Evaluation of Efficacy and Safety of VX-548 for Painful Diabetic Peripheral Neuropathy (DPN)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT05660538 |
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Recruitment Status :
Completed
First Posted : December 21, 2022
Last Update Posted : March 20, 2024
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Sponsor:
Vertex Pharmaceuticals Incorporated
Information provided by (Responsible Party):
Vertex Pharmaceuticals Incorporated
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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 |
|---|---|---|
| Diabetic Peripheral Neuropathy | Drug: VX-548 Drug: Pregabalin Drug: Placebo (matched to VX-548) Drug: Placebo (matched to pregabalin) | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 192 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 : | December 20, 2022 |
| Actual Primary Completion Date : | October 12, 2023 |
| Actual Study Completion Date : | October 25, 2023 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Peripheral Nerve Disorders
Drug Information
available for:
Pregabalin
| Arm | Intervention/treatment |
|---|---|
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Experimental: VX-548
Participants will be randomized to receive different dose levels of VX-548.
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Drug: VX-548
Tablets for oral administration.
Other Name: Suzetrigine Drug: Placebo (matched to pregabalin) Placebo matched to pregabalin for oral administration. |
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Active Comparator: Pregabalin
Participants will receive pregabalin.
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Drug: Pregabalin
Capsules for oral administration. Drug: Placebo (matched to VX-548) Placebo matched to VX-548 for oral administration. |
Primary Outcome Measures :
- Change from Baseline in the Weekly Average of Daily Pain Intensity on a Numeric Pain Rating Scale (NPRS) [ Time Frame: Baseline, Week 12 ]
Secondary Outcome Measures :
- Change from Baseline in the Weekly Average of the Daily Sleep Interference Scale (DSIS) [ Time Frame: 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 [ Time Frame: Baseline, Week 12 ]
- Proportion of Participants Categorized as "Much Improved" or "Very Much Improved" on the Patient Global Impression of Change (PGIC) Assessment [ Time Frame: At 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 14 ]
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| Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Key Inclusion Criteria:
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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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05660538
Locations
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Sponsors and Collaborators
Vertex Pharmaceuticals Incorporated
| Responsible Party: | Vertex Pharmaceuticals Incorporated |
| ClinicalTrials.gov Identifier: | NCT05660538 |
| Other Study ID Numbers: |
VX21-548-103 |
| First Posted: | December 21, 2022 Key Record Dates |
| Last Update Posted: | March 20, 2024 |
| Last Verified: | March 2024 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Plan Description: | 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 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
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Peripheral Nervous System Diseases Diabetic Neuropathies Neuromuscular Diseases Nervous System Diseases Diabetes Complications Diabetes Mellitus Endocrine System Diseases Pregabalin Analgesics Sensory System Agents Peripheral Nervous System Agents |
Physiological Effects of Drugs Anticonvulsants Calcium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Calcium-Regulating Hormones and Agents Anti-Anxiety Agents Tranquilizing Agents Central Nervous System Depressants Psychotropic Drugs |