Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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: April 20, 2016
Last verified: April 2016
Results First Received: October 9, 2014  
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
Condition: Parkinson's Disease
Interventions: Drug: Rasagiline
Drug: Placebo

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Rasagiline 1 mg Participants took a 1 mg rasagiline tablet orally each day for 18 weeks.
Placebo Participants took a matching placebo tablet once daily for 18 weeks.

Participant Flow:   Overall Study
    Rasagiline 1 mg   Placebo
STARTED   163   165 
Safety Population   162 [1]   164 [1] 
Modified Intent-to-treat Pop   159 [2]   162 [2] 
COMPLETED   144   146 
NOT COMPLETED   19   19 
Withdrawal by Subject                1                5 
Protocol Violation                3                4 
Lost to Follow-up                2                1 
Adverse Event                13                7 
Treatment failure                0                2 
[1] One patient was randomized but not dosed; omitted from safety population
[2] Took >= 1 dose of study drug and had both baseline and at least 1 post-baseline efficacy assessment



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Safety population

Reporting Groups
  Description
Rasagiline 1 mg Participants took a 1 mg rasagiline tablet orally each day for 18 weeks.
Placebo Participants took a matching placebo tablet once daily for 18 weeks.
Total Total of all reporting groups

Baseline Measures
   Rasagiline 1 mg   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 162   164   326 
Age 
[Units: Years]
Mean (Standard Deviation)
 62.3  (9.27)   62.8  (10.06)   62.5  (9.67) 
Age, Customized 
[Units: Participants]
     
30 to <65 years   97   89   186 
65 to <75 years   49   60   109 
>=75 years   16   15   31 
Gender 
[Units: Participants]
     
Female   53   53   106 
Male   109   111   220 
Ethnicity (NIH/OMB) 
[Units: Participants]
     
Hispanic or Latino   7   9   16 
Not Hispanic or Latino   154   155   309 
Unknown or Not Reported   1   0   1 
Race (NIH/OMB) 
[Units: Participants]
     
American Indian or Alaska Native   0   0   0 
Asian   2   3   5 
Native Hawaiian or Other Pacific Islander   0   2   2 
Black or African American   3   7   10 
White   156   151   307 
More than one race   1   1   2 
Unknown or Not Reported   0   0   0 
Parkinson's Disease Duration [1] 
[Units: Years]
Mean (Standard Deviation)
 2.19  (2.224)   2.07  (1.940)   2.13  (2.083) 
[1] Years since first diagnosis. Data based on the modified intent to treat population of 159, 162 participants.


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   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 ]

2.  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   [ Time Frame: Day 0 (baseline), Week 18 ]

3.  Secondary:   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 ]

4.  Secondary:   Clinical Global Improvement (CGI) Score at Week 18 As Assessed by the Site Rater   [ Time Frame: 18 weeks ]

5.  Secondary:   Clinical Global Improvement (CGI) Score at Week 18 As Assessed by the Participant   [ Time Frame: 18 weeks ]

6.  Secondary:   Illness Severity Score at Day 0 and Week 18 As Assessed by the Site Rater   [ Time Frame: Day 0 (baseline), Week 18 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Director, Clinical Research
Organization: Teva Branded Pharmaceutical Products, R&D Inc.
phone: 215-591-3000
e-mail: ustevatrials@tevapharm.com



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
Results First Received: October 9, 2014
Last Updated: April 20, 2016
Health Authority: United States: Food and Drug Administration