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

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Vertex Pharmaceuticals

Status and phase

Not yet enrolling
Phase 3

Conditions

Diabetic Peripheral Neuropathic Pain

Treatments

Drug: Suzetrigine

Study type

Interventional

Funder types

Industry

Identifiers

NCT06696443
VX24-548-112

Details and patient eligibility

About

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.

Enrollment

300 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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

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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

300 participants in 1 patient group

Suzetrigine (SUZ)
Experimental group
Description:
Participants will receive SUZ once daily (qd) up to 52 weeks.
Treatment:
Drug: Suzetrigine

Trial contacts and locations

0

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Central trial contact

Medical Information

Data sourced from clinicaltrials.gov

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