Evaluation of Efficacy and Safety of VX-993 for Pain Associated With Diabetic Peripheral Neuropathy

Part of paid clinical trials in Cullman, Alabama.

Sponsor
Vertex Pharmaceuticals Incorporated
Study ID
NCT06619860
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Diabetic Peripheral Neuropathic Pain

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • VX-993 — DRUG
    Tablets for oral administration.
  • Pregabalin — DRUG
    Capsules for oral administration.
  • Placebo (matched to pregabalin) — DRUG
    Placebo matched to pregabalin for oral administration.
  • Placebo (matched to VX-993) — DRUG
    Placebo matched to VX-993 for oral administration.

Study Details

The purpose of this study is to evaluate the efficacy, safety, and tolerability of VX-993 in participants with pain associated with Diabetic Peripheral Neuropathy (DPN)

Key Dates

Start date
Oct 18, 2024
Status verified
Apr 2026
Primary completion
Mar 25, 2027
Completion
Apr 22, 2027

Study Design

Enrollment
300 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: VX-993
    Participants will be randomized to receive multiple doses of different dose levels of VX-993.
  • Active Comparator: Pregabalin
    Participants will be randomized to receive Pregabalin.

Primary Outcome Measure

Change From Baseline in the Weekly Average of Daily Pain Intensity on the Numeric Pain Rating Scale (NPRS) at Week 12 [ Time Frame: From Baseline up to Week 12 ]

Central Contacts

Locations (25)

FacilityCityStateZIPSite coordinators
Cullman Clinical TrialsCullmanAlabama35055-
Trovare Clinical Research - Bakersfield CABakersfieldCalifornia93301-
Eximia Research - San DiegoLa MesaCalifornia91942-
Paradigm Clincial Research Centers, LLC., Wheat RidgeWheat RidgeColorado80033-
Accel Research - DelandDeLandFlorida32720-
AMR Fort Myers (The Clinical Study Center)Fort MyersFlorida33912-
Velocity Clinical Research - Hallandale BeachHallandaleFlorida33009-
Health Awareness, Inc., JupiterJupiterFlorida33458-
Suncoast Research Associates - MiamiMiamiFlorida33172-
Innovation Medical Research Center - PalmettoPalmetto BayFlorida33157-
Health Awareness, Inc. - Port St. LuciePort Saint LucieFlorida34952-
Atlanta Center for Medical ResearchAtlantaGeorgia30331-
Accel Research - DecaturDecaturGeorgia30030-
Velocity Clinical Research - BoiseMeridianIdaho83642-
Healthcare Research Network - Flossmoor ILFlossmoorIllinois604773027-
Quest Research InstituteFarmington HillsMichigan48334-
Healthcare Research Network - Hazelwood MOHazelwoodMissouri63042-
Eximia Research - RaleighRaleighNorth Carolina27607-
Velocity Clinical Research - ClevelandBeachwoodOhio44122-
Velocity Clinical Research - ProvidenceEast GreenwichRhode Island02818-
Clinical Trials of South Carolina - Berkeley - Moncks CornerMoncks CornerSouth Carolina29461-
Gadolin ResearchBeaumontTexas77702-
Velocity Clinical Research, DallasDallasTexas75230-
San Antonio Clinical TrialsSan AntonioTexas78240-
AMR NorfolkNorfolkVirginia23502-

Find similar trials in Cullman, AL

By research site
Cullman Clinical Trials· Cullman, ALTrovare Clinical Research - Bakersfield CA· Bakersfield, CAEximia Research - San Diego· La Mesa, CAParadigm Clincial Research Centers, LLC., Wheat Ridge· Wheat Ridge, COAccel Research - Deland· DeLand, FLAMR Fort Myers (The Clinical Study Center)· Fort Myers, FL

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