VX-993 for Painful diabetic peripheral neuropathy

Inclusion criteria

• {"criterion_text":"- Diagnosis of diabetes mellitus type 1 or type 2 with o glycosylated hemoglobin A1c (HbA1c) ≤9%; o in the opinion of the investigator, optimized glycemic control, and subject has been stable on anti-diabetic medicine/drugs or dietary treatment for ≥3 months before Screening Visit 1; and o presence of bilateral pain in lower extremities due to DPN (defined as a symmetric, length-dependent sensory or sensorimotor polyneuropathy) for at least 1 year."}

Exclusion criteria

• {"criterion_text":"- Painful neuropathy other than DPN, such as post-herpetic neuralgia, post-traumatic nerve injury, diabetic amyotrophy, human immunodeficiency virus (HIV) neuropathy, immune sensory and autonomic polyneuropathy (e.g., Sjogren’s syndrome), hereditary sensory and autonomic polyneuropathy, focal diabetic neuropathies (e.g., proximal motor neuropathy, mononeuropathy, mononeuropathy multiplex), or chronic regional pain syndrome. Previously diagnosed compressive neuropathy (e.g., carpal tunnel syndrome) with symptoms limited to upper extremities that is now resolved is not exclusionary"}
• {"criterion_text":"- Cardiac dysrhythmias requiring anti-arrhythmic treatment(s) within the last 2 years; history or evidence of abnormal study ECGs that in the opinion of the investigator or medical monitor would preclude the subject’s participation in the study; or history of QT prolongation or standard 12-lead ECG (performed in triplicate) demonstrating median QTcF >450 msec at Screening Visit 1; or clinical evidence of structural heart disease."}
• {"criterion_text":"- History of a clinical atherosclerotic event, such as myocardial infarction or stroke, within the past 12 months before Screening Visit 1."}

Primary endpoints

• {"endpoint_text":"- Change from baseline in the weekly average of daily pain intensity on the numeric pain rating scale (NPRS) at Week 12","definition_or_measurement_approach":"Change from baseline in the weekly average of daily pain intensity measured by the Numeric Pain Rating Scale (NPRS), assessed at Week 12 (weekly average of daily NPRS scores)."}

Secondary endpoints

• {"endpoint_text":"- Proportions of subjects with ≥30%, ≥50%, and ≥70% reductions from baseline in the weekly average of daily pain intensity on the NPRS at Week 12","definition_or_measurement_approach":"Proportion of subjects achieving ≥30%, ≥50%, and ≥70% reductions from baseline in the weekly average of daily pain intensity on the NPRS at Week 12."}
• {"endpoint_text":"- Safety and tolerability based on adverse events (AEs), laboratory test results, vital signs, and ECGs","definition_or_measurement_approach":"Safety and tolerability assessed by monitoring adverse events, laboratory test results, vital signs, and ECGs."}

Methods

• Online screener (documented: Online screener files present; country-specific versions for DE, IT)
• Phone screener (country-specific phone screener documents present: DE, IT)
• Flyers and printed brochures (Flyer_FutureMeds, Recruitment Brochure, Poster, Print Ad; country-specific versions DE, IT, FR)
• Digital outreach/advertisement (Images for outreach campaign, Advertisement copy; country-specific versions DE, IT, FR)
• Recruitment text/messages for local sites (Recruiment Text_FutureMeds Berlin, Offenbach - Germany)
• Invitation to trial letter / Patient Invitation to Trial Letter (country-specific versions)
• PI to Doctor Letter / Physician invitation (country-specific versions)
• Study fact sheet and recruitment brochure distributed to patients and HCPs (country-specific versions)

Germany

Earliest CTIS Part Ii Submission Date

12-03-2025

Latest Decision Or Authorization Date

31-03-2025

Processing Time Days

19

Number Of Sites

3

Number Of Participants

18

Italy

Earliest CTIS Part Ii Submission Date

17-03-2025

Latest Decision Or Authorization Date

26-03-2025

Processing Time Days

9

Number Of Sites

2

Number Of Participants

12

France

Earliest CTIS Part Ii Submission Date

07-03-2025

Latest Decision Or Authorization Date

31-03-2025

Processing Time Days

24

Number Of Sites

5

Number Of Participants

30

Primary sponsor

Full Name

Vertex Pharmaceuticals Inc.

Organisation Type

Pharmaceutical company

Country Of Registered Address

United States