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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-514689-38-01 | Other Identifier | EU Trial (CTIS) Number |
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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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VX-993 | Experimental | Participants will be randomized to receive multiple doses of different dose levels of VX-993. |
|
| Pregabalin | Active Comparator | Participants will be randomized to receive Pregabalin. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VX-993 | Drug | Tablets for oral administration. |
| |
| Pregabalin |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in the Weekly Average of Daily Pain Intensity on the Numeric Pain Rating Scale (NPRS) at Week 12 | From Baseline up to Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 |
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Key Inclusion Criteria:
Diagnosis of diabetes mellitus type 1 or type 2 with
Key Exclusion Criteria:
Other protocol defined Inclusion/Exclusion criteria may apply.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Medical Information | Contact | 617-341-6777 | medicalinfo@vrtx.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cullman Clinical Trials | Completed | Cullman | Alabama | 35055 | United States | |
| Trovare Clinical Research - Bakersfield CA |
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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| 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. |
|
| 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 | From Baseline up to Week 12 |
| Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Day 1 up to Week 16 |
| Completed |
| Bakersfield |
| California |
| 93301 |
| United States |
| Eximia Research - San Diego | Completed | La Mesa | California | 91942 | United States |
| Paradigm Clincial Research Centers, LLC., Wheat Ridge | Completed | Wheat Ridge | Colorado | 80033 | United States |
| Accel Research - Deland | Completed | DeLand | Florida | 32720 | United States |
| AMR Fort Myers (The Clinical Study Center) | Completed | Fort Myers | Florida | 33912 | United States |
| Velocity Clinical Research - Hallandale Beach | Completed | Hallandale | Florida | 33009 | United States |
| Health Awareness, Inc., Jupiter | Completed | Jupiter | Florida | 33458 | United States |
| Suncoast Research Associates - Miami | Completed | Miami | Florida | 33172 | United States |
| Innovation Medical Research Center - Palmetto | Completed | Palmetto Bay | Florida | 33157 | United States |
| Health Awareness, Inc. - Port St. Lucie | Completed | Port Saint Lucie | Florida | 34952 | United States |
| Atlanta Center for Medical Research | Completed | Atlanta | Georgia | 30331 | United States |
| Accel Research - Decatur | Completed | Decatur | Georgia | 30030 | United States |
| Velocity Clinical Research - Boise | Completed | Meridian | Idaho | 83642 | United States |
| Healthcare Research Network - Flossmoor IL | Completed | Flossmoor | Illinois | 604773027 | United States |
| Quest Research Institute | Completed | Farmington Hills | Michigan | 48334 | United States |
| Healthcare Research Network - Hazelwood MO | Completed | Hazelwood | Missouri | 63042 | United States |
| Eximia Research - Raleigh | Completed | Raleigh | North Carolina | 27607 | United States |
| Velocity Clinical Research - Cleveland | Completed | Beachwood | Ohio | 44122 | United States |
| Velocity Clinical Research - Providence | Completed | East Greenwich | Rhode Island | 02818 | United States |
| Clinical Trials of South Carolina - Berkeley - Moncks Corner | Completed | Moncks Corner | South Carolina | 29461 | United States |
| Gadolin Research | Completed | Beaumont | Texas | 77702 | United States |
| Velocity Clinical Research, Dallas | Completed | Dallas | Texas | 75230 | United States |
| San Antonio Clinical Trials | Completed | San Antonio | Texas | 78240 | United States |
| AMR Norfolk | Completed | Norfolk | Virginia | 23502 | United States |
| Centricity Research Brampton | Recruiting | Brampton | Canada |
| OCT Research ULC | Recruiting | Kelowna | Canada |
| Altasciences - Beaumont Clinic Montreal | Recruiting | Montreal | Canada |
| Mount Sinai Hospital - Leadership Sinai Centre for Diabetes (LSCD) | Recruiting | Toronto | Canada |
| Centre Hospitalier Universitaire de Clermont-Ferrand - Site Gabriel-Montpied | Recruiting | Clermont-Ferrand | France |
| CHU de Nîmes - Pain Assessment and Treatment Center | Recruiting | Nîmes | France |
| Hopital Cochin - Rheumatology | Recruiting | Paris | France |
| North Hospital | Recruiting | Saint-Priest-en-Jarez | France |
| Ruhr-Universitaet Bochum - Heart and Diabetes Center | Recruiting | Bad Oeynhausen | Germany |
| FutureMeds GmbH | Recruiting | Berlin | Germany |
| FutureMeds Frankfurt | Recruiting | Offenbach/Main | Germany |
| Fondazione IRCCS Istituto Neurologico Carlo Besta | Recruiting | Milan | Italy |
| IRCCS Ospedale San Raffaele - InSpe and Division of Neuroscience | Recruiting | Milan | Italy |
| Birmingham Heartlands Hospital - Heartlands Hospital Diabetes Centre and MIDRU | Recruiting | Birmingham | United Kingdom |
| FutureMeds Birmingham | Recruiting | Birmingham | United Kingdom |
| Ninewells Hospital - Endocrinology | Recruiting | Dundee | United Kingdom |
| FutureMeds Glasgow | Recruiting | Glasgow | United Kingdom |
| University of Liverpool - Aintree University Hospital | Recruiting | Liverpool | United Kingdom |
| St Pancras Clinical Research | Recruiting | London | United Kingdom |
| Manchester Diabetes Centre (MDC) | Recruiting | Manchester | United Kingdom |
| George Eliot Hospital NHS Trust | Recruiting | Nuneaton | United Kingdom |
| Royal Hallamshire Hospital - Endocrinology | Recruiting | Sheffield | United Kingdom |
| ID | Term |
|---|---|
| D000069583 | Pregabalin |
| ID | Term |
|---|---|
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
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