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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
Sponsor:
Information provided by (Responsible Party):
UCB Pharma

Brief Summary:
Study N01175 was to compare overall effectiveness (efficacy and safety) of levetiracetam (LEV) versus the 2 older antiepileptic drugs (AEDs), sodium valproate extended release (VPA-ER) and carbamazepine controlled release (CBZ-CR) in the treatment of subjects with newly diagnosed epilepsy.

Condition or disease Intervention/treatment Phase
Epilepsy Drug: Levetiracetam Drug: Carbamazepine Controlled Release (CBZ-CR) Drug: Valproate Extended Release Phase 3

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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.
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.
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.




Primary Outcome Measures :
  1. 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) ]

Secondary Outcome Measures :
  1. 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) ]
  2. The retention rate after 6 months comparing Levetiracetam versus the older Antiepileptic Drugs [ Time Frame: Visit 1 to Visit 4 (approximately 26 weeks) ]
  3. The retention rate after 12 months comparing Levetiracetam versus the older Antiepileptic Drugs [ Time Frame: Visit 1 to Visit 5 (approximately 52 weeks) ]
  4. 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) ]
  5. 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) ]
  6. Seizure freedom at 6 months comparing Levetiracetam versus older Antiepileptic Drugs [ Time Frame: Visit 1 to Visit 4 (approximately 26 weeks) ]
  7. Seizure freedom at 12 months comparing Levetiracetam versus older Antiepileptic Drugs [ Time Frame: Visit 1 to Visit 5 (approximately 52 weeks) ]
  8. 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) ]
  9. 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) ]
  10. Time to first seizure comparing Levetiracetam versus older Antiepileptic Drugs [ Time Frame: Visit 1 to End of Study (approximately 52 weeks) ]
  11. 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
Criteria

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

Information from the National Library of Medicine

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


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Locations
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Australia
Adelaide, Australia
Bedford Park, Australia
Brisbane, Australia
Cairns, Australia
Camperdown, Australia
Chatswood, Australia
Clayton, Australia
Maroochydore, Australia
Parkville, Australia
Perth, Australia
Randwick, Australia
West Heidelberg, Australia
Austria
Graz, Austria
Innsbrick, Austria
Klagenfurt, Austria
Linz, Austria
Steyr, Austria
Vienna, Austria
Belgium
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Dendermonde, Belgium
Edegem, Belgium
Gent, Belgium
Haine St Paul, Belgium
Jette, Belgium
Kortrijk, Belgium
Leuven, Belgium
Oostende, Belgium
Ottignies, Belgium
Bulgaria
Plovdiv, Bulgaria
Sofia, Bulgaria
Varna, Bulgaria
Czech Republic
Litomysl, Czech Republic
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Zlin, Czech Republic
Denmark
Aalborg, Denmark
Copenhagen, Denmark
Holbaek, Denmark
Holstebro, Denmark
Finland
Hus (Helsinki), Finland
Kuopio, Finland
Tampere, Finland
France
Blaye, France
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Brest, France
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Dijon, France
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Hungary
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Ireland
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Vittoria, Italy
Netherlands
Eindhoven, Netherlands
Heerenvegen, Netherlands
Leeuwarden, Netherlands
Maastricht, Netherlands
Nijmegen, Netherlands
Tilburg, Netherlands
Norway
Drammen, Norway
Fredrikstad, Norway
Lillehammer, Norway
Molde, Norway
Nordbyhagen, Norway
Sandvika, Norway
Stavanger, Norway
Tonsberg, Norway
Tromso, Norway
Trondheim, Norway
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Gdansk, Poland
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Romania
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Craiova, Romania
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Bratislava, Slovakia
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Dubnica Nad Vahom, Slovakia
Martin, Slovakia
Zilina, Slovakia
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Badalona, Spain
Barakaldo Vizcaya, Spain
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Vigo, Spain
Sweden
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Linkoping, Sweden
Motala, Sweden
Stockholm, Sweden
Varberg, Sweden
Switzerland
Bern, Switzerland
Biel, Switzerland
Geneve, Switzerland
Lausanne, Switzerland
St. Gallen, Switzerland
Zurich, Switzerland
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Adana, Turkey
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Ashford, United Kingdom
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Stoke on Trent, United Kingdom
Sunderland, United Kingdom
Swindon, United Kingdom
Truro, United Kingdom
Sponsors and Collaborators
UCB Pharma
Investigators
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Study Director: UCB Clinical Trial Call Center UCB Pharma

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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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
Keywords provided by UCB Pharma:
Newly Diagnosed Epilepsy
Levetiracetam
Keppra
Carbamazepine
Valproate
Additional relevant MeSH terms:
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Carbamazepine
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
Cytochrome P-450 CYP3A Inducers
Cytochrome P-450 Enzyme Inducers