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

Parkinson's Disease Clinical Trial

— ANDANTE  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01049984
• Other study ID #: TVP-1012/PM103
• Status: Completed
• Phase: Phase 4
• First received: January 13, 2010
• Last updated: October 9, 2014
• Start date: December 2009
• Est. completion date: October 2012

Study information

• Verified date: October 2014
• Source: Teva Pharmaceutical Industries
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 328
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Drug:
• Rasagiline
1mg tablet daily for 18 weeks
• Placebo
one tablet daily for 18 weeks

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Teva Neuroscience, Inc.	H. Lundbeck A/S

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline to Week 18 in the Unified Parkinson's Disease Rating Scale (UPDRS) Total Score for Parts I, II and III	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.	Day 0 (baseline), Week 18	No
Secondary	Change From Baseline to Week 18 in the Unified Parkinson's Disease Rating Scale (UPDRS) Total Score for Part II - Activities of Daily Living	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.	Day 0 (baseline), Week 18	No
Secondary	Change From Baseline to Week 18 in the Unified Parkinson's Disease Rating Scale (UPDRS) Total Score for Part III - Motor Function	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	18 weeks	No
Secondary	Clinical Global Improvement (CGI) Score at Week 18 As Assessed by the Site Rater	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.	18 weeks	No
Secondary	Clinical Global Improvement (CGI) Score at Week 18 As Assessed by the Participant	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).	18 weeks	No
Secondary	Illness Severity Score at Day 0 and Week 18 As Assessed by the Site Rater	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.	18 weeks	No