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NCT01850420 Clinical Trial

A Study of IMC-1 In Patients With Fibromyalgia

Chronic Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01850420
Other study ID # PRID-201
Secondary ID
Status Completed
Phase Phase 2
First received May 7, 2013
Last updated March 25, 2015
Start date May 2013
Est. completion date March 2014

Study information
Verified date March 2015
Source Innovative Med Concepts, LLC
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 143
Est. completion date March 2014
Est. primary completion date January 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• IMC-1

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

Sponsors (1)
Lead Sponsor Collaborator
Innovative Med Concepts, LLC

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in pain from baseline 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 No
Secondary Patient Global Impression of Change Patients will rate their global improvement over the duration of the trial 16 weeks No
Secondary Fibromyalgia Impact Questionnaire 16 weeks No
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