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Comparative Study Of Pregabalin And Gabapentin As Adjunctive Therapy In Subjects With Partial Seizures

Last updated on November 28, 2019

FOR MORE INFORMATION
Study Location
Hospital Clinica Biblica
San Jose, , Costa Rica
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Epilepsy, Partial Seizure Disorder, Partial Epilepsies, Complex Partial Seizure Disorder
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-80 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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.

- 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.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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

- 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.

- 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.

NCT00537940
Pfizer
Completed
Comparative Study Of Pregabalin And Gabapentin As Adjunctive Therapy In Subjects With Partial Seizures

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Partial Epilepsies
NCT00351611
All Genders
18+
Years
Multiple Sites
Descriptive Information
Brief Title  ICMJE Comparative Study Of Pregabalin And Gabapentin As Adjunctive Therapy In Subjects With Partial Seizures
Official Title  ICMJE A Randomized, Double-blind, Parallel-group Multi-center Comparative Flexible-dose Trial Of Pregabalin Versus Gabapentin As Adjunctive Therapy In Subjects With Partial Seizures.
Brief SummaryTo compare the efficacy of pregabalin and gabapentin, as adjunctive therapy in subjects with partial seizures.
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Epilepsy
  • Partial Seizure Disorder
  • Epilepsies, Partial
  • Complex Partial Seizure Disorder
Intervention  ICMJE
  • Drug: Pregabalin
    150, 300, 450 mg/day administered orally TID, until seizure control/improvement or intolerable side effects
  • Drug: Gabapentin
    300, 600, 1200, 2000 mg/day administered orally TID, until seizure control/improvement or intolerable side effects
Study Arms  ICMJE
  • Active Comparator: A
    Intervention: Drug: Pregabalin
  • Active Comparator: B
    Intervention: Drug: Gabapentin
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.


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 15, 2018)
482
Original Estimated Enrollment  ICMJE
 (submitted: September 28, 2007)
800
Actual Study Completion Date  ICMJE July 2013
Actual Primary Completion DateJuly 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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.
  • 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.

Exclusion Criteria:

  • 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.
  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Costa Rica,   El Salvador,   Guatemala,   Peru
Removed Location CountriesBulgaria,   China,   Croatia,   India,   Pakistan,   Portugal,   Romania,   Serbia,   Slovakia,   Spain
 
Administrative Information
NCT Number  ICMJE NCT00537940
Other Study ID Numbers  ICMJE A0081143
2007-003161-40 ( EudraCT Number )
207103 ( Other Identifier: Alias Study Number )
Has Data Monitoring CommitteeYes
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateNovember 2018

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

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[email protected]

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