Clinical trial NCT01262677: Once-A-Day Pregabalin For Partial Seizures
Official title: A Randomized, Double-blind, Placebo-controlled, Parallel Group, Multi-center Trial Of Pregabalin Controlled Release Formulation As Adjunctive Therapy In Adults With Partial Onset Seizures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Partial Seizures
Epilepsies, Partial
Keywords: Partial epilepsy
partial seizures
epilepsy
seizures
adjunctive therapy
intervention
controlled-release
placebo-controlled
seizure
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2010-12-17
Enrollment: 325
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: Approximately 30% percent of subjects with partial seizures are refractory to treatment with single or combination antiepileptic drugs. The present study will compare the efficacy of two different dosages of pregabalin CR dosed once daily as compared to placebo, when used as adjunctive therapy in subjects requiring adjunctive therapy for partial onset epilepsy, using a randomized, parallel group design.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of epilepsy with partial onset seizures (seizures may be simple or complex, with or without evolution into a bilateral, convulsive seizure)
* Currently taking 1 to 3 anti-epilepsy medicines (AEDs) at stable dosages, and who have taken at least 2 prior (or ongoing) AEDs

Exclusion Criteria:

* Primary generalized seizures (for example, absence, myoclonic seizures or Lennox-Gastaut Syndrome)
* Status epilepticus within one year prior to screening

Primary outcomes:
measure: Log Transformed (Loge) 28-day Seizure Rate for All Partial Onset Seizures During the Double-blind Treatment Phase
timeFrame: Week 0 to Week 14
Secondary outcomes:
measure: Percentage of Participants With a ≥50% Reduction in the 28-day Partial Seizure Rate From Baseline During the Double-blind Treatment Phase
timeFrame: Week 0 to Week 14
measure: Percentage Change From Baseline in 28-day Partial Seizure Rate During the Double-blind Treatment Phase
timeFrame: Week 0 to Week 14
measure: Frequency of Secondary Generalized Tonic-clonic Seizures (SGTC) During the Double-blind Treatment Phase
timeFrame: Week 0 to Week 14
measure: Log Transformed 28-day SGTC Rate for All SGTCs During the Double-blind Maintenance Phase
timeFrame: Week 2 to Week 14
measure: Percentage of Participants With ≥50% Reduction in 28-day SGTC Seizure Rate From Baseline During the Double-blind Treatment Phase
timeFrame: Week 0 to Week 14
measure: Loge 28-day Seizure Rate for All Partial Onset Seizures During the Double-blind Maintenance Phase
timeFrame: Week 2 to Week 14
measure: Change From Baseline in Hospital Anxiety and Depression Scale - Anxiety (HADS-A) Total Score at Week 14
timeFrame: Baseline, Week 14
measure: Change From Baseline in Hospital Anxiety and Depression Scale - Depression (HADS-D) Total Score at Week 14
timeFrame: Baseline, Week 14
measure: Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-SS) - Sleep Disturbance Score at Week 14
timeFrame: Baseline, Week 14
measure: Change From Baseline in MOS-SS - Snoring Score at Week 14
timeFrame: Baseline, Week 14
measure: Change From Baseline in MOS-SS - Awaken Short of Breath or With Headache Score at Week 14
timeFrame: Baseline, Week 14
measure: Change From Baseline in MOS-SS - Quantity of Sleep (Hours) at Week 14
timeFrame: Baseline, Week 14
measure: Change From Baseline in MOS-SS - Sleep Adequacy Score at Week 14
timeFrame: Baseline, Week 14
measure: Change From Baseline in MOS-SS - Sleep Somnolence Score at Week 14
timeFrame: Baseline, Week 14
measure: Change From Baseline in MOS-SS - Sleep Problems Index I Score at Week 14
timeFrame: Baseline, Week 14
measure: Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-SS) - Sleep Problems Index II Score at Week 14
timeFrame: Baseline, Week 14
measure: Percent of Participants Reporting Optimal Sleep on the MOS-SS - Optimal Sleep Subscale
timeFrame: Week 14
measure: Benefit, Satisfaction, and Willingness to Continue Measure (BSW): Benefit From Treatment Question
timeFrame: Week 14
measure: BSW: Satisfaction From Treatment Question
timeFrame: Week 14
measure: BSW: Willingness to Continue Question
timeFrame: Week 14
measure: Percentage of Participants With New or Intensified Physical Examination Findings During the Double-blind Treatment Phase
timeFrame: Day 1 to Week 15
measure: Percentage of Participants With New or Intensified Neurological Examination Findings During the Double-blind Treatment Phase
timeFrame: Day 1 to Week 15
measure: Percentage of Participants With Self-injurious or Suicidal Ideation or Behavior on Columbia Classification Algorithm of Suicide Assessment (C-CASA)
timeFrame: Week -8 (Screening), Week 0 (Baseline), and Week 14 (double-blind treatment phase)
measure: Percentage of Participants With a Relevant Increase in Sitting Blood Pressure (BP) From Baseline During the Double-blind Treatment Phase
timeFrame: Day 1 to Week 15
measure: Percentage of Participants With Corrected QT (QTc) Interval Greater Than or Equal to 450 ms
timeFrame: Week 15
measure: Percentage of Participants With Relevant ECG Interval-increases From Baseline During the Double-blind Treatment Phase
timeFrame: Week 15
measure: Percentage of Participants With Laboratory Test Abnormalities During the Study
timeFrame: Day 1 to Week 15
Other outcomes:
Locations:
city: Northport
country: United States
facility: Neurology Clinic, PC
state: Alabama
city: Jonesboro
country: United States
facility: NEA Baptist Clinic
state: Arkansas
city: Little Rock
country: United States
facility: Clinical Trials, Inc.
