Diabetic Peripheral Neuropathic PainPhase 2NCT06619860
Evaluation of Efficacy and Safety of VX-993 for Pain Associated With Diabetic Peripheral Neuropathy
A Phase 2 study testing VX-993 and Pregabalin in people with Diabetic Peripheral Neuropathic Pain, run by Vertex Pharmaceuticals Incorporated at 47 sites in 6 countries.
Trial summary
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) Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetic Peripheral Neuropathic Pain
- What is being tested?
- VX-993 and Pregabalin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 47 sitesin 6 countries
- Study dates
- 18 Oct 2024to 22 Apr 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of diabetes mellitus type 1 or type 2 with
- Glycosylated hemoglobin A1c (HbA1c) less than or equal to (≤) 9% and
- Presence of bilateral pain in lower extremities due to DPN (defined as a symmetric, length-dependent sensory or sensorimotor polyneuropathy) for at least 1 year
Who cannot join
- Painful neuropathy other than DPN
- History of cardiac dysrhythmias requiring anti-arrhythmia treatment(s)
- History of a clinical atherosclerotic event, such as myocardial infarction or stroke, within the past 12 months
- Other protocol defined Inclusion/Exclusion criteria may apply.
Trial locations and contacts
47 sites in 6 countries. Contact the study team or a site near you to ask about taking part.
47 sites in 6 countries
United States25 sites
- Completed
Atlanta Center for Medical Research
Atlanta, Georgia, 30331
- Completed
Trovare Clinical Research - Bakersfield CA
Bakersfield, California, 93301
- Completed
Velocity Clinical Research - Cleveland
Beachwood, Ohio, 44122
- Completed
Gadolin Research
Beaumont, Texas, 77702
- Completed
Cullman Clinical Trials
Cullman, Alabama, 35055
- Completed
Velocity Clinical Research, Dallas
Dallas, Texas, 75230
- Completed
Accel Research - Decatur
Decatur, Georgia, 30030
- Completed
Accel Research - Deland
DeLand, Florida, 32720
- Completed
Velocity Clinical Research - Providence
East Greenwich, Rhode Island, 02818
- Completed
Quest Research Institute
Farmington Hills, Michigan, 48334
- Completed
Healthcare Research Network - Flossmoor IL
Flossmoor, Illinois, 604773027
- Completed
AMR Fort Myers (The Clinical Study Center)
Fort Myers, Florida, 33912
- Completed
Velocity Clinical Research - Hallandale Beach
Hallandale, Florida, 33009
- Completed
Healthcare Research Network - Hazelwood MO
Hazelwood, Missouri, 63042
- Completed
Health Awareness, Inc., Jupiter
Jupiter, Florida, 33458
- Completed
Eximia Research - San Diego
La Mesa, California, 91942
- Completed
Velocity Clinical Research - Boise
Meridian, Idaho, 83642
- Completed
Suncoast Research Associates - Miami
Miami, Florida, 33172
- Completed
Clinical Trials of South Carolina - Berkeley - Moncks Corner
Moncks Corner, South Carolina, 29461
- Completed
AMR Norfolk
Norfolk, Virginia, 23502
- Completed
Innovation Medical Research Center - Palmetto
Palmetto Bay, Florida, 33157
- Completed
Health Awareness, Inc. - Port St. Lucie
Port Saint Lucie, Florida, 34952
- Completed
Eximia Research - Raleigh
Raleigh, North Carolina, 27607
- Completed
San Antonio Clinical Trials
San Antonio, Texas, 78240
- Completed
Paradigm Clincial Research Centers, LLC., Wheat Ridge
Wheat Ridge, Colorado, 80033
United Kingdom9 sites, 9 recruiting
- Recruiting
Birmingham Heartlands Hospital - Heartlands Hospital Diabetes Centre and MIDRU
Birmingham
- Recruiting
FutureMeds Birmingham
Birmingham
- Recruiting
Ninewells Hospital - Endocrinology
Dundee
- Recruiting
FutureMeds Glasgow
Glasgow
- Recruiting
University of Liverpool - Aintree University Hospital
Liverpool
- Recruiting
St Pancras Clinical Research
London
- Recruiting
Manchester Diabetes Centre (MDC)
Manchester
- Recruiting
George Eliot Hospital NHS Trust
Nuneaton
- Recruiting
Royal Hallamshire Hospital - Endocrinology
Sheffield
Canada4 sites, 4 recruiting
- Recruiting
Centricity Research Brampton
Brampton
- Recruiting
OCT Research ULC
Kelowna
- Recruiting
Altasciences - Beaumont Clinic Montreal
Montreal
- Recruiting
Mount Sinai Hospital - Leadership Sinai Centre for Diabetes (LSCD)
Toronto
France4 sites, 4 recruiting
- Recruiting
Centre Hospitalier Universitaire de Clermont-Ferrand - Site Gabriel-Montpied
Clermont-Ferrand
- Recruiting
CHU de Nîmes - Pain Assessment and Treatment Center
Nîmes
- Recruiting
Hopital Cochin - Rheumatology
Paris
- Recruiting
North Hospital
Saint-Priest-en-Jarez
Germany3 sites, 3 recruiting
- Recruiting
Ruhr-Universitaet Bochum - Heart and Diabetes Center
Bad Oeynhausen
- Recruiting
FutureMeds GmbH
Berlin
- Recruiting
FutureMeds Frankfurt
Offenbach/Main
Italy2 sites, 2 recruiting
- Recruiting
Fondazione IRCCS Istituto Neurologico Carlo Besta
Milan
- Recruiting
IRCCS Ospedale San Raffaele - InSpe and Division of Neuroscience
Milan
About this study
Official title: A Phase 2, Randomized, Double-blind, Active-controlled, Dose-ranging, Parallel-design Study of the Efficacy and Safety of Oral VX-993 in Subjects With Pain Associated With Diabetic Peripheral Neuropathy
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)
- Conditions
- Diabetic Peripheral Neuropathic Pain
- Being tested
- VX-993, Pregabalin, Placebo (matched to pregabalin), Placebo (matched to VX-993)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VX-993Drug
Tablets for oral administration.
