Trial record 1 of 1 for:
NCT01118962
Open-Label Extension Study to Assess the Safety and Seizure Frequency Associated With Lacosamide for Primary Generalized Tonic-Clonic Seizures in Subjects With Epilepsy
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| ClinicalTrials.gov Identifier: NCT01118962 |
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Recruitment Status :
Completed
First Posted : May 7, 2010
Results First Posted : December 4, 2013
Last Update Posted : July 17, 2018
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Sponsor:
UCB BIOSCIENCES, Inc.
Information provided by (Responsible Party):
UCB Pharma ( UCB BIOSCIENCES, Inc. )
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Brief Summary:
The purpose is to obtain data on the safety and seizure frequency associated with long-term oral Lacosamide for uncontrolled primary generalized tonic-clonic (PGTC) seizures in subjects with idiopathic generalized Epilepsy. Additionally, to allow subjects who have completed SP0961 (NCT01118949) to continue to receive Lacosamide.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Epilepsy | Drug: Lacosamide | Phase 2 |
Expanded Access : An investigational treatment associated with this study is no longer available outside the clinical trial. More info ...
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 39 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | An Open-Label Extension Study to Assess the Safety and Seizure Frequency Associated With Long-Term Oral Lacosamide for Uncontrolled Primary Generalized Tonic-Clonic Seizures in Subjects With Idiopathic Generalized Epilepsy |
| Study Start Date : | August 2010 |
| Actual Primary Completion Date : | October 2012 |
| Actual Study Completion Date : | October 2012 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Pyridoxal 5'-phosphate-dependent epilepsy
Drug Information available for:
Lacosamide
| Arm | Intervention/treatment |
|---|---|
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Experimental: Lacosamide
Lacosamide was supplied as 50 mg and 100 mg tablets. The starting Lacosamide dose was the same dose reached by a subject at the end of SP0961 (NCT01118949). Lacosamide was administered twice daily (approx. 12 hours apart, once in the morning and once in the evening) in 2 equally divided doses. |
Drug: Lacosamide
Lacosamide was supplied as 50 mg and 100 mg tablets. The starting Lacosamide dose was the same dose reached by a subject at the end of SP0961 (NCT01118949). At the beginning of SP0962, the dose may be maintained, or increased or decreased by 100 mg /day, as deemed clinically appropriate to optimize tolerability and seizure reduction. Dose increases should be no faster than 100 mg/ day per week up to a maximum of 800 mg/ day. Lacosamide was administered twice daily (approx. 12 hours apart, once in the morning and once in the evening) in 2 equally divided doses for up to a 56-week Treatment Phase. The Treatment Phase was followed by a 5-week End-of-Study Phase, during which subjects had to be tapered off Lacosamide at a recommended decrease rate of 200 mg/ day per week.
Other Name: Vimpat® |
Primary Outcome Measures :
- Number of Participants With Treatment-emergent Adverse Events (TEAEs) From Visit 1 to the End of Study (Approximately 61 Weeks) [ Time Frame: From Visit 1 to the end of study (Approximately 61 weeks) ]
- Number of Participants Withdrawn From the Study Due to Treatment-emergent Adverse Events (TEAEs) From Visit 1 to the End of Study (Approximately 61 Weeks) [ Time Frame: From Visit 1 to the end of study (Approximately 61 weeks) ]
Information from the National Library of Medicine
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| Ages Eligible for Study: | 16 Years to 65 Years (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Subject completed the SP0961 (NCT01118949) study
- Subject is expected to benefit from participation in an open-label extension study with Lacosamide, in the opinion of the investigator
Exclusion Criteria:
- Subject meets the withdrawal criteria for SP0961 (NCT01118949) or is experiencing an ongoing Serious Adverse Event (SAE)
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): NCT01118962
Locations
Show 19 study locations
Sponsors and Collaborators
UCB BIOSCIENCES, Inc.
Investigators
| Study Director: | UCB Clinical Trial Call Center | +1 877 822 9493 (UCB) |
Additional Information:
Publications of Results:
Publications of Results:
| Responsible Party: | UCB BIOSCIENCES, Inc. |
| ClinicalTrials.gov Identifier: | NCT01118962 |
| Other Study ID Numbers: |
SP0962 2014-004375-23 ( EudraCT Number ) |
| First Posted: | May 7, 2010 Key Record Dates |
| Results First Posted: | December 4, 2013 |
| Last Update Posted: | July 17, 2018 |
| Last Verified: | March 2018 |
Keywords provided by UCB Pharma ( UCB BIOSCIENCES, Inc. ):
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Primary Generalized Tonic-Clonic (PGTC) Seizures Absence Seizures Myoclonic Seizures Idiopathic Generalized Epilepsy (IGE) |
Additional relevant MeSH terms:
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Epilepsy Seizures Brain Diseases Central Nervous System Diseases Nervous System Diseases Neurologic Manifestations |
Lacosamide Anticonvulsants Voltage-Gated Sodium Channel Blockers Sodium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action |