Lyrica (Pregabalin) Administered as an Add-on Therapy for Partial Seizures (LEADER).

Epilepsy Clinical Trial

— LEADER  

Official title:

Lyrica (Pregabalin) Administered As An Add-On Therapy For Partial Seizures (LEADER) An Open-Label, Multicenter Add-On Therapy Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00288639
• Other study ID #: A0081088
• Status: Completed
• Phase: Phase 4
• Start date: December 2005
• Est. completion date: December 2007

Study information

• Verified date: November 2018
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective of study is to assess the clinical improvement (change in seizure frequency), safety, and tolerability of subjects with partial seizures following adjunctive therapy of pregabalin BID (150 to 600 mg/day titration) in addition to existing standards AEDs.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Outpatients equal to or greater than 18 years of age with diagnosis of epilepsy with partial seizures having minimum of two partial seizures during a two month period before the baseline visit

• Having a clinical history of epilepsy and AED treatment at least 1 year prior to inclusion

Exclusion Criteria:

• AED or Seizures/Epilepsy Related Exclusions:having a treatable cause of seizures

• Having absences seizures

• Having had status epileptics within the year prior to inclusion

• Having a progressive neurological or systematic disorder

• Having known significant renal or hepatic dysfunction

Related Conditions & MeSH terms

• Epilepsy
• Seizures

Intervention

Drug:
• Pregabalin
Pregabalin treatment, given as 2 divided doses, is initiated at a dose of 150 mg/day (75 mg BID). Based on individual subject response and tolerability, the dosage may be increased to 300 mg/day after 1 week (150 mg BID given as two 75-mg capsules BID). Based on subjects individual response and tolerability, dosage can be incrementally increased further after an additional week to 600 mg/day (300 mg BID given as four 75-mg capsules BID).

Locations

Country	Name	City	State
Greece	Pfizer Investigational Site	Athens
Greece	Pfizer Investigational Site	Athens
Greece	Pfizer Investigational Site	Heraklio
Greece	Pfizer Investigational Site	Mesogion, Athen
Greece	Pfizer Investigational Site	Patras
Greece	Pfizer Investigational Site	Thessaloniki
Greece	Pfizer Investigational Site	Thessaloniki
Greece	Pfizer Investigational Site	Thessaloniki

Sponsors (1)

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

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage Change in Partial Seizure Frequency (All Partial Seizure Types) Between Baseline and the 12 Week Observation Period	Percentage change from baseline=[(12 week treatment observation period seizure frequency rate minus 8 week baseline period seizure frequency rate)/ 8 week baseline period seizure frequency rate] x 100. Seizure frequencies per 28-day period: = (total # of partial seizures in period x 28 / (total # of days in period).	8 week baseline period & 12 week treatment observation period
Secondary	Percentage Change in Partial Seizure Frequency (All Partial Seizure Types) Between Baseline and the Whole 21 Week Open-label Treatment Period.	Percentage change from baseline = ((21 weeks-8 weeks)/8 weeks)*100. Negative mean R-Ratios and associated 95% CIs that do not include zero indicate reduction in partial seizure frequency.	8 week baseline period and 21 week treatment period
Secondary	Percentage Change in Partial Seizure Frequency (All Partial Seizure Types) Between the 8 Week Baseline Period and 4 Week Intervals During the 21 Week Open-label Treatment Period.	Percentage change from baseline = [(4 week seizure frequency minus 8 week baseline) / (8 week baseline seizure frequency)] x 100. Negative mean R-Ratios and associated 95% CIs that do not include zero indicate reduction in partial seizure frequency.	8 week baseline period and 21 week treatment period
Secondary	Number of Subjects Seizure-free	Count of subjects seizure free during the period.	last 4 weeks & whole 12 week treatment observation period
Secondary	Reduction in Partial Seizure Frequency Between Baseline and the Final 4 Weeks of the Observation Period.	Number of subjects with at least a 50% or 75% reduction in partial seizure frequency between baseline and treatment period.	8 week baseline observation period & last 4 weeks of observation period
Secondary	Subjects Achieving Seizure Freedom During Observation Period	Number of subjects achieving seizure freedom (no seizures) during last 4 weeks or duration of 12 week observation period.	Day 147 from the first dose of study drug
Secondary	Change in Partial Seizure Frequency (All Partial Seizure Types) Between Baseline and the 12 Week Observation Period Categorized by Baseline Seizure Frequency	Percentage change from baseline = ((12 weeks - 8 weeks)/8 weeks)*100. Negative mean R-Ratios and associated 95% CIs that do not include zero indicate reduction in partial seizure frequency.	8 week baseline observation period & 12 week treatment observation period
Secondary	Impression of Change in Overall Status Using the Patient Global Impression of Change (PGIC)	The PGIC is a patient-rated instrument that measures change in patient's overall status on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse).	End of 21-week treatment
Secondary	Subjects With Categorical Impression of Change in Overall Status Using the Clinical Global Impression of Change (CGIC)	The CGIC is a clinician's judgment of the overall change in the patient's condition over a defined period on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse).	End of 21-week treatment
Secondary	Changes From Baseline in Medical Outcomes Study (MOS) Sleep Scale Scores	Subjects recall sleep related activities over the previous 4 weeks. Low scores reflect greater impairment (except sleep adequacy, optimal sleep, &quantity). Range = 0 - 100 for Sleep Disturbance, Snoring, Awaken Short of Breath, Sleep Adequacy, Somnolence, & Sleep Problems Index. Quantity of Sleep Range = 0 - 24. Optimal Sleep Range 0 - 1.	Baseline, end of 21-week treatment
Secondary	Change From Baseline in Hospital Anxiety and Depression Scale(HADS) Depression and Anxiety Symptoms Subscales Between Baseline and Week 21.	Change in total HADS score between Baseline and Week 21. Each of the 14 items is scored 0, 1, 2 or 3 where a score of 3 corresponds to the most anxious/depressed. 7-item depression and 7-item anxiety subscales are summed; each resulting in a total score of 0-21.	Baseline, End of 21-week treatment
Secondary	Number of Subjects With a Weight Gain at End of Treatment of at Least 7% Relative to Baseline	Count of subjects with a weight gain of at least 7 percent relative to baseline.	Baseline, End of 21-week treatment
Secondary	Subjects Assessment of Optimal Sleep	Number of subjects that responded optimal or non-optimal sleep in Optimal Sleep subscale of Medical Outcomes Study (MOS) Sleep scale.	Baseline, End of 21-week treatment

External Links

•   To obtain contact information for a study center near you, click here.