EpilepsyPhase 4LEADERNCT00288639

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

A Phase 4 study testing Pregabalin in people with Epilepsy, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 8 sites in Greece.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Epilepsy
What is being tested?: Pregabalin
Type of treatment: Pill or oral medicine
How many people: 98 participants
Where: 8 sitesGreece
Study dates: Dec 2005to Dec 2007
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

8 sites in 1 country.

City, postcode or hospital

8 sites in 1 country

Greece8 sites

Pfizer Investigational Site
Athens, 11526
Pfizer Investigational Site
Athens, 11527
Pfizer Investigational Site
Heraklio, 71110
Pfizer Investigational Site
Mesogion, Athen, 15125
Pfizer Investigational Site
Pátrai, 26500
Pfizer Investigational Site
Thessaloniki, 54636
Pfizer Investigational Site
Thessaloniki, 57010
Pfizer Investigational Site
Thessaloniki

Other trials in Greece

About this study

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

Conditions: Epilepsy
Being tested: Pregabalin
Keywords: Pregabalin for partial seizures
Medical subject headings: Epilepsy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PregabalinDrug
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).

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: 8 week baseline period & 12 week treatment observation period

Secondary outcomes (12)

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.
Measured: 8 week baseline period and 21 week treatment period
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.
Measured: 8 week baseline period and 21 week treatment period
Number of Subjects Seizure-free
Count of subjects seizure free during the period.
Measured: last 4 weeks & whole 12 week treatment observation period
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.
Measured: 8 week baseline observation period & last 4 weeks of observation period
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.
Measured: Day 147 from the first dose of study drug
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.
Measured: 8 week baseline observation period & 12 week treatment observation period
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).
Measured: End of 21-week treatment
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).
Measured: End of 21-week treatment
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.
Measured: Baseline, end of 21-week treatment
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.
Measured: Baseline, End of 21-week treatment
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.
Measured: Baseline, End of 21-week treatment
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.
Measured: Baseline, End of 21-week treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2005Dec 2007

First posted8 Feb 2006 (estimated)
Study startDec 2005
Primary completionDec 2007
Study completionDec 2007

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for EpilepsyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 98 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00288639
Sponsor's protocol ID: A0081088
Acronym: LEADER
Status last verified: Nov 2018
First submitted: 7 Feb 2006
Last updated: 22 Jan 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Clinical Trial of SEEG for Drug-resistant Epilepsy
Drug-Resistant Epilepsy
RecruitingPhase 3
Investigate Efficacy and Safety of Carisbamate as Adjunctive Treatment for Seizures Associated With LGS in Children and Adults
Seizures, Lennox Gastaut Syndrome
RecruitingPhase 3
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures
Focal Seizure, Epilepsy
Active, not recruitingObservational study
Transforming Research and Clinical Knowledge in Traumatic Brain Injury Epileptogenesis Project (TRACK-TBI EPI)
Traumatic Brain Injury, Post-traumatic Epilepsy
RecruitingPhase 3
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures FOCUS-1
Focal Seizure, Epilepsy

All Epilepsy trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Lyrica (Pregabalin) Administered As An Add-On Therapy For Partial Seizures (LEADER) An Open-Label, Multicenter Add-On Therapy Trial
ClinicalTrials.gov ID: NCT00288639
Acronym / sponsor ID: LEADER / A0081088
Conditions: Epilepsy
Keywords: Pregabalin for partial seizures
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 98 participants (actual)
Lead sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
Study start: Dec 2005
Primary completion: Dec 2007 (actual)
Study completion: Dec 2007 (actual)
First posted: 8 Feb 2006 (estimated)
Results: Posted 8 Jul 2009

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PregabalinPregabalin 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).	Drug	–

Primary outcome

Percentage Change in Partial Seizure Frequency (All Partial Seizure Types) Between Baseline and the 12 Week Observation Period
Time frame: 8 week baseline period & 12 week treatment 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).

12 secondary outcomes

Percentage Change in Partial Seizure Frequency (All Partial Seizure Types) Between Baseline and the Whole 21 Week Open-label Treatment Period.
Time frame: 8 week baseline period and 21 week treatment period
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.
Time frame: 8 week baseline period and 21 week treatment period
Number of Subjects Seizure-free
Time frame: last 4 weeks & whole 12 week treatment observation period
Reduction in Partial Seizure Frequency Between Baseline and the Final 4 Weeks of the Observation Period.
Time frame: 8 week baseline observation period & last 4 weeks of observation period
Subjects Achieving Seizure Freedom During Observation Period
Time frame: Day 147 from the first dose of study drug
Change in Partial Seizure Frequency (All Partial Seizure Types) Between Baseline and the 12 Week Observation Period Categorized by Baseline Seizure Frequency
Time frame: 8 week baseline observation period & 12 week treatment observation period
Impression of Change in Overall Status Using the Patient Global Impression of Change (PGIC)
Time frame: End of 21-week treatment
Subjects With Categorical Impression of Change in Overall Status Using the Clinical Global Impression of Change (CGIC)
Time frame: End of 21-week treatment
Changes From Baseline in Medical Outcomes Study (MOS) Sleep Scale Scores
Time frame: Baseline, end of 21-week treatment
Change From Baseline in Hospital Anxiety and Depression Scale(HADS) Depression and Anxiety Symptoms Subscales Between Baseline and Week 21.
Time frame: Baseline, End of 21-week treatment
Number of Subjects With a Weight Gain at End of Treatment of at Least 7% Relative to Baseline
Time frame: Baseline, End of 21-week treatment
Subjects Assessment of Optimal Sleep
Time frame: Baseline, End of 21-week treatment

Results and safety

Results posted to the registry on 8 Jul 2009, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Pregabalin	98	86

Primary outcome: Percentage Change in Partial Seizure Frequency (All Partial Seizure Types) Between Baseline and the 12 Week Observation Period

Time frame: 8 week baseline period & 12 week treatment observation period. Median (Full Range). Unit: percentage change in events

Measure	Pregabalin n = 92
Value	-33.33 (-100.00 to 7566.67)

Pregabalin: Mean Response Ratio: -22.72 (95% CI -34.16 to -11.28)

Population analysed: Full analysis set (FAS)/intent-to-treat (ITT) population (all subjects who received at least 1 dose of study treatment \& had a minimum of 2 partial seizures during baseline period). Seizure rate was calculated on last observation carried forward (LOCF) basis, whereby data from last 84 days prior to last dose was used to calculate seizure frequency.

12 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Pregabalin	3 of ?	35 of ?	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.

Related trials for Epilepsy

Not yet recruiting
Clinical Trial of SEEG for Drug-resistant Epilepsy
Drug-Resistant Epilepsy
RecruitingPhase 3
Investigate Efficacy and Safety of Carisbamate as Adjunctive Treatment for Seizures Associated With LGS in Children and Adults
Seizures, Lennox Gastaut Syndrome
RecruitingPhase 3
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures
Focal Seizure, Epilepsy
Active, not recruitingObservational study
Transforming Research and Clinical Knowledge in Traumatic Brain Injury Epileptogenesis Project (TRACK-TBI EPI)
Traumatic Brain Injury, Post-traumatic Epilepsy
RecruitingPhase 3
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures FOCUS-1
Focal Seizure, Epilepsy

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pfizer CT.gov Call Center study director

Pfizer

8 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Pregabalin in people with Epilepsy, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 8 sites in Greece.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Jul 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage Change in Partial Seizure Frequency (All Partial Seizure Types) Between Baseline and the 12 Week Observation Period (time frame: 8 week baseline period & 12 week treatment observation period). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00288639.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2021.