A multicenter, multinational, phase 3b, open-label extension trial to assess the safety and tolerability of long-term treatment of rotigotine patch in subjects with idiopathic Parkinson's disease

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2004-002641-12-AT

Enrollment

220

Registered

2004-12-17

Start date

2005-01-21

Completion date

Unknown

Last updated

2013-04-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson's disease

Interventions

Product Name: Rotigotine Product Code: SPM 962 Pharmaceutical Form: Transdermal patch INN or Proposed INN: Rotigotine CAS Number: [99755-59-6] Current Sponsor code: SPM 962 Concentration unit: mg mill

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Subject is informed and given ample time and opportunity to think about her/his participation and has given her/his written informed consent. 2. Subject is willing and able to comply with all trial requirements. 3. Subject has completed Study SP824, SP825, or SP826. 4. Subject, in the opinion of the investigator, would benefit from long-term treatment of rotigotine. Are the trial subjects under 18? Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1. Subject has an ongoing serious adverse event that is assessed as related to study medication

Design outcomes

Primary

Measure	Time frame
Main Objective: to assess the safety and tolerability of long-term treatment of rotigotine, administered up to 2 years, until rotigotine is commercially available or until the sponsor closes the study, whichever comes first, in subjects with idiopathic Parkinson's disease;Secondary Objective: ;Primary end point(s): • Frequency and severity of adverse events (AEs), as reported spontaneously by the subject or observed by the investigator, recorded over the course of the trial • Changes in vital signs, body weight, electrocardiograms (ECGs), and clinical laboratory values over the course of the trial • Changes in physical and neurological examination data over the course of the trial • Changes in Epworth Sleepiness Scale (ESS) scores over the course of the trial • Adhesiveness of the patch • Clinical Global Impression (CGI) over the course of the trial • Patient Global Impression (PGI) over the course of the trial • Change from baseline in UPDRS Part I scores over the course of the trial • Change from baseline in UPDRS Part II scores over the course of the trial • Change from baseline in UPDRS Part III scores over the course of the trial • Change from baseline in UPDRS Part IV scores over the course of the trial • Change from pretreatment in Hoehn and Yahr stage over the course of the trial • Change in quality of life, from baseline to end of the trial, as assessed using the short-form Parkinson's Disease Questionnaire (PDQ-8) • Change in quality of sleep, from baseline to end of the trial, as assessed using the Parkinson's Disease Sleep Scale (PDSS) • Rating of patch application site preference and satisfaction with trial treatment as assessed by a patient preference questionnaire Baseline for this open-label extension trial is defined as the subject’s baseline in SP824, SP825, or SP826.	—

Measure

Time frame

Main Objective: to assess the safety and tolerability of long-term treatment of rotigotine, administered up to 2 years, until rotigotine is commercially available or until the sponsor closes the study, whichever comes first, in subjects with idiopathic Parkinson's disease;Secondary Objective: ;Primary end point(s): • Frequency and severity of adverse events (AEs), as reported spontaneously by the subject or observed by the investigator, recorded over the course of the trial • Changes in vital signs, body weight, electrocardiograms (ECGs), and clinical laboratory values over the course of the trial • Changes in physical and neurological examination data over the course of the trial • Changes in Epworth Sleepiness Scale (ESS) scores over the course of the trial • Adhesiveness of the patch • Clinical Global Impression (CGI) over the course of the trial • Patient Global Impression (PGI) over the course of the trial • Change from baseline in UPDRS Part I scores over the course of the trial • Change from baseline in UPDRS Part II scores over the course of the trial • Change from baseline in UPDRS Part III scores over the course of the trial • Change from baseline in UPDRS Part IV scores over the course of the trial • Change from pretreatment in Hoehn and Yahr stage over the course of the trial • Change in quality of life, from baseline to end of the trial, as assessed using the short-form Parkinson's Disease Questionnaire (PDQ-8) • Change in quality of sleep, from baseline to end of the trial, as assessed using the Parkinson's Disease Sleep Scale (PDSS) • Rating of patch application site preference and satisfaction with trial treatment as assessed by a patient preference questionnaire Baseline for this open-label extension trial is defined as the subject’s baseline in SP824, SP825, or SP826.

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Countries

Austria, Italy, Spain, United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026