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

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ClinicalTrials.gov Identifier: NCT01049984
Recruitment Status : Completed
First Posted : January 15, 2010
Results First Posted : October 15, 2014
Last Update Posted : May 20, 2016
Sponsor:
Collaborator:
H. Lundbeck A/S
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Teva Neuroscience, Inc. )

Tracking Information
First Submitted Date  ICMJE January 13, 2010
First Posted Date  ICMJE January 15, 2010
Results First Submitted Date  ICMJE October 9, 2014
Results First Posted Date  ICMJE October 15, 2014
Last Update Posted Date May 20, 2016
Study Start Date  ICMJE December 2009
Actual Primary Completion Date October 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 9, 2014)
Change From Baseline to Week 18 in the Unified Parkinson's Disease Rating Scale (UPDRS) Total Score for Parts I, II and III [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE
 (submitted: January 14, 2010)
Change from baseline to Week 18 in Total Unified Parkinson's Disease Rating Scale (Parts I, II, III, version 3) score. [ Time Frame: 18 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 20, 2016)
  • Change From Baseline to Week 18 in the Unified Parkinson's Disease Rating Scale (UPDRS) Total Score for Part II - Activities of Daily Living [ Time Frame: 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.
  • Change From Baseline to Week 18 in the Unified Parkinson's Disease Rating Scale (UPDRS) Total Score for Part III - Motor Function [ Time Frame: 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
  • Clinical Global Improvement (CGI) Score at Week 18 As Assessed by the Site Rater [ Time Frame: 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.
  • Clinical Global Improvement (CGI) Score at Week 18 As Assessed by the Participant [ Time Frame: 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).
  • Illness Severity Score at Day 0 and Week 18 As Assessed by the Site Rater [ Time Frame: 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 14, 2010)
  • Change from baseline to Week 18 in Unified Parkinson's Disease Rating Scale activities of daily living (Part II) score [ Time Frame: 18 weeks ]
  • Change from baseline to Week 18 in Unified Parkinson's Disease Rating Scale motor examination (Part III) score [ Time Frame: 18 weeks ]
  • Clinical Global Evaluation Improvement score at Week 18 - as determined by the Site Rater [ Time Frame: 18 weeks ]
  • Change from baseline to Week 18 in Clinical Global Evaluation illness severity score- as determined by Site Rater [ Time Frame: 18 weeks ]
  • Clinical Global Evaluation improvement score at Week 18 - Patient rated [ Time Frame: 18 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Rasagiline as Add on to Dopamine Agonists in the Treatment of Parkinson's Disease
Official Title  ICMJE 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
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Parkinson's Disease
Intervention  ICMJE
  • Drug: Rasagiline
    1mg tablet daily for 18 weeks
    Other Names:
    • TVP-1012
    • AZILECT®
  • Drug: Placebo
    one tablet daily for 18 weeks
Study Arms  ICMJE
  • Experimental: Rasagiline 1 mg
    Participants took a 1 mg rasagiline tablet orally each day for 18 weeks.
    Intervention: Drug: Rasagiline
  • Placebo Comparator: Placebo
    Participants took a matching placebo tablet once daily for 18 weeks.
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 9, 2014)
328
Original Estimated Enrollment  ICMJE
 (submitted: January 14, 2010)
360
Actual Study Completion Date  ICMJE October 2012
Actual Primary Completion Date October 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01049984
Other Study ID Numbers  ICMJE TVP-1012/PM103
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Teva Pharmaceutical Industries ( Teva Neuroscience, Inc. )
Study Sponsor  ICMJE Teva Neuroscience, Inc.
Collaborators  ICMJE H. Lundbeck A/S
Investigators  ICMJE
Study Director: Azhar Choudhry, M.D. Teva Neuroscience, Inc.
PRS Account Teva Pharmaceutical Industries
Verification Date April 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP