Trial Outcomes & Findings for Open-Label Extension Study of Rufinamide Given as Adjunctive Therapy in Patients With Refractory Partial Seizures (NCT NCT00448539)
NCT ID: NCT00448539
Last Updated: 2019-11-22
Results Overview
Seizure data was collected via patient diaries. "OL" refers to "open-label."
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
286 participants
Primary outcome timeframe
Baseline, Titration Phase (Days 1 to 18), Maintenance Phase
Results posted on
2019-11-22
Participant Flow
Participants who completed double-blind study E2080-A001-301 were allowed to enter in open-label extension Study 302. Participants completed a 12-day Transition Phase in Study 301 and received the same rufinamide maintenance dose that they achieved in Study 301 (Arm1), or transitioned from placebo to 3200 mg/day, beginning at 800 mg/day (Arm2).
Four participants who intended to enroll from Study 301 to 302 did not enroll and were considered screening failures.
Participant milestones
| Measure |
Rufinamide (Rufinamide During Core Study)
Participants entered this open-label extension study from E2080-A001-301 double-blind core study, where they received rufinamide in the core study. Prior to starting the extension study, participants completed a 12-day Transition Phase. For participants who immediately entered study 302 after study 301, rufinamide was maintained at dose of 2400 or 3200 milligram per day (mg/day) achieved at the end of study 301. Participants with delay between the end of Study 301 and the beginning of Study 302 started rufinamide at a dose of 800 mg/day, and had the dose titrated to the maximum tolerated dose (2400 or 3200 mg/day) over the next 12 to 18 days. During the open-ended open-label Maintenance Phase, changes in the rufinamide dose were permitted for all participants; however, the dose was maintained within the range of 2400 to 4800 mg/day (i.e., 1200 to 2400 mg twice daily).
|
Rufinamide (Placebo During Core Study)
Participants entered this open-label extension study from E2080-A001-301 double-blind core study, where they received placebo in the core study. Prior to starting the extension study, participants completed a 12-day Transition Phase where they transitioned from placebo to rufinamide at 800 mg/day at the start of transition phase, with subsequent dose increased to 3200 mg/day. During the open-ended open-label Maintenance Phase, changes in the rufinamide dose were permitted for all participants; however, the dose was maintained within the range of 2400 to 4800 mg/day (i.e., 1200 to 2400 mg twice daily).
|
|---|---|---|
|
Overall Study
STARTED
|
134
|
152
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
134
|
152
|
Reasons for withdrawal
| Measure |
Rufinamide (Rufinamide During Core Study)
Participants entered this open-label extension study from E2080-A001-301 double-blind core study, where they received rufinamide in the core study. Prior to starting the extension study, participants completed a 12-day Transition Phase. For participants who immediately entered study 302 after study 301, rufinamide was maintained at dose of 2400 or 3200 milligram per day (mg/day) achieved at the end of study 301. Participants with delay between the end of Study 301 and the beginning of Study 302 started rufinamide at a dose of 800 mg/day, and had the dose titrated to the maximum tolerated dose (2400 or 3200 mg/day) over the next 12 to 18 days. During the open-ended open-label Maintenance Phase, changes in the rufinamide dose were permitted for all participants; however, the dose was maintained within the range of 2400 to 4800 mg/day (i.e., 1200 to 2400 mg twice daily).
|
Rufinamide (Placebo During Core Study)
Participants entered this open-label extension study from E2080-A001-301 double-blind core study, where they received placebo in the core study. Prior to starting the extension study, participants completed a 12-day Transition Phase where they transitioned from placebo to rufinamide at 800 mg/day at the start of transition phase, with subsequent dose increased to 3200 mg/day. During the open-ended open-label Maintenance Phase, changes in the rufinamide dose were permitted for all participants; however, the dose was maintained within the range of 2400 to 4800 mg/day (i.e., 1200 to 2400 mg twice daily).
