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VX-548 for Sciatica

Phase 2
Recruiting
Research Sponsored by Vertex Pharmaceuticals Incorporated
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Body weight greater than or equal to (>=)45 kilogram (kg)
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from day 1 up to week 14
Awards & highlights

Study Summary

This trial is testing a new medication called VX-548 to see if it is effective and safe for treating people with PLSR.

Who is the study for?
This trial is for individuals who have been experiencing sciatica or radiculopathy pain for more than 3 months. Participants must have a consistent moderate level of pain and meet specific body weight (over 45 kg) and BMI (40 kg/m^2 or less) requirements.Check my eligibility
What is being tested?
The study aims to test the effectiveness and safety of a medication called VX-548 in treating painful lumbosacral radiculopathy. Some participants will receive VX-548, while others will be given a placebo to compare results.See study design
What are the potential side effects?
While the side effects of VX-548 are not detailed here, common side effects from similar medications may include nausea, dizziness, headache, or allergic reactions. The trial seeks to identify any potential adverse effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My weight is at least 45 kg.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from day 1 up to week 14
This trial's timeline: 3 weeks for screening, Varies for treatment, and from 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 leg 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)
Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: VX-548Experimental Treatment1 Intervention
Participants will receive VX-548 up to 12 weeks.
Group II: PlaceboPlacebo Group1 Intervention
Participants will receive placebo matched to VX-548 up to 12 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
VX-548
2022
Completed Phase 3
~3500

Find a Location

Who is running the clinical trial?

Vertex Pharmaceuticals IncorporatedLead Sponsor
243 Previous Clinical Trials
32,187 Total Patients Enrolled

Frequently Asked Questions

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

Is the eligibility criteria for this medical study inclusive of individuals below the age of 40?

"This clinical trial is seeking participants who are over 18 years of age but under the age of 70."

Answered by AI

What is the current number of individuals receiving treatment in this particular research study?

"To successfully conduct this clinical trial, a total of 200 eligible patients are required. Patients from various locations have the opportunity to participate in this study, including JBR Clinical Research located in Salt Lake City, Utah and Arizona Research Center situated in Phoenix, Arizona."

Answered by AI

Are individuals currently able to apply and participate in this ongoing research study?

"Indeed, the information available on clinicaltrials.gov indicates that this particular clinical trial is actively seeking eligible participants. The initial posting of the study occurred on December 13th, 2023, and it was most recently updated on January 10th, 2024. A total of 200 patients will be enrolled in this study across eleven different sites."

Answered by AI

At how many distinct sites is this clinical trial currently being conducted?

"At present, this clinical trial is accepting patient enrollment at 11 distinct locations. These sites are located in Salt Lake City, Phoenix, Banning, and various other places. For the convenience of participants, it is advisable to choose a site nearest to their location in order to minimize travel obligations."

Answered by AI

Has the FDA granted its approval for VX-548?

"Our team at Power has assigned a safety rating of 2 to VX-548, indicating that there is limited data supporting its safety but no evidence yet for efficacy. This assessment aligns with the phase 2 trial design."

Answered by AI

Who else is applying?

What site did they apply to?
Atlanta Center for Medical Research
Velocity Clinical Research - Rockville
AMR Las Vegas (Clinical Research Consortium)
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria

Why did patients apply to this trial?

There has to be something better than gabapentin or lyrica. This has really interrupted my life. And has made me have panic-anixity attacks.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
Evaluation of Efficacy and Safety of VX-548 for Painful Lumbosacral Radiculopathy (PLSR)
2023. "Evaluation of Efficacy and Safety of VX-548 for Painful Lumbosacral Radiculopathy (PLSR)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06176196.
All > Pflugerville Tx > Meridian
~133 spots leftby Apr 2025
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