Monotherapy With Levetiracetam or Carbamazepine in Patients Suffering From Epilepsy.
This study has been completed.
Sponsor:
UCB, Inc.
Information provided by:
UCB, Inc.
ClinicalTrials.gov Identifier:
NCT00150787
First received: September 6, 2005
Last updated: September 14, 2009
Last verified: September 2009
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Purpose
A double-blind follow-up trial assessing the long term safety of Levetiracetam as per adverse events reporting, physical and neurological examination and vital signs
| Condition | Intervention | Phase |
|---|---|---|
|
Epilepsy, Tonic-Clonic |
Drug: LEVETIRACETAM |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double-Blind |
| Official Title: | A Multicenter, Double-blind, Follow-up Trial Evaluating the Long-term Safety of Levetiracetam (1000 to 3000 mg/Day Oral b.i.d.) and Carbamazepine (400 to 1200 mg/Day Oral b.i.d.), Used as Monotherapy in Subjects (≥ 16 Years) Coming From the N01061 Trial. |
Resource links provided by NLM:
Genetics Home Reference related topics:
pyridoxal 5'-phosphate-dependent epilepsy
MedlinePlus related topics:
Epilepsy
U.S. FDA Resources
Further study details as provided by UCB, Inc.:
Primary Outcome Measures:
- Around 2 years of Safety assessment of levetiracetam via Adverse Events reporting, physical and neurological examination and vital signs
| Estimated Enrollment: | 250 |
| Study Start Date: | July 2003 |
| Study Completion Date: | November 2005 |
| Primary Completion Date: | November 2005 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 16 Years and older |
| Genders Eligible for Study: | Both |
Criteria
Inclusion Criteria:
- Subjects with a confirmed diagnosis of epilepsy.
- Subjects having experienced in the past unprovoked partial seizures (IA, IB, IC with clear focal origin), or generalized tonic-clonic seizures (without clear focal origin), that are classifiable according to the International Classification of Epileptic Seizures
- Subjects coming from the N01061 monotherapy trial and for whom double-blind continuation of investigational product is beneficial.
Exclusion Criteria:
- Need for an additional AED.
Contacts and Locations More Information
Publications:
M. J. Brodie, E. Perucca, P. Ryvlin, E. Ben-Menachem, H.-J Meencke for the Levetiracetam Monotherapy Study Group Comparison of levetiracetam and controlled-release carbamazepine in newly diagnosed epilepsy Neurology, Feb 2007; 68: 402 - 408.
| ClinicalTrials.gov Identifier: | NCT00150787 History of Changes |
| Other Study ID Numbers: | N01093 |
| Study First Received: | September 6, 2005 |
| Last Updated: | September 14, 2009 |
| Health Authority: | Belgium: Directorate general for the protection of Public health: Medicines Czech Republic: State Institute for Drug Control Spain: Ministry of Health and Consumption Netherlands: Medicines Evaluation Board (MEB) Germany: Federal Institute for Drugs and Medical Devices Hungary: National Institute of Pharmacy United Kingdom: Medicines and Healthcare Products Regulatory Agency Finland: Finnish Medicines Agency South Africa: Medicines Control Council France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Italy: Ministry of Health Poland: Ministry of Health Sweden: Medical Products Agency |
Keywords provided by UCB, Inc.:
|
Monotherapy, epilepsy Levetiracetam Keppra |
Additional relevant MeSH terms:
|
Epilepsy Epilepsy, Tonic-Clonic Epilepsy, Generalized Brain Diseases Central Nervous System Diseases Nervous System Diseases Carbamazepine Etiracetam Piracetam Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents |
Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Anticonvulsants Antimanic Agents Tranquilizing Agents Central Nervous System Depressants Psychotropic Drugs Nootropic Agents Neuroprotective Agents Protective Agents |
ClinicalTrials.gov processed this record on May 19, 2013