EpilepsyPhase 4NCT00537940
Comparative Study Of Pregabalin And Gabapentin As Adjunctive Therapy In Subjects With Partial Seizures
A Phase 4 study testing Pregabalin and Gabapentin in people with Epilepsy and Partial Seizure Disorder, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 8 sites in 4 countries.
Trial summary
To compare the efficacy of pregabalin and gabapentin, as adjunctive therapy in subjects with partial seizures. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Epilepsy, Partial Seizure Disorder, Epilepsies, Partial
- What is being tested?
- Pregabalin and Gabapentin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 482 participants
- Where
- 8 sitesin 4 countries
- Study dates
- Feb 2008to Jul 2013
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects (male or female) must be > 18 years or ≤ 80 years of age, with a diagnosis of epilepsy with partial seizures, as defined in the International League Against Epilepsy (ILAE) classification of seizures; partial seizures may be simple or complex, with or without secondary tonic-clonic generalization.
- Subjects must be have been diagnosed with epilepsy for at least 2 years, and must have been unresponsive to treatment with at least two but no more than five prior antiepileptic drugs (AEDs), and at the time of study enrollment are on stable dosages of 1 or 2 standard AEDs.
- They must have had a 12 lead electrocardiogram (ECG) without clinically significant abnormal findings prior to randomization.
- Subjects must have had magnetic resonance imaging or contrast enhance computed tomography scan of the brain that demonstrated no progressive structural central nervous system abnormality at the time of the diagnosis of epilepsy.
- Women of childbearing potential must be established on an effective method of contraception during the study. Women should also have a negative pregnancy test prior to study entry.
- During the 6-week baseline period, subjects must have had a minimum of four partial seizures, with no 28 day period free of partial seizures with or without secondary generalization. A caregiver or witness must be with the subject for a sufficient duration to accurately chronicle the occurrence of seizures. These seizures must have been documented in the subject's diary.
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- Subjects with electroencephalograph (EEG) testing done within 2 years of randomization. EEG abnormalities should be consistent with a diagnosis of focal-onset epilepsy.
- Signed and dated informed consent will be obtained from each subject (only include those able to consent) in accordance with the local regulatory and legal requirements.
- Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other trial procedures. Subjects who are willing, but need assistance for self administered questionnaires may be considered acceptable, but must first be discussed on a case-by-case basis with the Pfizer monitor prior to any to any screening tests or procedures for the study.
Who cannot join
- Females who are pregnant, breastfeeding, or intending to become pregnant during the course of the trial.
- Subjects with other neurologic illness that could impair endpoint assessment, or patients with Lennox-Gastaut syndrome, absence seizures, status epilepticus within the 12 months prior to study entry, or with seizures due to an underlying medical illness or metabolic syndrome.
- Subjects with clinically significant liver disease or with a calculated creatinine clearance of <60mL/min.
- Subjects with a history of lack of response, hypersensitivity or poor tolerability to gabapentin or pregabalin.
- Previous use of gabapentin or pregabalin within 2 weeks prior to screening or likelihood of engaging in these treatments during the study period.
- Use of prohibited medications as listed in the protocol in the absence of appropriate washout phase or the likelihood of requiring treatment during the study period with drugs not permitted by the study protocol.
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- Participation in any other studies involving investigational or marketed products, concomitantly or within 30 days prior to entry in the study.
- Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or investigational product administration or may interfere with the interpretation of trial results and, in the judgment of the investigator, would make the subject inappropriate for entry into this trial.
- Subjects who are not suitable to be treated with pregabalin or gabapentin according to the respective local labeling.
- Subjects with a history of retinal abnormalities or treatment with retinotoxic agents.
Trial locations and contacts
8 sites in 4 countries.
8 sites in 4 countries
Peru3 sites
Clinica Anglo Americana
Lima, 27
Torre de Consultorios Clinica Anglo Americana
Lima, L-27
Hospital Nacional Guillermo Almenara Irigoyen - Essalud
Lima, L13
El Salvador2 sites
Instituto de Neurociencias
San Salvador, 01503
Clinica de Especialidades Neurologicas
San Salvador
Guatemala2 sites
Private Office
Guatemala City
Private Office
Guatemala Ciudad, Departamento de Guatemala, 01014
About this study
Official title: A Randomized, Double-blind, Parallel-group Multi-center Comparative Flexible-dose Trial Of Pregabalin Versus Gabapentin As Adjunctive Therapy In Subjects With Partial Seizures.
To compare the efficacy of pregabalin and gabapentin, as adjunctive therapy in subjects with partial seizures.
- Being tested
- Pregabalin, Gabapentin
- Medical subject headings
- Epilepsy, Epilepsies, Partial, Epilepsy, Complex Partial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PregabalinDrug
150, 300, 450 mg/day administered orally TID, until seizure control/improvement or intolerable side effects
GabapentinDrug
300, 600, 1200, 2000 mg/day administered orally TID, until seizure control/improvement or intolerable side effects
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Not described Receives: Drug: Pregabalin |
| B | Active comparator | Not described Receives: Drug: Gabapentin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change From Baseline in 28-day Seizure Frequency at Week 21.
The seizures were recorded by the participants, by a family member, by a caregiver, or by a legal guardian and documented in a daily seizure diary. Participant's 28-day seizure frequency of all partial seizure was assessed during double blind (TP + MP) phase compared with baseline. Total partial seizure is defined as the total number of (simple partial seizure + complex partial seizure + secondary generalized tonic clonic seizure [SGTC]).
Measured: 6 weeks Baseline, 21 weeks through End of MP for 27 weeks
Secondary outcomes (8)
Percentage of Participants With 50% Reduction From Baseline in 28-day Seizure Rate at Week 21.
Participants who had at least 50% reduction in seizure frequency from Baseline to double-blind treatment (TP + MP) were considered as 50% responders. If percent change from baseline <= -50 then responder rate = 1 (yes) otherwise responder rate = 0 (no).
Measured: 6 weeks Baseline, 21 weeks through End of MP for 27 weeks
Percentage of Participants With 75% Reduction From Baseline in 28-day Seizure Rate at Week 21.
Participants who had at least 75% reduction in seizure frequency from Baseline to double-blind treatment (TP + MP) were considered as 75% responders. If percent change from baseline <= -75 then 75% responder rate = 1 (yes) otherwise responder rate = 0 (no). Total partial seizure is defined as the total number of (simple partial seizure + complex partial seizure + SGTC).
Measured: 6 weeks Baseline, 21 weeks through End of MP for 27 weeks
Percentage of Participants Without Seizures.
Seizure free for 28 days was defined as participants who have not experienced any seizure (simple partial, complex partial and SGTC) for at least 28 consecutive days from their last seizure until the end of the MP. Same participant could be seizure free for a specific type of seizure but not necessarily for the other types of seizure.
Measured: 6 weeks Baseline, 21 weeks through End of MP for 27 weeks
Change From Baseline in the 28-day Secondarily Generalized Tonic-clonic (SGTC) Seizure Frequency at Week 21.
Change in SGTC = (Proportion of SGTC/All Partial Seizure rate during at the double-blind phase) - (Proportion of SGTC/All Partial Seizure rate at Baseline). Negative values indicate reduction from baseline.
Measured: 6 weeks Baseline, 21 weeks through End of MP for 27 weeks
Reduction in Proportion of the 28-day SGTC Seizure Rate Over the Total Partial Seizure Rate at Week 21.
SGTC Responder is defined as a participant who shows reduction from Baseline to double-blind phase in proportion of 28-Day SGTC Seizure Rate to 28-Day All Partial Seizure Rate.
Measured: 6 weeks Baseline, 21 weeks through End of MP for 27 weeks
Hospital Anxiety and Depression Scale (HADS) Score.
HADS: participant rated questionnaire with 2 subscales. Hospital Anxiety and Depression Scale - anxiety (HADS-A) assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); Hospital Anxiety and Depression Scale - depression (HADS-D) assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale comprised of 7 items with range 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score 0 to 21 for each subscale; higher score indicates greater severity of anxiety and depression symptoms.
Measured: Baseline, Week 21
Medical Outcomes Study Sleep Scale (MOS-SS) Score.
Participant-rated 12-item questionnaire to assess constructs of sleep over past week; 7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence (range:0-100); sleep quantity (range:0-24), optimal sleep (yes/no), and 9 item index measures of sleep disturbance provide composite scores: sleep problem summary, overall sleep problem. Except adequacy, optimal sleep and quantity, higher scores=more impairment. Scores transformed (actual raw score [RS] minus lowest possible score divided by possible RS range*100); total score range:0-100; higher score=more intensity of attribute.
Measured: Baseline, Week 21
Percentage of Participants With Optimal Sleep Assessed Using Medical Outcomes Study-Sleep Scale (MOS-SS) Score.
MOS-SS: participant-rated 12 item questionnaire to assess constructs of sleep over past week. It included 7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence, sleep quantity and optimal sleep. Participants responded whether their sleep was optimal or not by choosing yes or no. Percentage of participants with optimal sleep are reported.
Measured: Baseline, Week 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2007 (estimated)
- Study startFeb 2008
- Primary completionJul 2013
- Study completionJul 2013
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.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 482 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00537940
- Sponsor's protocol ID
- A0081143
- Other IDs
- 2007-003161-40, 207103
- Status last verified
- Nov 2018
- First submitted
- 28 Sep 2007
- Last updated
- 22 Jan 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
French J, Glue P, Friedman D, Almas M, Yardi N, Knapp L, Pitman V, Posner HB. Adjunctive pregabalin vs gabapentin for focal seizures: Interpretation of comparative outcomes. Neurology. 2016 Sep 20;87(12):1242-9. doi: 10.1212/WNL.0000000000003118. Epub 2016 Aug 12.
PubMed 27521437
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
- A Randomized, Double-blind, Parallel-group Multi-center Comparative Flexible-dose Trial Of Pregabalin Versus Gabapentin As Adjunctive Therapy In Subjects With Partial Seizures.
