Clinical trial NCT00537238: Pregabalin Versus Levetiracetam In Partial Seizures
Official title: A Randomized, Double-Blind, Parallel-Group Multi-Center Comparative Flexible-Dose Study Of Pregabalin Versus Levetiracetam As Adjunctive Therapy To Reduce Seizure Frequency In Subjects With Partial Seizures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Partial Seizures
Keywords: Epilepsies partial
Partial Seizure Disorder
Complex Partial Seizure Disorder
Epilepsy
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2007-10-01
Enrollment: 509
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will compare pregabalin and levetiracetam in patients with partial seizures. It will also evaluate the safety and tolerability of pregabalin and levetiracetam in these patients.


Eligibility criteria: Inclusion Criteria:

* Subjects (male or female) must be \> 18 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.

Exclusion Criteria:

* Females who are pregnant, breastfeeding, or intend to become pregnant during the course of the trial will be excluded
* Subjects with other neurologic illness that could impair endpoint assessment, or subjects with Lennox-Gastaut syndrome, absence seizures, status epileptics within the 12 months prior to trial entry, or with seizures due to an underlying medical illness or metabolic syndrome, will be excluded.

Primary outcomes:
measure: Proportion of Participants With Response to Treatment
timeFrame: Baseline up to Week 16
Secondary outcomes:
measure: Percent Change From Baseline in 28 Day Seizure Frequency at Week 16
timeFrame: Baseline, Week 16
measure: Change From Baseline in the Proportion of 28-day Secondarily Generalized Tonic-clonic (SGTC) Seizure Rate to 28-day All Partial Seizure Rate at Week 16
timeFrame: Baseline, Week 16
measure: Percentage of Participants Without Seizures
timeFrame: Baseline up to Week 16
measure: Change From Baseline in Brief Psychiatric Rating Scale - Anchored (BPRS-A) Total and Core Score at Week 7, 10, 13, 16 and Follow-up
timeFrame: Baseline, Week 7, 10, 13, 16 and Follow-up (Day 7 of taper phase)
measure: Hospital Anxiety and Depression Scale (HADS) Score
timeFrame: Baseline, Week 16
measure: Medical Outcomes Study Sleep Scale (MOS-SS) Score
timeFrame: Baseline, Week 16
measure: Percentage of Participants With Optimal Sleep Assessed Using Medical Outcomes Study-Sleep Scale (MOS-SS) Score
timeFrame: Baseline, Week 16
Other outcomes:
Locations:
city: Duffel
country: Belgium
facility: Pfizer Investigational Site
city: Yvoir
country: Belgium
facility: Pfizer Investigational Site
city: Kyustendil 2500
country: Bulgaria
facility: Pfizer Investigational Site
city: Pernik
country: Bulgaria
facility: Pfizer Investigational Site
city: Plovdiv
country: Bulgaria
facility: Pfizer Investigational Site
city: Ruse 7002
country: Bulgaria
facility: Pfizer Investigational Site
city: Sofia
country: Bulgaria
facility: Pfizer Investigational Site
city: Sofia
country: Bulgaria
facility: Pfizer Investigational Site
city: Barranquilla
country: Colombia
facility: Pfizer Investigational Site
state: Atlantico
city: Bogota
country: Colombia
facility: Pfizer Investigational Site
state: Cundinamarca
city: Montes De Oca
country: Costa Rica
facility: Pfizer Investigational Site
state: San Jose
city: San Jose
country: Costa Rica
facility: Pfizer Investigational Site
city: Brno 2
country: Czechia
facility: Pfizer Investigational Site
city: Brno
country: Czechia
facility: Pfizer Investigational Site
city: Hradec Kralove 3
country: Czechia
facility: Pfizer Investigational Site
city: Olomouc
country: Czechia
facility: Pfizer Investigational Site
city: Ostrava-Trebovice
country: Czechia
facility: Pfizer Investigational Site
city: Praha 4
country: Czechia
facility: Pfizer Investigational Site
city: Pribram 8
country: Czechia
facility: Pfizer Investigational Site
city: Rychnov nad Kneznou
country: Czechia
facility: Pfizer Investigational Site
city: Strasbourg Cedex
country: France
facility: Pfizer Investigational Site
city: Toulouse
country: France
