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A Safety, Efficacy and Tolerability Trial of Pregabalin as Add-On Treatment in Pediatric and Adult Subjects With Primary Generalized Tonic-Clonic (i.e., Grand Mal) Seizures.

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NCT01747915

Last updated on December 5, 2018
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FOR MORE INFORMATION
Study Location
Axcess Medical Research
Loxahatchee Groves, Florida, 33470 United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Generalized Tonic Clonic Seizures
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
5-65 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Seizures classified as Primary Generalized Tonic Clonic Seizures

- Must have at least 1 PGTC seizure in the 8 weeks prior to screening

- Must have a minimum of 3 PGTC seizures during the 8-week baseline phase and at least 1
PGTC in each 4-week period of the baseline phase

- Currently receiving adequate and stable dosage of 1 to 3 anti-epileptic treatments
(stable within 28 days of screening)

- Signed informed consent and assent if a minor

- Ability to comply with daily seizure and dosing diary requirements and all study
procedures

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

- A current diagnosis of febrile seizures, or seizures related to an ongoing acute
medical illness

- Focal seizures (simple partial, complex partial, or partial becoming secondarily
generalized)

- Status Epilepticus within 1 year prior to screening

- Lennox-Gastaut syndrome, infantile spasms, Benign Epilepsy with Centrotemporal Spikes
(BECTS) and Dravet syndrome

- Seizures related to drugs, alcohol, or acute medical illness

- Any change in anti-epileptic treatment regimen (type of medication or dose; VNS
alteration) within 28 days of the screening visit or during the baseline phase

- Progressive or potentially progressive structural CNS lesion or a progressive
encephalopathy.

- Progressive inborn errors of metabolism.

NCT01747915
Pfizer
Recruiting
A Safety, Efficacy and Tolerability Trial of Pregabalin as Add-On Treatment in Pediatric and Adult Subjects With Primary Generalized Tonic-Clonic (i.e., Grand Mal) Seizures.

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[email protected]

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A Safety, Efficacy and Tolerability Trial of Pregabalin as Add-On Treatment in Pediatric and Adult Subjects With Primary Generalized Tonic-Clonic (i.e., Grand Mal) Seizures.
A Randomized, Double-blind, Placebo-controlled, Parallel Group, Multi-center Trial Of Pregabalin As Adjunctive Therapy In Pediatric And Adult Subjects With Primary Generalized Tonic-clonic Seizures - Protocol A0081105
The study is designed to evaluate the safety, tolerability and efficacy of two doses of pregabalin as add-on treatment in pediatric and adult subjects with Primary Generalized Tonic-Clonic (PGTC) seizures as compared to placebo. It is hypothesized that both doses of pregabalin will demonstrated superior efficacy when compared to placebo by reducing PGTC seizure frequency and that pregabalin will be safe and well tolerated.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Generalized Tonic Clonic Seizures
  • Drug: Pregabalin Dose Level 1
    Pregabalin, either liquid or capsule, dosed twice daily, escalated up to a maximum of 300 mg/day beginning at Randomization to Taper Phase, then tapered down to a maximum dose of 150 mg/day during 1 week Taper Phase to End of Study/Early Termination.
    Other Name: Lyrica Dose Level 1
  • Drug: Pregabalin Dose Level 2
    Pregabalin, either liquid or capsule, dosed twice daily, escalated up to a maximum of 600 mg/day beginning at Randomization to Taper Phase, then tapered down to a maximum of 150 mg/day during 1 week Taper Phase to End of Study/Early Termination.
    Other Name: Lyrica Dose Level 2
  • Drug: Placebo
    Placebo, either liquid or capsule, dosed twice daily beginning at Randomization to End of Study/Early Termination.
  • Experimental: Study Drug Level 1
    Intervention: Drug: Pregabalin Dose Level 1
  • Experimental: Study Drug Level 2
    Intervention: Drug: Pregabalin Dose Level 2
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
168
June 30, 2019
June 30, 2019   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Seizures classified as Primary Generalized Tonic Clonic Seizures
  • Must have at least 1 PGTC seizure in the 8 weeks prior to screening
  • Must have a minimum of 3 PGTC seizures during the 8-week baseline phase and at least 1 PGTC in each 4-week period of the baseline phase
  • Currently receiving adequate and stable dosage of 1 to 3 anti-epileptic treatments (stable within 28 days of screening)
  • Signed informed consent and assent if a minor
  • Ability to comply with daily seizure and dosing diary requirements and all study procedures

Exclusion Criteria:

  • A current diagnosis of febrile seizures, or seizures related to an ongoing acute medical illness
  • Focal seizures (simple partial, complex partial, or partial becoming secondarily generalized)
  • Status Epilepticus within 1 year prior to screening
  • Lennox-Gastaut syndrome, infantile spasms, Benign Epilepsy with Centrotemporal Spikes (BECTS) and Dravet syndrome
  • Seizures related to drugs, alcohol, or acute medical illness
  • Any change in anti-epileptic treatment regimen (type of medication or dose; VNS alteration) within 28 days of the screening visit or during the baseline phase
  • Progressive or potentially progressive structural CNS lesion or a progressive encephalopathy.
  • Progressive inborn errors of metabolism.
Sexes Eligible for Study: All
5 Years to 65 Years   (Child, Adult)
No

Contact: Pfizer CT.gov Call Center 1-800-718-1021 [email protected]
Argentina,   Austria,   Belarus,   Belgium,   Bosnia and Herzegovina,   Bulgaria,   China,   Croatia,   Denmark,   France,   Germany,   Greece,   Hungary,   India,   Israel,   Korea, Republic of,   Lebanon,   Lithuania,   Malaysia,   Montenegro,   Philippines,   Poland,   Romania,   Russian Federation,   Serbia,   Singapore,   Slovakia,   Spain,   Turkey,   Ukraine,   United Kingdom,   United States
Estonia,   Netherlands
 
NCT01747915
A0081105
2010-023263-18 ( EudraCT Number )
Yes
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
December 2017

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

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Contact

[email protected]

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