Clinical trial NCT01049984: Rasagiline as Add on to Dopamine Agonists in the Treatment of Parkinson's Disease
Official title: A 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Parkinson's Disease
Keywords: 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
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
Collaborators: name: H. Lundbeck A/S
First posted: 2010-01-15
Enrollment: 328
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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
* 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 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

Primary outcomes:
measure: Change From Baseline to Week 18 in the Unified Parkinson's Disease Rating Scale (UPDRS) Total Score for Parts I, II and III
timeFrame: Day 0 (baseline), Week 18
Secondary outcomes:
measure: Change From Baseline to Week 18 in the Unified Parkinson's Disease Rating Scale (UPDRS) Total Score for Part II - Activities of Daily Living
timeFrame: Day 0 (baseline), Week 18
measure: Change From Baseline to Week 18 in the Unified Parkinson's Disease Rating Scale (UPDRS) Total Score for Part III - Motor Function
timeFrame: Day 0 (baseline), Week 18
measure: Clinical Global Improvement (CGI) Score at Week 18 As Assessed by the Site Rater
timeFrame: 18 weeks
measure: Clinical Global Improvement (CGI) Score at Week 18 As Assessed by the Participant
timeFrame: 18 weeks
measure: Illness Severity Score at Day 0 and Week 18 As Assessed by the Site Rater
timeFrame: Day 0 (baseline), Week 18
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Teva Investigational Site 34
state: Arizona
city: Sun City
country: United States
facility: Teva Investigational Site 42
state: Arizona
city: Fountain Valley
country: United States
facility: Teva Investigational Site 15
state: California
city: Fresno
country: United States
facility: Teva Investigational Site 19
state: California
city: Fresno
country: United States
facility: Teva Investigational Site 36
state: California
city: La Jolla
country: United States
facility: Teva Investigational Site 04
state: California
city: Reseda
country: United States
facility: Teva Investigational Site 29
state: California
city: San Francisco
country: United States
facility: Teva Investigational Site 69
state: California
city: Sunnyvale
country: United States
facility: Teva Investigational Site 02
state: California
city: Ventura
country: United States
facility: Teva Investigational Site 43
state: California
city: Fairfield
country: United States
facility: Teva Investigational Site 44
state: Connecticut
city: Manchester
country: United States
facility: Teva Investigational Site 07
state: Connecticut
city: Newark
country: United States
facility: Teva Investigational Site 25
state: Delaware
city: Atlantis
country: United States
facility: Teva Investigative Site 63
state: Florida
city: Boca Raton
country: United States
facility: Teva Investigational Site 30
state: Florida
city: Clearwater
country: United States
facility: Teva Investigational Site 13
state: Florida
city: Sunrise
country: United States
facility: Teva Investigational Site 70
state: Florida
city: Tampa
country: United States
facility: Teva Investigational Site 41
state: Florida
city: Vero Beach
country: United States
facility: Teva Investigational Site 61
state: Florida
city: Decatur
country: United States
facility: Teva Investigational Site 01
state: Georgia
city: Boise
country: United States
facility: Teva Investigational Site 58
state: Idaho
city: Glenview
country: United States
facility: Teva Investigational Site 49
state: Illinois
city: Peoria
country: United States
facility: Teva Investigational Site 23
state: Illinois
city: Indianapolis
country: United States
facility: Teva Investigational Site 47
state: Indiana
city: Indianapolis
country: United States
facility: Teva Investigational Site 67
state: Indiana
city: Indianapolis
country: United States
facility: Teva Investigational Site 76
state: Indiana
city: Des Moines
country: United States
facility: Teva Investigational Site 55
state: Iowa
city: Lexington
country: United States
facility: Teva Investigational Site 17
state: Kentucky
city: Paducah
country: United States
facility: Teva Investigational Site 27
state: Kentucky
city: Scarborough
country: United States
facility: Teva Investigational Site 56
state: Maine
city: Elkridge
country: United States
facility: Teva Investigational Site 62
state: Maryland
city: Springfield
country: United States
facility: Teva Investigational Site 51
state: Massachusetts
city: Detroit
country: United States
facility: Teva Investigational Site 11
state: Michigan
city: West Bloomfield
country: United States
facility: Teva Investigational Site 33
state: Michigan
city: Golden Valley
country: United States
facility: Teva Investigational Site 39
state: Minnesota
city: St. Louis
country: United States
facility: Teva Investigational Site 22
state: Missouri
city: Great Falls
country: United States
facility: Teva Investigational Site 08
state: Montana
city: Missoula
country: United States
facility: Teva Investigational Site 59
state: Montana
city: Las Vegas
country: United States
facility: Teva Investigational Site 60
state: Nevada
city: Somerset
country: United States
facility: Teva Investigational Site 14
state: New Jersey
city: Commack
country: United States
facility: Teva Investigational Site 03
state: New York
city: Plainview
country: United States
facility: Teva Investigational Site 38
state: New York
city: Asheville
country: United States
facility: Teva Investigational Site 05
state: North Carolina
city: Charlotte
country: United States
facility: Teva Investigational Site 31
state: North Carolina
city: Raleigh
country: United States
facility: Teva Investigational Site 28
state: North Carolina
city: Fargo
country: United States
facility: Teva Investigational Site 26
state: North Dakota
city: Cincinnati
country: United States
facility: Teva Investigational Site 35
state: Ohio
city: Cincinnati
country: United States
facility: Teva Investigational Site 68
state: Ohio
city: Tulsa
country: United States
facility: Teva Investigational Site 64
state: Oklahoma
city: Medford
country: United States
facility: Teva Investigational Site 21
state: Oregon
city: Portland
country: United States
facility: Teva Investigational Site 40
state: Oregon
city: Cordova
country: United States
facility: Teva Investigative Site 65
state: Tennessee
city: Brownwood
country: United States
facility: Teva Investigational Site 71
state: Texas
city: San Antonio
country: United States
facility: Teva Investigational Site 18
state: Texas
city: Temple
country: United States
facility: Teva Investigational Site 32
state: Texas
city: Richmond
country: United States
facility: Teva Investigational Site 09
state: Virginia
city: Virginia Beach
country: United States
facility: Teva Investigational Site 46
state: Virginia
city: Madison
country: United States
facility: Teva Investigational Site 77
state: Wisconsin
Study officials:
affiliation: Teva Neuroscience, Inc.
name: Azhar Choudhry, M.D.
role: STUDY_DIRECTOR
References: