Clinical Trial 43594

Kenosha, WI 53144


Summary:

Study 43594 Flyer
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The main purpose of this study is to see whether TNX-102 SL can help people with fibromyalgia (FM). Researchers also want to find out if TNX-102 SL is safe and tolerable for use over 14 weeks. TNX-102 SL is the drug cyclobenzaprine in a new sublingual formulation, which means it is designed to be placed under the tongue and allowed to dissolve there.
In addition, this study will compare TNX-102 SL with a placebo to see if taking TNX-102 SL is better than taking a placebo. The placebo is a tablet that looks like the TNX-102 SL tablet but has no active drug (cyclobenzaprine) in it.

The researchers at Tonix Pharmaceuticals think that improving sleep quality will help reduce fatigue, tenderness, pain and other symptoms of fibromyalgia. TNX-102 SL is an investigational drug that may improve symptoms of fibromyalgia, such as pain and sleep disturbance. TNX-102 SL is taken at bedtime once per day and is to be taken sublingually. “Sublingually” means the tablet should be placed under the tongue and allowed to dissolve, which takes about 90 seconds. The goal is for the study drug to be absorbed directly from under the tongue so that it enters the blood stream more quickly than when swallowed

Your participation will last approximately 15-19 weeks with 6 visits.


Qualified Participants Must:

• Be 18 to 75 years of age
• Have had fibromyalgia symptoms at a similar level at least 3 months
• Have a daily fibro pain at 4 or higher on a scale of 1 to 10


Qualified Participants May Receive:

All study-related care, medication, and labs at no cost

Compensation for time and travel of $50 for each completed visit


Clinical trials are medical research studies designed to test the safety and/or effectiveness of new investigational drugs, devices, or treatments in humans. These studies are conducted worldwide for a range of conditions and illnesses. Learn more about clinical research and participating in a study at About Clinical Trials.