NCT06628908ClinicalTrials.gov
Evaluation of Efficacy and Safety of Suzetrigine for Pain Associated With Diabetic Peripheral Neuropathy
A Phase 3, Randomized, Double-blind, Placebo- and Active-Controlled Study of the Efficacy and Safety of Suzetrigine in Subjects With Pain Associated With Diabetic Peripheral Neuropathy
Kurz gefasst
The purpose of this study is to evaluate the efficacy, safety, and tolerability of Suzetrigine (SUZ) in participants with pain associated with diabetic peripheral neuropathy (DPN).
Phase 31.100 Teilnehmende gesucht76 Studienzentren1 Land
Kategorien
In 1 Register registriert
- ClinicalTrials.govNCT06628908Diesen Eintrag bei ClinicalTrials.gov öffnenSynchronisiert vor 2 Monaten
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How this study is set up
The points below are drawn from the public registry record for this study. Each one cites the field or sentence it came from. A dash (—) means the record does not state something — not that it is missing or wrong. Many well-run studies, especially small ones, leave some of these blank.
- Not stated: Registered after enrolment began (about 7 days after the recorded start)First posted 2024-10-08; recorded start 2024-10-01
- Present: Has a defined primary outcomeA primary outcome measure is listed in the record
- Present: The primary outcome states a time frameThe primary outcome measure records a time frame
- Present: Participants are randomly assignedAllocation is recorded as randomised
- Present: Has a comparison groupThe record lists a placebo or comparator arm, or more than one study arm
- Present: Uses blinding (masking)A masking level is recorded in the record
- Not stated: An ethics committee is not stated in the registry recordThis registry's ingested record has no ethics-committee field
- Not stated: Regulatory oversight (such as an IND or IDE) is not stated in the registry recordThis registry's ingested record has no regulatory-authorisation field
- Not stated: A data monitoring committee is not stated in the registry recordThis registry's ingested record has no data-monitoring-committee fieldA data monitoring committee is not required for many smaller studies, and its absence here is not unusual.
- Present: No cost to participants is mentioned in the recordChecked the summary, description and eligibility text; no cost-to-participant phrase found
- Present: Sponsor has 92 other studies in this databaseCounted from the lead sponsor named in the record (Vertex Pharmaceuticals Incorporated)
- Present: Sponsor has posted results for at least one studyBased on the sponsor’s studies in this database
- The record lists 1 condition.
- Lead sponsor type recorded as: industry.
- Intervention regulatory context: investigational, within a phased regulatory pathway.
Trial stature
Three independent measures of this study, described from its registry record — not a recommendation about it. A rigorous study by investigators nobody has heard of is better evidence than a weak study led by a famous one. How these are scored.
A definitive-grade design for a phase 3 study, judged from its ClinicalTrials.gov record.
How this score is built
- Randomised allocation20/20
Participants are randomly allocated between arms
- Blinding20/20
Quadruple-blind
- Control arm15/15
Active-comparator control arm
- Primary-outcome specificity10/10
Named primary outcome with a defined time frame
- Endpoint type3/10
Surrogate or intermediate endpoint (conservative default)
- Multi-centre8/8
Multi-centre: 76 sites
- Data monitoring committee0/7
Data monitoring committee not stated in the record
- Prospective registration5/5
Registered before the study start date
- Protocol / SAP posted0/5
No protocol or SAP posted to the registry
A large study: 1,100 participants (target), run at 76 sites.
How this score is built
- Enrolment30/40
1,100 participants (target)
- Site count22/25
76 sites
- Country count0/15
Single country
- Planned duration8/10
Planned over about 32 months
- Sponsor scale7/10
Vertex Pharmaceuticals Incorporated has led 90 trials in our corpus
We have no verifiable track record for the investigator named on this trial. That is common for early-career investigators and for records held outside ClinicalTrials.gov — it is not a negative signal.
How this score is built
- Investigator standing0/100
No investigator recorded in the registry for this trial
These describe the registry record only, and today we hold ClinicalTrials.gov data. Absent fields lower a score, and absence often reflects registration practice rather than study quality. A high-stature trial is not necessarily safer or a better choice for you — enrolling in a large definitive trial can mean a higher chance of receiving placebo, while a small early-phase study may be the only route to a new therapy.
