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The purpose of this study is to evaluate the efficacy and safety of VX-548 doses in treating Painful DPN.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pregabalin | Active Comparator | Participants received Pregabalin 100 mg 3 times per day (tid) for 12 weeks |
|
| Suzetrigine (SUZ): Low Dose | Experimental | Participants received SUZ 23 mg tablet once daily (qd) for 12 weeks. |
|
| Suzetrigine (SUZ): Mid Dose | Experimental | Participants received SUZ 46 mg tablet qd for 12 weeks. |
|
| Suzetrigine (SUZ): High Dose | Experimental | Participants received SUZ 69 mg tablet qd for 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Suzetrigine | Drug | Tablets for oral administration. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in the Weekly Average of Daily Pain Intensity on a Numeric Pain Rating Scale (NPRS) | Change from baseline in the weekly mean of the daily Numeric Pain Rating Scale (NPRS) score assessing average pain intensity in the last 24 hours. Pain intensity was recorded on 11-point NPRS, score range: 0 to 10, where 0= no pain and 10= worst imaginable pain. | Baseline, At Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in the Weekly Average of the Daily Sleep Interference Scale (DSIS) Score | Change from baseline in the weekly mean of the Daily Sleep Interference Scale (DSIS) score, which asks participants to describe how pain interfered with the participant's sleep. Response options for the DSIS range from 0 (none) to 10 (severe). | Baseline, 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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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pinnacle Research Group, LLC | Anniston | Alabama | 36207 | United States | ||
| Synexus Clinical Research US - Birmingham |
Details on Vertex data sharing criteria and process for requesting access can be found at: https://www.vrtx.com/independent-research/clinical-trial-data-sharing
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A total of 194 participants were randomized in this study, out of which 192 participants received the study drug. Of these 192 participants, 19 participants from one of the sites were excluded due to lack of compliance with the study drug. Therefore, 173 participants are reported below for Baseline section and Efficacy outcomes and 192 participants are reported for Safety outcome and Adverse event section.
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| ID | Title | Description |
|---|---|---|
| FG000 | Pregabalin | Participants received Pregabalin 100 mg 3 times per day (tid) for 12 weeks. |
| FG001 | Suzetrigine (SUZ): Low Dose | Participants received SUZ 23 mg tablet once daily (qd) for 12 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 17, 2023 | Jun 13, 2025 |
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| Pregabalin | Drug | Capsules for oral administration. |
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| Placebo (matched to SUZ) | Drug | Placebo matched to SUZ for oral administration. |
|
| Placebo (matched to pregabalin) | Drug | Placebo matched to pregabalin for oral administration. |
|
| Percentage of Participants With Greater Than or Equal to (≥) 30 Percent Reduction From Baseline in the Weekly Average of Daily Pain Intensity on the NPRS | Pain intensity was recorded on 11-point NPRS, score range: 0 to 10, where 0= no pain and 10= worst imaginable pain. The percentage of participants with ≥30% reduction from baseline in the weekly average NPRS score at Week 12 was reported. | Baseline, At Week 12 |
| Percentage of Participants With ≥50 Percent Reduction From Baseline in the Weekly Average of Daily Pain Intensity on the NPRS | Pain intensity was recorded on 11-point NPRS, score range: 0 to 10, where 0= no pain and 10= worst imaginable pain.The percentage of participants with ≥50% reduction from baseline in the weekly average NPRS score at Week 12 was reported. | Baseline, At Week 12 |
| Percentage of Participants With ≥70 Percent Reduction From Baseline in the Weekly Average of Daily Pain Intensity on the NPRS | Pain intensity was recorded on 11-point NPRS, score range: 0 to 10, where 0= no pain and 10= worst imaginable pain. The percentage of participants with ≥70% reduction from baseline in the weekly average NPRS score at Week 12 was reported. | Baseline, At Week 12 |
