Trial Outcomes & Findings for A Study to Evaluate the Safety and Tolerability and Explore the Efficacy of Zonisamide as add-on Therapy in Elderly Patients With Refractory Partial Seizures (NCT NCT01546688)
NCT ID: NCT01546688
Last Updated: 2016-01-08
Results Overview
The Computer Visual Search Task (CVST) of the Ferrum Psyche (FePsy)measured cognition. A decrease from Baseline (negative change value) signifies an improvement in the mean reaction time of CVST.
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
41 participants
Primary outcome timeframe
Baseline, Week 4, Week 8, Week 12, Week 16
Results posted on
2016-01-08
Participant Flow
Participant milestones
| Measure |
Placebo
Subjects took matching doses of placebo during both the Titration Period and Maintenance Period.
|
Zonisamide
Subjects started the Titration Period on a Total Daily Dose (TDD) of zonisamide 50mg (25mg capsules twice daily in the morning and evening) for a total of 8 weeks. Doses increased in 100mg increments up to a targeted TDD of 300mg with a range of 100mg to 500mg. Subjects entered the Maintenance Period on the same dose they were on at the end of the titration phase, taking the dose once daily (in the evening) or twice daily for a total of 8 weeks. Subjects were withdrawn if they required a TDD outside of the suggested range.
|
|---|---|---|
|
Overall Study
STARTED
|
18
|
33
|
|
Overall Study
COMPLETED
|
15
|
28
|
|
Overall Study
NOT COMPLETED
|
3
|
5
|
Reasons for withdrawal
| Measure |
Placebo
Subjects took matching doses of placebo during both the Titration Period and Maintenance Period.
|
Zonisamide
Subjects started the Titration Period on a Total Daily Dose (TDD) of zonisamide 50mg (25mg capsules twice daily in the morning and evening) for a total of 8 weeks. Doses increased in 100mg increments up to a targeted TDD of 300mg with a range of 100mg to 500mg. Subjects entered the Maintenance Period on the same dose they were on at the end of the titration phase, taking the dose once daily (in the evening) or twice daily for a total of 8 weeks. Subjects were withdrawn if they required a TDD outside of the suggested range.
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
4
|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
|
Overall Study
Lack of Efficacy
|
1
|
0
|
Baseline Characteristics
A Study to Evaluate the Safety and Tolerability and Explore the Efficacy of Zonisamide as add-on Therapy in Elderly Patients With Refractory Partial Seizures
Baseline characteristics by cohort
| Measure |
Placebo
n=18 Participants
Subjects took matching doses of placebo during both the Titration Period and Maintenance Period.
|
Zonisamide
n=33 Participants
Subjects started the Titration Period on a Total Daily Dose (TDD) of zonisamide 50mg (25mg capsules twice daily in the morning and evening) for a total of 8 weeks. Doses increased in 100mg increments up to a targeted TDD of 300mg with a range of 100mg to 500mg. Subjects entered the Maintenance Period on the same dose they were on at the end of the titration phase, taking the dose once daily (in the evening) or twice daily for a total of 8 weeks. Subjects were withdrawn if they required a TDD outside of the suggested range.
|
Total
n=51 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
71.1 Years
STANDARD_DEVIATION 4.61 • n=5 Participants
|
72.5 Years
STANDARD_DEVIATION 5.63 • n=7 Participants
|
72.0 Years
STANDARD_DEVIATION 5.29 • n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
18 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
17 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 4, Week 8, Week 12, Week 16Population: Intent-to-Treat Population: All randomized subjects who received at least one dose of study medication.
The Computer Visual Search Task (CVST) of the Ferrum Psyche (FePsy)measured cognition. A decrease from Baseline (negative change value) signifies an improvement in the mean reaction time of CVST.
