Pregabalin Versus Levetiracetam In Partial Seizures

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00537238
First received: September 27, 2007
Last updated: May 21, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention Phase
Partial Seizures
Drug: pregabalin
Drug: levetiracetam
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Proportion of Participants With Response to Treatment [ Time Frame: Baseline up to Week 16 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Percent Change From Baseline in 28 Day Seizure Frequency at Week 16 [ Time Frame: Baseline, Week 16 ] [ Designated as safety issue: No ]
    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.

  • 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 [ Time Frame: Baseline, Week 16 ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants Without Seizures [ Time Frame: Baseline up to Week 16 ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in Brief Psychiatric Rating Scale - Anchored (BPRS-A) Total and Core Score at Week 7, 10, 13, 16 and Follow-up [ Time Frame: Baseline, Week 7, 10, 13, 16 and Follow-up (Day 7 of taper phase) ] [ Designated as safety issue: No ]
    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.

  • Hospital Anxiety and Depression Scale (HADS) Score [ Time Frame: Baseline, Week 16 ] [ Designated as safety issue: No ]
    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.

  • Medical Outcomes Study Sleep Scale (MOS-SS) Score [ Time Frame: Baseline, Week 16 ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants With Optimal Sleep Assessed Using Medical Outcomes Study-Sleep Scale (MOS-SS) Score [ Time Frame: Baseline, Week 16 ] [ Designated as safety issue: No ]
    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.


Enrollment: 509
Study Start Date: October 2007
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: B Drug: pregabalin
300, 450, 600 mg/day administered orally, BID until seizure control/improvement or intolerable side effects
Active Comparator: A Drug: levetiracetam
1000, 2000, 3000 mg/day administered orally, BID until seizure control/improvement or intolerable side effects

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00537238

  Show 73 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00537238     History of Changes
Other Study ID Numbers: A0081157
Study First Received: September 27, 2007
Results First Received: May 21, 2013
Last Updated: May 21, 2013
Health Authority: Spain: Agencia Española del Medicamento y Productos Sanitarios

Keywords provided by Pfizer:
Epilepsies partial
Partial Seizure Disorder
Complex Partial Seizure Disorder
Epilepsy

Additional relevant MeSH terms:
Seizures
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Etiracetam
Pregabalin
Piracetam
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Nootropic Agents
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on July 20, 2014