Adjunctive (add on) therapy for adult subjects with partial onset seizures with or without secondary generalization. MedDRA version: 14.1 Level: LLT Classification code 10048674 Term: Partial seizures with secondary generalization System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Product Code: pregabalin
Pharmaceutical Form: Prolonged-release tablet
INN or Proposed INN: Pregabalin
CAS Number: 14553-50-8
Current Sponsor code: Not applicable
Other descriptive name: Not applicabl
Sponsors
Pfizer Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of and agrees to all pertinent aspects of the study. 2.Otherwise healthy men or non-pregnant, non-lactating women aged 18 years or older. Men and women must use an acceptable method of contraception as detailed in the lifestyle guidelines section. Women must have a confirmed negative pregnancy test prior to enrollment. 3.Diagnosis of epilepsy with partial onset seizures (as defined in the International League Against Epilepsy Classification of Seizures 1997, 2010, Appendix 3). Partial onset seizures may be simple or complex, with or without evolution into a bilateral, convulsive seizure (previously termed secondary generalization). In addition to this, for determination of eligibility the following definitions cross from the ILAE of 1997 to those of 2010. Seizures without impairment of consciousness or awareness must have an observable motor component and are termed "simple partial seizures". When there is impairment in consciousness or awareness, the 1997 term "complex partial seizures" is applied. Diagnosis must be established by subject’s history (eg, the phenomenology (description) of the seizures, excluding confounding disorders such as pseudo-seizures, syncopes, etc.), family history, neurological examination, the results of EEG testing done within 2 years prior to study participation and the results of brain imaging (if none available, must be obtained during the 8 week screening pre-randomization period and be available at V3). Results must be consistent with the diagnosis of focal-onset epilepsy. Simple partial seizures without a visible motor component (ie, lacking visible movements during the seizure) are not counted toward eligibility. 4.Subjects must have a minimum of 3 partial seizures during the 1 month (28 days) prior to the screening visit for entry into baseline observation phase and at least 6 partial seizures during the 8 week baseline observation phase with no 28 day period free of partial seizures. A caregiver or witness must be with the Subject for a sufficient duration to accurately chronicle the occurrence of seizures, if appropriate given the subject's seizure types. These seizures must be documented properly in the subject's seizure diary. Simple partial seizures without a visible motor component (ie, lacking visible movements during the seizure) will be recorded, but are not counted toward eligibility. 5.Subjects who currently take 1 to 3 AEDs that are at stable dosages, within clinically acceptable therapeutic range or within the range of tolerability of the subject, and who have taken at least 2 prior (or ongoing) AEDs. For two weeks prior to screening and during study participation subjects must remain on stable dosages (same dosage throughout the study: at screening, the baseline observation period, and the double blind maintenance period) of 1 to 3 AEDs concomitantly throughout the trial. Other AEDs must be discontinued completely at least 2 weeks prior to screening (this does not include rescue medication). 6.No progressive structural abnormality on a head CT scan (with contrast) or MRI within 2 years prior to study participation (if none available, must be obtained and evaluated prior to randomization). 7.Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures. S
Exclusion criteria
Exclusion criteria: Subjects presenting with any of the following will not be included in the study: 1.A progressive cause of seizures or a reversible cause of seizures 2.Subjects who only experience simple partial seizures without a motor component in the 8 week baseline seizure record phase. 3.Primary generalized seizures (including in setting of co-existing partial-onset epilepsy), which include for example: Clonic, tonic & tonic clonic seizures (secondarily generalized seizures are permitted); Absence seizures; Myoclonic, Myoclonic atonic, Myoclonic tonic seizures; Reflex epilepsies. 4.Lennox Gastaut Syndrome. 5.Status epilepticus within 1 year prior to screening. 6.Subjects with other neurologic illness that could impair endpoint assessment. 7.A significant psychiatric disorder, recurrent episodes of severe depression (any pharmacologic treatment or hospitalization for illness within 1 year prior to Screening) or subjects with serious suicidal risk. Subjects with mild, chronic depression without recent hospitalization who are being maintained on a stable dose of single antidepressant are acceptable. 8.Other severe acute or chronic medical or psychiatric condition or laboratory abnormality (including, for example, platelet count 60 mL/min, the subject is not excluded. 16.Alcohol or substance abuse or dependence within the previous year. 17.Use of prohibited medications as listed in protocol in absence of an washout phase, or likelihood of requiring treatment during study period with medications not permitted by the protocol.18.Subjects who are n
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of pregabalin CR administered once daily as compared to placebo as adjunctive treatment in reducing the frequency of seizures in partial onset epilepsy, utilizing the endpoint of Log transformed 28 day partial seizure rate, in adult subjects with partial onset seizures.;Secondary Objective: •To characterize the efficacy of pregabalin CR vs. placebo on the frequency of partial seizures as determined by responder rate, and percentage change from baseline on 28 day partial seizure rates. •To characterize the effects pregabalin CR vs. placebo on measures of anxiety, sleep disturbance, and treatment satisfaction. •To assess the safety and tolerability of pregabalin CR in adult subjects with partial onset seizures. ;Primary end point(s): The primary endpoint will be the log-transformed (loge) 28-day seizure rate for all partial onset seizures collected during the double-blind maintenance treatment phase.;Timepoint(s) of evaluation of this end point: Timepoints are Visit 1 (Week - 8) to Visit 7 (Week 14), where seizure information is captured daily on a diary. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Responder rate (proportion of subjects who have a ?50% reduction in partial seizure rate from baseline during the double-blind maintenance treatment phase compared to the 8-week baseline (screening) seizure period). - The percentage change from baseline in 28-day partial seizure rates during the double-blind maintenance treatment phase. - Frequency of secondary generalized tonic-clonic seizures (SGTC). - Log-transformed 28-day SGTC rate for all SGTCs collected during the double-blind maintenance treatment phase. - SGTC responder rate. - Changes from baseline in the anxiety and depression scores of the Hospital Anxiety and Depression Scale (HADS) scores. - Change from baseline in Medical Outcomes Study-Sleep Scale (MOS-Sleep Scale) domain scores. - Global scores on the patient-rated Benefit, Satisfaction, and Willingness to Continue Measure (BSW).;Timepoint(s) of evaluation of this end point: The secondary endpoints utilize the seizure diary and thus the same timepoints as the primary endpoint. Timepoints are Visit 1 (Week - 8) to Visit 7 (Week 14), where seizure information is captured daily on a diary. | — |
Countries
Bosnia and Herzegovina, Bulgaria, China, Croatia, Czech Republic, Estonia, Finland, Germany, Hong Kong, Hungary, India, Malaysia, Mexico, Poland, Romania, Russian Federation, Serbia, Singapore, South Africa, Thailand, Turkey
Contacts
Public ContactClinical Trials.gov Call Center
Pfizer Inc
Outcome results
None listed