You are here

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

Last updated on August 9, 2018

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

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

call now

Try a new search

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your zip code, city, or country to find studies near you.

Similar Trials

Sickle Cell Anemia, Sickle Cell Disease, Sickle Cell Disorders, Pain Crisis, Vaso-occlusive Crisis
NCT02433158
All Genders
6+
Years
Multiple Sites
Obsessive Compulsive Disorder
NCT01302080
All Genders
6+
Years
Multiple Sites
Comparative Study Of Pregabalin And Gabapentin As Adjunctive Therapy In Subjects With Partial Seizures
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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
  • Epilepsy
  • Partial Seizure Disorder
  • Epilepsies, Partial
  • Complex Partial Seizure Disorder
  • 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
  • Active Comparator: A
    Intervention: Drug: Pregabalin
  • Active Comparator: B
    Intervention: Drug: Gabapentin
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.
 
Completed
484
July 2013
July 2013   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Costa Rica,   El Salvador,   Guatemala,   Peru
Bulgaria,   China,   Croatia,   India,   Pakistan,   Portugal,   Romania,   Serbia,   Slovakia,   Spain
 
NCT00537940
A0081143
2007-003161-40 ( EudraCT Number )
207103 ( Other Identifier: Alias Study Number )
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
November 2014

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 thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



Call Now