A Study of IMC-1 In Patients With Fibromyalgia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

143 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Study Completion Date

2014-03-31

Brief Summary

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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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Detailed Description

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Conditions

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Fibromyalgia Chronic Pain Myofascial Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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IMC-1

Experimental intervention

Group Type EXPERIMENTAL

IMC-1

Intervention Type DRUG

Matching placebo

Group Type PLACEBO_COMPARATOR

No interventions assigned to this group

Interventions

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IMC-1

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No