|
|---|---|---|
|
Overall Study
Medication non-compliance
|
4
|
1
|
|
Overall Study
Protocol Violation
|
1
|
0
|
|
Overall Study
Request of the investigator or sponsor
|
67
|
54
|
|
Overall Study
Withdrawal by Subject
|
20
|
24
|
|
Overall Study
Diary non-compliance
|
1
|
0
|
|
Overall Study
Adverse Event
|
9
|
26
|
|
Overall Study
Lack of Efficacy
|
27
|
40
|
|
Overall Study
Miscellaneous
|
2
|
1
|
|
Overall Study
Change of meds
|
2
|
3
|
|
Overall Study
Lost to Follow-up
|
1
|
3
|
Baseline Characteristics
Open-Label Extension Study of Rufinamide Given as Adjunctive Therapy in Patients With Refractory Partial Seizures
Baseline characteristics by cohort
| Measure |
Rufinamide (Rufinamide During Core Study)
n=134 Participants
Participants entered this open-label extension study from E2080-A001-301 double-blind core study, where they received rufinamide in the core study. Prior to starting the extension study, participants completed a 12-day Transition Phase. For participants who immediately entered study 302 after study 301, rufinamide was maintained at dose of 2400 or 3200 mg/day achieved at the end of study 301. Participants with delay between the end of Study 301 and the beginning of Study 302 started rufinamide at a dose of 800 mg/day, and had the dose titrated to the maximum tolerated dose (2400 or 3200 mg/day) over the next 12 to 18 days. During the open-ended open-label Maintenance Phase, changes in the rufinamide dose were permitted for all participants; however, the dose was maintained within the range of 2400 to 4800 mg/day (i.e., 1200 to 2400 mg twice daily).
|
Rufinamide (Placebo During Core Study)
n=152 Participants
Participants entered this open-label extension study from E2080-A001-301 double-blind core study, where they received placebo in the core study. Prior to starting the extension study, participants completed a 12-day Transition Phase where they transitioned from placebo to rufinamide at 800 mg/day at the start of transition phase, with subsequent dose increased to 3200 mg/day. During the open-ended open-label Maintenance Phase, changes in the rufinamide dose were permitted for all participants; however, the dose was maintained within the range of 2400 to 4800 mg/day (i.e., 1200 to 2400 mg twice daily).
|
Total
n=286 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
12 to <18 years
|
6 participants
n=5 Participants
|
18 participants
n=7 Participants
|
24 participants
n=5 Participants
|
|
Age, Customized
18 to <65 years
|
123 participants
n=5 Participants
|
129 participants
n=7 Participants
|
252 participants
n=5 Participants
|
|
Age, Customized
>=65 years
|
5 participants
n=5 Participants
|
5 participants
n=7 Participants
|
10 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
63 Participants
n=5 Participants
|
80 Participants
n=7 Participants
|
143 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
71 Participants
n=5 Participants
|
72 Participants
n=7 Participants
|
143 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
7 participants
n=5 Participants
|
13 participants
n=7 Participants
|
20 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
115 participants
n=5 Participants
|
121 participants
n=7 Participants
|
236 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
10 participants
n=5 Participants
|
11 participants
n=7 Participants
|
21 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native American
|
0 participants
n=5 Participants
|
2 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian/Pacific Islander
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 participants
n=5 Participants
|
3 participants
n=7 Participants
|
3 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Titration Phase (Days 1 to 18), Maintenance PhasePopulation: Intent-to-treat (ITT) population: All subjects who completed titration to open-label medication
Seizure data was collected via patient diaries. "OL" refers to "open-label."
Outcome measures
| Measure |
Rufinamide (Rufinamide During Core Study)
n=134 Participants
Participants entered this open-label extension study from E2080-A001-301 double-blind core study, where they received rufinamide in the core study. Prior to starting the extension study, participants completed a 12-day Transition Phase. For participants who immediately entered study 302 after study 301, rufinamide was maintained at dose of 2400 or 3200 mg/day achieved at the end of study 301. Participants with delay between the end of Study 301 and the beginning of Study 302 started rufinamide at a dose of 800 mg/day, and had the dose titrated to the maximum tolerated dose (2400 or 3200 mg/day) over the next 12 to 18 days. During the open-ended open-label Maintenance Phase, changes in the rufinamide dose were permitted for all participants; however, the dose was maintained within the range of 2400 to 4800 mg/day (i.e., 1200 to 2400 mg twice daily).
