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A Prospective, Observational Study On The Effectiveness Of New Antiepileptic Drugs As First Bitherapy In The Daily Clinical Practice

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00855738
First received: March 3, 2009
Last updated: November 23, 2010
Last verified: November 2010
Results First Received: June 23, 2010  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Focal Epilepsy
Intervention: Drug: Gabapentin, Lamotrigine, Levetiracetam, Pregabalin, Oxcarbacepine, Tiagabine, Topiramate, Zonisamide

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Given the observational nature of the study, the selection of treatment and dose of study medication was independent from participation in the study and was determined by daily clinical practice.

Reporting Groups
  Description
All Antiepileptic Drugs Pregabalin, Levetiracetam, Topiramate, Lamotrigine, Oxcarbazepine, Zonisamide, Gabapentin: treatment, dose and frequency of administration determined by daily clinical practice

Participant Flow:   Overall Study
    All Antiepileptic Drugs  
STARTED     111  
At Least 1 Dose and 1 Endpoint     108 [1]
COMPLETED     106  
NOT COMPLETED     5  
Lost to Follow-up                 2  
Adverse Event                 1  
Subject Defaulted                 1  
Death                 1  
[1] Received at least 1 dose of study drug and had data for at least 1 efficacy endpoint.



  Baseline Characteristics


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percent of Participants Classified as Responders   [ Time Frame: Baseline, Month 3, Month 6 (last 3 months of treatment) ]

2.  Secondary:   Percent of Participants With Reduction in Number of Seizures >=25% and >=75% During the Last 3 Months of Treatment   [ Time Frame: Baseline, Month 3, Month 6 (last 3 months of treatment) ]

3.  Secondary:   Percent of Seizure-free Participants During the Last 3 Months Before Discontinuation   [ Time Frame: Baseline, Month 3, Month 6 (last 3 months of treatment) ]

4.  Secondary:   Percent Change From Baseline in the Median Number of Seizures During the Last 3 Months of Treatment   [ Time Frame: Baseline, Month 3, Month 6 (last 3 months of treatment) ]

5.  Secondary:   Percent of Days Without Crisis During the Study   [ Time Frame: Baseline through Month 6 (or end of treatment) ]

6.  Secondary:   Time to First Seizure   [ Time Frame: Baseline to Month 6 (or end of treatment) ]

7.  Secondary:   Percent of Participants Who Continued on Study Medication to Month 6   [ Time Frame: Baseline to Month 6 ]

8.  Secondary:   Time to Discontinuation Due to Lack of Efficacy   [ Time Frame: Baseline, Month 3, Month 6 ]

9.  Secondary:   Time to Discontinuation Due to Safety, Tolerability, or Treatment Compliance   [ Time Frame: Baseline, Month 3, Month 6 ]

10.  Secondary:   Time to Discontinuation Due to Other Reasons   [ Time Frame: Baseline, Month 3, Month 6 ]

11.  Secondary:   Treatment Satisfaction Evaluated by Patient Global Impression of Change Visual Analog Scale (VAS)   [ Time Frame: Baseline, Month 3, Month 6 ]

12.  Secondary:   Percent of Participants Reaching Monotherapy   [ Time Frame: Baseline through Month 6 (or end of study) ]

13.  Secondary:   Percent of Participants That Reduced, Maintained and Increased Their Doses of New Antiepileptic Drugs (AED)   [ Time Frame: Baseline to Month 6 (or end of treatment) ]

14.  Secondary:   Percent of Participants That Reduced, Maintained and Increased the Doses of the Initial Treatment Administered in Monotherapy   [ Time Frame: Baseline through Month 6 (or end of treatment) ]

15.  Secondary:   Change From Baseline to Month 6 in the Hospital Anxiety and Depression Scale (HADS)   [ Time Frame: Baseline to Month 6 ]

16.  Secondary:   Change From Baseline to Month 6 in Quality of Life 10 Domains (QOLIE-10)   [ Time Frame: Baseline to Month 6 ]

17.  Secondary:   Change From Baseline to Months 3 and 6 in Health Condition: Euro Quality of Life Scale (EQ-5D) Visual Analog Scale (VAS)   [ Time Frame: Baseline, Month 3, Month 6 ]

18.  Secondary:   Change in Sleep Disturbances From Baseline to Month 6: Medical Outcomes Study Sleep Scale (MOS-SS)   [ Time Frame: Baseline to Month 6 ]

19.  Secondary:   Percent of Participants Indicating Optimal Sleep on the Optimal Sleep Subscale: Medical Outcomes Study Sleep Scale (MOS-SS)   [ Time Frame: Baseline, Month 6 ]

20.  Secondary:   Change From Baseline to Month 6 in Visits to a Specialist or the Emergency Room Because of Epilepsy   [ Time Frame: Baseline to Month 6 ]

21.  Secondary:   Change From Baseline to Month 6 in Total Number of Days Hospitalized Because of Epilepsy   [ Time Frame: Baseline to Month 6 ]

22.  Secondary:   Percent of Participants With Cessation of Occupation, Requirement of Caregiver, or Admission to Intensive Care Unit   [ Time Frame: Month 6 ]


  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
This study was cancelled with 111 patients enrolled due to lack of recruitment, and inability to analyze the study by treatment groups. Seizures were analyzed by 3 month data instead of 2 month data as originally planned.


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