Clinical trial NCT00280059: Study Of The Safety And Efficacy Of Lyrica In The Treatment Of Newly Diagnosed Partial Epilepsy
Official title: A Randomized, Comparative, Double-Blind, Parallel-Group, Multicenter, Monotherapy, Study Of Pregabalin (Lyrica) And Lamotrigine (Lamictal) In Patients With Newly Diagnosed Partial Seizures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Epilepsy, Partial
Keywords: Epilepsy
partial seizures
pregabalin monotherapy
lamotrigine comparator
double-blind and randomized trial
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2006-01-20
Enrollment: 660
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess whether Lyrica is a safe and effective treatment for partial epilepsy in comparison with an established treatment, Lamictal.


Eligibility criteria: Inclusion Criteria:

* Patients must be diagnosed with partial epilepsy and have experienced at least 2 partial seizures (simple partial, complex partial or partial seizure with secondary generalization) in the past year with one in the past 6 months.

Exclusion Criteria:

* Treatable causes of seizures, for example identified etiologies including metabolic, neoplastic or active infectious origin.
* Primary generalized seizures.

Primary outcomes:
measure: Percentage of Seizure-free Participants (Responders) During Efficacy Assessment Phase
timeFrame: Week 5 up to Week 56
Secondary outcomes:
measure: Time to 6 Consecutive Months of Seizure-freedom After 4-week Dose Escalation Phase: All Seizures
timeFrame: Week 4 up to Week 56
measure: Exit Due to Adverse Events During the Double-blind Treatment Phase (Including Dose Escalation Phase)
timeFrame: Week 0 to Week 56
measure: Exit for Any Reason During the Double-blind Treatment Phase (Including Dose Escalation Phase)
timeFrame: Week 0 to Week 56
measure: Exit Due to Lack of Efficacy After 4-week Dose Escalation Phase
timeFrame: Week 4 up to Week 56
measure: Exit Due to Any Reason After 4-week Dose Escalation Phase
timeFrame: Week 4 up to Week 56
measure: Time to First Seizure After the 4-Week Dose Escalation Phase
timeFrame: Week 4 up to Week 56
measure: Median Monthy Seizure Frequency: All Partial Seizures
timeFrame: Baseline up to Week 60
measure: Mean Monthy Seizure Frequency: All Partial Seizures
timeFrame: Baseline up to Week 60
measure: Median Monthy Seizure Frequency: All Seizures
timeFrame: Baseline up to Week 60
measure: Mean Monthy Seizure Frequency: All Seizures
timeFrame: Baseline up to Week 60
measure: Median Monthy Seizure Frequency of Responders for the Months After Achieving 6 Consecutive Months of Seizure Freedom: All Partial Seizures
timeFrame: Month 1 through Month 9 (after 6 months seizure freedom achieved)
measure: Mean Monthy Seizure Frequency of Responders for the Months After Achieving 6 Consecutive Months of Seizure Freedom: All Partial Seizures
timeFrame: Month 1 through Month 9 (after 6 months seizure freedom achieved)
measure: Median Monthy Seizure Frequency of Responders for the Months After Achieving 6 Consecutive Months of Seizure Freedom: All Seizures
timeFrame: Month 1 through Month 9 (after 6 months seizure freedom achieved)
measure: Mean Monthy Seizure Frequency of Responders for the Months After Achieving 6 Consecutive Months of Seizure Freedom: All Seizures
timeFrame: Month 1 through Month 9 (after 6 months seizure freedom achieved)
measure: Percentage of Participants Who Achieved at Least 6 Consecutive Months of Seizure Freedom (Responders) by Final Dosage Levels and Treatment Group
timeFrame: Week 5 up to Week 56
measure: Change From Baseline to Week 56 in Hospital Anxiety and Depression Scale (HADS)
timeFrame: Baseline to Week 56
measure: Medical Outcomes Study Sleep Scale (MOS-SS): Optimal Sleep Subscale
timeFrame: Week 8, Week 32, and Week 56
Other outcomes:
Locations:
city: Brugge
country: Belgium
facility: Pfizer Investigational Site
city: Bruxelles
country: Belgium
facility: Pfizer Investigational Site
city: Leuven
country: Belgium
facility: Pfizer Investigational Site
city: Plovdiv
country: Bulgaria
facility: Pfizer Investigational Site
city: Sofia
country: Bulgaria
facility: Pfizer Investigational Site
city: Sofia
country: Bulgaria
facility: Pfizer Investigational Site
city: Sofia
country: Bulgaria
facility: Pfizer Investigational Site
city: Varna
country: Bulgaria
facility: Pfizer Investigational Site
city: Xi'an
country: China
facility: Pfizer Investigational Site
state: Shanxi
city: Cheng Du Si Chaun
country: China
facility: Pfizer Investigational Site
city: Chongqing
country: China
facility: Pfizer Investigational Site
city: Tian Jin
country: China
facility: Pfizer Investigational Site
city: Bogota
country: Colombia
facility: Pfizer Investigational Site
state: Cundinamarca
city: Cali
country: Colombia
facility: Pfizer Investigational Site
state: Valle Del Cauca
city: Brno 2
country: Czechia
facility: Pfizer Investigational Site
city: Hradec Kralove
country: Czechia
facility: Pfizer Investigational Site
city: Ostrava
country: Czechia
facility: Pfizer Investigational Site
city: Pelhrimov
country: Czechia
facility: Pfizer Investigational Site
city: Praha 4
country: Czechia
facility: Pfizer Investigational Site
city: Rychnov nad Kneznou
country: Czechia
facility: Pfizer Investigational Site
city: Zlin
country: Czechia
facility: Pfizer Investigational Site
city: Tallinn
country: Estonia
facility: Pfizer Investigational Site
city: Tartu
country: Estonia
facility: Pfizer Investigational Site
city: Kuopio
country: Finland