|
Rufinamide (Placebo During Core Study)
n=151 Participants
Participants entered this open-label extension study from E2080-A001-301 double-blind core study, where they received placebo in the core study. Prior to starting the extension study, participants completed a 12-day Transition Phase where they transitioned from placebo to rufinamide at 800 mg/day at the start of transition phase, with subsequent dose increased to 3200 mg/day. During the open-ended open-label Maintenance Phase, changes in the rufinamide dose were permitted for all participants; however, the dose was maintained within the range of 2400 to 4800 mg/day (i.e., 1200 to 2400 mg twice daily).
|
|---|---|---|
|
Percentage Change in Total Partial Seizure Frequency Per 28 Days Relative to the Baseline Phase
OL Titration Phase
|
-35.65 Percentage change
Interval -100.0 to 1570.7
|
-45.10 Percentage change
Interval -100.0 to 518.2
|
|
Percentage Change in Total Partial Seizure Frequency Per 28 Days Relative to the Baseline Phase
OL Maintenance Phase
|
-30.95 Percentage change
Interval -100.0 to 246.5
|
-31.10 Percentage change
Interval -100.0 to 322.4
|
Adverse Events
Rufinamide (Rufinamide During Core Study)
Serious events: 29 serious events
Other events: 88 other events
Deaths: 0 deaths
Rufinamide (Placebo During Core Study)
Serious events: 23 serious events
Other events: 114 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Rufinamide (Rufinamide During Core Study)
n=134 participants at risk
Participants entered this open-label extension study from E2080-A001-301 double-blind core study, where they received rufinamide in the core study. Prior to starting the extension study, participants completed a 12-day Transition Phase. For participants who immediately entered study 302 after study 301, rufinamide was maintained at dose of 2400 or 3200 mg/day achieved at the end of study 301. Participants with delay between the end of Study 301 and the beginning of Study 302 started rufinamide at a dose of 800 mg/day, and had the dose titrated to the maximum tolerated dose (2400 or 3200 mg/day) over the next 12 to 18 days. During the open-ended open-label Maintenance Phase, changes in the rufinamide dose were permitted for all participants; however, the dose was maintained within the range of 2400 to 4800 mg/day (i.e., 1200 to 2400 mg twice daily).
|
Rufinamide (Placebo During Core Study)
n=152 participants at risk
Participants entered this open-label extension study from E2080-A001-301 double-blind core study, where they received placebo in the core study. Prior to starting the extension study, participants completed a 12-day Transition Phase where they transitioned from placebo to rufinamide at 800 mg/day at the start of transition phase, with subsequent dose increased to 3200 mg/day. During the open-ended open-label Maintenance Phase, changes in the rufinamide dose were permitted for all participants; however, the dose was maintained within the range of 2400 to 4800 mg/day (i.e., 1200 to 2400 mg twice daily).
|
|---|---|---|
|
Cardiac disorders
Myocardial infarction
|
0.75%
1/134 • From the date of first dose of rufinamide through study termination (up to 3 years and 10 months)
|
0.00%
0/152 • From the date of first dose of rufinamide through study termination (up to 3 years and 10 months)
|
|
Gastrointestinal disorders
Gastritis erosive
|
0.00%
0/134 • From the date of first dose of rufinamide through study termination (up to 3 years and 10 months)
|
0.66%
1/152 • From the date of first dose of rufinamide through study termination (up to 3 years and 10 months)
|
|
Gastrointestinal disorders
Pancreatitis
|
0.75%
1/134 • From the date of first dose of rufinamide through study termination (up to 3 years and 10 months)
|
0.00%
0/152 • From the date of first dose of rufinamide through study termination (up to 3 years and 10 months)
|
|
Gastrointestinal disorders
Pancreatitis Acute
|
0.00%
0/134 • From the date of first dose of rufinamide through study termination (up to 3 years and 10 months)
|
0.66%
1/152 • From the date of first dose of rufinamide through study termination (up to 3 years and 10 months)
|
|
Gastrointestinal disorders
Upper Gastrointestinal Haemorrhage
|
0.75%
1/134 • From the date of first dose of rufinamide through study termination (up to 3 years and 10 months)
|
0.00%
0/152 • From the date of first dose of rufinamide through study termination (up to 3 years and 10 months)
|
|
Gastrointestinal disorders
Vomiting
|
0.75%
1/134 • From the date of first dose of rufinamide through study termination (up to 3 years and 10 months)
