Evaluation of Efficacy and Safety of VX-548 for Painful Diabetic Peripheral Neuropathy (DPN)
Sponsor
Vertex Pharmaceuticals Incorporated (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05660538
Collaborator
(none)
175
11
2
15.4
15.9
1
Study Details
Study Description
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of VX-548 doses in treating Painful DPN.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
175 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Phase 2, Randomized, Double-blind, Active-controlled, Dose-ranging, Parallel-design Study of the Efficacy and Safety of VX-548 in Subjects With Painful Diabetic Peripheral Neuropathy
Actual Study Start Date
:
Dec 20, 2022
Anticipated Primary Completion Date
:
Mar 1, 2024
Anticipated Study Completion Date
:
Apr 1, 2024
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: VX-548 Participants will be randomized to receive different dose levels of VX-548. |
Drug: VX-548
Tablets for oral administration.
Drug: Placebo (matched to VX-548)
Placebo matched to VX-548 for oral administration.
|
| Active Comparator: Pregabalin Participants will receive pregabalin. |
Drug: Pregabalin
Capsules for oral administration.
Drug: Placebo (matched to VX-548)
Placebo matched to VX-548 for oral administration.
|
Outcome Measures
Primary Outcome Measures
- Change from Baseline in the Weekly Average of Daily Pain Intensity on a Numeric Pain Rating Scale (NPRS) [Baseline, Week 12]
Secondary Outcome Measures
- Change from Baseline in the Weekly Average of the Daily Sleep Interference Scale (DSIS) [Baseline, Week 12]
- Proportions of Participants With Greater Than or Equal to (≥) 30 Percent (%), ≥50%, and ≥70% Reductions from Baseline in the Weekly Average of Daily Pain Intensity on the NPRS [Baseline, Week 12]
- Proportion of Participants Categorized as "Much Improved" or "Very Much Improved" on the Patient Global Impression of Change (PGIC) Assessment [At 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 14]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Key Inclusion Criteria:
-
Diagnosis of diabetes mellitus type 1 or type 2 with
-
Glycosylated hemoglobin A1c (HbA1c) ≤9%; and
-
Presence of bilateral pain in lower extremities due to DPN for at least 1 year
Key Exclusion Criteria:
-
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Velocity Clinical Research - Banning | Banning | California | United States | 92220 |
| 2 | Long Beach Clinical Trials Services, Inc. | Long Beach | California | United States | 90806 |
| 3 | University Clinical Investigators | Tustin | California | United States | 92780 |
| 4 | AMR Fort Myers (The Clinical Study Center) | Fort Myers | Florida | United States | 33912 |
| 5 | Healthcare Research Network - Chicago | Flossmoor | Illinois | United States | 60422 |
| 6 | Clinical Trials of America, LLC | Monroe | Louisiana | United States | 71201 |
| 7 | Boston Neuro Research Center, LLC | North Dartmouth | Massachusetts | United States | 02747 |
| 8 | Revival Research Institute | Dearborn | Michigan | United States | 48126 |
| 9 | Healthcare Research Network - Hazelwood | Hazelwood | Missouri | United States | 63042 |
| 10 | StudyMetrix Research, LLC | Saint Peters | Missouri | United States | 63303-3041 |
| 11 | The Center for Clinical Research | Winston-Salem | North Carolina | United States | 27103 |
Sponsors and Collaborators
- Vertex Pharmaceuticals Incorporated
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Vertex Pharmaceuticals Incorporated
ClinicalTrials.gov Identifier:
NCT05660538
Other Study ID Numbers:
- VX21-548-103
First Posted:
Dec 21, 2022
Last Update Posted:
Jan 31, 2023
Last Verified:
Dec 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: