's Hospital is the lead sponsor of 1,236 studies on the registry; 224 are open to participants now.
Of its 116 completed or terminated interventional studies of FDA-regulated products, 64 (55%) have results posted.
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Exclusion Criteria:
The patients will be titrated to the maintenance dose of 50 mg BID over a 7-day period. 12.5 mg QD on day 1 12.5 mg BID on days 2 and 3 25 mg BID on days 4, 5, 6, and 7 50 mg BID beginning day 8
Drug: Savella
The patients will be titrated to the maintenance dose of 50 mg BID over a 7-day period, and will be on the medication for 10 weeks. 12.5 mg QD on day 1 12.5 mg BID on days 2 and 3 25 mg BID on days 4, 5, 6, and 7 50 mg BID beginning day 8
Also known as: HCL (Savella), Milnacipran
Decreased Back Pain
Decreased Back Pain on the Brief Pain Inventory Scale.
Time frame: Over the course of 10 weeks
This study is withdrawn, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.
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Brigham and Women's Hospital