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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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ClinicalTrials.gov Identifier: NCT01747915
Recruitment Status : Completed
First Posted : December 12, 2012
Results First Posted : August 26, 2019
Last Update Posted : August 26, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE November 27, 2012
First Posted Date  ICMJE December 12, 2012
Results First Submitted Date  ICMJE August 8, 2019
Results First Posted Date  ICMJE August 26, 2019
Last Update Posted Date August 26, 2019
Actual Study Start Date  ICMJE April 3, 2013
Actual Primary Completion Date February 20, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 8, 2019)
Log-transformed (Log) 28-day Seizure Rate for All Primary Generalized Tonic-Clonic (PGTC) Seizures During 12-Week Double-Blind Treatment Phase [ Time Frame: Day 1 up to Week 12 ]
All PGTC seizures experienced during treatment phase were recorded by the participants or their parents/legal guardian in a daily seizure diary. 28-day seizure rate for all PGTC seizures= ([number of seizures in the double blind treatment phase] divided by [number of days in double blind treatment phase minus {-} number of missing diary days in treatment phase])*28. For log-transformation, the quantity 1 was added to the 28-day seizure rate for all participants to account for any possible "0" seizure incidence. This resulted in final calculation as: log transformed (28-day seizure rate +1).
Original Primary Outcome Measures  ICMJE
 (submitted: December 10, 2012)
Percent reduction of 28 day seizure rate for all PGTC seizures relative to placebo during the double blind assessment phase. [ Time Frame: Daily PGTC seizure counts collected for up to 21 weeks ]
Change History Complete list of historical versions of study NCT01747915 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 8, 2019)
Percentage of Participants With at Least 50 Percent (%) or Greater Reduction From Baseline in 28-day Primary Generalized Tonic-clonic (PGTC) Seizure Rate During the 12-Week Double-blind Treatment Phase [ Time Frame: Day 1 up to Week 12 ]
Percentage of participants with 50% or greater reduction from baseline in 28-day seizure rate during the 12 week double blind treatment phase were reported. 28-day seizure rate for all PGTC seizures= ([number of seizures in the double blind treatment phase] divided by [number of days in double blind treatment phase minus {-} number of missing diary days in treatment phase])*28.
Original Secondary Outcome Measures  ICMJE
 (submitted: December 10, 2012)
Responder rate, defined as the proportion of subjects who had at least a 50% reduction in 28 day PGTC seizure. [ Time Frame: Calculated from daily data from baseline to end of study for up to 21 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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.
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Generalized Tonic Clonic Seizures
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   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: April 17, 2019)
219
Original Estimated Enrollment  ICMJE
 (submitted: December 10, 2012)
168
Actual Study Completion Date  ICMJE February 20, 2019
Actual Primary Completion Date February 20, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 5 Years to 65 Years   (Child, 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 Austria,   Belarus,   Bosnia and Herzegovina,   Bulgaria,   China,   Croatia,   Denmark,   France,   Greece,   Hungary,   India,   Korea, Republic of,   Lebanon,   Malaysia,   Montenegro,   Philippines,   Poland,   Romania,   Russian Federation,   Serbia,   Slovakia,   Spain,   Turkey,   Ukraine,   United Kingdom,   United States
Removed Location Countries Argentina,   Belgium,   Estonia,   Germany,   Israel,   Lithuania,   Netherlands,   Singapore
 
Administrative Information
NCT Number  ICMJE NCT01747915
Other Study ID Numbers  ICMJE A0081105
2010-023263-18 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP