Rasagiline as Add on to Dopamine Agonists in the Treatment of Parkinson's Disease
NCT ID: NCT01049984
Last Updated: 2016-05-20
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
328 participants
INTERVENTIONAL
2009-12-31
2012-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Rasagiline 1 mg
Participants took a 1 mg rasagiline tablet orally each day for 18 weeks.
Rasagiline
1mg tablet daily for 18 weeks
Placebo
Participants took a matching placebo tablet once daily for 18 weeks.
Placebo
one tablet daily for 18 weeks
Interventions
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Rasagiline
1mg tablet daily for 18 weeks
Placebo
one tablet daily for 18 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 1\) Minimum dose of agonist will be 6 mg/day for ropinirole and 1.0 mg/day for pramipexole
* 2\) Stable dopamine agonist treatment must have been ongoing for ≥ 30 days, no longer than 5 years preceding baseline
* Males and females. Women of childbearing potential must agree to practice an acceptable method of birth control.
* Idiopathic Parkinson Disease confirmed at baseline by presence of at least 2 cardinal signs (resting tremor, bradykinesia, rigidity), w/o other known or suspected cause of Parkinsonism
* Hoehn \& Yahr \> 1 (symptoms on only one side of the body) with treatment and \< 3 (mild to moderate bilateral disease; some postural instability; physically independent).
* Dopamine agonist dose must be stable for ≥30 days preceding the baseline visit.
* For patients who are receiving amantadine or anticholinergics, the dose must have been stable for ≥30 days prior to screening.
* Medically stable outpatients (Investigator's judgment).
Exclusion Criteria
* receive levodopa \> 21 consecutive days within 90 days prior baseline
* moderate to severe motor fluctuations
* hepatic impairment
* investigational medications 30 days preceding baseline
* dopamine agonist use \> 5 years prior to baseline
* major depression as defined by Beck Depression Inventory (BDI) short form score greater than 14
* significant cognitive impairment as defined by Mini-Mental State Exam (MMSE) score less than 26.
* impulse control disorder (ICD) based on the Questionnaire for Impulsive-compulsive Disorders in Parkinson's Disease form (QUIP).
* pregnant or lactating or planning on becoming pregnant in the next 18 weeks
* uncontrolled hypertension. Patients whose hypertension is controlled with medications are eligible.
* Concomitant monoamine oxidase (MAO) inhibitors or medicines contraindicated w/ MAO inhibitors not allowed
30 Years
ALL
No
Sponsors
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H. Lundbeck A/S
INDUSTRY
Teva Neuroscience, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Azhar Choudhry, M.D.
Role: STUDY_DIRECTOR
Teva Neuroscience, Inc.
Locations
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Teva Investigational Site 34
Phoenix, Arizona, United States
Teva Investigational Site 42
Sun City, Arizona, United States
Teva Investigational Site 15
Fountain Valley, California, United States
Teva Investigational Site 19
Fresno, California, United States
Teva Investigational Site 36
Fresno, California, United States
Teva Investigational Site 04
La Jolla, California, United States
Teva Investigational Site 29
Reseda, California, United States
Teva Investigational Site 69
San Francisco, California, United States
Teva Investigational Site 02
Sunnyvale, California, United States
Teva Investigational Site 43
Ventura, California, United States
Teva Investigational Site 44
Fairfield, Connecticut, United States
Teva Investigational Site 07
Manchester, Connecticut, United States
Teva Investigational Site 25
Newark, Delaware, United States
Teva Investigative Site 63
Atlantis, Florida, United States
Teva Investigational Site 30
Boca Raton, Florida, United States
Teva Investigational Site 13
Clearwater, Florida, United States
Teva Investigational Site 70
Sunrise, Florida, United States
Teva Investigational Site 41
Tampa, Florida, United States
Teva Investigational Site 61
Vero Beach, Florida, United States
Teva Investigational Site 01
Decatur, Georgia, United States
Teva Investigational Site 58
Boise, Idaho, United States
Teva Investigational Site 49
Glenview, Illinois, United States
Teva Investigational Site 23
Peoria, Illinois, United States
Teva Investigational Site 47
Indianapolis, Indiana, United States
Teva Investigational Site 67
Indianapolis, Indiana, United States
Teva Investigational Site 76
Indianapolis, Indiana, United States
Teva Investigational Site 55
Des Moines, Iowa, United States
Teva Investigational Site 17
Lexington, Kentucky, United States
Teva Investigational Site 27
Paducah, Kentucky, United States
Teva Investigational Site 56
Scarborough, Maine, United States
Teva Investigational Site 62
Elkridge, Maryland, United States
Teva Investigational Site 51
Springfield, Massachusetts, United States
Teva Investigational Site 11
Detroit, Michigan, United States
Teva Investigational Site 33
West Bloomfield, Michigan, United States
Teva Investigational Site 39
Golden Valley, Minnesota, United States
Teva Investigational Site 22
St Louis, Missouri, United States
Teva Investigational Site 08
Great Falls, Montana, United States
Teva Investigational Site 59
Missoula, Montana, United States
Teva Investigational Site 60
Las Vegas, Nevada, United States
Teva Investigational Site 14
Somerset, New Jersey, United States
Teva Investigational Site 03
Commack, New York, United States
Teva Investigational Site 38
Plainview, New York, United States
Teva Investigational Site 05
Asheville, North Carolina, United States
Teva Investigational Site 31
Charlotte, North Carolina, United States
Teva Investigational Site 28
Raleigh, North Carolina, United States
Teva Investigational Site 26
Fargo, North Dakota, United States
Teva Investigational Site 35
Cincinnati, Ohio, United States
Teva Investigational Site 68
Cincinnati, Ohio, United States
Teva Investigational Site 64
Tulsa, Oklahoma, United States
Teva Investigational Site 21
Medford, Oregon, United States
Teva Investigational Site 40
Portland, Oregon, United States
Teva Investigative Site 65
Cordova, Tennessee, United States
Teva Investigational Site 71
Brownwood, Texas, United States
Teva Investigational Site 18
San Antonio, Texas, United States
Teva Investigational Site 32
Temple, Texas, United States
Teva Investigational Site 09
Richmond, Virginia, United States
Teva Investigational Site 46
Virginia Beach, Virginia, United States
Teva Investigational Site 77
Madison, Wisconsin, United States
Countries
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Other Identifiers
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TVP-1012/PM103
Identifier Type: -
Identifier Source: org_study_id
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