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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
History of Changes

June 17, 2009
July 19, 2011
September 2009
June 2010   (final data collection date for primary outcome measure)
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.
The primary efficacy parameter will be the responder rate - the proportion of subjects who had at least a 50% reduction in 28-day partial seizure rate during maintenance phase [ Time Frame: 11 month ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00922987 on ClinicalTrials.gov Archive Site
  • 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.
  • To assess the change in 29-day partial seizure frequency from baseline visit to final visit [ Time Frame: 11 months ] [ Designated as safety issue: No ]
  • to assess the seizure freedom [ Time Frame: 11 months ] [ Designated as safety issue: No ]
  • to assess the overall efficacy of pregabalin using following questionnaires - Visual Analogue Scale of Anxiety, Clinical Global Impressio, Medical Outcomes Study Sleep Scale [ Time Frame: 11 months ] [ Designated as safety issue: No ]
  • The tolerability of Lyrica [ Time Frame: 11 months ] [ Designated as safety issue: No ]
  • All adverse events should be recorded [ Time Frame: 11 months ] [ Designated as safety issue: Yes ]
  • What concomitant drugs are used? What previous and concommitant so-morbidities are present in patients with epilepsy? [ Time Frame: 11 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Clinical Study With Lyrica In Patients Suffering From Epilepsy
Non-Interventional Study (NIS) With Lyrica In Patients With Epilepsy As Adjunctive Therapy Of Partial Seizures To Reduce Seizure Frequency

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.

- Included all adult patients with partial seizures and without contraindications according to Summary of Product Characteristics (SmPC).
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample
  • Adult patiens with partial seizures.
  • Other inclusion criteria according to Summary of Product Characteristics (SmPC).
  • Neuralgia
  • Epilepsy
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)
Lyrica
Adult patients with partial seizures (type of epilepsy). Inclusion criteria according to Summary of Product Characteristics
Intervention: Drug: Lyrica (pregabalin)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
286
June 2010
June 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Adult patients with partial seizures.

Exclusion Criteria:

  • Contraindications according to Summary of Product Characteristics (SmPC).
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Slovakia
 
NCT00922987
A0081236
No
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP