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AzTrials

Parkinson's DiseasePhase 1NCT01338896

Study to Compare Adhesiveness of Two Different Rotigotine Patch Formulations

A Phase 1 study testing Rotigotine transdermal patch in people with Parkinson's Disease, run by UCB Pharma at 16 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The primary objective of the study is to compare the adhesiveness of two different patch formulations of rotigotine using patch size 40 cm2, under the assumption that both patch formulations show similar adhesiveness properties. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Parkinson's Disease
What is being tested?
Rotigotine transdermal patch
Could I receive a placebo?
No, everyone receives an active treatment
How many people
56 participants
Where
16 sitesin 3 countries
Study dates
Apr 2011to Jun 2011
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects with a diagnosis of idiopathic Parkinson´s disease, and continuous treatment with commercially available rotigotine transdermal patch for at least 3 months, and a stable rotigotine dose including an 8 mg/24 h patch for at least 2 weeks prior to enrollment

Who cannot join

  • Subjects has previously participated in this study, failed to be screened, or has participated in another study with an investigational medicinal product (IMP) or medical device within the last 30 days or is currently participating in such
  • Subject with a history of significant skin hypersensitivity to adhesives, other transdermal products or recently unsolved contact dermatitis

Trial locations and contacts

16 sites in 3 countries.

16 sites in 3 countries

Germany9 sites

  • Study site

    Alzenau in Unterfranken

  • Study site

    Berlin

  • Study site

    Böblingen

  • Study site

    Bochum

  • Study site

    Cologne

  • Study site

    Gera

  • Study site

    Karlstadt am Main

  • Study site

    Stuttgart

  • Study site

    Wolfach

Other trials in Germany

United Kingdom5 sites

  • Study site

    Blackpool

  • Study site

    Derby

  • Study site

    Liverpool

  • Study site

    Newcastle upon Tyne

  • Study site

    Norwich

Other trials in United Kingdom

Austria2 sites

  • Study site

    Innsbruck

  • Study site

    Vienna

Other trials in Austria

About this study

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

The primary objective of the study is to compare the adhesiveness of two different patch formulations of rotigotine using patch size 40 cm2, under the assumption that both patch formulations show similar adhesiveness properties.

Being tested
Rotigotine transdermal patch
Keywords
Rotigotine, Neupro
Medical subject headings
Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Rotigotine transdermal patchDrug

    Also called Neupro

    8 mg/24 h, transdermal patch 8 mg/24 h, 2 days

Study groups in NCT01338896
Study groupRoleWhat they receive
Sequence A-BExperimental4 day treatment (Treatment A: Rotigotine transdermal patch 8 mg/24 h, test product PR 2.2.1 followed by Treatment B: Rotigotine transdermal patch 8 mg/24 h reference patch PR 2.1.1)
Receives: Drug: Rotigotine transdermal patch
Sequence B-AExperimental4 day treatment (Treatment B: Rotigotine transdermal patch 8 mg/24 h reference patch PR 2.1.1 followed by Treatment A: Rotigotine transdermal patch 8 mg/24 h, test product PR 2.2.1)
Receives: Drug: Rotigotine transdermal patch

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The average adhesiveness score of 2 days of 24 hours patch application as rated by the investigator (or designee)

    The international patch adhesiveness score

    Measured: 2 days of 24 hours patch application

Secondary outcomes (2)

  1. Patch adhesiveness of first treatment day as rated by the investigator (or designee) 24 hours after patch application

    The international patch adhesiveness score

    Measured: after 24 hours of patch application

  2. Patch adhesiveness of second treatment day as rated by the investigator (or designee) 24 hours after patch application

    The international patch adhesiveness score

    Measured: after 24 hour of patch application

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Apr 2011 (estimated)
  2. Study startApr 2011
  3. Primary completionMay 2011
  4. Study completionJun 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
56 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01338896
Sponsor's protocol ID
SP1066
Other IDs
2010-024250-11
Status last verified
Jul 2011
First submitted
18 Apr 2011
Last updated
30 Aug 2011
Results posted
No
Data monitoring committee
No

Publications

  • Elshoff JP, Timmermann L, Schmid M, Arth C, Komenda M, Brunnert M, Bauer L. Comparison of the bioavailability and adhesiveness of different rotigotine transdermal patch formulations. Curr Med Res Opin. 2013 Dec;29(12):1657-62. doi: 10.1185/03007995.2013.841666. Epub 2013 Sep 23.

    PubMed 24006953

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Rotigotine transdermal patch in people with Parkinson's Disease, run by UCB Pharma at 16 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in Germany, United Kingdom, Austria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The average adhesiveness score of 2 days of 24 hours patch application as rated by the investigator (or designee) (time frame: 2 days of 24 hours patch application). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01338896, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2011.

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