Study to Assess Mechanisms in Peripheral Tissue Innervation for Fibromyalgia
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01127490|
Recruitment Status : Unknown
Verified December 2010 by Albany Medical College.
Recruitment status was: Recruiting
First Posted : May 21, 2010
Last Update Posted : June 23, 2011
The purpose of this study is to examine the characteristics of the nerves and the small veins in the skin of people with fibromyalgia. The investigators will then use this information to identify possible processes in the skin that may help explain why some people feel pain relief with the study drug (duloxetine) and others do not.
Duloxetine affects certain chemicals in the brain called neurotransmitters. An abnormality in these chemicals is thought to be related to fibromyalgia. Duloxetine is a selective serotonin and norepinephrine reuptake inhibitor (SNRI), similar to some drugs used for the treatment of depression. Duloxetine is approved for sale in the United States by the Food and Drug Administration (FDA) for the treatment of fibromyalgia.
|Condition or disease||Intervention/treatment||Phase|
|Fibromyalgia||Drug: Duloxetine Procedure: Skin biopsy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Duloxetine(Cymbalta) for Fibromyalgia: An Open-Label Pilot Study to Assess Potential Mechanisms for Fibromyalgia in Peripheral Tissue Innervation That Could Predict Therapeutic Responsiveness to Duloxetine|
|Study Start Date :||December 2010|
|Estimated Primary Completion Date :||December 2012|
|Estimated Study Completion Date :||December 2012|
- Drug: Duloxetine
Subjects will be titrated onto Duloxetine over one week by taking 30 mg every day for seven days. Week 2 the subject will begin to take 60 mg per day until the end of the study. If the subject wishes to stop taking Duloxetine, she will be given 30 mg per day for one week for down titration.Other Name: Cymbalta
- Procedure: Skin biopsy
3 mm skin biopsies will be obtained from the dominant trapezius and the glabrous hypothenar area of the handOther Name: Punch biopsy
- Efficacy of duloxetine will be determined by neurological and pain assessments. [ Time Frame: 9 weeks ]Patients will be evaluated prior to being started on duloxetine and again at eight weeks. We will use data from VAS scores, sleep diaries and quantative sensory testing.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01127490
|Contact: Charles E. Argoff, MD||518 firstname.lastname@example.org|
|United States, New York|
|Neurosciences Institute, Albany Medical College||Recruiting|
|Albany, New York, United States, 12208|
|Principal Investigator: Charles Argoff, MD|
|Principal Investigator:||James P. Wymer, MD||Albany Medical College|