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

NCT01049984 | Completed Phase 4 Results

• 1 other identifier: TVP-1012/PM103
• Study Type: interventional
• Target: 328
• Locations: 1 country
• Sites: 58

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.

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• 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

• 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

• Clinical Global Improvement (CGI) Score at Week 18 As Assessed by the Site Rater

  18 weeks

• Clinical Global Improvement (CGI) Score at Week 18 As Assessed by the Participant

  18 weeks

• Illness Severity Score at Day 0 and Week 18 As Assessed by the Site Rater

  Day 0 (baseline), Week 18

Study Arms (2)

Rasagiline 1 mg

EXPERIMENTAL

Participants took a 1 mg rasagiline tablet orally each day for 18 weeks.

Drug: Rasagiline

Placebo

PLACEBO COMPARATOR

Participants took a matching placebo tablet once daily for 18 weeks.

Drug: Placebo

Interventions

Rasagiline DRUG

1mg tablet daily for 18 weeks

Also known as: TVP-1012, AZILECT®

Rasagiline 1 mg

Placebo DRUG

one tablet daily for 18 weeks

Placebo

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• \) Minimum dose of agonist will be 6 mg/day for ropinirole and 1.0 mg/day for pramipexole
• \) 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Teva Neuroscience, Inc.: lead
• H. Lundbeck A/S: collaborator

Study Sites (58)

Teva Investigational Site 34

Phoenix, Arizona, United States

Location

Teva Investigational Site 42

Sun City, Arizona, United States

Location

Teva Investigational Site 15

Fountain Valley, California, United States

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Teva Investigational Site 19

Fresno, California, United States

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Teva Investigational Site 36

Fresno, California, United States

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Teva Investigational Site 04

La Jolla, California, United States

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Teva Investigational Site 29

Reseda, California, United States

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Teva Investigational Site 69

San Francisco, California, United States

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Teva Investigational Site 02

Sunnyvale, California, United States

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Teva Investigational Site 43

Ventura, California, United States

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Teva Investigational Site 44

Fairfield, Connecticut, United States

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Teva Investigational Site 07

Manchester, Connecticut, United States

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Teva Investigational Site 25

Newark, Delaware, United States

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Teva Investigative Site 63

Atlantis, Florida, United States

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Teva Investigational Site 30

Boca Raton, Florida, United States

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Teva Investigational Site 13

Clearwater, Florida, United States

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Teva Investigational Site 70

Sunrise, Florida, United States

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Teva Investigational Site 41

Tampa, Florida, United States

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Teva Investigational Site 61

Vero Beach, Florida, United States

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Teva Investigational Site 01

Decatur, Georgia, United States

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Teva Investigational Site 58

Boise, Idaho, United States

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Teva Investigational Site 49

Glenview, Illinois, United States

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Teva Investigational Site 23

Peoria, Illinois, United States

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Teva Investigational Site 47

Indianapolis, Indiana, United States

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Teva Investigational Site 67

Indianapolis, Indiana, United States

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Teva Investigational Site 76

Indianapolis, Indiana, United States

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Teva Investigational Site 55

Des Moines, Iowa, United States

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Teva Investigational Site 17

Lexington, Kentucky, United States

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Teva Investigational Site 27

Paducah, Kentucky, United States

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Teva Investigational Site 56

Scarborough, Maine, United States

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Teva Investigational Site 62

Elkridge, Maryland, United States

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Teva Investigational Site 51

Springfield, Massachusetts, United States

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Teva Investigational Site 11

Detroit, Michigan, United States

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Teva Investigational Site 33

West Bloomfield, Michigan, United States

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Teva Investigational Site 39

Golden Valley, Minnesota, United States

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Teva Investigational Site 22

St Louis, Missouri, United States

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Teva Investigational Site 08

Great Falls, Montana, United States

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Teva Investigational Site 59

Missoula, Montana, United States

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Teva Investigational Site 60

Las Vegas, Nevada, United States

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Teva Investigational Site 14

Somerset, New Jersey, United States

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Teva Investigational Site 03

Commack, New York, United States

Location

Teva Investigational Site 38

Plainview, New York, United States

Location

Teva Investigational Site 05

Asheville, North Carolina, United States

Location

Teva Investigational Site 31

Charlotte, North Carolina, United States

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Teva Investigational Site 28

Raleigh, North Carolina, United States

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Teva Investigational Site 26

Fargo, North Dakota, United States

Location

Teva Investigational Site 35

Cincinnati, Ohio, United States

Location

Teva Investigational Site 68

Cincinnati, Ohio, United States

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Teva Investigational Site 64

Tulsa, Oklahoma, United States

Location

Teva Investigational Site 21

Medford, Oregon, United States

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Teva Investigational Site 40

Portland, Oregon, United States

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Teva Investigative Site 65

Cordova, Tennessee, United States

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Teva Investigational Site 71

Brownwood, Texas, United States

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Teva Investigational Site 18

San Antonio, Texas, United States

Location

Teva Investigational Site 32

Temple, Texas, United States

Location

Teva Investigational Site 09

Richmond, Virginia, United States

Location

Teva Investigational Site 46

Virginia Beach, Virginia, United States

Location

Teva Investigational Site 77

Madison, Wisconsin, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

rasagiline

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Results Point of Contact

• Title: Director, Clinical Research
• Organization: Teva Branded Pharmaceutical Products, R&D Inc.

ustevatrials@tevapharm.com

215-591-3000

Study Officials

• Azhar Choudhry, M.D.

  Teva Neuroscience, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2010
• First Posted: January 15, 2010
• Study Start: December 1, 2009
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: May 20, 2016
• Results First Posted: October 15, 2014

Record last verified: 2016-04

Locations

US (58)