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Completed

NCT Number: NCT00599196

An Open-Label Extension Trial to Assess the Safety of Long-Term Treatment of Rotigotine in Early-Stage Parkinson's Disease

The objective of this open-label extension is to assess the safety and tolerability of long-term treatment of the rotigotine patch in subjects with early-stage idiopathic Parkinson's disease

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Key information

Conditions

Early Stage Parkinson's Disease

Age range

30 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Concord, Australia

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About this study

This is the open-label extension to the randomized, double-blind, placebo- and ropinirole-controlled SP513 trial that assessed the efficacy and safety and tolerability of the Rotigotine patch in subjects with early-stage idiopathic Parkinson's Disease

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjects who have completed six months of maintenance treatment in the SP513 double-blind trial

Exclusion criteria

  • Subjects who had an ongoing serious adverse event from SP513 double-blind trial that was assessed as related to study medication

Treatment and study plan

Rotigotine

Drug

Rotigotine trans-dermal patches, once daily:

10 cm2 (2 mg/24 hours); 20 cm2 (4 mg/24 hours); 30 cm2 (6 mg/24 hours); 40 cm2 (8 mg/24 hours); 50 cm2 (10 mg/24 hours); 60 cm2 (12 mg/24 hours); 70 cm2 (14 mg/24 hours); 80 cm2 (16 mg/24 hours);

Optimal dosing:

During the first year: The maximum Rotigotine dose allowed is 8 mg/24 hours.

After the first year: allowed dose increase of rotigotine up to a maximum of 16 mg/24 hours.

Other names: Neupro®

Primary outcomes

  1. Number of Subjects With at Least One Adverse Event During This Open-label Extension Study

    Time frame: six years

    Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.

Secondary outcomes

  1. Number of Subjects Who Withdrew From the Trial Due to an Adverse Event

    Time frame: six years

    Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.

  2. Mean Epworth Sleepiness Scale Score During the Open-label Extension

    Time frame: Visit 10 (end of year 1), Visit 14 (end of year 2), Visit 18 (end of year 3), Visit 22 (end of year 4), Visit 26 (end of year 5), Visit 30 (end of year 6), End of Treatment (last study visit or early withdrawal visit)

    The Epworth Sleepiness Scale (ESS) is a self-administered questionnaire with 8 questions. The total ESS score is the sum of 8 item-scores and can range between 0 and 24. The higher the score, the higher the person's level of daytime sleepiness.

Sponsors and collaborators

Lead sponsor

UCB Pharma

Industry

Registry information

Official study title

An Open-Label Extension to the Double-Blind SP513 Trial to Assess the Safety of Long-Term Treatment of Rotigotine in Subjects With Early-Stage Idiopathic Parkinson's Disease

Important dates

Study start
2002
Primary completion
2008
Study completion
2008
First posted
Jan 23, 2008
Registry last updated
Oct 2, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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