← Back to Search

Other

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 day 1 up to week 14
Awards & highlights

Study Summary

This trial tests the effectiveness & safety of a new drug for treating Painful Diabetic Peripheral Neuropathy (DPN) in people with diabetes.

Eligible Conditions
  • Diabetic Neuropathy

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 up to week 14
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 up to week 14 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from Baseline in the Weekly Average of Daily Pain Intensity on a Numeric Pain Rating Scale (NPRS)
Secondary outcome measures
Change from Baseline in the Weekly Average of the Daily Sleep Interference Scale (DSIS)
Proportion of Participants Categorized as "Much Improved" or "Very Much Improved" on the Patient Global Impression of Change (PGIC) Assessment
Proportions of Participants With Greater Than or Equal to (≥) 30 Percent (%), ≥50%, and ≥70% Reductions from Baseline in the Weekly Average of Daily Pain Intensity on the NPRS
+1 more

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
Placebo (matched to pregabalin)
2022
Completed Phase 2
~200
VX-548
2022
Completed Phase 3
~3500
Placebo (matched to VX-548)
2021
Completed Phase 3
~2970

Find a Location

Who is running the clinical trial?

Vertex Pharmaceuticals IncorporatedLead Sponsor
243 Previous Clinical Trials
32,195 Total Patients Enrolled

Media Library

VX-548 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05660538 — Phase 2
Diabetic Neuropathy Research Study Groups: Pregabalin, VX-548
Diabetic Neuropathy Clinical Trial 2023: VX-548 Highlights & Side Effects. Trial Name: NCT05660538 — Phase 2
VX-548 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05660538 — Phase 2
Diabetic Neuropathy Patient Testimony for trial: Trial Name: NCT05660538 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this investigation include geriatric patients?

"Patients older than 18 and younger than 80 are eligible to apply for participation in this medical study."

Answered by AI

Is VX-548 a benign treatment option for sufferers?

"Based on the existing research, VX-548 has been deemed as moderately safe and scored a 2. This is because this phase of testing only provides evidence that it can be used safely; there are no guarantees regarding its effectiveness."

Answered by AI

Are there any open slots for participants in this investigation?

"As noted on clinicaltrials.gov, this research is recruiting patients at the current moment. This investigation was first published January 1st 2021 and last revised on October 10th 2021."

Answered by AI

Are there any Canadian research centers currently performing this experiment?

"The clinical trial is being administered in 8 different locations, with 4 of them taking part in the study. These are Healthcare Research Network - Chicago in Flossmoor, Boston Neuro Research Center, LLC in North Dartmouth and Healthcare Research Network - Hazelwood in Hazelwood among others."

Answered by AI

What is the population size of participants engaging in this experiment?

"Vertex Pharmaceuticals Incorporated is responsible for recruiting 175 patients that meet the trial's inclusion criteria. These participants will be drawn from two sites, namely Healthcare Research Network - Chicago in Flossmoor, Illinois and Boston Neuro Research Center, LLC in North Dartmouth, Massachusetts."

Answered by AI

Is my participation in this research endeavor allowed?

"For this medical trial, 175 individuals aged 18 to 80 years old with diabetic neuropathy are being recruited. Eligible candidates must also fulfill the following criteria: Diagnosis of type 1 or type 2 diabetes mellitus; Glycosylated hemoglobin A1c (HbA1c) ≤9%, and presence of bilateral pain in lower extremities due to DPN for a minimum 12 months duration."

Answered by AI

Who else is applying?

What state do they live in?
California
Texas
Kansas
Other
What site did they apply to?
University Clinical Investigators
Healthcare Research Network - Chicago
Synexus Clinical Research- New York
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
1
3+

Why did patients apply to this trial?

I've tried gabapentin and although it helps, I'm still in a lot of pain and it seems to be spreading to my hands and getting worse.
PatientReceived no prior treatments
the pain in my feet has gotten so painful i will try almost anything to get it to stop ive been take 1800 mg a day of gabapentin an i think soon that might not be enough.
PatientReceived no prior treatments
I have been suffering with this lack of balance, inability to sleep numbness and off and on pain since 2017. I can't seem to find anything that will help deal with the side effects of Taxol. I was hoping this would be a welcome cure for this disability.
PatientReceived 2+ prior treatments

What questions have other patients asked about this trial?

Are travel costs paid for?
PatientReceived no prior treatments

How responsive is this trial?

Typically responds via
Phone Call
Email
Most responsive sites:
  1. Accel Research Sites - Maitland: < 48 hours
  2. Velocity Clinical Research - Cleveland: < 48 hours
  3. Carolina Institute for Clinical Research: < 48 hours
Average response time
  • < 2 Days
Recent research and studies
clinicaltrials.govStudy
Evaluation of Efficacy and Safety of VX-548 for Painful Diabetic Peripheral Neuropathy (DPN)
2022. "Evaluation of Efficacy and Safety of VX-548 for Painful Diabetic Peripheral Neuropathy (DPN)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05660538.
All > Meridian
~82 spots leftby Apr 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top