|
0.00%
0/152 • From the date of first dose of rufinamide through study termination (up to 3 years and 10 months)
|
|
General disorders
Asthenia
|
0.75%
1/134 • From the date of first dose of rufinamide through study termination (up to 3 years and 10 months)
|
0.00%
0/152 • From the date of first dose of rufinamide through study termination (up to 3 years and 10 months)
|
|
General disorders
Chest pain
|
0.00%
0/134 • From the date of first dose of rufinamide through study termination (up to 3 years and 10 months)
|
0.66%
1/152 • From the date of first dose of rufinamide through study termination (up to 3 years and 10 months)
|
|
Hepatobiliary disorders
Cholecystitis
|
0.75%
1/134 • From the date of first dose of rufinamide through study termination (up to 3 years and 10 months)
|
0.00%
0/152 • From the date of first dose of rufinamide through study termination (up to 3 years and 10 months)
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.75%
1/134 • From the date of first dose of rufinamide through study termination (up to 3 years and 10 months)
|
0.00%
0/152 • From the date of first dose of rufinamide through study termination (up to 3 years and 10 months)
|
|
Infections and infestations
Bronchopneumonia
|
0.75%
1/134 • From the date of first dose of rufinamide through study termination (up to 3 years and 10 months)
|
0.00%
0/152 • From the date of first dose of rufinamide through study termination (up to 3 years and 10 months)
|
|
Infections and infestations
Chronic sinusitis
|
0.75%
1/134 • From the date of first dose of rufinamide through study termination (up to 3 years and 10 months)
|
0.00%
0/152 • From the date of first dose of rufinamide through study termination (up to 3 years and 10 months)
|
|
Infections and infestations
Gastroenteritis
|
0.75%
1/134 • From the date of first dose of rufinamide through study termination (up to 3 years and 10 months)
|
0.00%
0/152 • From the date of first dose of rufinamide through study termination (up to 3 years and 10 months)
|
|
Infections and infestations
Influenza
|
0.00%
0/134 • From the date of first dose of rufinamide through study termination (up to 3 years and 10 months)
|
1.3%
2/152 • From the date of first dose of rufinamide through study termination (up to 3 years and 10 months)
|
|
Infections and infestations
Pneumococcal bacteraemia
|
0.00%
0/134 • From the date of first dose of rufinamide through study termination (up to 3 years and 10 months)
|
0.66%
1/152 • From the date of first dose of rufinamide through study termination (up to 3 years and 10 months)
|
|
Infections and infestations
Pneumonia
|
0.75%
1/134 • From the date of first dose of rufinamide through study termination (up to 3 years and 10 months)
|
0.00%
0/152 • From the date of first dose of rufinamide through study termination (up to 3 years and 10 months)
|
|
Infections and infestations
Wound infection staphylococcal
|
0.00%
0/134 • From the date of first dose of rufinamide through study termination (up to 3 years and 10 months)
|
0.66%
1/152 • From the date of first dose of rufinamide through study termination (up to 3 years and 10 months)
|
|
Injury, poisoning and procedural complications
Cervical vertebral fracture
|
0.75%
1/134 • From the date of first dose of rufinamide through study termination (up to 3 years and 10 months)
|
0.00%
0/152 • From the date of first dose of rufinamide through study termination (up to 3 years and 10 months)
|
|
Injury, poisoning and procedural complications
Drug toxicity
|
0.75%
1/134 • From the date of first dose of rufinamide through study termination (up to 3 years and 10 months)
|
0.00%
0/152 • From the date of first dose of rufinamide through study termination (up to 3 years and 10 months)
|
|
Injury, poisoning and procedural complications
Fall
|
0.75%
1/134 • From the date of first dose of rufinamide through study termination (up to 3 years and 10 months)
|
0.00%
0/152 • From the date of first dose of rufinamide through study termination (up to 3 years and 10 months)
|
|
Injury, poisoning and procedural complications
Jaw fracture
|
0.00%
0/134 • From the date of first dose of rufinamide through study termination (up to 3 years and 10 months)
|
0.66%
1/152 • From the date of first dose of rufinamide through study termination (up to 3 years and 10 months)
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.75%
1/134 • From the date of first dose of rufinamide through study termination (up to 3 years and 10 months)
|
0.00%
0/152 • From the date of first dose of rufinamide through study termination (up to 3 years and 10 months)
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.75%
1/134 • From the date of first dose of rufinamide through study termination (up to 3 years and 10 months)
|
0.00%
0/152 • From the date of first dose of rufinamide through study termination (up to 3 years and 10 months)
|
|
Injury, poisoning and procedural complications
Shunt malfunction
|
0.75%
1/134 • From the date of first dose of rufinamide through study termination (up to 3 years and 10 months)
|
0.00%
0/152 • From the date of first dose of rufinamide through study termination (up to 3 years and 10 months)
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/134 • From the date of first dose of rufinamide through study termination (up to 3 years and 10 months)
|
0.66%
1/152 • From the date of first dose of rufinamide through study termination (up to 3 years and 10 months)
|
|
Injury, poisoning and procedural complications
Subdural haemorrhage
|
0.75%
1/134 • From the date of first dose of rufinamide through study termination (up to 3 years and 10 months)
|
0.00%
0/152 • From the date of first dose of rufinamide through study termination (up to 3 years and 10 months)
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.00%
0/134 • From the date of first dose of rufinamide through study termination (up to 3 years and 10 months)
|
0.66%
1/152 • From the date of first dose of rufinamide through study termination (up to 3 years and 10 months)
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
1.5%
2/134 • From the date of first dose of rufinamide through study termination (up to 3 years and 10 months)
|
0.00%
0/152 • From the date of first dose of rufinamide through study termination (up to 3 years and 10 months)
|
|
Injury, poisoning and procedural complications
Ventriculoperitoneal shunt malfunction
|
0.75%
1/134 • From the date of first dose of rufinamide through study termination (up to 3 years and 10 months)
|
0.00%
0/152 • From the date of first dose of rufinamide through study termination (up to 3 years and 10 months)
|
|
Investigations
White blood cell count decreased
|
0.75%
1/134 • From the date of first dose of rufinamide through study termination (up to 3 years and 10 months)
|
0.00%
0/152 • From the date of first dose of rufinamide through study termination (up to 3 years and 10 months)
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.75%
1/134 • From the date of first dose of rufinamide through study termination (up to 3 years and 10 months)
|
0.00%
0/152 • From the date of first dose of rufinamide through study termination (up to 3 years and 10 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.75%
1/134 • From the date of first dose of rufinamide through study termination (up to 3 years and 10 months)
|
0.00%
0/152 • From the date of first dose of rufinamide through study termination (up to 3 years and 10 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leiomyosarcoma
|
0.75%
1/134 • From the date of first dose of rufinamide through study termination (up to 3 years and 10 months)
|
0.00%
0/152 • From the date of first dose of rufinamide through study termination (up to 3 years and 10 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.00%
0/134 • From the date of first dose of rufinamide through study termination (up to 3 years and 10 months)
|
0.66%
1/152 • From the date of first dose of rufinamide through study termination (up to 3 years and 10 months)
|
|
Nervous system disorders
Convulsion
|
3.7%
5/134 • From the date of first dose of rufinamide through study termination (up to 3 years and 10 months)
|
4.6%
7/152 • From the date of first dose of rufinamide through study termination (up to 3 years and 10 months)
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/134 • From the date of first dose of rufinamide through study termination (up to 3 years and 10 months)
|
0.66%
1/152 • From the date of first dose of rufinamide through study termination (up to 3 years and 10 months)
|
|
Nervous system disorders
Epilepsy
|
0.75%
1/134 • From the date of first dose of rufinamide through study termination (up to 3 years and 10 months)
|
0.66%
1/152 • From the date of first dose of rufinamide through study termination (up to 3 years and 10 months)
|
|
Nervous system disorders
Grand Mal Convulsion
|
0.75%
1/134 • From the date of first dose of rufinamide through study termination (up to 3 years and 10 months)
|
0.00%
0/152 • From the date of first dose of rufinamide through study termination (up to 3 years and 10 months)
|
|
Nervous system disorders
