Trial record 1 of 1 for:
NCT02408549
Safety and Efficacy of Lacosamide as Additional Therapy in Patients Suffering From Epileptic Tonic Clonic Seizures (VALUE)
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| ClinicalTrials.gov Identifier: NCT02408549 |
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Recruitment Status :
Active, not recruiting
First Posted : April 3, 2015
Last Update Posted : December 20, 2019
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Sponsor:
UCB BIOSCIENCES, Inc.
Information provided by (Responsible Party):
UCB Pharma ( UCB BIOSCIENCES, Inc. )
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Brief Summary:
Assessment of long-term safety and efficacy of oral lacosamide (LCM) as an adjunctive therapy for uncontrolled primary generalized tonic-clonic (PGTC) seizures in subjects >= 4 years of age with idiopathic generalized epilepsy (IGE). This study will enroll subjects from the LCM SP0982 (NCT02408523) study.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Epilepsy | Drug: Lacosamide Tablet Drug: Lasosamide Oral Solution | 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 : | 239 participants |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | An Open-label, Multicenter Extension Study to Evaluate the Long-term Safety and Efficacy of Lacosamide as Adjunctive Therapy for Uncontrolled Primary Generalized Tonic Clonic Seizures in Subjects With Idiopathic Generalized Epilepsy |
| Actual Study Start Date : | August 2015 |
| Estimated Primary Completion Date : | December 2023 |
| Estimated Study Completion Date : | February 2024 |
Resource links provided by the National Library of Medicine
Genetics Home Reference related topics:
Pyridoxal 5'-phosphate-dependent epilepsy
Drug Information available for:
Lacosamide
| Arm | Intervention/treatment |
|---|---|
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Experimental: Lacosamide
Start dose SP982 completers at V1:
SP982 Baseline failures at V1:
Oral solution (pediatric subjects <50 kg):
Tablets (pediatric subjects ≥50kg):
Tablets (adult subjects):
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Drug: Lacosamide Tablet
Other Name: Vimpat Drug: Lasosamide Oral Solution
Other Name: Vimpat |
Primary Outcome Measures :
- Number of subjects experiencing at least one Adverse Event (AE) during the study (up to 5 years) [ Time Frame: During the study (up to 5 years) ]Adverse Events will be reported spontaneously by the subject and/or caregiver or observed by the investigator.
- Number of subjects withdrawing due to Adverse Events (AEs) during the study (up to 5 years) [ Time Frame: During the study (up to 5 years) ]Adverse Events will be reported spontaneously by the subject and/or caregiver or observed by the investigator.
- Incidence of new seizure types during the Treatment Period [ Time Frame: During the Treatment Period (up to 5 years) ]
- Number of subjects with an increase of up to 25% in days with absence seizures per 28 days during the Treatment Period as compared to the Prospective Baseline (of study SP0982) [ Time Frame: From Visit 1 to End of Treatment Period (up to 5 years) ]
- Number of subjects with an increase of >25% to 50% in days with absence seizures per 28 days during the Treatment Period as compared to the Prospective Baseline (of study SP0982) [ Time Frame: From Visit 1 to End of Treatment Period (up to 5 years) ]
- Number of subjects with an increase of >50% to 75% in days with absence seizures per 28 days during the Treatment Period as compared to the Prospective Baseline (of study SP0982) [ Time Frame: From Visit 1 to End of Treatment Period (up to 5 years) ]
- Number of subjects with an increase of >75% in days with absence seizures per 28 days during the Treatment Period as compared to the Prospective Baseline (of study SP0982) [ Time Frame: From Visit 1 to End of Treatment Period (up to 5 years) ]
- Number of subjects with an increase of up to 25% in days with myoclonic seizures per 28 days during the Treatment Period as compared to the Prospective Baseline (of study SP0982) [ Time Frame: From Visit 1 to End of Treatment Period (up to 5 years) ]
- Number of subjects with an increase of >25% to 50% in days with myoclonic seizures per 28 days during the Treatment Period as compared to the Prospective Baseline (of study SP0982) [ Time Frame: From Visit 1 to End of Treatment Period (up to 5 years) ]
- Number of subjects with an increase of >50% to 75% in days with myoclonic seizures per 28 days during the Treatment Period as compared to the Prospective Baseline (of study SP0982) [ Time Frame: From Visit 1 to End of Treatment Period (up to 5 years) ]
- Number of subjects with an increase of >75% in days with myoclonic seizures per 28 days during the Treatment Period as compared to the Prospective Baseline (of study SP0982) [ Time Frame: From Visit 1 to End of Treatment Period (up to 5 years) ]
Secondary Outcome Measures :
- Percent change in Primary Generalized Tonic-clonic (PGTC) seizure frequency per 28 days from Combined Baseline [ Time Frame: From Combined Baseline until Termination Visit (up to 5 years) ]Percent change in PGTC seizure frequency per 28 days from Combined Baseline, where Combined Baseline is defined as the combined 12-week Historical Baseline and 4-week Prospective Baseline periods immediately prior to randomization in the parent study (SP0982).