facility: Pfizer Investigational Site
city: Bonn
country: Germany
facility: Pfizer Investigational Site
city: Hamburg
country: Germany
facility: Pfizer Investigational Site
city: Athens
country: Greece
facility: Pfizer Investigational Site
city: Thessaloniki
country: Greece
facility: Pfizer Investigational Site
city: Pune
country: India
facility: Pfizer Investigational Site
state: Maharashtra
city: Chandigarh
country: India
facility: Pfizer Investigational Site
state: Punjab
city: Ludhiana
country: India
facility: Pfizer Investigational Site
state: Punjab
city: Firenze
country: Italy
facility: Pfizer Investigational Site
city: Foggia
country: Italy
facility: Pfizer Investigational Site
city: Pisa
country: Italy
facility: Pfizer Investigational Site
city: Siena
country: Italy
facility: Pfizer Investigational Site
city: Busan
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Daejeon
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Seoul
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Seoul
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Seoul
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Seoul
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Seoul
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Kaunas
country: Lithuania
facility: Pfizer Investigational Site
city: Vilnius
country: Lithuania
facility: Pfizer Investigational Site
city: Distrito Federal
country: Mexico
facility: Pfizer Investigational Site
city: San Luis Potosi
country: Mexico
facility: Pfizer Investigational Site
city: Panama
country: Panama
facility: Pfizer Investigational Site
city: Lima
country: Peru
facility: Pfizer Investigational Site
city: Lima
country: Peru
facility: Pfizer Investigational Site
city: Tondo
country: Philippines
facility: Pfizer Investigational Site
state: Manila
city: Cebu City
country: Philippines
facility: Pfizer Investigational Site
city: Davao City
country: Philippines
facility: Pfizer Investigational Site
city: Makati City
country: Philippines
facility: Pfizer Investigational Site
city: Manila
country: Philippines
facility: Pfizer Investigational Site
city: Quezon City
country: Philippines
facility: Pfizer Investigational Site
city: Moscow
country: Russian Federation
facility: Pfizer Investigational Site
city: Moscow
country: Russian Federation
facility: Pfizer Investigational Site
city: Moscow
country: Russian Federation
facility: Pfizer Investigational Site
city: St. Petersburg
country: Russian Federation
facility: Pfizer Investigational Site
city: St. Petersburg
country: Russian Federation
facility: Pfizer Investigational Site
city: St. Petersburg
country: Russian Federation
facility: Pfizer Investigational Site
city: Donostia
country: Spain
facility: Pfizer Investigational Site
state: Guipuzcoa
city: Alicante
country: Spain
facility: Pfizer Investigational Site
city: Barcelona
country: Spain
facility: Pfizer Investigational Site
city: Cordoba
country: Spain
facility: Pfizer Investigational Site
city: Girona
country: Spain
facility: Pfizer Investigational Site
city: Sevilla
country: Spain
facility: Pfizer Investigational Site
city: Kaohsiung
country: Taiwan
facility: Pfizer Investigational Site
city: Taichung
country: Taiwan
facility: Pfizer Investigational Site
city: Tainan
country: Taiwan
facility: Pfizer Investigational Site
city: Capa
country: Turkey
facility: Pfizer Investigational Site
state: Istanbul
city: Ankara
country: Turkey
facility: Pfizer Investigational Site
city: Cerrahpasa / Istanbul
country: Turkey
facility: Pfizer Investigational Site
city: Caracas
country: Venezuela
facility: Pfizer Investigational Site
state: Libertador
city: Caracas
country: Venezuela
facility: Pfizer Investigational Site
state: Miranda
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Zaccara G, Almas M, Pitman V, Knapp L, Posner H. Efficacy and safety of pregabalin versus levetiracetam as adjunctive therapy in patients with partial seizures: a randomized, double-blind, noninferiority trial. Epilepsia. 2014 Jul;55(7):1048-57. doi: 10.1111/epi.12679. Epub 2014 Jun 5.