Headache
|
0.00%
0/134 • From the date of first dose of rufinamide through study termination (up to 3 years and 10 months)
|
0.66%
1/152 • From the date of first dose of rufinamide through study termination (up to 3 years and 10 months)
|
|
Nervous system disorders
Hemiparesis
|
0.75%
1/134 • From the date of first dose of rufinamide through study termination (up to 3 years and 10 months)
|
0.00%
0/152 • From the date of first dose of rufinamide through study termination (up to 3 years and 10 months)
|
|
Nervous system disorders
Hydrocephalus
|
0.75%
1/134 • From the date of first dose of rufinamide through study termination (up to 3 years and 10 months)
|
0.00%
0/152 • From the date of first dose of rufinamide through study termination (up to 3 years and 10 months)
|
|
Nervous system disorders
Partial seizures with secondary generalisation
|
0.75%
1/134 • From the date of first dose of rufinamide through study termination (up to 3 years and 10 months)
|
0.00%
0/152 • From the date of first dose of rufinamide through study termination (up to 3 years and 10 months)
|
|
Nervous system disorders
Postictal state
|
0.00%
0/134 • From the date of first dose of rufinamide through study termination (up to 3 years and 10 months)
|
1.3%
2/152 • From the date of first dose of rufinamide through study termination (up to 3 years and 10 months)
|
|
Nervous system disorders
Status epilepticus
|
2.2%
3/134 • From the date of first dose of rufinamide through study termination (up to 3 years and 10 months)
|
0.00%
0/152 • From the date of first dose of rufinamide through study termination (up to 3 years and 10 months)
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.75%
1/134 • From the date of first dose of rufinamide through study termination (up to 3 years and 10 months)
|
0.00%
0/152 • From the date of first dose of rufinamide through study termination (up to 3 years and 10 months)
|
|
Psychiatric disorders
Aggression
|
0.00%
0/134 • From the date of first dose of rufinamide through study termination (up to 3 years and 10 months)
|
0.66%
1/152 • From the date of first dose of rufinamide through study termination (up to 3 years and 10 months)
|
|
Psychiatric disorders
Agitation
|
0.00%
0/134 • From the date of first dose of rufinamide through study termination (up to 3 years and 10 months)
|
0.66%
1/152 • From the date of first dose of rufinamide through study termination (up to 3 years and 10 months)
|
|
Psychiatric disorders
Confusional state
|
0.75%
1/134 • From the date of first dose of rufinamide through study termination (up to 3 years and 10 months)
|
0.00%
0/152 • From the date of first dose of rufinamide through study termination (up to 3 years and 10 months)
|
|
Psychiatric disorders
Depression
|
0.75%
1/134 • From the date of first dose of rufinamide through study termination (up to 3 years and 10 months)
|
0.66%
1/152 • From the date of first dose of rufinamide through study termination (up to 3 years and 10 months)
|
|
Psychiatric disorders
Epileptic psychosis
|
0.75%
1/134 • From the date of first dose of rufinamide through study termination (up to 3 years and 10 months)
|
0.00%
0/152 • From the date of first dose of rufinamide through study termination (up to 3 years and 10 months)
|
|
Psychiatric disorders
Psychotic disorder
|
0.00%
0/134 • From the date of first dose of rufinamide through study termination (up to 3 years and 10 months)
|
0.66%
1/152 • From the date of first dose of rufinamide through study termination (up to 3 years and 10 months)
|
|
Psychiatric disorders
Suicidal behaviour
|
0.75%
1/134 • From the date of first dose of rufinamide through study termination (up to 3 years and 10 months)
|
0.66%
1/152 • From the date of first dose of rufinamide through study termination (up to 3 years and 10 months)
|
|
Psychiatric disorders
Suicidal ideation
|
0.75%
1/134 • From the date of first dose of rufinamide through study termination (up to 3 years and 10 months)
|
0.66%
1/152 • From the date of first dose of rufinamide through study termination (up to 3 years and 10 months)
|
|
Psychiatric disorders
Suicide attempt
|
0.75%
1/134 • From the date of first dose of rufinamide through study termination (up to 3 years and 10 months)
|
0.00%
0/152 • From the date of first dose of rufinamide through study termination (up to 3 years and 10 months)
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.75%
1/134 • From the date of first dose of rufinamide through study termination (up to 3 years and 10 months)
|
0.00%