Outcome measures
| Measure |
Placebo
n=18 Participants
Subjects took matching doses of placebo during both the Titration Period and Maintenance Period.
|
Zonisamide
n=33 Participants
Subjects started the Titration Period on a Total Daily Dose (TDD) of zonisamide 50mg (25mg capsules twice daily in the morning and evening) for a total of 8 weeks. Doses increased in 100mg increments up to a targeted TDD of 300mg with a range of 100mg to 500mg. Subjects entered the Maintenance Period on the same dose they were on at the end of the titration phase, taking the dose once daily (in the evening) or twice daily for a total of 8 weeks. Subjects were withdrawn if they required a TDD outside of the suggested range.
|
|---|---|---|
|
Change From Baseline in CVST of the FePsy Test (Mean Reaction Time) by Visit During Titration and Maintenance Period
Week 4
|
-3.448 Seconds
Standard Deviation 10.212
|
-3.898 Seconds
Standard Deviation 13.149
|
|
Change From Baseline in CVST of the FePsy Test (Mean Reaction Time) by Visit During Titration and Maintenance Period
Week 8
|
-2.776 Seconds
Standard Deviation 9.984
|
-0.650 Seconds
Standard Deviation 10.140
|
|
Change From Baseline in CVST of the FePsy Test (Mean Reaction Time) by Visit During Titration and Maintenance Period
Week 12
|
-7.223 Seconds
Standard Deviation 11.949
|
-2.731 Seconds
Standard Deviation 14.084
|
|
Change From Baseline in CVST of the FePsy Test (Mean Reaction Time) by Visit During Titration and Maintenance Period
Week 16
|
-3.324 Seconds
Standard Deviation 14.995
|
-5.102 Seconds
Standard Deviation 11.526
|
PRIMARY outcome
Timeframe: Baseline, Week 4, Week 8, Week 12, Week 16Population: Intent-to-Treat Population
The Bond-Lader mood rating scale measured sedation, with scores ranging from 0 to 100. A high score reflects a high level of sedation.
Outcome measures
| Measure |
Placebo
n=18 Participants
Subjects took matching doses of placebo during both the Titration Period and Maintenance Period.
|
Zonisamide
n=33 Participants
Subjects started the Titration Period on a Total Daily Dose (TDD) of zonisamide 50mg (25mg capsules twice daily in the morning and evening) for a total of 8 weeks. Doses increased in 100mg increments up to a targeted TDD of 300mg with a range of 100mg to 500mg. Subjects entered the Maintenance Period on the same dose they were on at the end of the titration phase, taking the dose once daily (in the evening) or twice daily for a total of 8 weeks. Subjects were withdrawn if they required a TDD outside of the suggested range.
|
|---|---|---|
|
Change From Baseline in Bond and Lader Visual Analogue Scale (VAS) Mood Sub-Scores for Sedation by Visit During Titration and Maintenance Period
Week 4
|
-1.337 Scores on a Scale
Standard Deviation 22.2976
|
1.654 Scores on a Scale
Standard Deviation 16.4085
|
|
Change From Baseline in Bond and Lader Visual Analogue Scale (VAS) Mood Sub-Scores for Sedation by Visit During Titration and Maintenance Period
Week 8
|
7.688 Scores on a Scale
Standard Deviation 17.0998
|
1.990 Scores on a Scale
Standard Deviation 16.0172
|
|
Change From Baseline in Bond and Lader Visual Analogue Scale (VAS) Mood Sub-Scores for Sedation by Visit During Titration and Maintenance Period
Week 12
|
1.386 Scores on a Scale
Standard Deviation 13.6130
|
-0.682 Scores on a Scale
Standard Deviation 18.0567
|
|
Change From Baseline in Bond and Lader Visual Analogue Scale (VAS) Mood Sub-Scores for Sedation by Visit During Titration and Maintenance Period
Week 16
|
2.502 Scores on a Scale
Standard Deviation 17.6228
|
3.943 Scores on a Scale
Standard Deviation 21.0086
|
SECONDARY outcome
Timeframe: Baseline and Month 4Population: Intent-to-Treat Population.
Seizure frequency was assessed by a seizure diary, maintained daily from Baseline, in which the subject recorded the occurrence of any seizure.
