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A Study of IMC-1 In Patients With Fibromyalgia

Primary Purpose

Fibromyalgia, Chronic Pain, Myofascial Pain

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
IMC-1
Sponsored by
Innovative Med Concepts, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fibromyalgia focused on measuring fibromyalgia, Myofascial

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • IMC Study Site
  • IMC Study Site
  • IMC Study Site
  • IMC Study Site
  • IMC Study Site
  • IMC Study Site
  • IMC Study Site
  • IMC Study Site
  • IMC Study Site
  • IMC Study Site
  • IMC Study Site
  • IMC Study Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

IMC-1

Matching placebo

Arm Description

Experimental intervention

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Patient Global Impression of Change
Patients will rate their global improvement over the duration of the trial
Fibromyalgia Impact Questionnaire

Full Information

First Posted
May 7, 2013
Last Updated
March 25, 2015
Sponsor
Innovative Med Concepts, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT01850420
Brief Title
A Study of IMC-1 In Patients With Fibromyalgia
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
May 2013 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
March 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Innovative Med Concepts, LLC

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia, Chronic Pain, Myofascial Pain
Keywords
fibromyalgia, Myofascial

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
143 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IMC-1
Arm Type
Experimental
Arm Description
Experimental intervention
Arm Title
Matching placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
IMC-1
Primary Outcome Measure Information:
Title
Change in pain from baseline
Description
Comparison of the change from baseline in patient self reported pain scores between IMC-1 and placebo treatment, over 16 weeks of treatment
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
Patient Global Impression of Change
Description
Patients will rate their global improvement over the duration of the trial
Time Frame
16 weeks
Title
Fibromyalgia Impact Questionnaire
Time Frame
16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
IMC Study Site
City
Birmingham
State/Province
Alabama
Country
United States
Facility Name
IMC Study Site
City
Sacramento
State/Province
California
Country
United States
Facility Name
IMC Study Site
City
San Diego
State/Province
California
Country
United States
Facility Name
IMC Study Site
City
Vista
State/Province
California
Country
United States
Facility Name
IMC Study Site
City
Jacksonville
State/Province
Florida
Country
United States
Facility Name
IMC Study Site
City
Tampa
State/Province
Florida
Country
United States
Facility Name
IMC Study Site
City
Evansville
State/Province
Indiana
Country
United States
Facility Name
IMC Study Site
City
Lafayette
State/Province
Indiana
Country
United States
Facility Name
IMC Study Site
City
Ann Arbor
State/Province
Michigan
Country
United States
Facility Name
IMC Study Site
City
Raleigh
State/Province
North Carolina
Country
United States
Facility Name
IMC Study Site
City
Medford
State/Province
Oregon
Country
United States
Facility Name
IMC Study Site
City
Salt Lake City
State/Province
Utah
Country
United States

12. IPD Sharing Statement

Learn more about this trial

A Study of IMC-1 In Patients With Fibromyalgia

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