0/152 • From the date of first dose of rufinamide through study termination (up to 3 years and 10 months)
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
0.00%
0/134 • From the date of first dose of rufinamide through study termination (up to 3 years and 10 months)
|
0.66%
1/152 • From the date of first dose of rufinamide through study termination (up to 3 years and 10 months)
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.75%
1/134 • From the date of first dose of rufinamide through study termination (up to 3 years and 10 months)
|
0.00%
0/152 • From the date of first dose of rufinamide through study termination (up to 3 years and 10 months)
|
|
Vascular disorders
Thrombosis
|
0.75%
1/134 • From the date of first dose of rufinamide through study termination (up to 3 years and 10 months)
|
0.00%
0/152 • From the date of first dose of rufinamide through study termination (up to 3 years and 10 months)
|
Other adverse events
| Measure |
Rufinamide (Rufinamide During Core Study)
n=134 participants at risk
Participants entered this open-label extension study from E2080-A001-301 double-blind core study, where they received rufinamide in the core study. Prior to starting the extension study, participants completed a 12-day Transition Phase. For participants who immediately entered study 302 after study 301, rufinamide was maintained at dose of 2400 or 3200 mg/day achieved at the end of study 301. Participants with delay between the end of Study 301 and the beginning of Study 302 started rufinamide at a dose of 800 mg/day, and had the dose titrated to the maximum tolerated dose (2400 or 3200 mg/day) over the next 12 to 18 days. During the open-ended open-label Maintenance Phase, changes in the rufinamide dose were permitted for all participants; however, the dose was maintained within the range of 2400 to 4800 mg/day (i.e., 1200 to 2400 mg twice daily).
|
Rufinamide (Placebo During Core Study)
n=152 participants at risk
Participants entered this open-label extension study from E2080-A001-301 double-blind core study, where they received placebo in the core study. Prior to starting the extension study, participants completed a 12-day Transition Phase where they transitioned from placebo to rufinamide at 800 mg/day at the start of transition phase, with subsequent dose increased to 3200 mg/day. During the open-ended open-label Maintenance Phase, changes in the rufinamide dose were permitted for all participants; however, the dose was maintained within the range of 2400 to 4800 mg/day (i.e., 1200 to 2400 mg twice daily).
|
|---|---|---|
|
Eye disorders
Diplopia
|
3.0%
4/134 • From the date of first dose of rufinamide through study termination (up to 3 years and 10 months)
|
6.6%
10/152 • From the date of first dose of rufinamide through study termination (up to 3 years and 10 months)
|
|
Gastrointestinal disorders
Abdominal pain upper
|
3.0%
4/134 • From the date of first dose of rufinamide through study termination (up to 3 years and 10 months)
|
5.3%
8/152 • From the date of first dose of rufinamide through study termination (up to 3 years and 10 months)
|
|
Gastrointestinal disorders
Diarrhoea
|
4.5%
6/134 • From the date of first dose of rufinamide through study termination (up to 3 years and 10 months)
|
5.9%
9/152 • From the date of first dose of rufinamide through study termination (up to 3 years and 10 months)
|
|
Gastrointestinal disorders
Nausea
|
9.0%
12/134 • From the date of first dose of rufinamide through study termination (up to 3 years and 10 months)
|
12.5%
19/152 • From the date of first dose of rufinamide through study termination (up to 3 years and 10 months)
|
|
Gastrointestinal disorders
Vomiting
|
10.4%
14/134 • From the date of first dose of rufinamide through study termination (up to 3 years and 10 months)
|
7.9%
12/152 • From the date of first dose of rufinamide through study termination (up to 3 years and 10 months)
|
|
General disorders
Fatigue
|
4.5%
6/134 • From the date of first dose of rufinamide through study termination (up to 3 years and 10 months)
|
9.9%
15/152 • From the date of first dose of rufinamide through study termination (up to 3 years and 10 months)
|
|
General disorders
Pyrexia
|
0.75%
1/134 • From the date of first dose of rufinamide through study termination (up to 3 years and 10 months)
|
5.9%
9/152 • From the date of first dose of rufinamide through study termination (up to 3 years and 10 months)
|
|
Infections and infestations
Sinusitis
|
9.0%
12/134 • From the date of first dose of rufinamide through study termination (up to 3 years and 10 months)
|
5.3%
