Trial record 1 of 1 for:
NCT00522275
Determine Safety and Efficacy of Long-term Oral Lacosamide in Patients With Partial Seizures
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT00522275 |
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Recruitment Status :
Completed
First Posted : August 29, 2007
Results First Posted : November 22, 2010
Last Update Posted : July 18, 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 of this trial is to determine whether lacosamide is safe and effective for long-term use in patients with partial-seizures from epilepsy
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Partial Epilepsies | Drug: lacosamide | Phase 3 |
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 : | 308 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | An Open-label Extension Trial to Determine Safety and Efficacy of Long-term Oral SPM 927 in Patients With Partial Seizures |
| Study Start Date : | October 2004 |
| Actual Primary Completion Date : | October 2009 |
| Actual Study Completion Date : | October 2009 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Pyridoxal 5'-phosphate-dependent epilepsy
Autosomal dominant partial epilepsy with auditory features
Drug Information available for:
Lacosamide
| Arm | Intervention/treatment |
|---|---|
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Experimental: Lacosamide
Up to 800 mg/day lacosamide (flexible dosing)
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Drug: lacosamide
50mg or 100 mg tablets, up to 800 mg/day given twice daily (BID) throughout the trial |
Primary Outcome Measures :
- Number of Subjects Reporting at Least 1 Treatment-Emergent Adverse Event (TEAE) During the Treatment Period (Maximum 6 Years) [ Time Frame: During the Treatment Period (Maximum 6 years) ]Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.
- Number of Subjects Prematurely Discontinuing Due to a Treatment-Emergent Adverse Event (TEAE) During the Treatment Period (Maximum 6 Years) [ Time Frame: During the Treatment Period (Maximum 6 years) ]Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.
- Number of Subjects Reporting at Least 1 Serious Adverse Event (SAE) During the Treatment Period (Maximum 6 Years) [ Time Frame: During the Treatment Period (Maximum 6 years) ]Serious adverse events are any untoward serious medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.
Secondary Outcome Measures :
- Median Percentage Change From Baseline in 28-day Seizure Frequency During the Treatment Period (Maximum 6 Years) [ Time Frame: Baseline (8-week Baseline Period from the parent study SP0754 [NCT00136019]), Treatment Period (Maximum 6 years) ]Negative changes from Baseline indicate an improvement (i.e., a reduction) in 28-day seizure frequency.
- Percentage of at Least 50 % Responders During the Treatment Period (Maximum 6 Years) [ Time Frame: Treatment Period (Maximum 6 years) ]At least 50 percent response is based on the percentage reduction in 28-day seizure frequency during the Treatment Period of the open-label extension relative to the Baseline Phase of the prior study.
Information from the National Library of Medicine
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| Ages Eligible for Study: | 16 Years to 70 Years (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Completion of parent clinical trial for treatment of partial seizures
Exclusion Criteria:
- Receiving any study drug or experimental device other than lacosamide
- Meets withdrawal criteria for parent trial or experiencing ongoing serious adverse event
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): NCT00522275
Locations
Show 60 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: | NCT00522275 |
| Other Study ID Numbers: |
SP0756 2014-004398-18 ( EudraCT Number ) |
| First Posted: | August 29, 2007 Key Record Dates |
| Results First Posted: | November 22, 2010 |
| Last Update Posted: | July 18, 2018 |
| Last Verified: | July 2017 |
Keywords provided by UCB Pharma ( UCB BIOSCIENCES, Inc. ):
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Adjunctive treatment in epilepsy add-on treatment for epilepsy partial seizures |
AEDs antiepileptic drugs seizures |
Additional relevant MeSH terms:
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Epilepsy Seizures Epilepsies, Partial 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 |