Outcome measures
| Measure |
Placebo
n=18 Participants
Subjects took matching doses of placebo during both the Titration Period and Maintenance Period.
|
Zonisamide
n=33 Participants
Subjects started the Titration Period on a Total Daily Dose (TDD) of zonisamide 50mg (25mg capsules twice daily in the morning and evening) for a total of 8 weeks. Doses increased in 100mg increments up to a targeted TDD of 300mg with a range of 100mg to 500mg. Subjects entered the Maintenance Period on the same dose they were on at the end of the titration phase, taking the dose once daily (in the evening) or twice daily for a total of 8 weeks. Subjects were withdrawn if they required a TDD outside of the suggested range.
|
|---|---|---|
|
Percent Change in Seizure Frequency From Baseline to the Last 28 Days of the Maintenance Period
|
-100 Percent Change
Interval -100.0 to 433.0
|
-100 Percent Change
Interval -100.0 to 50.0
|
SECONDARY outcome
Timeframe: Baseline and Month 4Population: Intent-to-Treat Population. Percentages are based on the number of subjects present in the Maintenance Phase.
Seizure frequency was assessed by a seizure diary, maintained daily from Baseline, in which the subject recorded the occurrence of any seizure. A responder is a subject who had at least a 50 percent or greater reduction in the seizure frequency of all seizures during the last 28 days of the Maintenance Period compared to the Baseline Period seizure frequency. Due to the exploratory nature of the objective for efficacy and the truncated study size, analysis of efficacy was based on observed cases, without imputation for missing data. As a result, there are some variations in sample sizes for efficacy at different visits, depending on if particular efficacy variables were missing for particular visits.
Outcome measures
| Measure |
Placebo
n=15 Participants
Subjects took matching doses of placebo during both the Titration Period and Maintenance Period.
|
Zonisamide
n=28 Participants
Subjects started the Titration Period on a Total Daily Dose (TDD) of zonisamide 50mg (25mg capsules twice daily in the morning and evening) for a total of 8 weeks. Doses increased in 100mg increments up to a targeted TDD of 300mg with a range of 100mg to 500mg. Subjects entered the Maintenance Period on the same dose they were on at the end of the titration phase, taking the dose once daily (in the evening) or twice daily for a total of 8 weeks. Subjects were withdrawn if they required a TDD outside of the suggested range.
|
|---|---|---|
|
Percentage of Responders During Last 28 Days of Maintenance Period
Non-Responders (No)
|
12.5 Percentage of Participants
|
14.3 Percentage of Participants
|
|
Percentage of Responders During Last 28 Days of Maintenance Period
Responders (Yes)
|
62.5 Percentage of Participants
|
75 Percentage of Participants
|
|
Percentage of Responders During Last 28 Days of Maintenance Period
Missing
|
25 Percentage of Participants
|
10.7 Percentage of Participants
|
Adverse Events
Placebo
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
Zonisamide
Serious events: 6 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=18 participants at risk
Subjects took matching doses of placebo during both the Titration Period and Maintenance Period.
|
Zonisamide
n=33 participants at risk
Subjects started the Titration Period on a Total Daily Dose (TDD) of zonisamide 50mg (25mg capsules twice daily in the morning and evening) for a total of 8 weeks. Doses increased in 100mg increments up to a targeted TDD of 300mg with a range of 100mg to 500mg. Subjects entered the Maintenance Period on the same dose they were on at the end of the titration phase, taking the dose once daily (in the evening) or twice daily for a total of 8 weeks. Subjects were withdrawn if they required a TDD outside of the suggested range.
|
|---|---|---|
|
Cardiac disorders
Cardiovascular insufficiency
|
0.00%
0/18 • Treatment-Emergent Adverse Events (TEAE) were collected, and includes all Adverse Events (AE) with a start date on or after Day 1 and within 15 Days of last dose, including AEs with missing start dates. Participants were followed for up to 27 weeks.
|
3.0%
1/33 • Treatment-Emergent Adverse Events (TEAE) were collected, and includes all Adverse Events (AE) with a start date on or after Day 1 and within 15 Days of last dose, including AEs with missing start dates. Participants were followed for up to 27 weeks.
|
|
Nervous system disorders
Convulsion
|
0.00%
0/18 • Treatment-Emergent Adverse Events (TEAE) were collected, and includes all Adverse Events (AE) with a start date on or after Day 1 and within 15 Days of last dose, including AEs with missing start dates. Participants were followed for up to 27 weeks.
|
3.0%
1/33 • Treatment-Emergent Adverse Events (TEAE) were collected, and includes all Adverse Events (AE) with a start date on or after Day 1 and within 15 Days of last dose, including AEs with missing start dates. Participants were followed for up to 27 weeks.
