Rasagiline as Add on to Dopamine Agonists in the Treatment of Parkinson's Disease

Phase 4

Completed

Conditions: Parkinson's Disease

Interventions: Drug: Placebo
Drug: Rasagiline

Registration Number: NCT01049984

Lead Sponsor: Teva Neuroscience, Inc.

Brief Summary: To assess the efficacy of rasagiline 1 mg as a first add-on treatment to dopamine agonist therapy in early Parkinson Disease (PD) patients, , not optimally controlled on dopamine agonists as compared to placebo.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 328

Inclusion Criteria

receiving stable dose of oral ropinirole or pramipexole whose symptoms are not optimally controlled or whose oral dopamine agonist titration regimen was truncated due to intolerability:
1. Minimum dose of agonist will be 6 mg/day for ropinirole and 1.0 mg/day for pramipexole
1. 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 rasagiline or other monoamine oxidase (MAO) inhibitors 60 days preceding baseline
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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Participants took a matching placebo tablet once daily for 18 weeks.
Rasagiline 1 mg	Rasagiline	Participants took a 1 mg rasagiline tablet orally each day for 18 weeks.

Primary Outcome Measures

Name	Time	Method
Change From Baseline to Week 18 in the Unified Parkinson's Disease Rating Scale (UPDRS) Total Score for Parts I, II and III	Day 0 (baseline), Week 18	The UPDRS was developed as a comprehensive tool to monitor the impact of Parkinson's Disease and the degree of disability caused. Version 3 of UPDRS contains four parts, three of which are totaled and reported in this outcome. Part I is a clinician's evaluation of mentation (mental activity or state of mind), cognition (ability to acquire knowledge), behaviour and mood. Part II is the participants' evaluation of the disease's impact on normal activities. Part III is a clinician's evaluation of motor function. Parts I, II, and III contain a total of 31 questions, which are each rated on a scale of 0 (normal or no disease effect) to 4 (maximum negative effect), for a total scale of 0-124. Negative change from baseline values indicate improvement. All site raters (medical doctor \[MD\], doctor of osteopathy \[DO\], nurse practitioner, or physician assistant) received training on how to complete the UPDRS. The same site rater completed the UPDRS at all visits.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline to Week 18 in the Unified Parkinson's Disease Rating Scale (UPDRS) Total Score for Part II - Activities of Daily Living	Day 0 (baseline), Week 18	The UPDRS was developed as a comprehensive tool to monitor the impact of Parkinson's Disease and the degree of disability caused. UPDRS contains four parts, the second of which is reported in this outcome. Part II is the participants' evaluation of the disease's impact on normal activities. Part II contains a total of 13 questions, which are each rated on a scale of 0 (normal or no disease effect) to 4 (maximum negative effect), for a total scale of 0-52. Negative change from baseline values indicate improvement.
Clinical Global Improvement (CGI) Score at Week 18 As Assessed by the Participant	18 weeks	CGI is used by the participant to rate his/her total improvement during the study. Specifically, participants are asked to compare their condition at the beginning of the study to his/her condition at Week 18, how much has he/she changed? Answers are 0 (not assessed), 1 (very much improved), 2 (much improved), 3 (minimally improved), 4 (no change), 5 (minimally worse), 6 (much worse), 7(very much worse).
Change From Baseline to Week 18 in the Unified Parkinson's Disease Rating Scale (UPDRS) Total Score for Part III - Motor Function	Day 0 (baseline), Week 18	The UPDRS was developed as a comprehensive tool to monitor the impact of Parkinson's Disease and the degree of disability caused. Version 3 of UPDRS contains four parts, the third of which is reported in this outcome. Part III is a clinician's evaluation of motor function. Part III contains 14 questions, which are each rated on a scale of 0 (normal or no disease effect) to 4 (maximum negative effect), for a total scale of 0-56. Negative change from baseline values indicate improvement. All site raters (medical doctor \[MD\], doctor of osteopathy \[DO\], nurse practitioner, or physician assistant) received training on how to complete the UPDRS. The same site rater completed the UPDRS at all visits
Illness Severity Score at Day 0 and Week 18 As Assessed by the Site Rater	Day 0 (baseline), Week 18	Site raters were asked: Considering your total clinical experience with the particular population, how ill is the patient at this time? Answers were based on a 0-7 scale, with 0=not assessed, 1= normal, not at all ill, and 7= among the most extremely ill of patients. Site raters can be the medical doctor \[MD\], doctor of osteopathy \[DO\], nurse practitioner, or physician assistant.
Clinical Global Improvement (CGI) Score at Week 18 As Assessed by the Site Rater	18 weeks	CGI is used by the site rater to rate participants total improvement during the study whether or not, in the investigators' judgment, it is due entirely to drug treatment. Specifically, site raters are asked to compare the participants condition at the beginning of the study to his/her condition at Week 18, how much has he/she changed? Answers are 0 (not assessed), 1 (very much improved), 2 (much improved), 3 (minimally improved), 4 (no change), 5 (minimally worse), 6 (much worse), 7(very much worse). Site raters can be the medical doctor \[MD\], doctor of osteopathy \[DO\], nurse practitioner, or physician assistant.

