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

UCB

Status and phase: Terminated; Phase 4

Conditions: Advanced Idiopathic Parkinson's Disease

Treatments: Other: Placebo; Other: Rotigotine

Study type: Interventional

Funder types: Industry

Identifiers

NCT01519882

SP0919

2011-000056-42 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 1 patient

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo Transdermal Patches

Treatment:

Other: Placebo

Rotigotine

Experimental group

Description:

Rotigotine Transdermal Patches

Treatment:

Other: Rotigotine