Trial intelligence / Profile preview

Adhesiveness of Rotigotine Patch in Parkinson's Disease

NCT06247410Phase 2

Key facts

Status
Completed
Start
Aug 2021
Primary completion
Oct 2021
Countries
1
Modality
Small Molecules
Conditions
Parkinson's disease (PD)
01

Overview

Phase 2, randomised, open-label trial of rotigotine in Parkinson's disease (PD) (2 arms), sponsored by SocraTec R&D. Primary endpoint: Assessment of patch adhesion properties at 24 hours. Started Aug 2021; status: completed.

02

Design

2 arms
Study design
RandomizedOpen-label
  • Sequence: Reference-Test-Reference-Test

    Reference (Neupro) -> Test (ROT-TDS) -> Reference -> Test

  • Sequence: Test-Reference-Test-Reference

    Test (ROT-TDS) -> Reference (Neupro) -> Test -> Reference

03

Who it enrols

Patients with idiopathic Parkinson's disease on a stable dose of rotigotine (at least 8 mg/24 h) including use of an 8 mg/24 h patch.

04

Endpoints

Primary

  • Assessment of patch adhesion properties

Secondary

  • Skin tolerability of Test and Reference

  • Descriptive characterisation of safety and tolerability

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