state: Arkansas
city: Long Beach
country: United States
facility: Collaborative Neuroscience Network, Inc.
state: California
city: Murrieta
country: United States
facility: Viking Clinic Research Center
state: California
city: Murrieta
country: United States
facility: Viking Clinical Research Center
state: California
city: Santa Monica
country: United States
facility: Neurological Research Institute
state: California
city: Temecula
country: United States
facility: Viking Clinical Research Center
state: California
city: Gainesville
country: United States
facility: Sarkis Clinical Trials
state: Florida
city: Gainesville
country: United States
facility: Optima Neurological Services, LLC
state: Florida
city: Gainesville
country: United States
facility: Sleep Disorders Center of Georgia - Gainesville
state: Georgia
city: Springfield
country: United States
facility: Southern Illinois University School of Medicine
state: Illinois
city: Wichita
country: United States
facility: VCMA Comprehensive Epilepsy Center
state: Kansas
city: Wichita
country: United States
facility: Via Christi Research
state: Kansas
city: Lexington
country: United States
facility: Associates in Neurology, PSC
state: Kentucky
city: Pikesville
country: United States
facility: Mid Atlantic Headache Institute
state: Maryland
city: Asheville
country: United States
facility: Asheville Neurology Specialists, PA
state: North Carolina
city: Oklahoma City
country: United States
facility: Lynn Health Science Institute
state: Oklahoma
city: Oklahoma City
country: United States
facility: Mark A. Fisher, M.D.- Private Practice
state: Oklahoma
city: Oklahoma City
country: United States
facility: Sooner Clinical Research
state: Oklahoma
city: Oklahoma City
country: United States
facility: Veroniqe Sebastian, MD
state: Oklahoma
city: Oklahoma City
country: United States
facility: Angelique Barreto, MD
state: Oklahoma
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Austin
country: United States
facility: FutureSearch Trials of Neurology
state: Texas
city: Temple
country: United States
facility: Scott and White Healthcare-Office of Sponsored Research Administration
state: Texas
city: Temple
country: United States
facility: Scott & White Healthcare
state: Texas
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: Fundacion Argentina Contra las Enfermedades Neurologicas (FACENE)
city: Sarajevo
country: Bosnia and Herzegovina
facility: Clinic of Neurology,Clinical Centar University Sarajevo
city: Blagoevgrad
country: Bulgaria
facility: MBAL Puls AD, Nevrologichno otdelenie
city: Pleven
country: Bulgaria
facility: UMBAL Dr. Georgi Stranski, Vtora nevrologichna klinika
city: Sevlievo
country: Bulgaria
facility: DKTs Akta Medika, Konsultativen kabinet po Nevrologiya
city: Sofia
country: Bulgaria
facility: MBALNP Sveti Naum EAD, Klinika po nervni bolesti za paroksizmalnite sastoyaniya,
city: Sofia
country: Bulgaria
facility: Vtora Mnogoprofilna Bolnitsa za Aktivno Lechenie, Nevrologichno Otdelenie
city: Litomysl
country: Czechia
facility: Litomyslská nemocnice, a.s.
city: Praha 4
country: Czechia
facility: Fakultni Thomayerova nemocnice s poliklinikou,Neurologicka klinika IPVZ/FTNsP
city: Praha 6
country: Czechia
facility: Neurologicka ambulance
city: Bielefeld
country: Germany
facility: Epilepsie-Zentrum Bethel
city: Bielefeld
country: Germany
facility: Praxis fuer Neurologie und Psychiatrie, Psychotherapie
city: Bonn
country: Germany
facility: Klinik fuer Epileptologie, Universitaet Bonn
city: Duesseldorf
country: Germany
facility: Neuro Consil GmbH
city: Kehl-Kork
country: Germany
facility: Epilepsieklinik fuer Erwachsene Epilepsiezentrum Kork
city: Muenchen
country: Germany
facility: Studienzentrum Dr. Stephan Arnold
city: Hong Kong
country: Hong Kong
facility: Pamela Youde Nethersole Eastern Hospital
city: Kowloon
country: Hong Kong
facility: Department of Medicine, Queen Elizabeth Hospital
city: Balassagyarmat
country: Hungary
facility: Dr. Kennessey Albert Korhaz-Rendelointezet, Neurologiai Osztaly
city: Budapest
country: Hungary
facility: Synexus Magyarorszag Kft.