- ClinicalTrials.gov ID
- NCT00537940
- Acronym / sponsor ID
- A0081143
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 482 participants (actual)
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2008
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 2 Oct 2007 (estimated)
- Results
- Posted 8 Aug 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To compare the efficacy of pregabalin and gabapentin, as adjunctive therapy in subjects with partial seizures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Drug: Pregabalin |
| B | Active comparator | Drug: Gabapentin |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Subjects (male or female) must be > 18 years or ≤ 80 years of age, with a diagnosis of epilepsy with partial seizures, as defined in the International League Against Epilepsy (ILAE) classification of seizures; partial seizures may be simple or complex, with or without secondary tonic-clonic generalization.
- Subjects must be have been diagnosed with epilepsy for at least 2 years, and must have been unresponsive to treatment with at least two but no more than five prior antiepileptic drugs (AEDs), and at the time of study enrollment are on stable dosages of 1 or 2 standard AEDs.
- They must have had a 12 lead electrocardiogram (ECG) without clinically significant abnormal findings prior to randomization.
- Subjects must have had magnetic resonance imaging or contrast enhance computed tomography scan of the brain that demonstrated no progressive structural central nervous system abnormality at the time of the diagnosis of epilepsy.
- Women of childbearing potential must be established on an effective method of contraception during the study. Women should also have a negative pregnancy test prior to study entry.
Key exclusion criteria (10 listed)
- Females who are pregnant, breastfeeding, or intending to become pregnant during the course of the trial.
- Subjects with other neurologic illness that could impair endpoint assessment, or patients with Lennox-Gastaut syndrome, absence seizures, status epilepticus within the 12 months prior to study entry, or with seizures due to an underlying medical illness or metabolic syndrome.
- Subjects with clinically significant liver disease or with a calculated creatinine clearance of <60mL/min.
- Subjects with a history of lack of response, hypersensitivity or poor tolerability to gabapentin or pregabalin.
- Previous use of gabapentin or pregabalin within 2 weeks prior to screening or likelihood of engaging in these treatments during the study period.
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 |
|---|---|---|
| Pregabalin150, 300, 450 mg/day administered orally TID, until seizure control/improvement or intolerable side effects | Drug | A |
| Gabapentin300, 600, 1200, 2000 mg/day administered orally TID, until seizure control/improvement or intolerable side effects | Drug | B |
Primary outcome
Percent Change From Baseline in 28-day Seizure Frequency at Week 21.
Time frame: 6 weeks Baseline, 21 weeks through End of MP for 27 weeks
The seizures were recorded by the participants, by a family member, by a caregiver, or by a legal guardian and documented in a daily seizure diary. Participant's 28-day seizure frequency of all partial seizure was assessed during double blind (TP + MP) phase compared with baseline. Total partial seizure is defined as the total number of (simple partial seizure + complex partial seizure + secondary generalized tonic clonic seizure [SGTC]).
8 secondary outcomes
Percentage of Participants With 50% Reduction From Baseline in 28-day Seizure Rate at Week 21.
Time frame: 6 weeks Baseline, 21 weeks through End of MP for 27 weeks
Percentage of Participants With 75% Reduction From Baseline in 28-day Seizure Rate at Week 21.
Time frame: 6 weeks Baseline, 21 weeks through End of MP for 27 weeks
Percentage of Participants Without Seizures.
Time frame: 6 weeks Baseline, 21 weeks through End of MP for 27 weeks
Change From Baseline in the 28-day Secondarily Generalized Tonic-clonic (SGTC) Seizure Frequency at Week 21.
Time frame: 6 weeks Baseline, 21 weeks through End of MP for 27 weeks
Reduction in Proportion of the 28-day SGTC Seizure Rate Over the Total Partial Seizure Rate at Week 21.
Time frame: 6 weeks Baseline, 21 weeks through End of MP for 27 weeks
Hospital Anxiety and Depression Scale (HADS) Score.
Time frame: Baseline, Week 21
Medical Outcomes Study Sleep Scale (MOS-SS) Score.
Time frame: Baseline, Week 21
Percentage of Participants With Optimal Sleep Assessed Using Medical Outcomes Study-Sleep Scale (MOS-SS) Score.
Time frame: Baseline, Week 21
Results and safety
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.
- Derived from this study: PubMed 27521437French J, Glue P, Friedman D, Almas M, Yardi N, Knapp L, Pitman V, Posner HB. Adjunctive pregabalin vs gabapentin for focal seizures: Interpretation of comparative outcomes. Neurology. 2016 Sep 20;87(12):1242-9. doi: 10.1212/WNL.0000000000003118. Epub 2016 Aug 12.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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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 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Pregabalin and Gabapentin in people with Epilepsy and Partial Seizure Disorder, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 8 sites in 4 countries.
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 9 inclusion and 10 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 Peru, El Salvador, Guatemala, Costa Rica. 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 Aug 2014). 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?
Percent Change From Baseline in 28-day Seizure Frequency at Week 21. (time frame: 6 weeks Baseline, 21 weeks through End of MP for 27 weeks). 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 NCT00537940, which also lists 1 linked publication.
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.