|
|
Nervous system disorders
Epilepsy
|
5.6%
1/18 • Treatment-Emergent Adverse Events (TEAE) were collected, and includes all Adverse Events (AE) with a start date on or after Day 1 and within 15 Days of last dose, including AEs with missing start dates. Participants were followed for up to 27 weeks.
|
0.00%
0/33 • Treatment-Emergent Adverse Events (TEAE) were collected, and includes all Adverse Events (AE) with a start date on or after Day 1 and within 15 Days of last dose, including AEs with missing start dates. Participants were followed for up to 27 weeks.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/18 • Treatment-Emergent Adverse Events (TEAE) were collected, and includes all Adverse Events (AE) with a start date on or after Day 1 and within 15 Days of last dose, including AEs with missing start dates. Participants were followed for up to 27 weeks.
|
3.0%
1/33 • Treatment-Emergent Adverse Events (TEAE) were collected, and includes all Adverse Events (AE) with a start date on or after Day 1 and within 15 Days of last dose, including AEs with missing start dates. Participants were followed for up to 27 weeks.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/18 • Treatment-Emergent Adverse Events (TEAE) were collected, and includes all Adverse Events (AE) with a start date on or after Day 1 and within 15 Days of last dose, including AEs with missing start dates. Participants were followed for up to 27 weeks.
|
3.0%
1/33 • Treatment-Emergent Adverse Events (TEAE) were collected, and includes all Adverse Events (AE) with a start date on or after Day 1 and within 15 Days of last dose, including AEs with missing start dates. Participants were followed for up to 27 weeks.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/18 • Treatment-Emergent Adverse Events (TEAE) were collected, and includes all Adverse Events (AE) with a start date on or after Day 1 and within 15 Days of last dose, including AEs with missing start dates. Participants were followed for up to 27 weeks.
|
3.0%
1/33 • Treatment-Emergent Adverse Events (TEAE) were collected, and includes all Adverse Events (AE) with a start date on or after Day 1 and within 15 Days of last dose, including AEs with missing start dates. Participants were followed for up to 27 weeks.
|
|
Nervous system disorders
Status epilepticus
|
0.00%
0/18 • Treatment-Emergent Adverse Events (TEAE) were collected, and includes all Adverse Events (AE) with a start date on or after Day 1 and within 15 Days of last dose, including AEs with missing start dates. Participants were followed for up to 27 weeks.
|
3.0%
1/33 • Treatment-Emergent Adverse Events (TEAE) were collected, and includes all Adverse Events (AE) with a start date on or after Day 1 and within 15 Days of last dose, including AEs with missing start dates. Participants were followed for up to 27 weeks.
|
|
General disorders
Sudden Death
|
0.00%
0/18 • Treatment-Emergent Adverse Events (TEAE) were collected, and includes all Adverse Events (AE) with a start date on or after Day 1 and within 15 Days of last dose, including AEs with missing start dates. Participants were followed for up to 27 weeks.
|
3.0%
1/33 • Treatment-Emergent Adverse Events (TEAE) were collected, and includes all Adverse Events (AE) with a start date on or after Day 1 and within 15 Days of last dose, including AEs with missing start dates. Participants were followed for up to 27 weeks.
|
|
Nervous system disorders
Vertebrobasilar insuffficiency
|
0.00%
0/18 • Treatment-Emergent Adverse Events (TEAE) were collected, and includes all Adverse Events (AE) with a start date on or after Day 1 and within 15 Days of last dose, including AEs with missing start dates. Participants were followed for up to 27 weeks.
|
3.0%
1/33 • Treatment-Emergent Adverse Events (TEAE) were collected, and includes all Adverse Events (AE) with a start date on or after Day 1 and within 15 Days of last dose, including AEs with missing start dates. Participants were followed for up to 27 weeks.
|
Other adverse events
| Measure |
Placebo
n=18 participants at risk
Subjects took matching doses of placebo during both the Titration Period and Maintenance Period.