8/152 • From the date of first dose of rufinamide through study termination (up to 3 years and 10 months)
|
|
Infections and infestations
Upper respiratory tract infection
|
6.7%
9/134 • From the date of first dose of rufinamide through study termination (up to 3 years and 10 months)
|
3.9%
6/152 • From the date of first dose of rufinamide through study termination (up to 3 years and 10 months)
|
|
Injury, poisoning and procedural complications
Contusion
|
6.0%
8/134 • From the date of first dose of rufinamide through study termination (up to 3 years and 10 months)
|
2.6%
4/152 • From the date of first dose of rufinamide through study termination (up to 3 years and 10 months)
|
|
Injury, poisoning and procedural complications
Fall
|
5.2%
7/134 • From the date of first dose of rufinamide through study termination (up to 3 years and 10 months)
|
3.3%
5/152 • From the date of first dose of rufinamide through study termination (up to 3 years and 10 months)
|
|
Injury, poisoning and procedural complications
Skin laceration
|
6.7%
9/134 • From the date of first dose of rufinamide through study termination (up to 3 years and 10 months)
|
3.3%
5/152 • From the date of first dose of rufinamide through study termination (up to 3 years and 10 months)
|
|
Metabolism and nutrition disorders
Weight decreased
|
6.0%
8/134 • From the date of first dose of rufinamide through study termination (up to 3 years and 10 months)
|
5.9%
9/152 • From the date of first dose of rufinamide through study termination (up to 3 years and 10 months)
|
|
Metabolism and nutrition disorders
Decreased appetite
|
1.5%
2/134 • From the date of first dose of rufinamide through study termination (up to 3 years and 10 months)
|
7.2%
11/152 • From the date of first dose of rufinamide through study termination (up to 3 years and 10 months)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.5%
10/134 • From the date of first dose of rufinamide through study termination (up to 3 years and 10 months)
|
3.3%
5/152 • From the date of first dose of rufinamide through study termination (up to 3 years and 10 months)
|
|
Nervous system disorders
Convulsion
|
7.5%
10/134 • From the date of first dose of rufinamide through study termination (up to 3 years and 10 months)
|
13.2%
20/152 • From the date of first dose of rufinamide through study termination (up to 3 years and 10 months)
|
|
Nervous system disorders
Dizziness
|
8.2%
11/134 • From the date of first dose of rufinamide through study termination (up to 3 years and 10 months)
|
28.3%
43/152 • From the date of first dose of rufinamide through study termination (up to 3 years and 10 months)
|
|
Nervous system disorders
Headache
|
11.2%
15/134 • From the date of first dose of rufinamide through study termination (up to 3 years and 10 months)
|
11.2%
17/152 • From the date of first dose of rufinamide through study termination (up to 3 years and 10 months)
|
|
Nervous system disorders
Somnolence
|
1.5%
2/134 • From the date of first dose of rufinamide through study termination (up to 3 years and 10 months)
|
9.2%
14/152 • From the date of first dose of rufinamide through study termination (up to 3 years and 10 months)
|
|
Psychiatric disorders
Anxiety
|
5.2%
7/134 • From the date of first dose of rufinamide through study termination (up to 3 years and 10 months)
|
3.9%
6/152 • From the date of first dose of rufinamide through study termination (up to 3 years and 10 months)
|
|
Psychiatric disorders
Depression
|
9.0%
12/134 • From the date of first dose of rufinamide through study termination (up to 3 years and 10 months)
|
2.0%
3/152 • From the date of first dose of rufinamide through study termination (up to 3 years and 10 months)
|
|
Psychiatric disorders
Insomnia
|
9.7%
13/134 • From the date of first dose of rufinamide through study termination (up to 3 years and 10 months)
|
6.6%
10/152 • From the date of first dose of rufinamide through study termination (up to 3 years and 10 months)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.5%
2/134 • From the date of first dose of rufinamide through study termination (up to 3 years and 10 months)
|
5.3%
8/152 • From the date of first dose of rufinamide through study termination (up to 3 years and 10 months)
|
|
Nervous system disorders
Coordination Abnormal
|
3.0%
4/134 • From the date of first dose of rufinamide through study termination (up to 3 years and 10 months)
|
6.6%
10/152 • From the date of first dose of rufinamide through study termination (up to 3 years and 10 months)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place