CompletedPhase 3

Safety and Efficacy of Lacosamide as Additional Therapy in Patients Suffering From Epileptic Tonic-Clonic Seizures

United States239 participantsStarted 2015-08-03

Plain-language summary

Assessment of long-term safety and efficacy of oral lacosamide (LCM) as an adjunctive therapy for uncontrolled primary generalized tonic-clonic seizures (PGTCS) in subjects \>= 4 years of age with idiopathic generalized epilepsy (IGE). This study will enroll subjects from the LCM SP0982 \[NCT02408523\] study.

Who can participate

Age range4 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: \- Subject must have completed or be an eligible Baseline failure from the parent study (SP0982 \[NCT02408523\]). 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 all subjects who entered EP0012 directly with a Baseline result \>ULN for ALT, AST, ALP, or total bilirubin, a Baseline diagnosis and/or the cause of any clinically meaningful elevation …

What they're measuring

Number of Study Participants With Treatment-emergent Adverse Events (TEAEs) Over the Duration of the Treatment Period

Timeframe: From Visit 1 (Week 0) to End of Treatment Period (up to approximately 5 years)

Number of Study Participants Withdrawn Due to TEAEs

Timeframe: From Visit 1 (Week 0) to End of Treatment Period (up to approximately 5 years)

Number of Study Participants With New Appearance of Absence and/or Myoclonic Seizures During the Treatment Period

Timeframe: From Visit 1 (Week 0) to End of Treatment Period (up to approximately 5 years)

Number of Study Participants 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)

Timeframe: From Visit 1 (Week 0) to End of Treatment Period (up to approximately 5 years), compared to the Prospective SP0982 Baseline Period

Number of Study Participants With an Increase of Greater Than (>)25% to 50% in Days With Absence Seizures Per 28 Days During the Treatment Period as Compared to the Prospective Baseline (of Study SP0982)

Timeframe: From Visit 1 (Week 0) to End of Treatment Period (up to approximately 5 years), compared to the Prospective SP0982 Baseline Period

Number of Study Participants 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)

Trial details

NCT IDNCT02408549

SponsorUCB BIOSCIENCES, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-03-30

Results submitted2023-09-28

View on ClinicalTrials.gov More Epilepsy trials

Plain-language summary

Who can participate

Age range4 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Number of Study Participants With Treatment-emergent Adverse Events (TEAEs) Over the Duration of the Treatment Period

Timeframe: From Visit 1 (Week 0) to End of Treatment Period (up to approximately 5 years)

Number of Study Participants Withdrawn Due to TEAEs

Timeframe: From Visit 1 (Week 0) to End of Treatment Period (up to approximately 5 years)

Number of Study Participants With New Appearance of Absence and/or Myoclonic Seizures During the Treatment Period

Timeframe: From Visit 1 (Week 0) to End of Treatment Period (up to approximately 5 years)

Number of Study Participants 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)

Timeframe: From Visit 1 (Week 0) to End of Treatment Period (up to approximately 5 years), compared to the Prospective SP0982 Baseline Period

Number of Study Participants 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)