Rotigotine Patch in Subjects With Advanced Stage, Idiopat... | NCT00244387

Studies
Rotigotine Patch in Subjects With Advanced Stage, Idiopathic Parkinson's Disease Who Are Not Well Controlled on Levodopa

NCT00244387

Sponsor

UCB Pharma

Status

Completed

Last Update Posted

Sep 25, 2014Estimated

Enrollment

506Actual

Phase

Phase 3

Conditions

Parkinson Disease, Idiopathic

Interventions

SPM 962

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Official Title

A Multi-centre, Multi-national, Phase 3, Randomized, Double-blind, Double-dummy, 3- Arm Parallel Group, Placebo- and Pramipexole- Controlled Trial of the Efficacy and Safety of Rotigotine Patch in Subjects With Advanced Stage, Idiopathic Parkinson's Disease Who Are Not Well Controlled on Levodopa

Status Module

Record Verification Date

Feb 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Not provided

Start Date

Mar 2004

Primary Completion Date

Jul 2005Actual

Completion Date

Jul 2005Actual

First Submitted Date

Oct 24, 2005

First Submission Date that Met QC Criteria

Oct 24, 2005

First Posted Date

Oct 26, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 24, 2014

Last Update Posted Date

Sep 25, 2014Estimated

Description Module

Brief Summary

Male and female patients aged ≥ 30 years with advanced stage idiopathic Parkinson's disease, not well controlled on existing levodopa will take part in a research study at approximately 82 sites in Europe, Israel, South Africa, Australia and new Zealand.

The purpose of the study is to evaluate the effectiveness, safety and tolerability of the rotigotine patch (SPM 962) at an individual patient's optimal dose for a period of 4 months

Each patient who qualifies and chooses to participate in the study will receive either rotigotine, pramipexole, or placebo at gradually increasing doses over a period of up to 7 weeks, and then maintain their optimal dose for 4 months.

The study clinic visits will include a medical history and physical exam, ECG, blood and urine sample collection, completion of various questionnaires, and completion of a diary to record the severity of their Parkinson's symptoms.

Patients who complete the study may enroll in an extension trial and receive active study drug.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

506Actual

Name	Type	Description	Arm Group Labels	Other Names
SPM 962	Drug

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Advanced stage idiopathic Parkinson's disease

Exclusion Criteria:

Well controlled on levodopa

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
UCB Clinical Trial Call Center	UCB Pharma	Study Director

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
17509486	Result	Poewe WH, Rascol O, Quinn N, Tolosa E, Oertel WH, Martignoni E, Rupp M, Boroojerdi B; SP 515 Investigators. Efficacy of pramipexole and transdermal rotigotine in advanced Parkinson's disease: a double-blind, double-dummy, randomised controlled trial. Lancet Neurol. 2007 Jun;6(6):513-20. doi: 10.1016/S1474-4422(07)70108-4.
17895872

ID	Term
D020734	Parkinsonian Disorders
D001480	Basal Ganglia Diseases
D001927	Brain Diseases
D002493	Central Nervous System Diseases