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

This study has been terminated.
(Due to major recruitment issues, a decision was made to terminate this trial)
Sponsor:
Information provided by (Responsible Party):
UCB, Inc.
ClinicalTrials.gov Identifier:
NCT01519882
First received: January 24, 2012
Last updated: March 18, 2013
Last verified: March 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Advanced Idiopathic Parkinson's Disease
 Other: Placebo
Other: Rotigotine
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multi-Centre, Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Effects of Rotigotine on Sleep Efficiency in Patients With Advanced Parkinson's Disease.

Resource links provided by NLM:

Drug Information available for: Rotigotine
U.S. FDA Resources

Further study details as provided by UCB, Inc.:

Primary Outcome Measures:
  • Percentage change from Baseline in Sleep Efficiency Index (SEI) to Week 4 of the Maintenance Period [ Time Frame: From Baseline to Week 4 of the Maintenance Period ] [ Designated as safety issue: No ]
    SEI in percent is the ratio of total sleep time to time in bed.


Secondary Outcome Measures:
  • Change from Baseline in the Parkinson's Disease Sleep Scale score version 2 (PDSS2) to Day 1 of the Maintenance Period [ Time Frame: From Baseline to Day 1 of the Maintenance Period ] [ Designated as safety issue: No ]
  • Change from Baseline in the Parkinson's Disease Sleep Scale score version 2 (PDSS2) to Week 4 of the Maintenance Period [ Time Frame: From Baseline to Week 4 of the Maintenance Period ] [ Designated as safety issue: No ]
  • Change from Baseline in the Epworth Sleepiness Score (ESS) to Day 1 of the Maintenance Period [ Time Frame: From Baseline to Day 1 of the Maintenance Period ] [ Designated as safety issue: No ]
  • Change from Baseline in the Epworth Sleepiness Score (ESS) to Week 4 of the Maintenance Period [ Time Frame: From Baseline to Week 4 of the Maintenance Period ] [ Designated as safety issue: No ]
  • Change from Baseline in the Sleep Period time in Non-Rapid Eye Movement (Non-REM) sleep to Week 4 of the Maintenance Period [ Time Frame: From Baseline to Week 4 of the Maintenance period. ] [ Designated as safety issue: No ]
  • Change from Baseline in the Nocturnal Akinesia, Dystonia, and Cramps Score (NACDS) to Day 1 of the Maintenance Period [ Time Frame: From Baseline to Day 1 of the Maintenance Period ] [ Designated as safety issue: No ]
  • Change from Baseline in the Nocturnal Akinesia, Dystonia and Cramps Score (NACDS) to Week 4 of the Maintenance Period [ Time Frame: From Baseline to Week 4 of the Maintenance period. ] [ Designated as safety issue: No ]
  • Change from Baseline in the total Wake Time After Sleep Onset (WASO) to Week 4 of the Maintenance Period [ Time Frame: From Baseline to Week 4 of the Maintenance Period ] [ Designated as safety issue: No ]
  • Change from Baseline in the total number of turnings in bed to Week 4 of the Maintenance Period [ Time Frame: From Baseline to Week 4 of the Maintenance Period ] [ Designated as safety issue: No ]

Enrollment: 1
Study Start Date: March 2012
Study Completion Date: January 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Placebo Transdermal Patches
 Other: Placebo

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.
Experimental: Rotigotine
Rotigotine Transdermal Patches
 Other: Rotigotine

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.

Other Names:
  • Neupro®
  • (6S)-6-propyl-[2-(2-thienyl)ethyl]amino-5,6,7,8-tetrahydro-1-naphthalenol

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01519882

Locations
United Kingdom
1
Middlesborough, United Kingdom
Sponsors and Collaborators
UCB, Inc.
Investigators
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
  More Information

No publications provided

Responsible Party: UCB, Inc.
ClinicalTrials.gov Identifier: NCT01519882     History of Changes
Other Study ID Numbers: SP0919, 2011-000056-42
Study First Received: January 24, 2012
Last Updated: March 18, 2013
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by UCB, Inc.:
Rotigotine
Neupro
Polysomnography
 Sleep efficiency
Advanced Idiopathic Parkinson's Disease
Sleep Disorder

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
 N 0437
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 21, 2013