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

January 13, 2010
February 19, 2014
November 2009
October 2012   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01049984 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Rasagiline as Add on to Dopamine Agonists in the Treatment of Parkinson's Disease
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

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

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Parkinson's Disease
  • Drug: Rasagiline
    1mg tablet, daily, for 18 weeks
  • Drug: Placebo
    placebo
  • Active Comparator: Arm 1
    Rasagiline, 1mg
    Intervention: Drug: Rasagiline
  • Placebo Comparator: Arm 2
    Matching placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
239
November 2012
October 2012   (final data collection date for primary outcome measure)

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
Both
30 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01049984
TVP-1012/PM103
Not Provided
Teva Pharmaceutical Industries ( Teva Neuroscience, Inc. )
Teva Neuroscience, Inc.
H. Lundbeck A/S
Study Director: Azhar Choudhry, M.D. Teva Neuroscience, Inc.
Teva Pharmaceutical Industries
February 2014

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