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Clinical Trials/NCT01850420
NCT01850420
Completed
Phase 2

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

Innovative Med Concepts, LLC1 site in 1 country143 target enrollmentMay 2013
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ConditionsFibromyalgiaChronic PainMyofascial Pain
InterventionsIMC-1
DrugsIMC-1

Overview

Phase
Phase 2
Intervention
IMC-1
Conditions
Fibromyalgia
Sponsor
Innovative Med Concepts, LLC
Enrollment
143
Locations
1
Primary Endpoint
Change in pain from baseline
Status
Completed
Last Updated
11 years ago
OverviewInvestigatorsEligibility CriteriaArms & InterventionsOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 2013
End Date
March 2014
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Innovative Med Concepts, LLC
Responsible Party
Sponsor

Eligibility 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

Arms & Interventions

IMC-1

Experimental intervention

Intervention: IMC-1

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • Patient Global Impression of Change(16 weeks)
  • Fibromyalgia Impact Questionnaire(16 weeks)

Study Sites (1)

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