- Percentage of treatment-emergent marked abnormalities in hematology parameters [ Time Frame: During the study (up to 5 years) ]
- Percentage of treatment-emergent marked abnormalities in chemistry parameters [ Time Frame: During the study (up to 5 years) ]
- Percentage of treatment-emergent marked abnormalities in 12-lead electrocardiogram (ECGs) [ Time Frame: During the study (up to 5 years) ]
- Percentage of treatment-emergent marked abnormalities in vital sign measurements [ Time Frame: During the study (up to 5 years) ]
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| Ages Eligible for Study: | 4 Years and older (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
-Subject must have completed or be an eligible Baseline failure from the parent study (SP0982). Note: Other subjects screened for SP0982 may be considered for roll-over to EP0012 if the investigator considers that the subject could benefit from treatment with open-label lacosamide (LCM) and based on prior discussion with and approval from the UCB Study Physician or representative.
Exclusion Criteria:
- Subject is receiving any investigational drugs or using any experimental devices in addition to Lacosamide (LCM)
- Subject meets the withdrawal criteria for SP0982 or is experiencing an ongoing serious adverse event (SAE)
- Subject has an active suicidal ideation as indicated by a positive response ("Yes") to either Question 4 or Question 5 of the "Since Last Visit" version of the Columbia-Suicide Severity Rating Scale (C-SSRS)
- Subject has >=2x upper limit of normal (ULN) of any of the following: alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), or >ULN total bilirubin (≥1.5xULN total bilirubin if known Gilbert's syndrome). If subject has elevations only in total bilirubin that are >ULN and <1.5xULN, fractionate bilirubin to identify possible undiagnosed Gilbert's syndrome (ie, direct bilirubin <35%).
For randomized subjects with a Baseline result >ULN for ALT, AST, ALP, or total bilirubin, a Baseline diagnosis and/or the cause of any clinically meaningful elevation must be understood and recorded in the Case Report form (CRF).
If subject has >ULN ALT, AST, or ALP that does not meet the exclusion limit at screening, repeat the tests, if possible, prior to dosing to ensure there is no further ongoing clinically relevant increase. In case of a clinically relevant increase, inclusion of the subject must be discussed with the Medical Monitor. Tests that result in ALT, AST, or ALP up to 25% above the exclusion limit may be repeated once for confirmation. This includes re-screening.
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): NCT02408549
Locations
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Sponsors and Collaborators
UCB BIOSCIENCES, Inc.
Investigators
| Study Director: | UCB Cares | +18445992273 (UCB) |
| Responsible Party: | UCB BIOSCIENCES, Inc. |
| ClinicalTrials.gov Identifier: | NCT02408549 |
| Other Study ID Numbers: |
EP0012 2012-001770-29 ( EudraCT Number ) |
| First Posted: | April 3, 2015 Key Record Dates |
| Last Update Posted: | December 20, 2019 |
| Last Verified: | December 2019 |
Keywords provided by UCB Pharma ( UCB BIOSCIENCES, Inc. ):
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Lacosamide Vimpat Epilepsy Children |
Primary Generalized Tonic Clonic seizures Idiopathic Generalized Epilepsy Adults |
Additional relevant MeSH terms:
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Epilepsy Seizures Brain Diseases Central Nervous System Diseases Nervous System Diseases Neurologic Manifestations Signs and Symptoms |
Lacosamide Anticonvulsants Voltage-Gated Sodium Channel Blockers Sodium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action |