| Percentage of Participants Categorized as "Much Improved" or "Very Much Improved" on the Patient Global Impression of Change (PGIC) Assessment | PGIC is an instrument that measures change in participants' overall status on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). | Baseline, At Week 12 |
| Safety and Tolerability as Assessed by Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Day 1 up to Week 14 |
| Birmingham |
| Alabama |
| 35211 |
| United States |
| Synexus Clinical Research US - Phoenix West | Phoenix | Arizona | 85020 | United States |
| Velocity Clinical Research - Banning | Banning | California | 92220 | United States |
| Long Beach Clinical Trials Services, Inc. | Long Beach | California | 90806 | United States |
| University Clinical Investigators | Tustin | California | 92780 | United States |
| Lynn Institute of the Rockies | Colorado Springs | Colorado | 80918 | United States |
| Fleming Island Center for Clinical Research | Fleming Island | Florida | 32003 | United States |
| AMR Fort Myers (The Clinical Study Center) | Fort Myers | Florida | 33912 | United States |
| Velocity Clinical Research - Hallandale Beach | Hallandale | Florida | 33009-4427 | United States |
| Westside Center for Clinical Research | Jacksonville | Florida | 32205 | United States |
| Accel Research Sites - Tampa | Largo | Florida | 33777 | United States |
| Accel Research Sites - Maitland | Maitland | Florida | 32751 | United States |
| Suncoast Research Associates | Miami | Florida | 33137 | United States |
| Synexus - Orlando | Orlando | Florida | 32806-1041 | United States |
| Synexus - The Villages | The Villages | Florida | 32162-7116 | United States |
| Accel Research Sites - Neurostudies | Decatur | Georgia | 30030 | United States |
| Velocity Clinical Research - Boise (Advanced Clinical Research) | Meridian | Idaho | 83642 | United States |
| Healthcare Research Network - Chicago | Flossmoor | Illinois | 60422 | United States |
| Synexus Clinical Research - Evansville | Evansville | Indiana | 47714 | United States |
| AMR El Dorado | El Dorado | Kansas | 67042 | United States |
| AMR Newton | Newton | Kansas | 67114 | United States |
| AMR Wichita East, KS | Wichita | Kansas | 67207 | United States |
| Clinical Trials of America, LLC | Monroe | Louisiana | 71201 | United States |
| Brigham and Women's Hospital (BWH) - Translational Pain Research | Boston | Massachusetts | 02115 | United States |
| Boston Neuro Research Center, LLC | North Dartmouth | Massachusetts | 02747 | United States |
| Boston PainCare Center | Waltham | Massachusetts | 02451 | United States |
| Revival Research Institute | Dearborn | Michigan | 48126 | United States |
| StudyMetrix Research, LLC | City of Saint Peters | Missouri | 63303-3041 | United States |
| Healthcare Research Network - Hazelwood | Hazelwood | Missouri | 63042 | United States |
| AMR Kansas City | Kansas City | Missouri | 64114-4866 | United States |
| Synexus Clinical Research US - St. Louis | St Louis | Missouri | 63141 | United States |
| Synexus Clinical Research - Henderson | Henderson | Nevada | 89052 | United States |
| Hassman Research Institute | Berlin | New Jersey | 08009 | United States |
| Synexus Clinical Research- New York | New York | New York | 10017 | United States |
| Carolina Institute for Clinical Research | Fayetteville | North Carolina | 28303 | United States |
| Triad Clinical Trials | Greensboro | North Carolina | 27410 | United States |
| The Center for Clinical Research | Winston-Salem | North Carolina | 27103 | United States |
| Synexus - Cincinnati | Cincinnati | Ohio | 45236 | United States |
| Velocity Clinical Research - Cleveland | Cleveland | Ohio | 44122 | United States |
| Velocity Clinical Research - Medford | Medford | Oregon | 97504 | United States |
| Velocity Clinical Research - Providence | East Greenwich | Rhode Island | 02818 | United States |
| Synexus Clinical Research- Anderson | Anderson | South Carolina | 29621 | United States |
| Clinical Trials of South Carolina - Charleston | Charleston | South Carolina | 29406 | United States |
| South Carolina Clinical Research | Orangeburg | South Carolina | 29118 | United States |
| Inquest Clinical Research | Baytown | Texas | 77521 | United States |
| Synexus - Dallas | Dallas | Texas | 75234-7858 | United States |
| Diabetes & Glandular Disease Clinic, P.A | San Antonio | Texas | 78229-4801 | United States |
| Wasatch Clinical Research | Salt Lake City | Utah | 84107 | United States |
