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Evaluation of Efficacy and Safety of Suzetrigine for Pain Associated With Diabetic Peripheral Neuropathy

ConditionDiabetic Peripheral Neuropathic Pain
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-80
SponsorVertex Pharmaceuticals Incorporated

About 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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Body weight greater than or equal to (≥) 45 kilogram (kg)

Body mass index (BMI) ≥18.0 to less than (<) 40.0 kilogram per meter square (kg/m²)

Diagnosis of diabetes mellitus type 1 or type 2 by glycosylated hemoglobin A1c (HbA1c) ≤9% and the presence of bilateral pain in lower extremities due to DPN

Weekly average of daily NPRS score ≥4 and less than or equal to (≤) 9 with limited variation in the 7-day Baseline Period

Disqualifiers

More than 3 missing daily NPRS scores during the 7-day Baseline Period

Any sensory abnormality (excluding DPN) as pre-specified in the protocol

Trial design

Design model

Parallel

Treatments tested in this trial

  • Suzetrigine

    Drug

    Tablets for oral administration.

  • Placebo (matched to SUZ)

    Drug

    Placebo matched to SUZ for oral administration.

  • Pregabalin

    Drug

    Capsules for oral administration.

  • Placebo (matched to Pregabalin)

    Drug

    Placebo matched to Pregabalin for oral administration.

Treatment groups

1,100 Participants
are divided into 3 treatment groups
Group A: Suzetrigine (SUZ)Experimental treatment 2 interventions
Group B: PregabalinActive comparator 2 interventions
Group C: PlaceboPlacebo comparator 2 interventions

Trial outcomes

Primary outcomes

1

Change From Baseline in the Weekly Average of Daily Pain Intensity on the Numeric Pain Rating Scale (NPRS) at Week 12 Compared to Placebo

Time frame
From Baseline up to Week 12

Secondary outcomes

1

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)

Time frame
From Baseline up to Week 12
2

Change From Baseline in the Weekly Average of Daily Pain Intensity on the NPRS at Week 12 Compared to Pregabalin

Time frame
From Baseline up to Week 12

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Vertex Pharmaceuticals Incorporated

Lead sponsor

Source ClinicalTrials.gov
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