Randomized Evaluation of the 24-Hour Coverage: Efficacy of Rotigotine (RECOVER)

UCB

Status and phase: Completed; Phase 3

Conditions: Parkinson's Disease

Treatments: Drug: Rotigotine; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00474058

SP0889

EudraCT No.: 2006-006752-35 (Other Identifier)

Details and patient eligibility

About

The objective of this trial is to assess the effects of transdermal rotigotine on the control of early morning motor function and sleep disorders compared to placebo in subjects with idiopathic Parkinsons´s disease. In addition, effects of rotigotine on specific nocturnal and non-motor symptoms of Parkinson´s disease will be evaluated.

Full description

The objective of this trial is to assess the effects of rotigotine on the control of early morning motor function and sleep disorders compared to placebo in subjects with idiopathic Parkinsons´s disease. In addition, effects of rotigotine on specific nocturnal and non-motor symptoms of Parkinson´s disease will be evaluated.

After a Screening Period of up to 28 days subjects will be hospitalized for two nights. After the second overnight stay, subjects will be randomly assigned either to rotigotine patch or placebo patch. Afterwards patients will be titrated to their optimal dose. After subjects have reached their optimal dose (or the highest dose) they will be maintained on this dose for a certain period. At the end of maintenance the subjects will be hospitalized for two nights. Afterwards the doses will be continuously decreased.

Efficacy will be assessed by application of sleep quality scores, motor examination scores, and scores to evaluate non-motor symptoms of Parkinsons. Safety assessments include adverse events, 12-lead electrocardiograms, blood pressure and heart rate assessments, and laboratory checks.

Enrollment: 287 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Early and advanced Idiopathic Parkinson Disease with early morning motor impairment

Exclusion criteria

• Atypical Parkinsonian syndromes

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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287 participants in 2 patient groups, including a placebo group

Rotigotine

Experimental group

Description:

Rotigotine transdermal patch

Treatment:

Drug: Rotigotine

Placebo

Placebo Comparator group

Description:

Placebo transdermal patch

Treatment:

Other: Placebo