A Study of IMC-1 In Patients With Fibromyalgia

March 25, 2015 updated by: Innovative Med Concepts, LLC

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

143

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States
        • IMC Study Site
    • California
      • Sacramento, California, United States
        • IMC Study Site
      • San Diego, California, United States
        • IMC Study Site
      • Vista, California, United States
        • IMC Study Site
    • Florida
      • Jacksonville, Florida, United States
        • IMC Study Site
      • Tampa, Florida, United States
        • IMC Study Site
    • Indiana
      • Evansville, Indiana, United States
        • IMC Study Site
      • Lafayette, Indiana, United States
        • IMC Study Site
    • Michigan
      • Ann Arbor, Michigan, United States
        • IMC Study Site
    • North Carolina
      • Raleigh, North Carolina, United States
        • IMC Study Site
    • Oregon
      • Medford, Oregon, United States
        • IMC Study Site
    • Utah
      • Salt Lake City, Utah, United States
        • IMC Study Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Matching placebo
Experimental: IMC-1
Experimental intervention
Drug: IMC-1

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
16 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Global Impression of Change
Time Frame: 16 weeks
Patients will rate their global improvement over the duration of the trial
16 weeks
Fibromyalgia Impact Questionnaire
Time Frame: 16 weeks
16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Innovative Med Concepts, LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2013

Primary Completion (Actual)

January 1, 2014

Study Completion (Actual)

March 1, 2014

Study Registration Dates

First Submitted

May 7, 2013

First Submitted That Met QC Criteria

May 7, 2013

First Posted (Estimate)

May 9, 2013

Study Record Updates

Last Update Posted (Estimate)

March 27, 2015

Last Update Submitted That Met QC Criteria

March 25, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRID-201

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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