Rasagiline as Add on to Dopamine Agonists in the Treatment of Parkinson's Disease - Full Text View

Sponsor:	Teva Neuroscience, Inc.
Collaborator:	H. Lundbeck A/S
Information provided by (Responsible Party):	Teva Pharmaceutical Industries ( Teva Neuroscience, Inc. )
ClinicalTrials.gov Identifier:	NCT01049984

Purpose

To assess the efficacy of rasagiline 1 mg as a first add on treatment to dopamine agonist therapy in early PD patients.

Condition	Intervention	Phase
Parkinson's Disease	Drug: Rasagiline Drug: Placebo	Phase IV

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:	Double-blind, Placebo Controlled, Randomized, Multicenter Study to Assess the Safety and Clinical Benefit of Rasagiline as an Add on Therapy to Stable Dose of Dopamine Agonists in the Treatment of Early Parkinson's Disease

Resource links provided by NLM:

Genetics Home Reference related topics: familial paroxysmal nonkinesigenic dyskinesia Parkinson disease Perry syndrome

MedlinePlus related topics: Parkinson's Disease

Drug Information available for: Dopamine Dopamine hydrochloride Rasagiline Rasagiline mesylate

U.S. FDA Resources

Further study details as provided by Teva Pharmaceutical Industries:

Primary Outcome Measures:

Change from baseline to Week 18 in Total Unified Parkinson's Disease Rating Scale (Parts I, II, III, version 3) score. [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change from baseline to Week 18 in Unified Parkinson's Disease Rating Scale activities of daily living (Part II) score [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]
Change from baseline to Week 18 in Unified Parkinson's Disease Rating Scale motor examination (Part III) score [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]
Clinical Global Evaluation Improvement score at Week 18 - as determined by the Site Rater [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]
Change from baseline to Week 18 in Clinical Global Evaluation illness severity score- as determined by Site Rater [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]
Clinical Global Evaluation improvement score at Week 18 - Patient rated [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	239
Study Start Date:	November 2009
Estimated Study Completion Date:	November 2012
Estimated Primary Completion Date:	October 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Arm 1 Rasagiline, 1mg	Drug: Rasagiline 1mg tablet, daily, for 18 weeks
Placebo Comparator: Arm 2 Matching placebo	Drug: Placebo placebo

Eligibility

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

Criteria

Inclusion Criteria:

receiving stable dose of oral ropinirole or pramipexole whose SX are not optimally controlled or oral DA titration regimen was truncated due to intolerability:
1. Min dose of agonist will be 6 mg/day for ropinirole and 1.0 mg/day for pramipexole
2. Stable Dopamine agonist TX must have been ongoing for ≥ 30 days, no longer than 5 years preceding baseline
M & F (BC)
- 30 YO
Idiopathic PD confirmed at baseline by presence of at least 2 cardinal signs (resting tremor, bradykinesia, rigidity), w/o other cause of Parkinsonism
H & Y > 1 w/ tx & < 3
receive amantadine or anticholinergics, stable ≥ 30 days prior to screen
written IC

Exclusion Criteria:

receive rasagiline or other MAO inhibitor 60 days preceding baseline
receive levodopa > 21 consecutive days within 90 days prior baseline
mod to severe motor fluctuations
hepatic impairment
investigational meds 30 days preceding baseline
DA use > 5 years prior to baseline
depression defined by BDI >score 14
sig. cog impairment (MMSE score <26)
ICD based on the QUIP
PG or lactating or planning on PG next 18 weeks
uncontrolled htn
Hypertensive controlled w/meds
Concomitant MAO inhibitors or meds contraindicated w/ MAO inhibitors not allowed

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01049984

Contacts

Contact: Shared Solutions

800-887-8100

Show 58 Study Locations

Sponsors and Collaborators

Teva Neuroscience, Inc.

H. Lundbeck A/S

Investigators

Study Director:

Azhar Choudhry, M.D.

Teva Neuroscience, Inc.

More Information

No publications provided

Responsible Party:	Teva Pharmaceutical Industries ( Teva Neuroscience, Inc. )
ClinicalTrials.gov Identifier:	NCT01049984 History of Changes
Other Study ID Numbers:	TVP-1012/PM103
Study First Received:	January 13, 2010
Last Updated:	February 7, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by Teva Pharmaceutical Industries:

Parkinson's Disease
UPDRS
Clinical Global Evaluation Illness Severity score
Clinical Global Evaluation Improvement
B-SIT
SCOPA - Sleep Daytime Sleepiness

PDQ -39
SCOPA - Cognition
Levodopa
rasagiline
Dopamine Agonist Therapy
monoamine oxidase type B inhibitor

Additional relevant MeSH terms:

Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Dopamine
Dopamine Agents
Rasagiline
Dopamine Agonists
Cardiotonic Agents
Cardiovascular Agents

Therapeutic Uses
Pharmacologic Actions
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Protective Agents
Monoamine Oxidase Inhibitors
Enzyme Inhibitors
Neuroprotective Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 09, 2012