Lamotrigine monotherapy in newly diagnosed epilepsy or recurrent epilepsy:A multi-center, open-label study

Yamamoto, Takamichi; Hong, Seung Bong; Shimizu, Masahiro; Sato, Katsuaki; Numachi, Yotaro

doi:10.3805/eands.7.55

Cited by 5 publications

(9 citation statements)

References 7 publications

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“…In meta-analyses, the rate of rash was 8-11% including various conditions [13][14][15], and increased from 6.0% to 12.2% with concomitant use of VPA compared with LTG monotherapy [13]. As shown in Figure 3, skin rash occurred at the very beginning of the LTG escalation phase (within 10 days on average, range: 2-26 days) at an LTG dose of either 25 mg every other day (n = 6) or 25 mg daily (n = 2), which was comparable to previous studies [12,13]. Importantly, although skin rash occurred in some patients in this study, the impact on each individual patient was minimal.…”

Section: Safety Analysessupporting

confidence: 74%

“…Previous metaanalyses have reported several risk factors for skin rash [12][13][14][15], but we did not find any The QOLIE-31-P [10] and QOLIE-AD-48 [11] were used for patients aged ≥18 (A) and <18 (B), respectively. Only 20 patients who completed the entire study period were included.…”

Section: Discussioncontrasting

confidence: 44%

“…All these adverse events have been reported previously [12,13], and included skin rash (drug eruption or rash) in 8 patients (24.2%), somnolence in 4 patients (12.1%), and dizziness in 2 patients (6.1%). The rates of somnolence and dizziness were lower than those in the prescribing information in Japan (18.5% and 15.2%), while rash occurred at a rate higher than that reported in a recent adult phase III monotherapy study conducted both in Japan and Korea (10 of 65 patients, 15.4%) [12] and that described in the prescribing information in Japan (21 of 335 patients, 6.3%; LTG add-on therapy). These differences in rate might be explained simply by the difference in the number of patients studied.…”

Section: Safety Analysesmentioning

confidence: 99%

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Appropriate conversion from valproate monotherapy to lamotrigine monotherapy in Japanese women with epilepsy

Yamamoto

Kubota

Murayama

et al. 2016

E&S

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Purpose: Exposur e to sodium valpr oate (VPA) dur ing pr egnancy may incr ease the r isk of fetal malformations and cognitive developmental deficits. We therefore assessed a clinically practical method to change treatment from VPA monotherapy to lamotrigine (LTG) monotherapy in Japanese women of childbearing potential whose seizures were controlled by VPA. Methods:In an open-label, single arm, multicenter study, we evaluated the reduction in VPA dose and change in seizure frequency from baseline when VPA monotherapy was switched to LTG monotherapy in female patients by the following protocol. (1) The LTG dose was increased up to 200 mg/day while the initial VPA dose was maintained. (2) The VPA dose was reduced to 0 mg/day while the LTG dose was maintained. (3) When VPA was removed, the LTG dose was simultaneously increased by up to 100 mg/day. (4) The LTG dose was further adjusted. Due to the risk of break-through seizures during adjustment of VPA and LTG doses, LTG trough serum concentration was measured for seizure control. Results: Of 33 patients enr olled, 20 completed the entir e pr otocol, with VPA r emoval in 19 patients. Thirteen patients were withdrawn from the study during LTG escalation, mainly due to LTG-related skin rash (n = 8) in the early stage of LTG initiation (10 days on average). Seizures were observed once in 2 patients during LTG monotherapy (7 and 13 weeks after VPA removal). Discussions: By paying car eful attention to the occur r ence of skin r ash or any sign of hypersensitivity at the beginning of LTG escalation, Japanese women receiving VPA monotherapy can be converted to LTG monotherapy.

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Section: Safety Analysessupporting

confidence: 74%

Section: Discussioncontrasting

confidence: 44%

Section: Safety Analysesmentioning

confidence: 99%

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Appropriate conversion from valproate monotherapy to lamotrigine monotherapy in Japanese women with epilepsy

Yamamoto

Kubota

Murayama

et al. 2016

E&S

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“…After completion of the initial phase of study [1] and having provided additional written informed consent, Japanese subjects who had partial seizures (including secondarily generalized seizures) or generalized tonicclonic seizures and who had responded to lamotrigine without tolerability issues by investigator's judgment were eligible to enter the extension phase. In the extension phase, subjects visited the clinic every 12 weeks for assessment of efficacy and safety.…”

