A Study of IMC-1 In Patients With Fibromyalgia
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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: NCT01850420 |
Recruitment Status :
Completed
First Posted : May 9, 2013
Last Update Posted : March 27, 2015
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Fibromyalgia Chronic Pain Myofascial Pain | Drug: IMC-1 | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 143 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | A Double-Blinded, Randomized, Placebo-Controlled, Proof of Concept Phase 2a Study Exploring the Safety and Efficacy of IMC-1 for the Treatment of Patients With Fibromyalgia |
Study Start Date : | May 2013 |
Actual Primary Completion Date : | January 2014 |
Actual Study Completion Date : | March 2014 |

Arm | Intervention/treatment |
---|---|
Experimental: IMC-1
Experimental intervention
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Drug: IMC-1 |
Placebo Comparator: Matching placebo |
- Change in pain from baseline [ Time Frame: 16 weeks ]Comparison of the change from baseline in patient self reported pain scores between IMC-1 and placebo treatment, over 16 weeks of treatment
- Patient Global Impression of Change [ Time Frame: 16 weeks ]Patients will rate their global improvement over the duration of the trial
- Fibromyalgia Impact Questionnaire [ Time Frame: 16 weeks ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Diagnosis of fibromyalgia
- English speaker
Exclusion Criteria:
- Rheumatologic diseases
- Bipolar disease, OCD, severe anxiety, schizophrenia
- Systemic infection, severe cardiac disease, chronic steroid usage
- chronic opioid usage

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): NCT01850420
United States, Alabama | |
IMC Study Site | |
Birmingham, Alabama, United States | |
United States, California | |
IMC Study Site | |
Sacramento, California, United States | |
IMC Study Site | |
San Diego, California, United States | |
IMC Study Site | |
Vista, California, United States | |
United States, Florida | |
IMC Study Site | |
Jacksonville, Florida, United States | |
IMC Study Site | |
Tampa, Florida, United States | |
United States, Indiana | |
IMC Study Site | |
Evansville, Indiana, United States | |
IMC Study Site | |
Lafayette, Indiana, United States | |
United States, Michigan | |
IMC Study Site | |
Ann Arbor, Michigan, United States | |
United States, North Carolina | |
IMC Study Site | |
Raleigh, North Carolina, United States | |
United States, Oregon | |
IMC Study Site | |
Medford, Oregon, United States | |
United States, Utah | |
IMC Study Site | |
Salt Lake City, Utah, United States |
Responsible Party: | Innovative Med Concepts, LLC |
ClinicalTrials.gov Identifier: | NCT01850420 |
Other Study ID Numbers: |
PRID-201 |
First Posted: | May 9, 2013 Key Record Dates |
Last Update Posted: | March 27, 2015 |
Last Verified: | March 2015 |
fibromyalgia Myofascial |
Fibromyalgia Myofascial Pain Syndromes Chronic Pain Pain Neurologic Manifestations |
Muscular Diseases Musculoskeletal Diseases Rheumatic Diseases Neuromuscular Diseases Nervous System Diseases |