| Northwest Clinical Research Center (NWCRC) | Bellevue | Washington | 98007-4209 | United States |
| FG002 | Suzetrigine (SUZ): Mid Dose | Participants received SUZ 46 mg tablet qd for 12 weeks. |
| FG003 | Suzetrigine (SUZ): High Dose | Participants received SUZ 69 mg tablet qd for 12 weeks. |
| Safety Set | Safety set included all participants who received at least 1 dose of the study drug. |
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| Modified Full Analysis Set (mFAS) | The mFAS is defined as all randomized participants who have received at least 1 dose of study drug and are not from Site 115. |
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Baseline data was analyzed based on the Modified Full Analysis Set (mFAS), defined as all randomized participants who have received at least 1 dose of study drug and are not from Site 115.
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| ID | Title | Description |
|---|---|---|
| BG000 | Pregabalin | Participants received Pregabalin 100 mg tid for 12 weeks. |
| BG001 | Suzetrigine (SUZ): Low Dose | Participants received SUZ 23 mg tablet qd for 12 weeks. |
| BG002 | Suzetrigine (SUZ): Mid Dose | Participants received SUZ 46 mg tablet qd for 12 weeks. |
| BG003 | Suzetrigine (SUZ): High Dose | Participants received SUZ 69 mg tablet qd for 12 weeks. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||
| Sex: Female, Male | Count of Participants | Participants | No |
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| Race/Ethnicity, Customized | Count of Participants | Participants | No |
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| Race/Ethnicity, Customized | Count of Participants | Participants | No |
| ||||||||||
| Baseline Weekly Average Pain Intensity as Recorded on Numeric Pain Rating Scale (NPRS) | Baseline weekly average pain intensity is defined as the average of non-missing pain intensity scores collected Days -7 to -1. Pain intensity was recorded on 11-point NPRS, score range: 0 to 10, where 0=no pain and 10=worst imaginable pain.Here "Number analyzed" signifies those participants who are evaluated for this specific baseline measure. | Mean | Standard Deviation | units on a scale |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in the Weekly Average of Daily Pain Intensity on a Numeric Pain Rating Scale (NPRS) | Change from baseline in the weekly mean of the daily Numeric Pain Rating Scale (NPRS) score assessing average pain intensity in the last 24 hours. Pain intensity was recorded on 11-point NPRS, score range: 0 to 10, where 0= no pain and 10= worst imaginable pain. | Modified Full Analysis Set (mFAS) included all randomized participants who have received at least 1 dose of study drug and are not from Site 115. Here "Overall Number of Participants Analyzed" signifies those participants who were evaluated for this outcome measure. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Baseline, At Week 12 |
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| Secondary | Change From Baseline in the Weekly Average of the Daily Sleep Interference Scale (DSIS) Score | Change from baseline in the weekly mean of the Daily Sleep Interference Scale (DSIS) score, which asks participants to describe how pain interfered with the participant's sleep. Response options for the DSIS range from 0 (none) to 10 (severe). | mFAS. Here "Overall Number of Participants Analyzed" signifies those participants who were evaluated for this outcome measure. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Baseline, At Week 12 |
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| Secondary | Percentage of Participants With Greater Than or Equal to (≥) 30 Percent Reduction From Baseline in the Weekly Average of Daily Pain Intensity on the NPRS | Pain intensity was recorded on 11-point NPRS, score range: 0 to 10, where 0= no pain and 10= worst imaginable pain. The percentage of participants with ≥30% reduction from baseline in the weekly average NPRS score at Week 12 was reported. | mFAS. Here "Overall Number of Participants Analyzed" signifies those participants who were evaluated for this outcome measure. | Posted | Number | percentage of participants | Baseline, At Week 12 |
