A Study of IMC-1 In Patients With Fibromyalgia

Phase 2

Completed

• Conditions: Chronic Pain; Myofascial Pain; Fibromyalgia
• Interventions: Drug: IMC-1

• Registration Number: NCT01850420
• Lead Sponsor: Innovative Med Concepts, LLC

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-05
• Study First Submitted: 2013-05-07
• Study First Submitted QC: 2013-05-07
• Study First Posted: 2013-05-09
• Primary Completion: 2014-01
• Study Completion: 2014-03
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-25
• Last Update Posted: 2015-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 143

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IMC-1	IMC-1	Experimental intervention

Primary Outcome Measures

Name	Time	Method
Change in pain from baseline	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

Name	Time	Method
Patient Global Impression of Change	16 weeks	Patients will rate their global improvement over the duration of the trial
Fibromyalgia Impact Questionnaire	16 weeks

Trial Locations

Locations (1)

IMC Study Site; 🇺🇸 Salt Lake City, Utah, United States