A Trial to Evaluate the Effects of Rotigotine Transdermal Patch on Early Morning Motor Impairment and Sleep Disorders Idiopathic Parkinson's Disease

September 24, 2014 updated by: UCB Pharma

A Phase 3b, Open-Label, Multicenter, Multinational Trial to Evaluate the Effects of Rotigotine Transdermal Patch on Early Morning Motor Impairment and Sleep Disorders in Patients With Idiopathic Parkinson's Disease

The objective of this trial is to assess the effect of rotigotine (SPM 962) on the control of early morning motor impairment and sleep disorders in subjects with idiopathic PD.

Subjects who meet eligibility criteria will begin treatment with rotigotine transdermal patches. Trial medication will be titrated to an optimal daily dose, or to the maximal dose. Following a Titration period of up to 8 weeks, subjects will be maintained on the optimal or maximal dose for 4 weeks. After the Maintenance period, subjects will have the option to enter into an open-label extension study.

The first subject was enrolled in December 2004. The last subject was enrolled in April 2005 and the last subject visit was conducted in July 2005. This study is now closed

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

58

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

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

N/A

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Idiopathic Parkinson's disease

Exclusion Criteria:

  • Subject has previously participated in a trial with rotigotine.
  • Subject has participated in another trial of an investigational drug within the last 28 days or is currently participating in another trial of an investigational drug.
  • Subject discontinued from previous therapy with a dopamine agonist after an adequate length of treatment at an adequate dose due to lack of efficacy as assessed by the investigator.
  • Subject has had prior therapy with a dopamine agonist within 28 days prior to Baseline.
  • Subject is receiving therapy with controlled-release levodopa within 28 days prior to baseline or is receiving therapy with tolcapone.
  • Subject is receiving therapy with one of the following drugs either concurrently or within 28 days prior to Visit 2: alpha-methyl dopa, metoclopramide, reserpine, neuroleptics (including atypical), monoamine oxidase A (MAO-A) inhibitors, methylphenidate, or amphetamine.
  • Subject has a history of symptomatic (not asymptomatic) orthostatic hypotension in the 6 months prior to baseline.
  • Subject has atypical Parkinsonian syndromes (including drug-induced Parkinsonian syndromes).
  • Subject has a history of atopic eczema and/or active skin disease, such as atopic eczema.
  • Presence of dementia, active psychosis, or hallucinations (not due to antiparkinsonian medication).
  • Subject is receiving CNS therapy (eg, sedatives, hypnotics, selective serotonin reuptake inhibitors [SSRIs], anxiolytics, other sleep-modifying medication) unless dose has been stable daily for at least 28 days prior to baseline and is likely to remain stable for the duration of the trial.
  • Subject has a history of seizures or stroke within 1 year, or a history of myocardial infarction within the last 6 months prior to enrollment.
  • Subject has neoplastic disease requiring therapy within 12 months prior to enrollment.
  • Presence of clinically relevant hepatic dysfunction.
  • Presence of clinically relevant renal dysfunction.
  • Evidence of clinically relevant cardiovascular disorders.
  • Subject has a QTcB interval of ³500msec at Screening or Baseline (Visit 1 or 2; repeated measurements within 1 hour).
  • Subject has a history of chronic alcohol or drug abuse within the last 6 months.
  • Subject has clinically significant laboratory results that, in the opinion of the investigator, would make the subject unsuitable for entry into the trial.
  • Subject is pregnant or nursing, or is of child bearing potential but (i) not surgically sterile, or, (ii) not using adequate birth control methods (including at least one barrier method) or, (iii) not sexually abstinent, or (iv) subject is not at least two years post menopausal.
  • Subject has any medical or psychiatric condition that, in the opinion of the investigator, can jeopardize or would compromise the subject's ability to participate in this trial.
  • Subject has a known hypersensitivity to any components of the trial medication stated in this protocol.
  • Subject has a previous diagnosis of narcolepsy, sleep apnea syndrome, rapid eye movement (REM) behavior disorder, restless legs syndrome, or periodic limb movement disorder.

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: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Motor performance; Sleep disorders; Clinical Global Impression; Patient Global Impression; Safety & Tolerability

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

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

December 1, 2004

Primary Completion (Actual)

July 1, 2005

Study Completion (Actual)

July 1, 2005

Study Registration Dates

First Submitted

October 24, 2005

First Submitted That Met QC Criteria

October 24, 2005

First Posted (Estimate)

October 25, 2005

Study Record Updates

Last Update Posted (Estimate)

September 25, 2014

Last Update Submitted That Met QC Criteria

September 24, 2014

Last Verified

September 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SP0826
  • 2004-002598-21 (EudraCT Number)

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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