A Study of IMC-1 In Patients With Fibromyalgia

Innovative Med Concepts

Status and phase: Completed; Phase 2

Conditions: Fibromyalgia; Chronic Pain; Myofascial Pain

Treatments: Drug: IMC-1

Study type: Interventional

Funder types: Industry

Identifiers

NCT01850420

PRID-201

Details and patient eligibility

About

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.

Enrollment: 143 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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143 participants in 2 patient groups, including a placebo group

IMC-1

Experimental group

Description:

Experimental intervention

Treatment:

Drug: IMC-1

Matching placebo

Placebo Comparator group