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Adhesion and Safety of Rotigexole Compared to Neupro®

NCT07015346 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-08-07

No results posted yet for this study

Summary

A non-inferiority open-labelled crossover randomized controlled trial, of two arms, to investigate the adhesiveness and safety of Rotigexole 8 mg/24 hours transdermal patch, manufactured by Eva pharma, Egypt, compared to the innovator product, Neupro® 8 mg/ 24 hours transdermal patch, manufactured by UCB Pharma S.A., Belgium, after 24 hours of application

Conditions

  • Idiopathic Parkinson Disease

Interventions

DRUG

Rotigexole 8 mg

Rotigotine 8 mg

DRUG

Neupro ® 8 mg

Rotigotine 8 mg

Sponsors & Collaborators

  • MARC-CRO

    collaborator UNKNOWN

  • Eva Pharma

    lead INDUSTRY

Principal Investigators

  • Hatem S Mohammed, Dr. · Al-Manial Specialized Hospital - Cairo University

  • Ali S Shalash, Dr. · Ain Shams Specialized Hospital - Ain Shams University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-01
Primary Completion
2025-10-15
Completion
2025-10-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07015346 on ClinicalTrials.gov