Trial intelligence / Profile preview

NerBloc for Digital Ulcers in Systemic Sclerosis

NCT03007004Phase 2

Key facts

Status: Completed
Start: Dec 2016
Primary completion: May 2019
Countries: 1
Sponsor: Gunma University
Modality: Recombinant Proteins and Enzymes

Drugs: botulinum toxin type b
Conditions: Digital ulcerRaynaud phenomenon

Overview

Phase 2, randomised, double-blind trial of botulinum toxin type b in Digital ulcer and Raynaud phenomenon (2 arms), sponsored by Gunma University. Primary endpoint: Percentage of subjects who completely lost index ulcer at 8 weeks. Started Dec 2016; status: completed.

Design

2 arms

Study design: RandomizedDouble-blind

Botulinum toxin group
NerBloc injection
Physiological saline group
Placebo injection

Who it enrols

Adult patients with systemic sclerosis and Raynaud's phenomenon-related digital ulcers (at least 0.5 cm). Excludes patients with neuromuscular junction disorders, advanced respiratory dysfunction, or recent use of botulinum toxin or certain vasoactive drugs.

Endpoints

Primary

Percentage of subjects who completely lost index ulcer8 weeks

Secondary

Percentage of subjects with complete disappearance of index ulcer16 weeks
Rate of change in the number of DUs per hand16 weeks
Number of newly formed DUs16 weeks
Raynaud's Condition Score16 weeks
Visual Analog Scale for Pain/Numbness16 weeks
Recovery of skin temperature in the finger with the index ulcer16 weeks
Attack duration of Raynaud's phenomenon16 weeks
Number of attacks of Raynaud's phenomenon per day16 weeks

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