Non-Interventional Study With LYRICA (Pregabalin) In Patients With Epilepsy As Adjunctive Therapy Of Partial Seizures To Reduce Seizure Frequency

Epilepsy Clinical Trial

Official title:

Non-Interventional Study (NIS) With Lyrica In Patients With Epilepsy As Adjunctive Therapy Of Partial Seizures To Reduce Seizure Frequency

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00684424
• Other study ID #: A0081213
• Status: Completed
• Start date: July 2008
• Est. completion date: March 2009

Study information

• Verified date: May 2010
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The primary efficacy parameter will be the responder rate, defined as the proportion of subjects who had at least a 50% reduction in 28 day seizure rate during the maintenance phase

Recruitment information / eligibility

• Status: Completed
• Enrollment: 199
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• age over 18 years old, patients with epilepsia with partial seizures

• Enrollment to study is fully on physician decision in compliance with current SPC.

Exclusion Criteria:

• Patient who did not meet indication according to SPC Lyrica

Related Conditions & MeSH terms

• Epilepsy
• Seizures

Intervention

Other:
• Non-Interventional Study
Observational Only

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Responders: Number of Subjects With a 50% or Greater Reduction in Seizure Frequency	Responders: number of subjects with a 50 percent (%) or greater reduction in partial seizure frequency from Baseline to Final visit. Seizure frequency in treatment period = total number of partial seizures in maintenance treatment phase * 28 divided by total number of days in the maintenance treatment phase. Missing category includes subjects with missing attack date, insufficient length of treatment period or no seizures in both baseline and treatment periods. Subjects with zero seizures in the baseline period and some seizures in the treatment period were treated as non-responders.	Baseline through Week 16
Secondary	Antiepileptic Drugs Used in the Past	Antiepileptic drug history: number of subjects who took each class of antiepileptic drug prior to entering the study. Subjects who took more than one antiepileptic drug were counted for each of the drug classes.	Baseline
Secondary	Change in 28 Day Partial Seizure Frequency	Change in 28-day partial seizure frequency between the baseline period and treatment period. Baseline period = the 4 weeks (28 days) prior to Baseline visit. Treatment period = last 12 weeks (84 days) of the study (maintenance treatment phase excluding 4-week titration phase). Seizure frequency in baseline period = total number of partial seizures in baseline phase * 28 divided by total number of days in the baseline phase. Seizure frequency in treatment period = total number of partial seizures in maintenance treatment phase * 28 divided by total number of days in maintenance treatment phase.	Baseline through Week 16 (Final Visit )
Secondary	Seizure Freedom: Number of Seizure-free Subjects During the Last 4 Weeks of the Study	Seizure Freedom (responders): subjects with no seizures (partial or other) during the last 4 weeks of the study. Non-responders: subjects with seizures (partial or other)during the last 4 weeks of the study. Subjects, who discontinued less than 4 weeks into the observation period were excluded from analysis. The 4 week period excludes the titration phase of the study. Missing category includes subjects with missing attack date or insufficient length of treatment period.	Week 8 up to Week 16 (Last 4 weeks of the treatment period)
Secondary	Concomitant Drug Treatments	Concomitant drugs treatments (drugs other than, and in addition to study medication): number of subjects who took each concomitant drug during the study (baseline through end of study). World Health Organization (WHO) Drug (v02Q2) coding dictionary applied.	Baseline through Week 16 (Final Visit)
Secondary	Average Dosage of Pregabalin Taken at Baseline and Final Visit	Average doses of pregabalin in milligrams per day (mg/day) taken at baseline and final visit shown by number of participants at each dose.	Baseline, Week 16 (Final Visit )
Secondary	Visual Analog Scale of Anxiety (VAS-A)	Visual Analog Scale of anxiety self assessment: metric measurement (in 2 mm interval) from the visual analog scale; 0 mm = no anxiety, 100 mm = extreme anxiety at each visit.	Baseline, Week 4, Week 16 (Final Visit), Last Observation Carried Forward
Secondary	Change From Baseline to Final Visit in Visual Analog Scale of Anxiety (VAS-A)	Visual Analog Scale of anxiety self assessment: metric measurement (in 2 mm interval) from the visual analog scale; 0 mm = no anxiety, 100 mm = extreme anxiety. Change from Baseline to Final Visit: score at final visit minus score at baseline.	Baseline, Week 16 (Final Visit), Last Observation Carried Forward
Secondary	Number of Subjects With Categorical Scores on Clinical Global Impression of Severity (CGI-S)	CGI-S scale: physician's global impression of a subject's clinical condition, at baseline in terms of severity. Numerical scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill subjects). Numbers of subjects in each category are presented.	Baseline
Secondary	Number of Subjects With Categorical Scores on Clinical Global Impression of Change(CGI-C)	CGI-C scale: physician's global impression of a subject's clinical condition in terms of change from baseline. 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.	Week 16 (Final Visit)
Secondary	Medical Outcomes Sleep Scale (MOS-S)	MOS-S: subject reported measure with 12 items that assess key constructs of sleep over the past week. Scoring based on 7 subscales: sleep disturbance, snoring, awakened short of breath or with headache, sleep adequacy, and somnolence (range:0-100); sleep quantity (range:0-24), and optimal sleep (yes:1, no:0). Six(6) and 9 item index measures of sleep disturbance were constructed to provide composite scores. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range * 100); total score range: 0 to 100; higher score = greater intensity of attribute.	Baseline, Week 16 (Final Visit )
Secondary	Number of Subjects With Change in Response Categories in Medical Outcomes Sleep Scale (MOS-S): Optimal Sleep Subscale	MOS: subject rated questionnaire to assess sleep quality and quantity. Optimal sleep subscale is derived from Sleep Quantity average hours of sleep each night during the past week. Number of subjects with response: YES (Optimal) if sleep quantity was 7 or 8 hours per night, or response = NO (Non-Optimal) if sleep quantity was less than (<) 7 hours per night. Number of participants with shift in response categories from Baseline to Final Visit.	Baseline, Week 16 (Final Visit)

External Links

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