Pregabalin Versus Levetiracetam In Partial Seizures

Partial Seizures Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00537238
• Other study ID #: A0081157
• Status: Completed
• Phase: Phase 3
• Start date: October 2007
• Est. completion date: May 2012

Study information

• Verified date: May 2013
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 509
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Partial Seizures
• Seizures

Intervention

Drug:
• pregabalin
300, 450, 600 mg/day administered orally, BID until seizure control/improvement or intolerable side effects
• levetiracetam
1000, 2000, 3000 mg/day administered orally, BID until seizure control/improvement or intolerable side effects

Locations

Country	Name	City	State
Belgium	Pfizer Investigational Site	Duffel
Belgium	Pfizer Investigational Site	Yvoir
Bulgaria	Pfizer Investigational Site	Kyustendil 2500
Bulgaria	Pfizer Investigational Site	Pernik
Bulgaria	Pfizer Investigational Site	Plovdiv
Bulgaria	Pfizer Investigational Site	Ruse 7002
Bulgaria	Pfizer Investigational Site	Sofia
Bulgaria	Pfizer Investigational Site	Sofia
Colombia	Pfizer Investigational Site	Barranquilla	Atlantico
Colombia	Pfizer Investigational Site	Bogota	Cundinamarca
Costa Rica	Pfizer Investigational Site	Montes De Oca	San Jose
Costa Rica	Pfizer Investigational Site	San Jose
Czechia	Pfizer Investigational Site	Brno
Czechia	Pfizer Investigational Site	Brno 2
Czechia	Pfizer Investigational Site	Hradec Kralove 3
Czechia	Pfizer Investigational Site	Olomouc
Czechia	Pfizer Investigational Site	Ostrava-Trebovice
Czechia	Pfizer Investigational Site	Praha 4
Czechia	Pfizer Investigational Site	Pribram 8
Czechia	Pfizer Investigational Site	Rychnov nad Kneznou
France	Pfizer Investigational Site	Strasbourg Cedex
France	Pfizer Investigational Site	Toulouse
Germany	Pfizer Investigational Site	Bonn
Germany	Pfizer Investigational Site	Hamburg
Greece	Pfizer Investigational Site	Athens
Greece	Pfizer Investigational Site	Thessaloniki
India	Pfizer Investigational Site	Chandigarh	Punjab
India	Pfizer Investigational Site	Ludhiana	Punjab
India	Pfizer Investigational Site	Pune	Maharashtra
Italy	Pfizer Investigational Site	Firenze
Italy	Pfizer Investigational Site	Foggia
Italy	Pfizer Investigational Site	Pisa
Italy	Pfizer Investigational Site	Siena
Korea, Republic of	Pfizer Investigational Site	Busan
Korea, Republic of	Pfizer Investigational Site	Daejeon
Korea, Republic of	Pfizer Investigational Site	Seoul
Korea, Republic of	Pfizer Investigational Site	Seoul
Korea, Republic of	Pfizer Investigational Site	Seoul
Korea, Republic of	Pfizer Investigational Site	Seoul
Korea, Republic of	Pfizer Investigational Site	Seoul
Lithuania	Pfizer Investigational Site	Kaunas
Lithuania	Pfizer Investigational Site	Vilnius
Mexico	Pfizer Investigational Site	Distrito Federal
Mexico	Pfizer Investigational Site	San Luis Potosi
Panama	Pfizer Investigational Site	Panama
Peru	Pfizer Investigational Site	Lima
Peru	Pfizer Investigational Site	Lima
Philippines	Pfizer Investigational Site	Cebu City
Philippines	Pfizer Investigational Site	Davao City
Philippines	Pfizer Investigational Site	Makati City
Philippines	Pfizer Investigational Site	Manila
Philippines	Pfizer Investigational Site	Quezon City
Philippines	Pfizer Investigational Site	Tondo	Manila
Russian Federation	Pfizer Investigational Site	Moscow
Russian Federation	Pfizer Investigational Site	Moscow
Russian Federation	Pfizer Investigational Site	Moscow
Russian Federation	Pfizer Investigational Site	St. Petersburg
Russian Federation	Pfizer Investigational Site	St. Petersburg
Russian Federation	Pfizer Investigational Site	St. Petersburg
Spain	Pfizer Investigational Site	Alicante
Spain	Pfizer Investigational Site	Barcelona
Spain	Pfizer Investigational Site	Cordoba
Spain	Pfizer Investigational Site	Donostia	Guipuzcoa
Spain	Pfizer Investigational Site	Girona
Spain	Pfizer Investigational Site	Sevilla
Taiwan	Pfizer Investigational Site	Kaohsiung
Taiwan	Pfizer Investigational Site	Taichung
Taiwan	Pfizer Investigational Site	Tainan
Turkey	Pfizer Investigational Site	Ankara
Turkey	Pfizer Investigational Site	Capa	Istanbul
Turkey	Pfizer Investigational Site	Cerrahpasa / Istanbul
Venezuela	Pfizer Investigational Site	Caracas	Libertador
Venezuela	Pfizer Investigational Site	Caracas	Miranda

