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A Study of IMC-1 In Patients With 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: NCT01850420
Recruitment Status : Completed
First Posted : May 9, 2013
Last Update Posted : March 27, 2015
Sponsor:
Information provided by (Responsible Party):
Innovative Med Concepts, LLC

Study Description
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Brief Summary:
This is a randomized, double-blind, placebo-controlled, 16-week study designed to evaluate the hypothesis that tissue-resident herpes virus may be causally related to fibromyalgia symptoms or recurrence. IMC-1 is a combination treatment that is designed to suppress this suspected virus and thus alleviate fibromyalgia symptoms.

Condition or disease Intervention/treatment Phase
Fibromyalgia Chronic Pain Myofascial Pain Drug: IMC-1 Phase 2

Study Design
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia

Arms and Interventions
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Arm Intervention/treatment
Experimental: IMC-1
Experimental intervention
 Drug: IMC-1
Placebo Comparator: Matching placebo


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Patient Global Impression of Change [ Time Frame: 16 weeks ]
    Patients will rate their global improvement over the duration of the trial

  2. Fibromyalgia Impact Questionnaire [ Time Frame: 16 weeks ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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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
Sponsors and Collaborators
Innovative Med Concepts, LLC
More Information
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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
Keywords provided by Innovative Med Concepts, LLC:
fibromyalgia
Myofascial
Additional relevant MeSH terms:
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Fibromyalgia
Myofascial Pain Syndromes
Chronic Pain
Pain
Neurologic Manifestations
Signs and Symptoms
 Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases