Sleep Efficiency Assessed by Polysomnography (PSG Sleep Lab Testing) in Advanced Parkinson's Disease

NCT01519882 | Terminated Phase 4 Results

• 2 other identifiers: SP09192011-000056-42
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

This is a phase 4 study to evaluate with Polysomnography (PSG) and subjective measures the effect of Rotigotine on sleep efficiency, maintenance, insomnia, nocturnal akinesia and night-time movement in bed, in patients with advanced Parkinson's disease.

Conditions

Advanced Idiopathic Parkinson's Disease

Keywords

Rotigotine; Neupro; Polysomnography; Sleep efficiency; Advanced Idiopathic Parkinson's Disease; Sleep Disorder

Outcome Measures

Primary Outcomes (1)

• Percentage Change From Baseline in Sleep Efficiency Index (SEI) to Week 4 of the Maintenance Period

  The Sleep Efficiency Index in percent is the ratio of total sleep time (based on Polysomnography recordings) to time in bed (period between "lights off" and "lights on").

  From Baseline to Week 4 of the Maintenance Period (up to 11 weeks post-baseline)

Secondary Outcomes (9)

• Change From Baseline in the Parkinson's Disease Sleep Scale Score Version 2 (PDSS2) to Day 1 of the Maintenance Period

  From Baseline to Day 1 of the Maintenance Period (up to 7 weeks post-baseline)

• Change From Baseline in the Parkinson's Disease Sleep Scale Score Version 2 (PDSS2) to Week 4 of the Maintenance Period

  From Baseline to Week 4 of the Maintenance Period (up to 11 weeks post-baseline)

• Change From Baseline in the Epworth Sleepiness Score (ESS) to Day 1 of the Maintenance Period

  From Baseline to Day 1 of the Maintenance Period (up to 7 weeks post-baseline)

• Change From Baseline in the Epworth Sleepiness Score (ESS) to Week 4 of the Maintenance Period

  From Baseline to Week 4 of the Maintenance Period (up to 11 weeks post-baseline)

• Change From Baseline in the Sleep Period Time in Non-Rapid Eye Movement (Non-REM) Sleep to Week 4 of the Maintenance Period

  From Baseline to Week 4 of the Maintenance Period (up to 11 weeks post-baseline)

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo Transdermal Patches

Other: Placebo

Rotigotine

EXPERIMENTAL

Rotigotine Transdermal Patches

Other: Rotigotine

Interventions

Placebo OTHER

Placebo patches size equivalent to 4, 6 \& 8 mg/24 h. Daily application of Placebo patches starting at 4 mg/24 h. Dose will be up-titrated weekly by increments of 2 mg/24 h until optimal or maximal dose is reached. Maximal dose is 16 mg/24 h. Optimal or maximal dose will be maintained for 4 Weeks followed by a de-escalation by 2 mg/24 h every other day.

Placebo

Rotigotine OTHER

Rotigotine patches of 4,6 \& 8 mg/24 h. Daily application of Rotigotine patches starting at 4 mg/24 h. Dose will be up-titrated weekly by increments of 2 mg/24 h until optimal or maximal dose is reached. Maximal dose is 16 mg/24 h. Optimal or maximal dose will be maintained for 4 weeks followed by a de-escalation by 2 mg/24 h every other day.

Also known as: Neupro®, (6S)-6-propyl-[2-(2-thienyl)ethyl]amino-5,6,7,8-tetrahydro-1-naphthalenol

Rotigotine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Advanced Parkinson's disease (ie, takes Levodopa (L-DOPA))
• Hoehn and Yahr stage score of 2 to 4
• Subject has sleep-maintenance insomnia

You may not qualify if:

• Significant skin disease that would make transdermal drug use inappropriate
• Subject received therapy with controlled-release Levodopa (L-DOPA), entacapone or Stalevo® within 28 days prior to the Baseline Visit or has received therapy with Tolcapone
• Atypical Parkinsonian syndromes
• Previous diagnosis of Narcolepsy, Sleep Apnoea Syndrome, significant Rapid Eye Movement (REM) Sleep Behavior Disorder (RBD), moderate to severe Restless Legs Syndrome (RLS) or Periodic Limb Movement Disorder

Sponsors & Collaborators

• UCB Pharma SA: lead

Study Sites (1)

1

Middlesbrough, United Kingdom

Location

Related Links

• FDA Safety Alerts and Recalls

MeSH Terms

Conditions

Sleep Wake Disorders

Interventions

rotigotine

Condition Hierarchy (Ancestors)

Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Limitations and Caveats

Despite many attempts by study sites to recruit subjects, only 1 subject was randomized by Oct 2012. The decision to terminate the study was taken in Nov 2012. The subject completed in Jan 2013. No planned efficacy/safety analyses were performed.

Results Point of Contact

• Title: UCB Clinical Trial Call Center
• Organization: UCB

+1 877 822 9493 (UCB)

Study Officials

• UCB Clinical Trial Call Center

  +1 877 822 9493 (UCB)

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2012
• First Posted: January 27, 2012
• Study Start: March 1, 2012
• Primary Completion: December 1, 2012
• Study Completion: January 1, 2013
• Last Updated: April 3, 2025
• Results First Posted: January 28, 2014

Record last verified: 2025-04

Locations

GB (1)