A Study of IMC-1 In Patients With Fibromyalgia | NCT01850420

Studies
A Study of IMC-1 In Patients With Fibromyalgia

NCT01850420

Sponsor

Innovative Med Concepts, LLC

Status

Completed

Last Update Posted

Mar 27, 2015Estimated

Enrollment

143Actual

Phase

Phase 2

Conditions

Fibromyalgia
Chronic Pain
Myofascial Pain

Interventions

IMC-1

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2013

Primary Completion Date

Jan 2014Actual

Completion Date

Mar 2014Actual

First Submitted Date

May 7, 2013

First Submission Date that Met QC Criteria

May 7, 2013

First Posted Date

May 9, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 25, 2015

Last Update Posted Date

Mar 27, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

143Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
IMC-1	Experimental	Experimental intervention	Drug: IMC-1
Matching placebo	Placebo Comparator

Interventions

Name	Type	Description	Arm Group Labels	Other Names
IMC-1	Drug		IMC-1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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	16 weeks

Secondary Outcomes

Measure	Description	Time Frame
Patient Global Impression of Change	Patients will rate their global improvement over the duration of the trial	16 weeks
Fibromyalgia Impact Questionnaire		16 weeks

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
IMC Study Site		Birmingham	Alabama		United States
IMC Study Site

Type	Date	Date Unknown
Release	May 18, 2021
Reset	Jun 11, 2021
Release	Mar 25, 2022
Reset	Apr 21, 2022

Submission Tracking

Estimated Results First Submitted Date

May 18, 2021

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
May 18, 2021			Jun 11, 2021
Mar 25, 2022

Condition Browse Module

MeSH Terms

ID	Term
D005356	Fibromyalgia
D059350	Chronic Pain

Ancestor Terms

ID	Term
D009135	Muscular Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases
D009468	Neuromuscular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided