NCT01338896

Brief 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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Apr 2011

Shorter than P25 for phase_1

Geographic Reach
3 countries

16 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2011

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

April 18, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 20, 2011

Completed
11 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

August 30, 2011

Status Verified

July 1, 2011

Enrollment Period

1 month

First QC Date

April 18, 2011

Last Update Submit

August 26, 2011

Conditions

Parkinson's Disease

Keywords

RotigotineNeupro

Outcome Measures

Primary Outcomes (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

    2 days of 24 hours patch application

Secondary Outcomes (2)

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

    after 24 hours of patch application

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

    after 24 hour of patch application

Study Arms (2)

Sequence A-B

EXPERIMENTAL

4 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)

Drug: Rotigotine transdermal patch

Sequence B-A

EXPERIMENTAL

4 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)

Drug: Rotigotine transdermal patch

Interventions

Rotigotine transdermal patchDRUG

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

Also known as: Neupro
Sequence A-BSequence B-A

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

Unknown Facility

Innsbruck, Austria

Location

Unknown Facility

Vienna, Austria

Location

Unknown Facility

Alzenau in Unterfranken, Germany

Location

Unknown Facility

Berlin, Germany

Location

Unknown Facility

Bochum, Germany

Location

Unknown Facility

Böblingen, Germany

Location

Unknown Facility

Cologne, Germany

Location

Unknown Facility

Gera, Germany

Location

Unknown Facility

Karlstadt am Main, Germany

Location

Unknown Facility

Stuttgart, Germany

Location

Unknown Facility

Wolfach, Germany

Location

Unknown Facility

Blackpool, United Kingdom

Location

Unknown Facility

Derby, United Kingdom

Location

Unknown Facility

Liverpool, United Kingdom

Location

Unknown Facility

Newcastle upon Tyne, United Kingdom

Location

Unknown Facility

Norwich, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 24006953DERIVED

MeSH Terms

Conditions

Parkinson Disease

Interventions

rotigotine

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • UCB Clinical Trial Call Center

    +1 877 822 9493 (UCB)

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 18, 2011

First Posted

April 20, 2011

Study Start

April 1, 2011

Primary Completion

May 1, 2011

Study Completion

June 1, 2011

Last Updated

August 30, 2011

Record last verified: 2011-07

Locations

DE(9)AU(2)GB(5)