PregabalinDrug
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 group | Role | What they receive |
|---|---|---|
| VX-993 | Experimental | Participants will be randomized to receive multiple doses of different dose levels of VX-993. Receives: Drug: VX-993; Drug: Placebo (matched to pregabalin) |
| Pregabalin | Active comparator | Participants will be randomized to receive Pregabalin. Receives: Drug: Pregabalin; Drug: Placebo (matched to VX-993) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in the Weekly Average of Daily Pain Intensity on the Numeric Pain Rating Scale (NPRS) at Week 12
Measured: From Baseline up to Week 12
Secondary outcomes (4)
Proportion of Participants with Greater than or Equal to (≥) 30 Percent (%) Reduction From Baseline in the Weekly Average of Daily Pain Intensity on the NPRS at Week 12
Measured: From Baseline up to Week 12
Proportion of Participants with ≥50% Reduction From Baseline in the Weekly Average of Daily Pain Intensity on the NPRS at Week 12
Measured: From Baseline up to Week 12
Proportion of Participants with ≥70% Reduction From Baseline in the Weekly Average of Daily Pain Intensity on the NPRS at Week 12
Measured: From Baseline up to Week 12
Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Measured: Day 1 up to Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2024
- Study start18 Oct 2024
- Primary completion25 Mar 2027 (estimated)
- Study completion22 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Peripheral Neuropathic PainStudies of the same condition, open and under way.
- More trials run by Vertex Pharmaceuticals IncorporatedThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vertex Pharmaceuticals Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06619860
- Sponsor's protocol ID
- VX24-993-103
- Other IDs
- 2024-514689-38-01
- Status last verified
- Apr 2026
- First submitted
- 27 Sep 2024
- Last updated
- 1 Jun 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Details on Vertex data sharing criteria and process for requesting access can be found at: https://www.vrtx.com/our-science/clinical-trials-data-sharing/
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Double-blind, Active-controlled, Dose-ranging, Parallel-design Study of the Efficacy and Safety of Oral VX-993 in Subjects With Pain Associated With Diabetic Peripheral Neuropathy
- ClinicalTrials.gov ID
- NCT06619860
- Acronym / sponsor ID
- VX24-993-103
- Conditions
- Diabetic Peripheral Neuropathic Pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Vertex Pharmaceuticals IncorporatedIndustry (pharma, biotech, devices)
- Study start
- 18 Oct 2024 (actual)
- Primary completion
- 25 Mar 2027 (estimated)
- Study completion
- 22 Apr 2027 (estimated)
- First posted
- 1 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VX-993 | Experimental | Drug: VX-993, Drug: Placebo (matched to pregabalin)Participants will be randomized to receive multiple doses of different dose levels of VX-993. |
| Pregabalin | Active comparator | Drug: Pregabalin, Drug: Placebo (matched to VX-993)Participants will be randomized to receive Pregabalin. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of diabetes mellitus type 1 or type 2 with
Key exclusion criteria (4 listed)
- Painful neuropathy other than DPN
- History of cardiac dysrhythmias requiring anti-arrhythmia treatment(s)
- History of a clinical atherosclerotic event, such as myocardial infarction or stroke, within the past 12 months
- Other protocol defined Inclusion/Exclusion criteria may apply.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VX-993Tablets for oral administration. | Drug | VX-993 |
| PregabalinCapsules for oral administration. | Drug | Pregabalin |
| Placebo (matched to pregabalin)Placebo matched to pregabalin for oral administration. | Drug | VX-993 |
| Placebo (matched to VX-993)Placebo matched to VX-993 for oral administration. | Drug | Pregabalin |
Primary outcome
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
4 secondary outcomes
Proportion of Participants with Greater than or Equal to (≥) 30 Percent (%) Reduction From Baseline in the Weekly Average of Daily Pain Intensity on the NPRS at Week 12
Time frame: From Baseline up to Week 12
Proportion of Participants with ≥50% Reduction From Baseline in the Weekly Average of Daily Pain Intensity on the NPRS at Week 12
Time frame: From Baseline up to Week 12
Proportion of Participants with ≥70% Reduction From Baseline in the Weekly Average of Daily Pain Intensity on the NPRS at Week 12
Time frame: From Baseline up to Week 12
Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Day 1 up to Week 16
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
- Individual participant dataSharing planned: No. Details on Vertex data sharing criteria and process for requesting access can be found at: https://www.vrtx.com/our-science/clinical-trials-data-sharing/
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
47 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing VX-993 and Pregabalin in people with Diabetic Peripheral Neuropathic Pain, run by Vertex Pharmaceuticals Incorporated at 47 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 47 sites in United States, United Kingdom, Canada, France, Germany and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Medical Information (617-341-6777, medicalinfo@vrtx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2026.