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
• 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

• Chronic Pain
• Fibromyalgia
• Myofascial Pain
• Myofascial Pain Syndromes

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