Suzetrigine for Diabetic Neuropathy
Palo Alto (17 mi)Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: Vertex Pharmaceuticals Incorporated
Pivotal Trial (Near Approval)
Prior Safety Data
Approved in 1 jurisdiction
Trial Summary
What is the purpose of this trial?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).
What data supports the idea that Suzetrigine for Diabetic Neuropathy is an effective drug?The available research does not provide specific data on Suzetrigine for Diabetic Neuropathy. Instead, it discusses other treatments like benfotiamine, ligustrazine with citicoline, and antioxidant drugs, which have shown effectiveness in reducing symptoms of diabetic neuropathy. Without direct data on Suzetrigine, we cannot compare its effectiveness to these treatments.23467
Do I have to stop taking my current medications for the trial?The protocol does not specify whether you need to stop taking your current medications.
Is the drug Suzetrigine a promising treatment for diabetic neuropathy?The provided research articles do not mention Suzetrigine or its effects on diabetic neuropathy, so we cannot determine if it is a promising treatment based on this information.134911
What safety data exists for Suzetrigine (VX-548) in treating diabetic neuropathy?The provided research does not contain specific safety data for Suzetrigine (VX-548). However, the study titled 'Efficacy and safety of vixotrigine in idiopathic or diabetes-associated painful small fibre neuropathy (CONVEY)' evaluates the safety of vixotrigine, which may be related to Suzetrigine, as both are sodium channel blockers. This study is a phase 2 placebo-controlled trial assessing the safety and efficacy of vixotrigine in treating painful small fibre neuropathy, including cases associated with diabetes.3581012
Eligibility Criteria
This trial is for adults with diabetic peripheral neuropathy who weigh at least 45 kg, have a BMI of 18.0-40.0, and experience consistent pain levels. They must have type 1 or type 2 diabetes with an HbA1c ≤9% and bilateral lower extremity pain due to DPN.Inclusion Criteria
My average pain score is between 4 and 9 over the past week.
I weigh at least 45 kilograms.
I have diabetes with an HbA1c ≤9% and pain in both legs due to nerve damage.
Exclusion Criteria
I have previously participated in a study where I received SUZ.
Treatment Details
The study tests the effectiveness and safety of Suzetrigine (SUZ) compared to Pregabalin and placebos in managing pain from diabetic peripheral neuropathy. Participants will be randomly assigned to receive either SUZ, its placebo, Pregabalin, or its placebo.
3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Suzetrigine (SUZ)Experimental Treatment2 Interventions
Participants will be randomized to receive SUZ.
Group II: PregabalinActive Control2 Interventions
Participants will be randomized to receive Pregabalin.
Group III: PlaceboPlacebo Group2 Interventions
Participants will be randomized to receive placebo matched to SUZ and Pregabalin.
Suzetrigine is already approved in United States for the following indications:
🇺🇸 Approved in United States as Suzetrigine for:
- Moderate-to-severe acute pain
Find a clinic near you
Research locations nearbySelect from list below to view details:
AMR Daphne, ALDaphne, AL
Clinical Trials ResearchSacramento, CA
Velocity Clinical Research - Washington DCWashington, United States
Velocity Clinical Research - NorfolkNorfolk, NE
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Who is running the clinical trial?
Vertex Pharmaceuticals IncorporatedLead Sponsor
References
The use of low-dose trazodone in the treatment of painful diabetic neuropathy. [2022]Thirty-one adult diabetic patients with painful distal symmetrical polyneuropathy were treated with low doses of oral trazodone (50 or 100 mg/day). After 2 weeks of therapy, 19 patients (61.3%) experienced symptomatic relief, and 7 (22.6%) experienced complete relief. Although 8 patients (25.8%) discontinued the drug because of side effects, these were relatively minor (dizziness, headache, insomnia). Low-dose trazodone is recommended as an effective treatment option for painful diabetic neuropathy.
[An effect of antioxidant drugs on symptoms of sensomotor polyneuropathy and affective disorders in patients with diabetes mellitus]. [2016]An effect of 3-oxypiridine and succinic acid derivates--emoxipine, reamberin and mexidole--on severity of clinical symptoms of distal sensomotor polyneuropathy, anxiety and depression was studied in 120 patients with diabetes mellitus with syndrome of diabetic foot. These medications were used in addition to basic antidiabetic therapy. After 14 days of the treatment an equally pronounced decrease of integral index of "negative" neurological symptoms and reduction of anxiety-depressive disorders were detected.
