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Evaluation of the Long-term Safety and Effectiveness of Suzetrigine (SUZ) in Participants With Painful Diabetic Peripheral Neuropathy (DPN)
Evaluation of the Long-term Safety and Effectiveness of Suzetrigine (SUZ) in Participants With Painful Diabetic Peripheral Neuropathy (DPN)

NCT06696443

Active Not RecruitingPhase 3

Sponsor: Vertex Pharmaceuticals Incorporated

Conditions: Diabetic Peripheral Neuropathic Pain

Interventions: Suzetrigine

Countries: United States

The purpose of this study is to evaluate the long-term safety and tolerability of SUZ and long-term effectiveness of SUZ in treating pain associated with DPN.

Eligibility overview

Sex: ALL

Age: 18 Years to 80 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Key Inclusion Criteria:

• Completed the final visit in the Treatment Period (i.e., Week 12) and subsequent 7-day period (to allow for taper of blinded capsule study drug) in a parent study such as VX24-548-110 or VX24-548-111

Key Exclusion Criteria:

* Any sensory abnormality (excluding DPN)
* History of drug intolerance in a parent study that would pose an additional risk to the participant in the opinion of the investigator
* Current participation in an investigational drug trial (other than a parent study)

Other protocol defined Inclusion/Exclusion criteria may apply.
Locations (65)
  • Anniston, Alabama, United States
  • Daphne, Alabama, United States
  • Scottsdale, Arizona, United States
  • Fresno, California, United States
  • Long Beach, California, United States
  • Los Angeles, California, United States
  • Pomona, California, United States
  • Sacramento, California, United States
  • San Bernardino, California, United States
  • Thousand Oaks, California, United States
  • Englewood, Colorado, United States
  • Washington D.C., District of Columbia, United States
  • Coral Gables, Florida, United States
  • DeLand, Florida, United States
  • Doral, Florida, United States
  • Fort Myers, Florida, United States
  • Hallandale, Florida, United States
  • Jacksonville, Florida, United States
  • Largo, Florida, United States
  • Maitland, Florida, United States
  • Miami Lakes, Florida, United States
  • New Port Richey, Florida, United States
  • Orlando, Florida, United States
  • Winter Park, Florida, United States
  • Decatur, Georgia, United States
  • Meridian, Idaho, United States
  • Chicago, Illinois, United States
  • Tinley Park, Illinois, United States
  • Evansville, Indiana, United States
  • Wichita, Kansas, United States
  • + 35 more on CT.gov