Long-term Safety of Rivastigmine Capsule and Patch in Patients With Mild to Moderately-severe Dementia Associated With Parkinson's Disease (PDD)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT00623103
First received: February 14, 2008
Last updated: October 19, 2011
Last verified: October 2011
Results First Received: October 19, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Parkinson's Disease Dementia
Interventions: Drug: Rivastigmine capsule
Drug: Rivastigmine transdermal patch

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Rivastigmine Capsule Rivastigmine capsules starting at a total dose of 3 mg/day (1.5 mg twice daily orally) titrated up in 3 mg/day increments every 4 weeks to a final dose of 12 mg/day (6 mg twice daily orally0. The 12 mg/day dose or the highest dose tolerated was maintained until week 76.
Rivastigmine Patch Rivastigmine patch once a day in the morning, worn for 24 hours, starting at 5 cm^2 (delivering 4.6 mg rivastigmine over a 24 hour period) for 4 weeks then titrated up to 10 cm^2 daily (delivering 9.5 mg rivastigmine over a 24 hour period). The 10 cm^2 patch or the highest well tolerated dose was maintained until week 76.

Participant Flow:   Overall Study
    Rivastigmine Capsule     Rivastigmine Patch  
STARTED     295     288  
Safety Set: Received Study Drug     294 [1]   288  
COMPLETED     184     175  
NOT COMPLETED     111     113  
Adverse Event                 70                 60  
Unsatisfactory therapeutic effect                 4                 12  
Withdrawal by Subject                 18                 24  
Lost to Follow-up                 4                 1  
Administrative problems                 2                 4  
Death                 11                 11  
Protocol deviation                 2                 1  
[1] One randomized participant did not receive study drug and was not included in the Safety set.



  Baseline Characteristics
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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.
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Reporting Groups
  Description
Rivastigmine Capsule Rivastigmine capsules starting at a total dose of 3 mg/day (1.5 mg twice daily orally) titrated up in 3 mg/day increments every 4 weeks to a final dose of 12 mg/day (6 mg twice daily orally0. The 12 mg/day dose or the highest dose tolerated was maintained until week 76.
Rivastigmine Patch Rivastigmine patch once a day in the morning, worn for 24 hours, starting at 5 cm^2 (delivering 4.6 mg rivastigmine over a 24 hour period) for 4 weeks then titrated up to 10 cm^2 daily (delivering 9.5 mg rivastigmine over a 24 hour period). The 10 cm^2 patch or the highest well tolerated dose was maintained until week 76.
Total Total of all reporting groups

Baseline Measures
    Rivastigmine Capsule     Rivastigmine Patch     Total  
Number of Participants  
[units: participants]
  295     288     583  
Age  
[units: years]
Mean ± Standard Deviation
  72.35  ± 6.295     72.26  ± 6.352     72.31  ± 6.318  
Gender  
[units: participants]
     
Female     88     97     185  
Male     207     191     398  



  Outcome Measures
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1.  Primary:   Percentage of Participants With Adverse Events (AEs) Due, or Potentially Due, to Worsening of Parkinson Disease (PD) Motor Symptoms (Tremor, Muscle Rigidity, Bradykinesia, Fall)   [ Time Frame: 76 Weeks ]

2.  Primary:   Percentage of Participants With Study Drug Discontinuations Due to Predefined AEs That Are Due, or Potentially Due, to Worsening of PD Motor Symptoms (Tremor, Muscle Rigidity, Bradykinesia, Fall)   [ Time Frame: 76 Weeks ]

3.  Secondary:   Change in Unified Parkinson Disease Rating Scale (UPDRS) Part III Motor Examination Scores at Weeks 8, 16, 24, 52 and 76 (or Early Discontinuation) Compared to Baseline   [ Time Frame: From Baseline to Weeks 8, 16, 24, 52 and 76 ]

4.  Secondary:   Change in Mattis Dementia Rating Scale (Mattis DRS-2) Scores at Weeks 16, 24, 52 and 76 Compared to Baseline   [ Time Frame: From Baseline to Weeks 16, 24, 52 and 76 ]

5.  Secondary:   Change in Ten Point Clock Test (TPCT) Scores at Weeks 16, 24, 52 and 76 (or Early Discontinuation) Compared to Baseline   [ Time Frame: From Baseline to Weeks 16, 24, 52 and 76 ]

6.  Secondary:   Change in Neuropsychiatric Inventory-10 (NPI-10) Scores at Weeks 16, 24, 52 and 76 (or Early Discontinuation) Compared to Baseline   [ Time Frame: At Week 16, 24, 52 and 76 (or early discontinuation) ]

7.  Secondary:   Change in Alzheimer's Disease Cooperative Study-Activities Of Daily Living (ADCS-ADL) Scores at Weeks 16, 24, 52 and 76 (or Early Discontinuation) Compared to Baseline   [ Time Frame: From Baseline to Week 16, 24, 52 and 76 (or early discontinuation) ]

8.  Secondary:   UPDRS Part V Stage (Modified Hoehn and Yahr Staging)at Baseline, Week 8,16,24,52 and 76 (or Early Discontinuation)   [ Time Frame: From Baseline to Week 8, 16, 24, 52 and 76 (or early discontinuation) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  More Information
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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: Study Director
Organization: Novartis Pharmaceuticals
phone: 862-778-8300


No publications provided


Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00623103     History of Changes
Other Study ID Numbers: CENA713B2315
Study First Received: February 14, 2008
Results First Received: October 19, 2011
Last Updated: October 19, 2011
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
Austria: Agency for Health and Food Safety
Belgium: Federal Agency for Medicinal Products and Health Products
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Italy: Ministry of Health
Netherlands: Medicines Evaluation Board (MEB)
Spain: Spanish Agency of Medicines
Turkey: Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency