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A Study of IMC-1 In Patients With Fibromyalgia

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Innovative Med Concepts, LLC
ClinicalTrials.gov Identifier:
NCT01850420
First received: May 7, 2013
Last updated: October 15, 2013
Last verified: October 2013

May 7, 2013
October 15, 2013
May 2013
January 2014   (final data collection date for primary outcome measure)
Change in pain from baseline [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
Comparison of the change from baseline in patient self reported pain scores between IMC-1 and placebo treatment, over 16 weeks of treatment
Same as current
Complete list of historical versions of study NCT01850420 on ClinicalTrials.gov Archive Site
  • Patient Global Impression of Change [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    Patients will rate their global improvement over the duration of the trial
  • Fibromyalgia Impact Questionnaire [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Study of IMC-1 In Patients With Fibromyalgia
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

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Fibromyalgia
  • Chronic Pain
  • Myofascial Pain
Drug: IMC-1
  • Experimental: IMC-1
    Experimental intervention
    Intervention: Drug: IMC-1
  • Placebo Comparator: Matching placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
140
March 2014
January 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01850420
PRID-201
No
Innovative Med Concepts, LLC
Innovative Med Concepts, LLC
Not Provided
Not Provided
Innovative Med Concepts, LLC
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP