EpilepsyPhase 3NCT00372528

An Open-Label Study Of Pregabalin In Subjects With Refractory Partial Seizures

A Phase 3 study testing pregabalin (LYRICA) in people with Epilepsy, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 5 sites in Canada.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

The main purpose of this trial is to allow continued access to pregabalin to Canadian subjects who participated in global pregabalin epilepsy studies 1008-010; 1008-035; 1008-114 and 1008-164 and to continue to study the long term safety of pregabalin administered as adjunctive therapy at dosages from 150 mg/day to… 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 (LYRICA)
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 21 participants
Where: 5 sitesCanada
Study dates: Mar 2007to Oct 2011
Phase: Phase 3
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

Must have completed Pfizer open-label studies 1008-010; 1008-035; 1008-114 or 1008-164 and wishes to continue receiving open-label pregabalin
Must have responded favorably to pregabalin in Pfizer open-label study 1008-010, 1008-035, 1008-114 or 1008-164 and in the clinical opinion of the investigator continued treatment with pregabalin is in the the patient's best medical interest

Who cannot join

Is pregnant or is considering becoming pregnant during the course of the study
Experienced a serious adverse event during open-label Pfizer study 1008-010, 1008-035, 1008-114 or 1008-164

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

Canada5 sites

Pfizer Investigational Site
Barrie, Ontario, L4M 4S5
Pfizer Investigational Site
Calgary, Alberta, T2N 2T9
Pfizer Investigational Site
Halifax, Nova Scotia, B3H 3A7
Pfizer Investigational Site
Toronto, Ontario, M5C 1R6
Pfizer Investigational Site
Windsor, Ontario, N8X 5A6

Other trials in Canada

About this study

Official title: An Open-Label, Multi-Center, Add-On Study Of Pregabalin (LYRICA) In Subjects With Refractory Partial Seizures Who Have Completed Studies 1008-010, 1008-035, 1008-114 Or 1008-164

Conditions: Epilepsy
Being tested: pregabalin (LYRICA)
Medical subject headings: Epilepsy

What participants receive

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

pregabalin (LYRICA)Drug
150 mg up to a maximum of 600 mg per day bid or tid as required

Study groups in NCT00372528
Study group	Role	What they receive
pregabalin	Experimental	open label treatment Receives: Drug: pregabalin (LYRICA)

What is being measured

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

Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 30 days after last dose that were absent before treatment or that worsened relative to pretreatment state.
Measured: Baseline up to Year 5 and follow-up (30 days after last dose)

Secondary outcomes (1)

Mean Number of Seizures
Seizures were episodes of disturbed brain activity that cause changes in attention or behavior. The different types of seizures observed were complex partial, secondarily generalized tonic-clonic, simple partial and others. Mean number of seizures were calculated between each study visit.
Measured: Month 6 thereafter every 6 months up to Month 54 or End of Study (EOS) and follow-up (30 days after last dose)

Timeline

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

Mar 2007Oct 2011

First posted7 Sep 2006 (estimated)
Study startMar 2007
Primary completionOct 2011
Study completionOct 2011

Why it stopped: This study was terminated on April 8, 2011 as Pfizer Canada could no longer supply study drug. No efficacy or safety concerns factored into this decision.

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 3
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 21 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00372528
Sponsor's protocol ID: A0081140
Status last verified: Sep 2012
First submitted: 5 Sep 2006
Last updated: 26 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
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Investigate Efficacy and Safety of Carisbamate as Adjunctive Treatment for Seizures Associated With LGS in Children and Adults
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Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures
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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 26 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-Label, Multi-Center, Add-On Study Of Pregabalin (LYRICA) In Subjects With Refractory Partial Seizures Who Have Completed Studies 1008-010, 1008-035, 1008-114 Or 1008-164
ClinicalTrials.gov ID: NCT00372528
Acronym / sponsor ID: A0081140
Conditions: Epilepsy
Phase: Phase 3
Study type: Interventional
Recruitment status: TerminatedReason stopped: This study was terminated on April 8, 2011 as Pfizer Canada could no longer supply study drug. No efficacy or safety concerns factored into this decision.
Enrolment: 21 participants (actual)
Lead sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
Study start: Mar 2007
Primary completion: Oct 2011 (actual)
Study completion: Oct 2011 (actual)
First posted: 7 Sep 2006 (estimated)
Results: Posted 23 Oct 2012

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)
Number of arms: 1

Arm	Type	Receives
pregabalin	Experimental	Drug: pregabalin (LYRICA)open label treatment

Who may qualify

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

Key inclusion criteria (2 listed)

Must have completed Pfizer open-label studies 1008-010; 1008-035; 1008-114 or 1008-164 and wishes to continue receiving open-label pregabalin
Must have responded favorably to pregabalin in Pfizer open-label study 1008-010, 1008-035, 1008-114 or 1008-164 and in the clinical opinion of the investigator continued treatment with pregabalin is in the the patient's best medical interest

Key exclusion criteria (2 listed)

Is pregnant or is considering becoming pregnant during the course of the study
Experienced a serious adverse event during open-label Pfizer study 1008-010, 1008-035, 1008-114 or 1008-164

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
pregabalin (LYRICA)150 mg up to a maximum of 600 mg per day bid or tid as required	Drug	pregabalin

Primary outcome

Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
Time frame: Baseline up to Year 5 and follow-up (30 days after last dose)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 30 days after last dose that were absent before treatment or that worsened relative to pretreatment state.

1 secondary outcome

Mean Number of Seizures
Time frame: Month 6 thereafter every 6 months up to Month 54 or End of Study (EOS) and follow-up (30 days after last dose)

Results and safety

Results posted to the registry on 23 Oct 2012, 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	21	0

Primary outcome: Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)

Time frame: Baseline up to Year 5 and follow-up (30 days after last dose). Number. Unit: Participants

Measure	Pregabalin n = 21
AEs	21
SAEs	3

Population analysed: Safety Analysis Set (SAS) included all participants who had received at least 1 dose of study medication in the open label period.

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Pregabalin	3 of 21 (14.3%)	21 of 21 (100%)	Not reported

Limitations and caveats (from the sponsor): This was a compassionate use study and no formal primary outcome measure was specified a priori. Descriptive safety data were collected, subsequently safety outcome was designated as primary outcome as per National Institute of Health (NIH) criteria.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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

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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing pregabalin (LYRICA) in people with Epilepsy, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 5 sites in Canada.

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 2 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: stopped early, as of the sponsor's last update on 26 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 5 sites in Canada. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 23 Oct 2012). 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?

Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) (time frame: Baseline up to Year 5 and follow-up (30 days after last dose)). 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 NCT00372528.

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 26 Jan 2021.