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| Secondary | Percentage of Participants With ≥50 Percent Reduction From Baseline in the Weekly Average of Daily Pain Intensity on the NPRS | Pain intensity was recorded on 11-point NPRS, score range: 0 to 10, where 0= no pain and 10= worst imaginable pain.The percentage of participants with ≥50% reduction from baseline in the weekly average NPRS score at Week 12 was reported. | mFAS. Here "Overall Number of Participants Analyzed" signifies those participants who were evaluated for this outcome measure. | Posted | Number | percentage of participants | Baseline, At Week 12 |
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| Secondary | Percentage of Participants With ≥70 Percent Reduction From Baseline in the Weekly Average of Daily Pain Intensity on the NPRS | Pain intensity was recorded on 11-point NPRS, score range: 0 to 10, where 0= no pain and 10= worst imaginable pain. The percentage of participants with ≥70% reduction from baseline in the weekly average NPRS score at Week 12 was reported. | mFAS. Here "Overall Number of Participants Analyzed" signifies those participants who were evaluated for this outcome measure. | Posted | Number | percentage of participants | Baseline, At Week 12 |
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| Secondary | Percentage of Participants Categorized as "Much Improved" or "Very Much Improved" on the Patient Global Impression of Change (PGIC) Assessment | PGIC is an instrument that measures change in participants' overall status on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). | mFAS.Here "Overall Number of Participants Analyzed" signifies those participants who were evaluated for this outcome measure. | Posted | Number | percentage of participants | Baseline, At Week 12 |
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| Secondary | Safety and Tolerability as Assessed by Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Safety set included all participants who had received at least 1 dose of study drug. | Posted | Count of Participants | Participants | No | Day 1 up to Week 14 |
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Day 1 up to Week 14
Safety set included all participants who had received at least 1 dose of study drug.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pregabalin | Participants received Pregabalin 100 mg 3 tid for 12 weeks. | 0 | 54 | 1 | 54 | 12 | 54 |
| EG001 | Suzetrigine (SUZ): Low Dose | Participants received SUZ 23 mg tablet qd for 12 weeks. | 0 | 28 | 0 | 28 | 4 | 28 |
| EG002 | Suzetrigine (SUZ): Mid Dose | Participants received SUZ 46 mg tablet qd for 12 weeks. | 1 | 55 | 2 | 55 | 5 | 55 |
| EG003 | Suzetrigine (SUZ): High Dose | Participants received SUZ 69 mg tablet qd for 12 weeks. | 0 | 55 | 1 | 55 | 7 | 55 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | MedDRA 26.1 | Systematic Assessment |
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| Cellulitis | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
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| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
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| Arteriosclerosis | Vascular disorders | MedDRA 26.1 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Oedema peripheral | General disorders | MedDRA 26.1 | Systematic Assessment |
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| Creatinine renal clearance decreased | Investigations | MedDRA 26.1 | Systematic Assessment |
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| Weight increased | Investigations | MedDRA 26.1 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Monitor | Vertex Pharmaceuticals Incorporated | 617-341-6777 | medicalinfo@vrtx.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 8, 2023 | Jun 13, 2025 | SAP_001.pdf |
| 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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| Not Hispanic or Latino |
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| Black or African American |
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| Asian |
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| American Indian or Alaska Native |
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| Other |
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| Multiracial |
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| Units | Counts |
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| Participants |
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| Participants |
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