CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 57 enrolled
Drug / intervention
Rotigotine (Test product PR 2.3.1) +1 moredrug
Likely dose
Rotigotine (Test product PR 2.3.1) 8 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02230904
NCT02230904Phase 1Completed
CompareCT.gov

A Multicenter, Randomized, Double-blind, 2-way Cross-over Study to Compare the Adhesiveness of 2 Different Rotigotine Patch Formulations in Subjects With Parkinson's Disease

UCB BIOSCIENCES GmbH·interventional·Posted Sep 3, 2014·Updated Nov 2, 2015

In Brief

A Phase 1 clinical trial evaluating Rotigotine (Test product PR 2.3.1) and Rotigotine (Reference product PR 2.1.1) for Parkinson's Disease. Completed, enrolled 57 participants across 11 sites.

Detailed Summary

The primary objective of the study is to compare the adhesiveness of 2 different patch formulations of Rotigotine using the largest patch size of 40 cm\^2, under the assumption that both patch formulations show similar adhesiveness properties.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsParkinson's Disease
CountriesGermany
CollaboratorsPharmaceutical Health Sciences, Bracket Global

Timeline

Phase 1CompletedFinished
201520162017201820192020202120222023202420252026
First PostedSep 3, 2014
Enrollment StartSep 1, 2014
Primary CompletionNov 1, 2014
Study CompletionDec 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 11.8 years ago

Interventions

Rotigotine (Test product PR 2.3.1)drug

* Pharmaceutical form: Transdermal patch * Concentration: 8 mg/24 hours * Route of administration: Transdermal

Rotigotine (Reference product PR 2.1.1)drug

* Pharmaceutical form: Transdermal patch * Concentration: 8 mg/24 hours * Route of administration: Transdermal