CAT-Trial: CGRP monoclonal Antibody for Treatment of painful diabetic neuropathy: a double-blind, multicenter, placebo-controlled, international phase II clinical trial

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2022-500338-27-00

Enrollment

Registered

2023-02-27

Start date

2023-09-14

Completion date

Unknown

Last updated

2025-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Painful diabetic polyneuropathy

Brief summary

Difference in self-reported average pain intensity between eptinezumab treated group and placebo treated group by the average numerical rating scale (NRS) (0-10) using a modified version of the BPI from baseline (1 week before randomization) over 24 weeks after first administration.

Detailed description

Difference between groups in neuropathic pain severity as measured by Neuropathic Pain Scale (NPS) at baseline, weeks 12 and 24, Difference in pain relief (complete, good, moderate, mild, none, worse) at weeks 12 and 24

Interventions

DRUGVYEPTI 100 mg concentrate for solution for infusion

DRUGSaline Nebuliser Solution (Sodium Chloride 0.9% w/v)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Difference in self-reported average pain intensity between eptinezumab treated group and placebo treated group by the average numerical rating scale (NRS) (0-10) using a modified version of the BPI from baseline (1 week before randomization) over 24 weeks after first administration.	—

Secondary

Measure	Time frame
Difference between groups in neuropathic pain severity as measured by Neuropathic Pain Scale (NPS) at baseline, weeks 12 and 24, Difference in pain relief (complete, good, moderate, mild, none, worse) at weeks 12 and 24	—

Countries

Denmark

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026