Zusammenfassung
The purpose of this study is to evaluate the efficacy, safety, and tolerability of Suzetrigine (SUZ) in participants with pain associated with diabetic peripheral neuropathy (DPN).
Erkrankungen
- Diabetic Peripheral Neuropathic Pain
Eignung
| Geschlecht | Alle |
|---|---|
| Alter | 18 Years – 80 Years |
| Gesunde Freiwillige | Nein |
Eignung im Wortlaut des Registers
Eignung in einfachen Aussagen
Die Kriterien dieses Eintrags wurden noch nicht in einzelne Aussagen aufgeschlüsselt. Der Registertext oben ist vollständig und ist die maßgebliche Fassung.
Studiendesign
| Studientyp | Interventionell |
|---|---|
| Phase | Phase 3 |
| Zuteilung | Randomisiert |
| Interventionsmodell | PARALLEL |
| Primäres Ziel | TREATMENT |
| Verblindung | QUADRUPLE (4) |
| Teilnahme | 1.100 Teilnehmende gesucht |
Sponsor und Mitwirkende
- Vertex Pharmaceuticals Incorporated Sponsor
Studienarme und Interventionen
- Suzetrigine (SUZ)EXPERIMENTAL
Participants will be randomized to receive SUZ.
- PregabalinACTIVE_COMPARATOR
Participants will be randomized to receive Pregabalin.
- PlaceboPLACEBO_COMPARATOR
Participants will be randomized to receive placebo matched to SUZ and Pregabalin.
Interventionen
- Arzneimittel Placebo (matched to Pregabalin)
Placebo matched to Pregabalin for oral administration.
- Arzneimittel Placebo (matched to SUZ)
Placebo matched to SUZ for oral administration.
- Arzneimittel Pregabalin
Capsules for oral administration.
- Arzneimittel Suzetrigine
Tablets for oral administration.
Endpunkte
Primärer Endpunkt
Change From Baseline in the Weekly Average of Daily Pain Intensity on the Numeric Pain Rating Scale (NPRS) at Week 12 Compared to Placebo
Zeitrahmen From Baseline up to Week 12
Sekundärer Endpunkt
Change From Baseline in the Medical Outcomes Study 36-item Short-form Health Status (SF 36v2) Physical Component Summary (PCS) Score at Week 12 Compared to Placebo (pooled with data from Study VX24-548-111)
Zeitrahmen From Baseline up to Week 12
Sekundärer Endpunkt
Change From Baseline in the Weekly Average of Daily Pain Intensity on the NPRS at Week 12 Compared to Pregabalin
Zeitrahmen From Baseline up to Week 12
Daten
| Startdatum | 1. Oktober 2024 (tatsächlich) |
|---|---|
| Primärer Abschluss | 31. Mai 2027 (geschätzt) |
| Abschluss | 31. Mai 2027 (geschätzt) |
| Erstveröffentlichung | 8. Oktober 2024 (tatsächlich) |
| Zuletzt aktualisiert | 15. Juni 2026 |
| Ergebnisse veröffentlicht | Im Registereintrag nicht angegeben |
| Status zuletzt bestätigt | Juni 2026 |
Tatsächlich bedeutet, dass das Ereignis eingetreten ist. Geschätzt bedeutet, dass der Sponsor es erwartet. Die beiden bedeuten Unterschiedliches.