city: Budapest
country: Hungary
facility: Fovarosi Onkormanyzat Uzsoki utcai Korhaza, Ideggyogyaszati Osztaly
city: Dunaujvaros
country: Hungary
facility: Szent Pantaleon Korhaz Nonprofit Kft., Idegosztaly
city: Guntur
country: India
facility: Lalitha Super Specialities Hospital (P) Ltd.
state: Andhra Pradesh
city: Mysore
country: India
facility: Jagadguru Sri Shivathreeshwara Medical College and Hospital,
state: Karnataka
city: Pune
country: India
facility: Deenanath Mangeshkar Hospital and Research Centre
state: Maharashtra
city: Pune
country: India
facility: Sahyadri Clinical Research & Development Center,
state: Maharashtra
city: Pune
country: India
facility: KEM Hospital Research Centre
state: Maharashtra
city: Pune
country: India
facility: Sahyadri Speciality Hospital
state: Maharashtra
city: Pune
country: India
facility: Poona Hospital and Research Centre Department of Neurology
state: Maharashtra
city: Nehru Nagar
country: India
facility: Vidyasagar Institute of Mental Health , Neuro& Allied Sciences,
state: NEW Delhi
city: Kubang Kerian
country: Malaysia
facility: Jabatan Neurosains, Pusat Pengajian Sains Perubatan, Universiti Sains Malaysia.
state: Kelantan
city: Kelantan Darul Naim
country: Malaysia
facility: Hospital Universiti Sains Malaysia
city: Kuala Lumpur
country: Malaysia
facility: Hospital Kuala Lumpur
city: Delagación Cuauhtemoc
country: Mexico
facility: Private Office 201
state: DF
city: Guadalajara
country: Mexico
facility: Hospital Civil de Guadalajara Fray Antonio Alcalde
state: Jalisco
city: Monterrey
country: Mexico
facility: Hospital Universitario Dr. Jose Eleuterio Gonzalez
state: Nuevo LEON
city: Culiacan
country: Mexico
facility: Hospital Angeles Culiacan
state: Sinaloa
city: Aguascalientes
country: Mexico
facility: Instituto Biomedico de Investigacion A. C.
city: Gdansk
country: Poland
facility: Indywidualna Specjalistyczna Praktyka Lekarska
city: Krakow
country: Poland
facility: Centrum Neurologii Klinicznej Sp. z o. o.
city: Lodz
country: Poland
facility: Gabinet Lekarski A. Klimek
city: Swidnik
country: Poland
facility: Niepubliczny Zaklad Opieki Zdrowotnej IGNIS dr med. Alicja Lobinska
city: San Juan
country: Puerto Rico
facility: Epilepsy Control Institute
city: Iasi
country: Romania
facility: Spitalul Clinic de Urgenta "Prof. Dr. Nicolae Oblu"
state: Jud. Iasi
city: Bucuresti
country: Romania
facility: Cabinet Medical Individual " Dr. Adina Maria Roceanu"
city: Barnaul
country: Russian Federation
facility: Municipal Healthcare Institution City Hospital #5, Neurology Department
city: Kazan
country: Russian Federation
facility: State Medical Institution Republican Clinical Hospital
city: Moscow
country: Russian Federation
facility: Central Clinical Hospital #2 N.A. Semashko OAO RZD / Department of Rehabilitation
city: Pyatigorsk
country: Russian Federation
facility: Pyatigorsk City Hospital #2, Neurology Department,
city: Saint-Petersburg
country: Russian Federation
facility: State Institution St. Petersburg Psychoneurological Research Institute V.M. Bekhterev of Roszdrav
city: Samara
country: Russian Federation
facility: Samara Regional Clinical Hospital M.I. Kalinin, Neurology and Neurosurgery Department
city: Belgrade
country: Serbia
facility: Institute for Mental Health
city: Singapore
country: Singapore
facility: National University Hospital
city: Singapore
country: Singapore
facility: Singapore General Hospital
city: Muang
country: Thailand
facility: Khon Kaen University, Faculty of Medicine, Neurology Unit, Department of Medicine
state: Khon Kaen
city: Bangkok
country: Thailand
facility: Neurology Division, Department of Medicine, Pramongkutklao College of Medicine
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: French J, Brandt C, Friedman D, Biton V, Knapp L, Pitman V, Chew M, Dubrava S, Posner HB. Adjunctive use of controlled-release pregabalin in adults with treatment-resistant partial seizures: a double-blind, randomized, placebo-controlled trial. Epilepsia. 2014 Aug;55(8):1220-8. doi: 10.1111/epi.12690. Epub 2014 Jun 24.