Trial Locations

Locations (58): Teva Investigational Site 21
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Medford, Oregon, United States
Teva Investigational Site 31
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Charlotte, North Carolina, United States
Teva Investigational Site 09
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Richmond, Virginia, United States
Teva Investigational Site 05
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Asheville, North Carolina, United States
Teva Investigative Site 65
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Cordova, Tennessee, United States
Teva Investigational Site 71
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Brownwood, Texas, United States
Teva Investigational Site 28
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Raleigh, North Carolina, United States
Teva Investigational Site 46
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Virginia Beach, Virginia, United States
Teva Investigational Site 32
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Temple, Texas, United States
Teva Investigational Site 64
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Tulsa, Oklahoma, United States
Teva Investigational Site 77
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Madison, Wisconsin, United States
Teva Investigational Site 60
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Las Vegas, Nevada, United States
Teva Investigational Site 35
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Cincinnati, Ohio, United States
Teva Investigational Site 68
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Cincinnati, Ohio, United States
Teva Investigational Site 26
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Fargo, North Dakota, United States
Teva Investigational Site 34
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Phoenix, Arizona, United States
Teva Investigational Site 18
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San Antonio, Texas, United States
Teva Investigational Site 40
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Portland, Oregon, United States
Teva Investigational Site 44
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Fairfield, Connecticut, United States
Teva Investigational Site 58
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Boise, Idaho, United States
Teva Investigational Site 08
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Great Falls, Montana, United States
Teva Investigational Site 14
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Somerset, New Jersey, United States
Teva Investigational Site 15
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Fountain Valley, California, United States
Teva Investigational Site 42
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Sun City, Arizona, United States
Teva Investigational Site 19
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Fresno, California, United States
Teva Investigational Site 36
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Fresno, California, United States
Teva Investigational Site 69
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San Francisco, California, United States
Teva Investigational Site 29
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Reseda, California, United States
Teva Investigational Site 02
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Sunnyvale, California, United States
Teva Investigational Site 43
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Ventura, California, United States
Teva Investigational Site 07
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Manchester, Connecticut, United States
Teva Investigational Site 25
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Newark, Delaware, United States
Teva Investigative Site 63
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Atlantis, Florida, United States
Teva Investigational Site 30
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Boca Raton, Florida, United States
Teva Investigational Site 70
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Sunrise, Florida, United States
Teva Investigational Site 41
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Tampa, Florida, United States
Teva Investigational Site 61
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Vero Beach, Florida, United States
Teva Investigational Site 01
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Decatur, Georgia, United States
Teva Investigational Site 49
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Glenview, Illinois, United States
Teva Investigational Site 23
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Peoria, Illinois, United States
Teva Investigational Site 47
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Indianapolis, Indiana, United States
Teva Investigational Site 67
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Indianapolis, Indiana, United States
Teva Investigational Site 76
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Indianapolis, Indiana, United States
Teva Investigational Site 55
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Des Moines, Iowa, United States
Teva Investigational Site 27
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Paducah, Kentucky, United States
Teva Investigational Site 17
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Lexington, Kentucky, United States
Teva Investigational Site 56
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Scarborough, Maine, United States
Teva Investigational Site 62
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Elkridge, Maryland, United States
Teva Investigational Site 51
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Springfield, Massachusetts, United States
Teva Investigational Site 11
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Detroit, Michigan, United States
Teva Investigational Site 33
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West Bloomfield, Michigan, United States
Teva Investigational Site 22
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St. Louis, Missouri, United States
Teva Investigational Site 59
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Missoula, Montana, United States
Teva Investigational Site 39
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Golden Valley, Minnesota, United States
Teva Investigational Site 03
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Commack, New York, United States
Teva Investigational Site 38
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Plainview, New York, United States
Teva Investigational Site 13
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Clearwater, Florida, United States
Teva Investigational Site 04
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La Jolla, California, United States