Standorte
59 Studienzentren rekrutieren
United States
| Einrichtung | Stadt | Bundesland oder Region | Status |
|---|---|---|---|
| Albany Medical College | Albany | New York | Abgeschlossen |
| Velocity Clinical Research - Albuquerque | Albuquerque | New Mexico | Rekrutiert |
| Synexus Clinical Research- Anderson | Anderson | South Carolina | Abgeschlossen |
| Pinnacle Research Group, LLC | Anniston | Alabama | Rekrutiert |
| Velocity Clinical Research - Baton Rouge | Baton Rouge | Louisiana | Rekrutiert |
| Velocity Clinical Research - Cleveland | Beachwood | Ohio | Rekrutiert |
| Northwest Clinical Research Center (NWCRC) | Bellevue | Washington | Rekrutiert |
| Synexus Clinical Research - Birmingham | Birmingham | Alabama | Abgeschlossen |
| Mass General Brigham - Brigham and Women's Hospital - Main Campus | Boston | Massachusetts | Rekrutiert |
| Swift Clinical OpCo, Inc | Brooklyn | New York | Rekrutiert |
| Clinical Trials of South Carolina - Berkeley - Charleston | Charleston | South Carolina | Rekrutiert |
| M3 Wake Research - Charleston | Charleston | South Carolina | Rekrutiert |
| Feinberg School of Medicine - Anesthesiology | Chicago | Illinois | Rekrutiert |
| Synexus Clinical Research - Cincinnati | Cincinnati | Ohio | Abgeschlossen |
| Tandem Clinical Research- Covington | Covington | Louisiana | Rekrutiert |
| Synexus Clinical Research - Dallas (DFW) (DRS) | Dallas | Texas | Abgeschlossen |
| Zenos Clinical Research | Dallas | Texas | Rekrutiert |
| AMR Daphne, AL | Daphne | Alabama | Abgeschlossen |
| META Medical Research Institute | Dayton | Ohio | Rekrutiert |
| Accel Research - Deland | DeLand | Florida | Rekrutiert |
| Accel Research - Decatur | Decatur | Georgia | Rekrutiert |
| AMR-Miami | Doral | Florida | Rekrutiert |
| Velocity Clinical Research - Providence | East Greenwich | Rhode Island | Rekrutiert |
| Velocity Clinical Research - Syracuse | East Syracuse | New York | Rekrutiert |
| Velocity Clinical Research - Denver | Englewood | Colorado | Rekrutiert |
| Synexus Clinical Research - Evansville | Evansville | Indiana | Abgeschlossen |
| Healthcare Research Network - Flossmoor IL | Flossmoor | Illinois | Rekrutiert |
| AMR Fort Myers (The Clinical Study Center) | Fort Myers | Florida | Rekrutiert |
| Neuro-Pain Medical Center | Fresno | California | Rekrutiert |
| Velocity Clinical Research - Grants Pass | Grants Pass | Oregon | Abgeschlossen |
| Velocity Clinical Research - Hallandale Beach | Hallandale | Florida | Rekrutiert |
| Healthcare Research Network - Hazelwood MO | Hazelwood | Missouri | Rekrutiert |
| CNS Healthcare - Jacksonville | Jacksonville | Florida | Rekrutiert |
| AMR Kansas City | Kansas City | Missouri | Rekrutiert |
| Accel Research - St. Petersburg-Largo | Largo | Florida | Rekrutiert |
| Synexus Clinical Research - Las Vegas | Las Vegas | Nevada | Abgeschlossen |
| AMR Lexington | Lexington | Kentucky | Rekrutiert |
| Long Beach Research Institute | Long Beach | California | Rekrutiert |
| Angel City Research, Inc | Los Angeles | California | Rekrutiert |
| Accel Research - Maitland | Maitland | Florida | Abgeschlossen |
| HRI - Hassman Research Institute | Marlton | New Jersey | Abgeschlossen |
| Velocity Clinical Research - Medford | Medford | Oregon | Rekrutiert |
| Suburban Research Associates - Media | Media | Pennsylvania | Rekrutiert |
| Velocity Clinical Research - Boise | Meridian | Idaho | Rekrutiert |
| Suncoast Research Associates - Miami | Miami | Florida | Rekrutiert |
| 3Sync Research - Miami Lakes | Miami Lakes | Florida | Rekrutiert |
| West Clinical Research | Morehead City | North Carolina | Rekrutiert |
| AMR Nashville, TN | Nashville | Tennessee | Abgeschlossen |
| Suncoast Clinical Research - New Port Richey | New Port Richey | Florida | Rekrutiert |
| Columbia Presbyterian - The Neurological Institute of New York | New York | New York | Rekrutiert |
26 weitere Studienzentren sind im Registereintrag aufgeführt.
Studiendokumente
In diesem Registereintrag sind keine Dokumente verlinkt.
Änderungen im Zeitverlauf
Seit wir diesen Eintrag erstmals eingelesen haben, wurden keine Änderungen erfasst.
Eine Änderung wird jedes Mal erfasst, wenn der Sponsor den Registereintrag aktualisiert. Status, Daten, Teilnahme und Studienzentren erscheinen hier, sobald sie sich ändern.