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

This study has been completed.
Sponsor:
Collaborator:
H. Lundbeck A/S
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Teva Neuroscience, Inc. )
ClinicalTrials.gov Identifier:
NCT01049984
First received: January 13, 2010
Last updated: February 19, 2014
Last verified: February 2014
  Purpose

To assess the efficacy of rasagiline 1 mg as a first add on treatment to dopamine agonist therapy in early PD patients.


Condition Intervention Phase
Parkinson's Disease
Drug: Rasagiline
Drug: Placebo
Phase 4

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

Resource links provided by NLM:


Further study details as provided by Teva Pharmaceutical Industries:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline to Week 18 in Unified Parkinson's Disease Rating Scale activities of daily living (Part II) score [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to Week 18 in Unified Parkinson's Disease Rating Scale motor examination (Part III) score [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]
  • Clinical Global Evaluation Improvement score at Week 18 - as determined by the Site Rater [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to Week 18 in Clinical Global Evaluation illness severity score- as determined by Site Rater [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]
  • Clinical Global Evaluation improvement score at Week 18 - Patient rated [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]

Enrollment: 239
Study Start Date: November 2009
Study Completion Date: November 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm 1
Rasagiline, 1mg
Drug: Rasagiline
1mg tablet, daily, for 18 weeks
Placebo Comparator: Arm 2
Matching placebo
Drug: Placebo
placebo

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • receiving stable dose of oral ropinirole or pramipexole whose SX are not optimally controlled or oral DA titration regimen was truncated due to intolerability:

    1. Min dose of agonist will be 6 mg/day for ropinirole and 1.0 mg/day for pramipexole
    2. Stable Dopamine agonist TX must have been ongoing for ≥ 30 days, no longer than 5 years preceding baseline
  • M & F (BC)

    • 30 YO
  • Idiopathic PD confirmed at baseline by presence of at least 2 cardinal signs (resting tremor, bradykinesia, rigidity), w/o other cause of Parkinsonism
  • H & Y > 1 w/ tx & < 3
  • receive amantadine or anticholinergics, stable ≥ 30 days prior to screen
  • written IC

Exclusion Criteria:

  • receive rasagiline or other MAO inhibitor 60 days preceding baseline
  • receive levodopa > 21 consecutive days within 90 days prior baseline
  • mod to severe motor fluctuations
  • hepatic impairment
  • investigational meds 30 days preceding baseline
  • DA use > 5 years prior to baseline
  • depression defined by BDI >score 14
  • sig. cog impairment (MMSE score <26)
  • ICD based on the QUIP
  • PG or lactating or planning on PG next 18 weeks
  • uncontrolled htn
  • Hypertensive controlled w/meds
  • Concomitant MAO inhibitors or meds contraindicated w/ MAO inhibitors not allowed
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01049984

  Show 58 Study Locations
Sponsors and Collaborators
Teva Neuroscience, Inc.
H. Lundbeck A/S
Investigators
Study Director: Azhar Choudhry, M.D. Teva Neuroscience, Inc.
  More Information

No publications provided

Responsible Party: Teva Pharmaceutical Industries ( Teva Neuroscience, Inc. )
ClinicalTrials.gov Identifier: NCT01049984     History of Changes
Other Study ID Numbers: TVP-1012/PM103
Study First Received: January 13, 2010
Last Updated: February 19, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Teva Pharmaceutical Industries:
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

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Dopamine
Dopamine Agents
Rasagiline
Dopamine Agonists
Cardiotonic Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Protective Agents
Monoamine Oxidase Inhibitors
Enzyme Inhibitors
Neuroprotective Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on August 28, 2014