facility: Pfizer Investigational Site
city: Tampere
country: Finland
facility: Pfizer Investigational Site
city: Bordeaux Cedex
country: France
facility: Pfizer Investigational Site
city: Nancy Cedex
country: France
facility: Pfizer Investigational Site
city: Strasbourg Cedex
country: France
facility: Pfizer Investigational Site
city: Berlin
country: Germany
facility: Pfizer Investigational Site
city: Bonn
country: Germany
facility: Pfizer Investigational Site
city: Essen
country: Germany
facility: Pfizer Investigational Site
city: Frankfurt
country: Germany
facility: Pfizer Investigational Site
city: Ulm
country: Germany
facility: Pfizer Investigational Site
city: Ulm
country: Germany
facility: Pfizer Investigational Site
city: Hong Kong
country: Hong Kong
facility: Pfizer Investigational Site
city: Kowloon
country: Hong Kong
facility: Pfizer Investigational Site
city: Shatin
country: Hong Kong
facility: Pfizer Investigational Site
city: Budapest
country: Hungary
facility: Pfizer Investigational Site
city: Gyor
country: Hungary
facility: Pfizer Investigational Site
city: Nyiregyhaza
country: Hungary
facility: Pfizer Investigational Site
city: Bangalore
country: India
facility: Pfizer Investigational Site
state: Karnataka
city: Indore
country: India
facility: Pfizer Investigational Site
state: Madhya Pradesh
city: Chennai
country: India
facility: Pfizer Investigational Site
state: Tamil Nadu
city: Bangalore
country: India
facility: Pfizer Investigational Site
city: Lucknow
country: India
facility: Pfizer Investigational Site
city: New Delhi
country: India
facility: Pfizer Investigational Site
city: Tallaght
country: Ireland
facility: Pfizer Investigational Site
state: Dublin
city: Bologna
country: Italy
facility: Pfizer Investigational Site
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: Daejeon
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Gwangju
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Incheon
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: Seoul
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Riga
country: Latvia
facility: Pfizer Investigational Site
city: Riga
country: Latvia
facility: Pfizer Investigational Site
city: Kaunas
country: Lithuania
facility: Pfizer Investigational Site
city: Vilnius
country: Lithuania
facility: Pfizer Investigational Site
city: Vilnius
country: Lithuania
facility: Pfizer Investigational Site
city: Mexico
country: Mexico
facility: Pfizer Investigational Site
state: DF
city: San Luis Potosi
country: Mexico
facility: Pfizer Investigational Site
city: Den Haag
country: Netherlands
facility: Pfizer Investigational Site
state: ZH
city: Lillehammer
country: Norway
facility: Pfizer Investigational Site
city: Trondheim
country: Norway
facility: Pfizer Investigational Site
city: Amadora
country: Portugal
facility: Pfizer Investigational Site
city: Coimbra
country: Portugal
facility: Pfizer Investigational Site
city: Coimbra
country: Portugal
facility: Pfizer Investigational Site
city: Porto
country: Portugal
facility: Pfizer Investigational Site
city: Porto
country: Portugal
facility: Pfizer Investigational Site
city: Cluj-Napoca
country: Romania
facility: Pfizer Investigational Site
state: Jud. Cluj
city: Bucuresti
country: Romania
facility: Pfizer Investigational Site
city: Bucuresti
country: Romania
facility: Pfizer Investigational Site
city: Singapore
country: Singapore
facility: Pfizer Investigational Site
city: Bratislava
country: Slovakia
facility: Pfizer Investigational Site
city: Bratislava
country: Slovakia
facility: Pfizer Investigational Site
city: Bratislava
country: Slovakia
facility: Pfizer Investigational Site
city: Kosice
country: Slovakia
facility: Pfizer Investigational Site
city: Zilina
country: Slovakia
facility: Pfizer Investigational Site
city: Badalona
country: Spain
facility: Pfizer Investigational Site
state: Barcelona
city: Girona
country: Spain
facility: Pfizer Investigational Site
city: Madrid
country: Spain
facility: Pfizer Investigational Site
city: Valencia
country: Spain
facility: Pfizer Investigational Site
city: Valencia
country: Spain
facility: Pfizer Investigational Site
city: Goteborg
country: Sweden
facility: Pfizer Investigational Site
city: Linkoping
country: Sweden
facility: Pfizer Investigational Site
city: Uppsala
country: Sweden
facility: Pfizer Investigational Site
city: Tainan
country: Taiwan
facility: Pfizer Investigational Site
city: Taipei
country: Taiwan
facility: Pfizer Investigational Site
city: Taipei
country: Taiwan
facility: Pfizer Investigational Site
city: Rajthevee
country: Thailand
facility: Pfizer Investigational Site
state: Bangkok
city: Muang
country: Thailand
facility: Pfizer Investigational Site
state: Khon Kaen
city: Bangkok
country: Thailand
facility: Pfizer Investigational Site
city: Stoke-on-Trent
country: United Kingdom
facility: Pfizer Investigational Site
state: Staffordshire
city: Glasgow
country: United Kingdom
facility: Pfizer Investigational Site
city: Liverpool
country: United Kingdom
facility: Pfizer Investigational Site
city: Treliske, Truro, Cornwall
country: United Kingdom
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Kwan P, Brodie MJ, Kalviainen R, Yurkewicz L, Weaver J, Knapp LE. Efficacy and safety of pregabalin versus lamotrigine in patients with newly diagnosed partial seizures: a phase 3, double-blind, randomised, parallel-group trial. Lancet Neurol. 2011 Oct;10(10):881-90. doi: 10.1016/S1474-4422(11)70154-5. Epub 2011 Aug 31.