Fibromyalgia Research Study

  • STATUS
    Recruiting
  • sponsor
    Tonix
Updated on 6 May 2021

Summary

The study is double-blind, placebo-controlled study of an investigational medication for fibromyalgia. The purpose of the study is to determine how safe and effective the study medication is for fibromyalgia symptoms when taken under the tongue.

Summit Research has been researching fibromyalgia and other medical and mental health conditions since 1976. Our team of doctors, nurses and research staff is dedicated to finding better future treatments.

Description

  • This is a 14 week, double-blind, placebo-controlled study of an investigational medication to be taken under the tongue at bedtime. 
  • There are 7 visits during the course of the study some of which may be able to be completed via telemedicine visit.
  • Participants will be asked to keep a diary of symptoms during the study.
  • Study medication will be taken at bedtime
  • Lab tests and other clinical assessments such as electrocardiogram (ECG) and physical exams will occur at designated times through the study
  • Qualified participants receive all study related care, study drug, and study related office visits at no cost. Health insurance is not required to participate in this study. 
  • Compensation for time and effort may be available. 

Details
Condition Fibromyalgia, Muscle Pain
Clinical Study IdentifierTX272815
SponsorTonix
Last Modified on6 May 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

18 to 65 years of age
Diagnosed with or experiencing symptoms of fibromyalgia
Be able to attend clinic visits (some visits may be able to be conducted via telemedicine)

Exclusion Criteria

Have another condition that may account for fibromyalgia symptoms
Some medications may need to be discontinued temporarily to participate in the study: this should only be done after talking with the prescribing physician
Other criteria may apply. The best way to learn if about a study and if it is right for you is to contact the Recruitment Team at Summit Research
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How to participate?

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What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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