Levetiracetam Versus Standard Antiepileptic Drugs (Carbamazepine and Valproate) Used as Monotherapy in Patients With Newly Diagnosed Epilepsy
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ClinicalTrials.gov Identifier: NCT00175903 |
Recruitment Status :
Completed
First Posted : September 15, 2005
Last Update Posted : March 17, 2015
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Epilepsy | Drug: Levetiracetam Drug: Carbamazepine Controlled Release (CBZ-CR) Drug: Valproate Extended Release | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 1701 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Therapeutic Confirmatory, Open-label, Multi-center, Randomized 2 Parallel Groups, Community-based Trial Studying the Efficacy and Safety of Levetiracetam (1000 to 3000 mg/Day Oral Tablets 250-500 mg b.i.d.) Compared to Sodium Valproate (1000 to 2000 mg/Day Oral ER Tablets 300-500 mg b.i.d.) and Carbamazepine (600 to 1600 mg/Day Oral CR Tablets 200-400 mg b.i.d.) as Monotherapy in Subjects With Newly Diagnosed Epilepsy. |
Study Start Date : | February 2005 |
Actual Primary Completion Date : | October 2007 |
Actual Study Completion Date : | October 2007 |

Arm | Intervention/treatment |
---|---|
Experimental: Levetiracetam
Daily dose of 1000 to 3000 mg film-coated oral tablets, 250-500 mg twice daily.
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Drug: Levetiracetam
Daily dose of 1000 to 3000 mg film-coated oral tablets, 250-500 mg twice daily. |
Active Comparator: Older Antepileptic Drugs
Older AEDs consist of CBZ-CR 200 mg and 400 mg and VPA-ER 300 mg and 500 mg.
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Drug: Carbamazepine Controlled Release (CBZ-CR)
Daily dose of 600-1600 mg CR oral tablets, 200 mg and 400 mg twice daily. Drug: Valproate Extended Release Daily dose of 1000-2000 mg ER oral tablets, 300 mg and 500 mg twice daily. |
- Time to withdrawal from study medication (starting at V1) as a measure of combined efficacy and safety [ Time Frame: Visit 1 to End of Study (approximately 52 weeks) ]
- The time to withdrawal comparing Levetiracetam versus the older Antiepileptic Drugs based on the subset of subjects whose best recommended treatment was Carbamazepine Controlled Release or Sodium Valproate Extended Release [ Time Frame: Visit 1 to End of Study (approximately 52 weeks) ]
- The retention rate after 6 months comparing Levetiracetam versus the older Antiepileptic Drugs [ Time Frame: Visit 1 to Visit 4 (approximately 26 weeks) ]
- The retention rate after 12 months comparing Levetiracetam versus the older Antiepileptic Drugs [ Time Frame: Visit 1 to Visit 5 (approximately 52 weeks) ]
- The retention rate after 6 months comparing Levetiracetam versus older Antiepileptic Drugs based on the subset of subjects whose best recommended treatment was Carbamazepine Controlled Release or Sodium Valproate Extended Release [ Time Frame: Visit 1 to Visit 4 (approximately 26 weeks) ]
- The retention rate after 12 months comparing Levetiracetam versus older Antiepileptic Drugs based on the subset of subjects whose best recommended treatment was Carbamazepine Controlled Release or Sodium Valproate Extended Release [ Time Frame: Visit 1 to Visit 5 (approximately 52 weeks) ]
- Seizure freedom at 6 months comparing Levetiracetam versus older Antiepileptic Drugs [ Time Frame: Visit 1 to Visit 4 (approximately 26 weeks) ]
- Seizure freedom at 12 months comparing Levetiracetam versus older Antiepileptic Drugs [ Time Frame: Visit 1 to Visit 5 (approximately 52 weeks) ]
- Seizure freedom at 6 months comparing Levetiracetam versus older Antiepileptic Drugs based on based on the subset of subjects whose best recommended treatment was Carbamazepine Controlled Release or Sodium Valproate Extended Release [ Time Frame: Visit 1 to Visit 4 (approximately 26 weeks) ]
- Seizure freedom at 12 months comparing Levetiracetam versus older Antiepileptic Drugs based on based on the subset of subjects whose best recommended treatment was Carbamazepine Controlled Release or Sodium Valproate Extended Release [ Time Frame: Visit 1 to Visit 5 (approximately 52 weeks) ]
- Time to first seizure comparing Levetiracetam versus older Antiepileptic Drugs [ Time Frame: Visit 1 to End of Study (approximately 52 weeks) ]
- Time to first seizure comparing Levetiracetam versus older Antiepileptic Drugs based on the subset of subjects whose best recommended treatment was Carbamazepine Controlled Release or Sodium Valproate Extended Release [ Time Frame: Visit 1 to End of Study (approximately 52 weeks) ]

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Ages Eligible for Study: | 16 Years and older (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Diagnosis of epilepsy (all types of seizures) was made during the past year
- Subjects must have had at least two unprovoked seizures in the past 2 years with at least one during the last 6 months
- Female subjects without childbearing potential are eligible. Female subjects with childbearing potential are eligible if they use a medically accepted contraceptive method
Exclusion Criteria:
- Subjects previously allocated to a trial treatment (CBZ, VPA and LEV) used in this trial
- Participation in another clinical trial with an investigational drug or device within 12 weeks of the selection visit (V1), or at any time during this trial
- Pregnant or lactating women
- Presence of known pseudoseizures within the last year
- Uncountable seizures (clusters) or history of convulsive status epilepticus
- Any disorder or condition that may interfere with the absorption, distribution, metabolisation or excretion of drugs
- History of suicide attempt, current suicidal ideation, or other serious psychiatric disorders requiring or having required hospitalization or medication within the previous five years
- Presence of progressive cerebral disease, any other progressively degenerative neurological disease, or any cerebral tumors
- Presence of a terminal illness or any medical condition that might interfere with the subject's trial participation

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00175903

Study Director: | UCB Clinical Trial Call Center | UCB Pharma |
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | UCB Pharma |
ClinicalTrials.gov Identifier: | NCT00175903 History of Changes |
Other Study ID Numbers: |
N01175 2004-001339-41 ( EudraCT Number ) |
First Posted: | September 15, 2005 Key Record Dates |
Last Update Posted: | March 17, 2015 |
Last Verified: | March 2015 |
Newly Diagnosed Epilepsy Levetiracetam Keppra Carbamazepine Valproate |
Carbamazepine Cytochrome P-450 CYP3A Inducers Cytochrome P-450 Enzyme Inducers Epilepsy Brain Diseases Central Nervous System Diseases Nervous System Diseases Levetiracetam Valproic Acid Anticonvulsants Nootropic Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
GABA Agents Neurotransmitter Agents Physiological Effects of Drugs Antimanic Agents Tranquilizing Agents Central Nervous System Depressants Psychotropic Drugs Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Sodium Channel Blockers Membrane Transport Modulators |