SP1066: Rotigotine patch adhesiveness

• Research type

  Research Study

• Full title

  A Multicentre, Randomized, Double Blind, Two-Way Cross-over Study to Compare The Adhesiveness Of Two Different Rotigotine Patch Formulations In Subject With Parkinson's Disease.

• IRAS ID

  65470

• Contact name

  David Burn

• Sponsor organisation

  UCB Celltech

• Eudract number

  2010-024250-11

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  The purpose of this study is to compare the adhesive properties of the currently marketed Rotigotine transdermal patch against a new adhesive formulation of this patch. Rotigotine is currently licensed in the UK as Neupro© for the treatment of idiopathic Parkinson's Disease and has a storage requirement of refrigeration between 2-8 øC. The aim of the study is to assess the adhesiveness of the marketed patch against a reformulation which is stable at room temperature. In order to be eligible for the study subjects must have a diagnosis of idiopathic Parkinson's disease and have been treated continuously with any dosage of commercially available rotigotine transdermal patch(s) (Neupro©) in which the past two weeks prior to enrolment their treatment dose is acquired by one or more 8mg/24/40cm2 patch. In addition they must be over 18 years of age and fulfil all of the inclusion/exclusion criteria. During the treatment phase of the study, patients will be treated with both transdermal patch formulations for two days each over the four day treatment period. The starting treatment will be assigned by randomisation using an IVRS system and patch adhesiveness will be measured immediately after each patch application and 24 hours after application of each treatment (i.e., before the removal of the patch).Following the four day treatment period, patients may then resume treatment with commercially available rotigotine transdermal patch as prescribed by their physician. The study will be conducted in Austria, Germany, Spain and the UK with a total of 52 eligible patients being randomized in order to complete with 50 subjects suitable for analysis of patch adhesiveness. It is anticipated that 25 sites will be opened globally with 5 of these located in the UK.

• REC name

  North East - Newcastle & North Tyneside 2 Research Ethics Committee

• REC reference

  11/NE/0017

• Date of REC Opinion

  22 Feb 2011

• REC opinion

  Favourable Opinion