Randomized Evaluation of the 24-Hour Coverage: Efficacy of Rotigotine (RECOVER)

May 26, 2015 updated by: UCB Pharma

Phase 3B, Multicenter, Multinational, Double-Blind, Placebo Controlled, 2-Arm Trial to Evaluate the Effect of the 24-Hour Transdermal Delivery of Rotigotine on the Control of Early Morning Motor Function, Sleep Quality, Nocturnal Symptoms, and Non-Motor Symptoms in Subjects With Idiopathic Parkinson's Disease

The objective of this trial is to assess the effects of transdermal rotigotine on the control of early morning motor function and sleep disorders compared to placebo in subjects with idiopathic Parkinsons´s disease. In addition, effects of rotigotine on specific nocturnal and non-motor symptoms of Parkinson´s disease will be evaluated.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The objective of this trial is to assess the effects of rotigotine on the control of early morning motor function and sleep disorders compared to placebo in subjects with idiopathic Parkinsons´s disease. In addition, effects of rotigotine on specific nocturnal and non-motor symptoms of Parkinson´s disease will be evaluated.

After a Screening Period of up to 28 days subjects will be hospitalized for two nights. After the second overnight stay, subjects will be randomly assigned either to rotigotine patch or placebo patch. Afterwards patients will be titrated to their optimal dose. After subjects have reached their optimal dose (or the highest dose) they will be maintained on this dose for a certain period. At the end of maintenance the subjects will be hospitalized for two nights. Afterwards the doses will be continuously decreased.

Efficacy will be assessed by application of sleep quality scores, motor examination scores, and scores to evaluate non-motor symptoms of Parkinsons. Safety assessments include adverse events, 12-lead electrocardiograms, blood pressure and heart rate assessments, and laboratory checks.

Study Type

Interventional

Enrollment (Actual)

287

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Fitzroy, Australia
    • New South Wales
      • Concord, New South Wales, Australia
    • South Australia
      • Adelaide, South Australia, Australia
  • Austria
      • Innsbruck, Austria, 6020
  • Finland
      • Hyvinkää, Finland
      • Oulu, Finland, 90220
  • Germany
      • Berlin, Germany, 10713
      • Berlin, Germany, 12163
      • Dresden, Germany, 01307
      • Kassel, Germany, 34128
      • Leipzig, Germany
      • Marburg, Germany, 35039
      • Naumburg, Germany
      • Ulm, Germany, 89081
  • Hungary
      • Budapest, Hungary
      • Debrecen, Hungary
      • Nyiregyhaza, Hungary
      • Zalaegerszeg, Hungary
  • Italy
      • Chieti, Italy, 66013
      • Milano, Italy
      • Torino, Italy
  • New Zealand
      • Christ Church, New Zealand
      • Wellington, New Zealand
  • Poland
      • Gdansk, Poland
      • Krakow, Poland
      • Lublin, Poland
      • Olsztyn, Poland
      • Szczecin, Poland
      • Warszawa, Poland
  • South Africa
      • Cape Town, South Africa
      • Capetown, South Africa
      • Johannesburg, South Africa
      • Pretoria/Gauteng, South Africa
      • Tygerberg, South Africa
  • Spain
      • Barcelona, Spain, 08036
      • Madrid, Spain
  • United Kingdom
      • Bristol, United Kingdom
      • Lancashire, United Kingdom
      • Liverpool, United Kingdom
      • London, United Kingdom
  • United States
    • California
      • Reseda, California, United States
      • Ventura, California, United States
    • Florida
      • St. Petersburg, Florida, United States, 33701
    • North Carolina
      • Salisbury, North Carolina, United States, 28144
      • Winston_Salem, North Carolina, United States
    • Rhode Island
      • Warwick, Rhode Island, United States
    • Texas
      • Houston, Texas, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Early and advanced Idiopathic Parkinson Disease with early morning motor impairment

Exclusion Criteria:

  • Atypical Parkinsonian syndromes

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Rotigotine
Rotigotine transdermal patch
Drug: Rotigotine

Rotigotine transdermal patches:

10cm2 (2mg/24h); 20cm2 (4mg/24h); 30cm2 (6mg/24h); 40cm2 (8mg/24h)

Optimal dosing: The maximum Rotigotine dose allowed is 16mg/24h

Other Names:
  • Neupro
PLACEBO_COMPARATOR: Placebo
Placebo transdermal patch
Other: Placebo
Placebo transdermal patches

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Early Morning UPDRS Part III Score
Time Frame: From baseline to end of maintenance (after 4 weeks maintenance)
The Unified Parkinson´s Disease Rating Scale Part III score is an accepted and validated sumscore of 14 items for the assessment of motor function in Parkinson´s disease. Each of the 14 items in the UPDRS part III is measured on a scale of 0 to 4, where 0 is normal and 4 represents severe abnormalities.
From baseline to end of maintenance (after 4 weeks maintenance)
Change in Parkinson's Disease Sleep Scale (PDSS)
Time Frame: From baseline to end of maintenance (after 4 weeks maintenance)
The Parkinson´s Disease Sleep Scale (PDSS) is a questionnaire with 15 questions to assess sleep and nocturnal disability in Parkinson´s disease. The item- scores can range between 0= never and 4= very often. The PDSS score is a sumscore of all 15 questions.
From baseline to end of maintenance (after 4 weeks maintenance)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Nocturnal Akinesia, Dystonia, and Cramps Score (NADCS)
Time Frame: From baseline to end of maintenance (after 4 weeks maintenance)
Subjects were asked to assess nocturnal akinesia, dystonia and cramps, using an ordinal severity scale. While a score of 0= normal and 4= maximal severity, subjects could also rate their symptoms with values of 0.5, 1.5, 2.5, 3.5. The nocturnal akinesia score was used to evaluate motor performance while the dystonia and cramps scores were used to evaluate sleep.
From baseline to end of maintenance (after 4 weeks maintenance)
Change in Number of Nocturias
Time Frame: From baseline to end of maintenance (after 4 weeks maintenance)
Nocturia is the need to get up during the night and interrupt sleep in order to urinate. It is a typical nocturnal symptom of Parkinson´s disease. The change from baseline in number of nocturias was used to evaluate improvements in sleep disorders.
From baseline to end of maintenance (after 4 weeks maintenance)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UCB Pharma

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2007

Primary Completion (ACTUAL)

March 1, 2009

Study Completion (ACTUAL)

March 1, 2009

Study Registration Dates

First Submitted

May 14, 2007

First Submitted That Met QC Criteria

May 15, 2007

First Posted (ESTIMATE)

May 16, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

June 22, 2015

Last Update Submitted That Met QC Criteria

May 26, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SP0889
  • EudraCT No.: 2006-006752-35 (OTHER: EudraCT)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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