Trial to Assess PD Symptom Control to Four Doses of Rotigotine in a Transdermal Patch - Full Text View

Purpose

The purpose of this study is to show rotigotine dose response at four doses of rotigotine used with L-dopa in treating advanced stage Parkinson's disease

Condition	Intervention	Phase
Parkinson's Disease	Drug: Rotigotine Other: Placebo	Phase III

Genetics Home Reference related topics:

familial paroxysmal nonkinesigenic dyskinesia Parkinson disease

MedlinePlus related topics:

Parkinson's Disease

ChemIDplus related topics:

Dopamine Dopamine hydrochloride Rotigotine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study

Official Title:	A Multicenter, Randomized, Double-Blind, Placebo-Controlled, 5-Arm, Parallel-Group Trial to Assess Rotigotine Transdermal System Dose Response in Subjects With Advanced-Stage Parkinson's Disease

Further study details as provided by UCB:

Primary Outcome Measures:

The change in the absolute time spent "off" from Baseline to the end of the Maintenance Period as recorded by the subject in a daily diary. [ Time Frame: 16 weeks treatment (4 weeks titration period and 12 weeks maintenance period) ]

Secondary Outcome Measures:

The relative time spent "off" from baseline to the end of the maintenance period as recorded by the subject in a daily diary. [ Time Frame: 16 weeks treatment (4 weeks titration period and 12 weeks maintenance period) ]
The change in the absolute and relative time spent "on' from baseline to the end of the maintenance period as recorded by the subject in a daily diary. [ Time Frame: 16 week treatment (4 weeks titration period and 12 weeks maintenance period) ]
The status of the subject ("on"/"off") after wake-up from baseline to the end of the maintenance period as recorded by the subject in a daily diary. [ Time Frame: 16 week treatment (4 weeks titration period and 12 weeks maintenance period) ]
The change in UPDRS Parts 1, II, III and IV from baseline to the end of the maintenance period as recorded by the subject in a daily diary. [ Time Frame: 16 week treatment (4 weeks titration period and 12 weeks maintenance period) ]
The number of "off" periods from baseline to the end of the maintenance period as recorded by the subject in a daily dairy. [ Time Frame: 16 week treatment (4 weeks titration period and 12 weeks maintenance period) ]

Estimated Enrollment:	500
Study Start Date:	July 2007
Estimated Study Completion Date:	April 2009
Estimated Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
2: Experimental 4mg used in combination with 2 mg to make 4mg/24hr doses	Drug: Rotigotine 10cm (2mg) transdermal patch applied daily for titration and maintenance period -16 weeks Drug: Rotigotine 20cm (4mg) transdermal patch applied daily for titration and maintenance period - 16 weeks
3: Placebo Comparator Placebo	Other: Placebo Placebo transdermal patch applied daily
1: Experimental 2mg/24hr doses	Drug: Rotigotine 10cm (2mg) transdermal patch applied daily for titration and maintenance period -16 weeks
4: Experimental 4mg used in combination with 2 mg to make 6mg/24hr doses	Drug: Rotigotine 10cm (2mg) transdermal patch applied daily for titration and maintenance period -16 weeks Drug: Rotigotine 20cm (4mg) transdermal patch applied daily for titration and maintenance period - 16 weeks
5: Experimental 4mg used in combination with 2 mg to make 8mg/24hr doses	Drug: Rotigotine 10cm (2mg) transdermal patch applied daily for titration and maintenance period -16 weeks Drug: Rotigotine 20cm (4mg) transdermal patch applied daily for titration and maintenance period - 16 weeks

Eligibility

Ages Eligible for Study:	30 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

PD greater than 3 years
Stable dose L-dopa but symptoms not adequately controlled and have "off" time.
Able and willing to complete diary on specific days.

Exclusion Criteria:

Previous use of rotigotine or Neupro
Atypical Parkinson's syndrome
Pallidotomy
Thalamotomy
Deep brain stimulation
Fetal tissue transplant
Dementia
Psychosis
Hallucinations
Epilepsy
Renal or hepatic dysfunction
Clinically relevant cardiac dysfunction
Symptomatic orthostatic hypotension
Skin sensitivity to adhesives or unresolved contact dermatitis
History of chronic alcohol or drug abuse
Pregnant or of child-bearing potential
Impulse control disorder.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00522379

Contacts


Contact: UCB Clinical Trial Call Center	+1 877 822 9493

Show 62 Study Locations

Sponsors and Collaborators

UCB

Investigators


Study Director:	UCB Clinical Trial Call Center	+1 877 822 9493 (UCB)

More Information

Responsible Party:	UCB ( Study Director )
Study ID Numbers:	SP921
First Received:	August 28, 2007
Last Updated:	September 2, 2008
ClinicalTrials.gov Identifier:	NCT00522379
Health Authority:	United States: Food and Drug Administration

Keywords provided by UCB:

Parkinson's disease, rotigotine, patch, transdermal, dopamine agonist, off time, Neupro.

Study placed in the following topic categories:

Dopamine

Ganglion Cysts

Movement Disorders

Parkinson Disease

Basal Ganglia Diseases

Central Nervous System Diseases

Parkinsonian Disorders

Neurodegenerative Diseases

Brain Diseases

N 0437

Additional relevant MeSH terms:

Neurotransmitter Agents

Molecular Mechanisms of Pharmacological Action

Physiological Effects of Drugs

Nervous System Diseases

Dopamine Agents

Dopamine Agonists

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 10, 2008

Sponsored by:	UCB
Information provided by:	UCB
ClinicalTrials.gov Identifier:	NCT00522379