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VX-548 for Peripheral Neuropathy
Phase 2
Waitlist Available
Research Sponsored by Vertex Pharmaceuticals Incorporated
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Summary
This trial is testing a medication called VX-548 to see if it can help reduce pain in people with diabetic nerve pain. The medication works by blocking pain signals from traveling through the nerves.
Eligible Conditions
- Diabetic Neuropathy
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: VX-548Experimental Treatment3 Interventions
Participants will be randomized to receive different dose levels of VX-548.
Group II: PregabalinActive Control2 Interventions
Participants will receive pregabalin.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
VX-548
2022
Completed Phase 3
~3790
Placebo (matched to pregabalin)
2022
Completed Phase 2
~200
Placebo (matched to VX-548)
2021
Completed Phase 3
~2970
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Who is running the clinical trial?
Vertex Pharmaceuticals IncorporatedLead Sponsor
255 Previous Clinical Trials
34,493 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have been diagnosed with type 1 or type 2 diabetes.Your HbA1c level is less than or equal to 9%.It seems like there might be a typo or incomplete information. Can you provide more details or clarify the criterion you'd like me to summarize?You have nerve pain that is not caused by diabetic peripheral neuropathy.You have a history of heart rhythm problems that needed medication to treat.You had a heart attack or stroke in the last year.You have diabetes, and your HbA1c level is higher than 9%.You have had pain in both legs due to diabetic neuropathy for at least 1 year.You have diabetes with a certain level of blood sugar control and have been experiencing pain in both legs due to diabetes for at least a year.
Research Study Groups:
This trial has the following groups:- Group 1: Pregabalin
- Group 2: VX-548
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Diabetic Neuropathy Patient Testimony for trial: Trial Name: NCT05660538 — Phase 2
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