Clinical Study With Lyrica In Patients Suffering From Epilepsy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00922987
Recruitment Status : Completed
First Posted : June 18, 2009
Results First Posted : June 21, 2011
Last Update Posted : July 22, 2011
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Brief Summary:
Clinical study with Lyrica (pregabalin) in patients suffering from epilepsy. This drug is used as adjunctive therapy with one or more antiepileptics. Lyrica has potential to reduce seizure frequency.

Condition or disease Intervention/treatment
Neuralgia Epilepsy Drug: Lyrica (pregabalin)

Detailed Description:
- Included all adult patients with partial seizures and without contraindications according to Summary of Product Characteristics (SmPC).

Study Type : Observational
Actual Enrollment : 286 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Non-Interventional Study (NIS) With Lyrica In Patients With Epilepsy As Adjunctive Therapy Of Partial Seizures To Reduce Seizure Frequency
Study Start Date : September 2009
Actual Primary Completion Date : June 2010
Actual Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy Seizures
Drug Information available for: Pregabalin
U.S. FDA Resources

Group/Cohort Intervention/treatment
Adult patients with partial seizures (type of epilepsy). Inclusion criteria according to Summary of Product Characteristics
Drug: Lyrica (pregabalin)
The daily dose may range from 150mg to 600mg, administered as two single doses. The treatment should be started with 150mg daily dose (2x75mg). Depending on response and tolerability after 7 days may the dose be increased to 300mg/day (2x150mg) and after further 7 days to maximum dose 600mg/day (2x300mg)

Primary Outcome Measures :
  1. Percentage of Participants With a 50 Percent or Greater Reduction From Baseline in 28 Day Partial Seizure Frequency [ Time Frame: Baseline through week 16 or early termination (ET) ]
    Responder rate was defined as the percentage of participants with at least a 50% reduction in 28-day partial seizure frequency from baseline during the maintenance phase (Week 4 - Week 16). The percent change in partial seizure frequency in the maintenance phase was the change from baseline in partial seizure frequency * 100, divided by the partial seizure frequency at the baseline visit.

Secondary Outcome Measures :
  1. Percentage Change From Baseline in 28 Day Partial Seizure Frequency at Final Visit [ Time Frame: Baseline and week 16 or ET ]
    The partial seizure frequency for the baseline period was the total number of partial seizures recorded for that period at Visit 0 (week 0). For each participant's final visit, the 28 day partial seizure frequency equals total number of partial seizures since the last visit * 28 divided by total number of days since the last visit. For percent change from baseline: change from baseline in partial seizure frequency*100 divided by partial seizure frequency at baseline visit.

  2. Number of Participants With no Seizures (Partial or Other) During the Last 4 Weeks in the Study [ Time Frame: Week 4 through week 16 or ET ]
    Participants were regarded as seizure-free if no seizures (partial or other) were reported for the participant during the last 4 weeks in the study.

  3. Change From Baseline in Visual Analog Scale of Anxiety (VAS-A) Scores at Week 4 and Final Visit [ Time Frame: Baseline, week 4 and week 16 or ET ]
    VAS-A consists of a visual analog scale ranging from, 0 mm (no anxiety) to 100 mm (extreme anxiety).

  4. Number of Participants With Categorical Scores on Clinical Global Impression of Severity (CGI-S) [ Time Frame: Baseline ]
    CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected.

  5. Number of Participants With Change in Clinical Global Impression of Severity (CGI-C) From Baseline at Final Visit [ Time Frame: Week 16 or ET ]

    The CGI-C scale measures a physician's global impression of a participant's clinical condition at final visit in terms of change relative to the start of treatment (CGI-C).

    At final visit, the participants CGI-C will be categorized into a three point scale as: improvement: CGI response of very much improved, much improved or minimally improved; no change: CGI response of no change; worsening: CGI response of very much worse, much worse or minimally worse.

  6. Change From Baseline in Medical Outcome Study (MOS) Sleep Scale Sub-scores at Week 16 or ET [ Time Frame: Baseline and week 16 or ET ]
    MOS: participant rated questionnaire, assess sleep quality and quantity. Consists of 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); 7 subscales rated 1 (all the time) to 6 (none of the time): sleep disturbance, snoring, awaken short of breath (SOB) or with a headache, somnolence adequacy, and sleep quantity. Transformed scores (actual raw score minus lowest possible score divided by possible raw score range multiplied by 100); sub-scales total score range= 0-100; higher score indicates greater intensity of attribute.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
  • Adult patiens with partial seizures.
  • Other inclusion criteria according to Summary of Product Characteristics (SmPC).

Inclusion Criteria:

  • Adult patients with partial seizures.

Exclusion Criteria:

  • Contraindications according to Summary of Product Characteristics (SmPC).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00922987

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Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc. Identifier: NCT00922987     History of Changes
Other Study ID Numbers: A0081236
First Posted: June 18, 2009    Key Record Dates
Results First Posted: June 21, 2011
Last Update Posted: July 22, 2011
Last Verified: July 2011

Keywords provided by Pfizer:
lyrica pregabalin epilepsy partial seizures

Additional relevant MeSH terms:
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs