Clinical Study With Lyrica In Patients Suffering From Epilepsy

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00922987
First received: June 17, 2009
Last updated: July 19, 2011
Last verified: July 2011
  Purpose

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 Intervention
Neuralgia
Epilepsy
Drug: Lyrica (pregabalin)

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    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:
  • Percentage Change From Baseline in 28 Day Partial Seizure Frequency at Final Visit [ Time Frame: Baseline and week 16 or ET ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    VAS-A consists of a visual analog scale ranging from, 0 mm (no anxiety) to 100 mm (extreme anxiety).

  • Number of Participants With Categorical Scores on Clinical Global Impression of Severity (CGI-S) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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.

  • Number of Participants With Change in Clinical Global Impression of Severity (CGI-C) From Baseline at Final Visit [ Time Frame: Week 16 or ET ] [ Designated as safety issue: No ]

    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.


  • 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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 286
Study Start Date: September 2009
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Lyrica
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)

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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).
Criteria

Inclusion Criteria:

  • Adult patients with partial seizures.

Exclusion Criteria:

  • Contraindications according to Summary of Product Characteristics (SmPC).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00922987

  Show 61 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00922987     History of Changes
Other Study ID Numbers: A0081236
Study First Received: June 17, 2009
Results First Received: May 31, 2011
Last Updated: July 19, 2011
Health Authority: Bratislava: Ethics Commitee of Bratislava

Keywords provided by Pfizer:
lyrica pregabalin epilepsy partial seizures

Additional relevant MeSH terms:
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Pregabalin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on October 19, 2014