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Countries where clinical trial is conducted

Belgium,  Bulgaria,  Colombia,  Costa Rica,  Czechia,  France,  Germany,  Greece,  India,  Italy,  Korea, Republic of,  Lithuania,  Mexico,  Panama,  Peru,  Philippines,  Russian Federation,  Spain,  Taiwan,  Turkey,  Venezuela, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of Participants With Response to Treatment	Participants who had at least 50% reduction in 28-day seizure rate from baseline to the end of the maintenance phase were considered as responders. The 28-day seizure rate was calculated as number of partial seizures in the period divided by difference of number of days in the period and number of missing diary day entries in the period, multiplied by 28.	Baseline up to Week 16
Secondary	Percent Change From Baseline in 28 Day Seizure Frequency at Week 16	The seizures were recorded by the participants, by a family member, by a caregiver, or by a legal guardian and documented in a daily seizure diary. Participant's 28-day seizure frequency of all partial seizure was assessed during double blind (TP + MP) phase compared with baseline.	Baseline, Week 16
Secondary	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	Change was calculated as (proportion of SGTC seizure rate divided by all partial seizure rates during double blind phase) minus (proportion of SGTC seizure rate divided by all partial seizure rates at baseline). Negative values indicated reductions in seizures.	Baseline, Week 16
Secondary	Percentage of Participants Without Seizures	Seizure free for 28 days was defined as participants who have not experienced any seizure (simple partial, complex partial and SGTC) for at least 28 consecutive days from their last seizure until the end of the maintenance phase. Same participant could be seizure free for a specific type of seizure but not necessarily for the other types of seizure.	Baseline up to Week 16
Secondary	Change From Baseline in Brief Psychiatric Rating Scale - Anchored (BPRS-A) Total and Core Score at Week 7, 10, 13, 16 and Follow-up	BPRS-A:18-item clinician rated scale assesses somatic concern,anxiety, emotional withdrawal,conceptual disorganization,hallucinatory behavior(HB), guilt feelings,suspiciousness,disorientation,tension,mannerisms and posturing,grandiosity,depressive mood,hostility,motor retardation,uncooperativeness,unusual thought content,blunted affect,excitement. Items rated on 7-point scale 1 (not reported) to 7 (very severe). Total score=sum of items(range 18-126), core score=sum of conceptual disorganization, suspiciousness, HB, unusual thought content(range 4-28). Higher total/core score=more impairment.	Baseline, Week 7, 10, 13, 16 and Follow-up (Day 7 of taper phase)
Secondary	Hospital Anxiety and Depression Scale (HADS) Score	HADS: participant rated questionnaire with 2 subscales. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale comprised of 7 items with range 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score 0 to 21 for each subscale; higher score indicates greater severity of anxiety and depression symptoms.	Baseline, Week 16
Secondary	Medical Outcomes Study Sleep Scale (MOS-SS) Score	Participant-rated 12-item questionnaire to assess constructs of sleep over past week; 7 subscales:sleep disturbance,snoring,awakened short of breath,sleep adequacy,somnolence (range:0-100);sleep quantity (range:0-24),optimal sleep(yes/no), and 9 item index measures of sleep disturbance provide composite scores:sleep problem summary,overall sleep problem. Except adequacy,optimal sleep and quantity, higher scores=more impairment. Scores transformed (actual raw score[RS] minus lowest possible score divided by possible RS range*100);total score range:0-100;higher score=more intensity of attribute.	Baseline, Week 16
Secondary	Percentage of Participants With Optimal Sleep Assessed Using Medical Outcomes Study-Sleep Scale (MOS-SS) Score	MOS-SS: participant-rated 12 item questionnaire to assess constructs of sleep over past week. It included 7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence, sleep quantity and optimal sleep. Participants responded whether their sleep was optimal or not by choosing yes or no. Percentage of participants with optimal sleep are reported.	Baseline, Week 16

External Links

•   To obtain contact information for a study center near you, click here.