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

History of Changes

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

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Reporting Groups

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

Baseline Measures

	All Antiepileptic Drugs
Number of Participants [units: participants]	111
Age [units: years] Mean ± Standard Deviation	45.3 ± 16.1
Gender [units: participants]
Female	52
Male	59

Outcome Measures

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1. Primary:

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

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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) ]

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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) ]

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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) ]

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5. Secondary:

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

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6. Secondary:

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

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7. Secondary:

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

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8. Secondary:

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

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9. Secondary:

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

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10. Secondary:

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

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11. Secondary:

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

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12. Secondary:

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

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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) ]

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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) ]

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Measure Type	Secondary
Measure Title	Percent of Participants That Reduced, Maintained and Increased the Doses of the Initial Treatment Administered in Monotherapy
Measure Description	No text entered.
Time Frame	Baseline through Month 6 (or end of treatment)
Safety Issue	No

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.
FAS; LOCF. N= number of subjects with initial treatment administered as monotherapy.

Reporting Groups

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

Measured Values

	All Antiepileptic Drugs
Number of Participants Analyzed [units: participants]	3
Percent of Participants That Reduced, Maintained and Increased the Doses of the Initial Treatment Administered in Monotherapy [units: percent of participants]
Reduced	0.0
Maintained	100.0
Increased	0.0

No statistical analysis provided for Percent of Participants That Reduced, Maintained and Increased the Doses of the Initial Treatment Administered in Monotherapy

15. Secondary:

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

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16. Secondary:

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

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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 ]

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18. Secondary:

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

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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 ]

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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 ]

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21. Secondary:

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

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22. Secondary:

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

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Serious Adverse Events

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Other Adverse Events

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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:

	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.
	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.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.

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
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.

Results Point of Contact:

Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.gov_Inquiries@pfizer.com

No publications provided

Responsible Party:	Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier:	NCT00855738 History of Changes
Other Study ID Numbers:	A0081144, LICEO STUDY
Study First Received:	March 3, 2009
Results First Received:	June 23, 2010
Last Updated:	November 23, 2010
Health Authority:	Spain: Consejeria de Sanidad y Consumo de la Comunidad de Madrid and AEMyPS

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