Last updated on November 2017

Fibromyalgia Study


Other Details:

Risks and Benefits for Study Subjects:
The results from nonclinical studies suggest that subjects treated with DS-5565 may experience improvement in pain associated with FM. The clinical efficacy of DS-5565 has been evaluated in two Phase 2, multi-center, randomized, double-blind, placebo and active-comparator controlled adaptive studies in subjects with DPNP. In the first study (conducted in the US), the DS-5565 15 mg QD, 10 mg BID, and 15 mg BID treatment groups demonstrated statistically significant mean reductions in ADPS from baseline to end-of-treatment compared to placebo. These data provide proof-of-concept for DS-5565 as a treatment for chronic pain. The second Phase 2 study was similarly designed and conducted in Asia (Japan, South Korea, and Taiwan). The DS-5565 5 mg BID, 10 mg BID, and 15 mg BID treatment groups did not demonstrate statistically significant mean reductions in ADPS; however, trends favoring DS-5565 over placebo were evident in some secondary efficacy endpoints including mean reductions in VAS for the Short-fom1 McGill Pain Questionnaire at the highest dose.

Anticipated risks of DS-5565 include the occurrence of adverse reactions related to CNS depression, such as dizziness and somnolence, as well as peripheral edema. Other notable TEAEs that have been observed in Phase l and Phase 2 studies include elevations of hepatic transaminases and suicide. For the approved a21i ligands, in addition to dizziness, somnolence, and peripheral edema, certain adverse reactions requiring caution have also been reported, including but not limited to: weight gain, ophthalmologic disorders, suicidal behavior and ideation, angioedema, hypersensitivity, abrupt or rapid discontinuation, abuse potential, congestive heart failure, renal failure, and creatine kinase elevations.

A full description of safety data related to DS-5565, including the results of Phase 1 and Phase 2 clinical studies of DS-5565, is provided in the DS-5565 Investigator's Brochure. Safety monitoring procedures described in the protocol are considered to be adequate to protect subject safety.



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Laurie Johnson

Northern California Research
Sacramento, CA USA
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Amy Strombach

Upstate Clinical Research Associates
Williamsville, NY USA
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