A Study of IMC-1 In Patients With Fibromyalgia

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Innovative Med Concepts, LLC
ClinicalTrials.gov Identifier:
NCT01850420
First received: May 7, 2013
Last updated: October 15, 2013
Last verified: October 2013
  Purpose

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 Intervention Phase
Fibromyalgia
Chronic Pain
Myofascial Pain
Drug: IMC-1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Innovative Med Concepts, LLC:

Primary Outcome Measures:
  • Change in pain from baseline [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    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:
  • Patient Global Impression of Change [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    Patients will rate their global improvement over the duration of the trial

  • Fibromyalgia Impact Questionnaire [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 140
Study Start Date: May 2013
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: IMC-1
Experimental intervention
Drug: IMC-1
Placebo Comparator: Matching placebo

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01850420

Locations
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

No publications provided

Responsible Party: Innovative Med Concepts, LLC
ClinicalTrials.gov Identifier: NCT01850420     History of Changes
Other Study ID Numbers: PRID-201
Study First Received: May 7, 2013
Last Updated: October 15, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Innovative Med Concepts, LLC:
fibromyalgia
Myofascial

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Chronic Pain
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on August 20, 2014