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OpenTrials
Completed

NCT Number: NCT01850420

A Study of IMC-1 In 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.

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Key information

Conditions

Fibromyalgia Chronic Pain Muscular Diseases Musculoskeletal Diseases Myofascial Pain Nervous System Diseases Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Rheumatic Diseases Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

IMC Study Site, Birmingham, Alabama, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

IMC-1

Drug

Primary outcomes

  1. 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

  1. Patient Global Impression of Change

    Time frame: 16 weeks

    Patients will rate their global improvement over the duration of the trial

  2. Fibromyalgia Impact Questionnaire

    Time frame: 16 weeks

Sponsors and collaborators

Lead sponsor

Innovative Med Concepts, LLC

Industry

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
May 9, 2013
Registry last updated
Mar 27, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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