Benfotiamine in diabetic polyneuropathy (BENDIP): results of a randomised, double blind, placebo-controlled clinical study. [2013]Efficacy and safety of benfotiamine in treatment of diabetic polyneuropathy.
[Clinical effect of ligustrazine combined with citicoline for treatment of diabetic peripheral neuropathy]. [2016]To assess the clinical efficacy of the therapeutic schema for treatment of diabetic peripheral neuropathy (DPN) with ligustrazine and citicoline injection in combination.
Safety and tolerability of duloxetine in the acute management of diabetic peripheral neuropathic pain: analysis of pooled data from three placebo-controlled clinical trials. [2015]Summarize safety and tolerability of duloxetine in treating diabetic peripheral neuropathic pain.
Evidence-based guideline: Treatment of painful diabetic neuropathy: report of the American Academy of Neurology, the American Association of Neuromuscular and Electrodiagnostic Medicine, and the American Academy of Physical Medicine and Rehabilitation. [2022]To develop a scientifically sound and clinically relevant evidence-based guideline for the treatment of painful diabetic neuropathy (PDN).
Evidence-based guideline: Treatment of painful diabetic neuropathy: report of the American Academy of Neurology, the American Association of Neuromuscular and Electrodiagnostic Medicine, and the American Academy of Physical Medicine and Rehabilitation. [2022]To develop a scientifically sound and clinically relevant evidence-based guideline for the treatment of painful diabetic neuropathy (PDN).
Sustained-release oxycodone tablets for moderate to severe painful diabetic peripheral neuropathy: a multicenter, open-labeled, postmarketing clinical observation. [2013]To evaluate the efficacy and safety of sustained-release (SR) oxycodone tablets in the treatment of moderate to severe painful diabetic peripheral neuropathy (DPN). Design. This was a multicenter, randomized, open-labeled study.
Efficacy and Safety of Low Doses of Trazodone in Patients Affected by Painful Diabetic Neuropathy and Treated with Gabapentin: A Randomized Controlled Pilot Study. [2022]Painful diabetic neuropathy is an important therapeutic challenge as the efficacy of analgesic drugs in this setting is still unsatisfactory. Monotherapy with available treatments is often not sufficient and a combination of drugs is necessary. Trazodone (TRZ) is a compound with a multi-modal mechanism of action, being a serotonin-2 antagonist/reuptake inhibitor developed and approved for the treatment of depression in several countries. Previous clinical trials suggest a possible beneficial effect of low doses of trazodone for the treatment of patients affected by painful diabetic neuropathy.
Management of Neuropathic Pain in Polyneuropathy. [2021]Many polyneuropathies cause significant neuropathic pain, resulting in substantial morbidity and reduced quality of life. Appropriate management is crucial for maintaining quality of life for patients with painful polyneuropathies. The US Food and Drug Administration (FDA) has only approved one new drug for painful diabetic neuropathy in the past decade, a topical capsaicin patch that was initially approved for the treatment of postherpetic neuralgia in 2009. Gabapentinoids and serotonin norepinephrine reuptake inhibitors (SNRIs) continue to have an advantage in safety profiles and efficacy. Other antiepileptic medications remain second-line agents because of fewer studies documenting efficacy.
Salviae miltiorrhizae and ligustrazine hydrochloride injection combined with mecobalamin for treating diabetic peripheral neuropathy: A protocol for systematic review and meta-analysis. [2023]Currently, it is unclear whether the salviae miltiorrhizae (Danshen Salvia) and ligustrazine hydrochloride (Chuanxiong Chuanxiong) (SMLH) injection combined with mecobalamin can improve diabetic peripheral neuropathy (DPN). We conducted a systematic analysis to evaluate the clinical effects of SMLH injection combined with mecobalamin for treating DPN.
Efficacy and safety of vixotrigine in idiopathic or diabetes-associated painful small fibre neuropathy (CONVEY): a phase 2 placebo-controlled enriched-enrolment randomised withdrawal study. [2023]No pharmacological treatments are specifically indicated for painful small fibre neuropathy (SFN). CONVEY, a phase 2 enriched-enrolment study, evaluated the efficacy and safety of vixotrigine, a voltage- and use-dependent sodium channel blocker, in participants with idiopathic or diabetes-associated painful SFN.