Section: Methodsmentioning

confidence: 99%

“…A clinical study of lamotrigine monotherapy in epilepsy patients was started in September 2011. We have previously reported the efficacy and safety of lamotrigine monotherapy administered for up to 30 weeks (including the dose escalation and maintenance phases) in Japanese and Korean adult patients with newly diagnosed epilepsy or recurrent epilepsy [1]. Japanese patients who completed 30 weeks of treatment with lamotrigine monotherapy in the study were eligible to enter an extension phase aiming to assess the long-term tolerability and efficacy of lamotrigine.…”

Section: Introductionmentioning

confidence: 99%

Long-term efficacy and safety of lamotrigine: Results from the open-label extension of the lamotrigine monotherapy study in adult Japanese patients with epilepsy

Yamamoto

Shimizu

Sato

et al. 2017

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To investigate the efficacy and safety of long-term lamotrigine monotherapy, 22 Japanese patients (19 with newly diagnosed epilepsy and 3 with recurrent epilepsy) were enrolled in the extension phase of the study after completion of 30 weeks of lamotrigine treatment. More than 80% of patients remaining at each time point achieved seizure-free status at all time points up to week 120 in the extension phase. No unexpected adverse events were reported. Our findings suggest that long-term lamotrigine monotherapy appears to be effective and generally well tolerated in adult Japanese patients with partial seizures and generalized tonic-clonic seizures.

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Efficacy and safety of perampanel monotherapy in patients with focal‐onset seizures with newly diagnosed epilepsy or recurrence of epilepsy after a period of remission: The open‐label Study 342 (FREEDOM Study)

et al. 2020

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Objective: Our study assessed perampanel monotherapy in patients (aged ≥12 years) with focal-onset seizures (FOS) with or without focal to bilateral tonic-clonic seizures (FBTCS) in Japan and South Korea. Methods: Study 342 (NCT03201900; FREEDOM) is a single-arm, open-label, Phase III study. Patients initially received perampanel in a 32-week 4-mg/d Treatment Phase (6-week Titration; 26-week Maintenance Periods). If they experienced a seizure during the 4-mg/d Maintenance Period, they could be up-titrated to 8 mg/d across an additional 30-week Treatment Phase (4-week Titration; 26-week Maintenance Periods). Primary endpoint was the seizure-freedom rate during the Maintenance Period (4 mg/d and last evaluated dose [4 or 8 mg/d]). Secondary endpoints included time to first seizure onset and to withdrawal during Maintenance. Treatment-emergent adverse events (TEAEs) were monitored. Results: At data cutoff (February 28, 2019), 89 patients with FOS (84 [94.4%] with newly diagnosed epilepsy and 5 [5.6%] with recurrence of epilepsy after a period of remission) had received ≥1 perampanel dose; 16 patients discontinued during the 4-mg/d Titration Period, meaning 73 patients entered the 4-mg/d Maintenance Period and were included in the primary analysis set for efficacy. Seizure-freedom rate in the 26-week Maintenance Period was 46/73 (63.0%; 95% confidence interval [CI]: 50.9-74.0) at 4 mg/d and 54/73 (74.0%; 95% CI: 62.4-83.5) at 4 or 8 mg/d. | 275 YAMAMOTO eT Al.F I G U R E 1 Study design. a In the event of tolerability issues, the dose of perampanel could be reduced from 4 mg/d to 2 mg/d during Weeks 3 and 4 of the Titration Period, at the investigators' discretion. If the dose could not be up-titrated back to 4 mg/d, patients were discontinued from the study. b Patients experiencing seizures while receiving perampanel 4 mg/d could receive perampanel 8 mg/d at the investigators' discretion. If the 8-mg/d dose was not tolerated, patients could be down-titrated to 6 mg/d and continue the Maintenance Period. If patients experienced seizures while receiving perampanel 6 or 8 mg/d, or if the 6-mg/d dose was not tolerated, they ended the Treatment Phase. Abbreviation: QD, once daily

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Lamotrigine monotherapy in newly diagnosed epilepsy or recurrent epilepsy:A multi-center, open-label study

Cited by 5 publications

References 7 publications

Appropriate conversion from valproate monotherapy to lamotrigine monotherapy in Japanese women with epilepsy

Appropriate conversion from valproate monotherapy to lamotrigine monotherapy in Japanese women with epilepsy

Long-term efficacy and safety of lamotrigine: Results from the open-label extension of the lamotrigine monotherapy study in adult Japanese patients with epilepsy

Efficacy and safety of perampanel monotherapy in patients with focal‐onset seizures with newly diagnosed epilepsy or recurrence of epilepsy after a period of remission: The open‐label Study 342 (FREEDOM Study)

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