|
Zonisamide
n=33 participants at risk
Subjects started the Titration Period on a Total Daily Dose (TDD) of zonisamide 50mg (25mg capsules twice daily in the morning and evening) for a total of 8 weeks. Doses increased in 100mg increments up to a targeted TDD of 300mg with a range of 100mg to 500mg. Subjects entered the Maintenance Period on the same dose they were on at the end of the titration phase, taking the dose once daily (in the evening) or twice daily for a total of 8 weeks. Subjects were withdrawn if they required a TDD outside of the suggested range.
|
|---|---|---|
|
Nervous system disorders
Dizziness
|
11.1%
2/18 • Treatment-Emergent Adverse Events (TEAE) were collected, and includes all Adverse Events (AE) with a start date on or after Day 1 and within 15 Days of last dose, including AEs with missing start dates. Participants were followed for up to 27 weeks.
|
15.2%
5/33 • Treatment-Emergent Adverse Events (TEAE) were collected, and includes all Adverse Events (AE) with a start date on or after Day 1 and within 15 Days of last dose, including AEs with missing start dates. Participants were followed for up to 27 weeks.
|
|
Psychiatric disorders
Anxiety
|
5.6%
1/18 • Treatment-Emergent Adverse Events (TEAE) were collected, and includes all Adverse Events (AE) with a start date on or after Day 1 and within 15 Days of last dose, including AEs with missing start dates. Participants were followed for up to 27 weeks.
|
3.0%
1/33 • Treatment-Emergent Adverse Events (TEAE) were collected, and includes all Adverse Events (AE) with a start date on or after Day 1 and within 15 Days of last dose, including AEs with missing start dates. Participants were followed for up to 27 weeks.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.6%
1/18 • Treatment-Emergent Adverse Events (TEAE) were collected, and includes all Adverse Events (AE) with a start date on or after Day 1 and within 15 Days of last dose, including AEs with missing start dates. Participants were followed for up to 27 weeks.
|
3.0%
1/33 • Treatment-Emergent Adverse Events (TEAE) were collected, and includes all Adverse Events (AE) with a start date on or after Day 1 and within 15 Days of last dose, including AEs with missing start dates. Participants were followed for up to 27 weeks.
|
|
Investigations
Asparatate aminotransferase increased
|
5.6%
1/18 • Treatment-Emergent Adverse Events (TEAE) were collected, and includes all Adverse Events (AE) with a start date on or after Day 1 and within 15 Days of last dose, including AEs with missing start dates. Participants were followed for up to 27 weeks.
|
0.00%
0/33 • Treatment-Emergent Adverse Events (TEAE) were collected, and includes all Adverse Events (AE) with a start date on or after Day 1 and within 15 Days of last dose, including AEs with missing start dates. Participants were followed for up to 27 weeks.
|
|
General disorders
Asthenia
|
0.00%
0/18 • Treatment-Emergent Adverse Events (TEAE) were collected, and includes all Adverse Events (AE) with a start date on or after Day 1 and within 15 Days of last dose, including AEs with missing start dates. Participants were followed for up to 27 weeks.
|
6.1%
2/33 • Treatment-Emergent Adverse Events (TEAE) were collected, and includes all Adverse Events (AE) with a start date on or after Day 1 and within 15 Days of last dose, including AEs with missing start dates. Participants were followed for up to 27 weeks.
|
|
Investigations
Blood creatine phosphokinase increased
|
5.6%
1/18 • Treatment-Emergent Adverse Events (TEAE) were collected, and includes all Adverse Events (AE) with a start date on or after Day 1 and within 15 Days of last dose, including AEs with missing start dates. Participants were followed for up to 27 weeks.
|
0.00%
0/33 • Treatment-Emergent Adverse Events (TEAE) were collected, and includes all Adverse Events (AE) with a start date on or after Day 1 and within 15 Days of last dose, including AEs with missing start dates. Participants were followed for up to 27 weeks.
|
|
Investigations
Blood pressure decreased
|
5.6%
1/18 • Treatment-Emergent Adverse Events (TEAE) were collected, and includes all Adverse Events (AE) with a start date on or after Day 1 and within 15 Days of last dose, including AEs with missing start dates. Participants were followed for up to 27 weeks.
|
0.00%
0/33 • Treatment-Emergent Adverse Events (TEAE) were collected, and includes all Adverse Events (AE) with a start date on or after Day 1 and within 15 Days of last dose, including AEs with missing start dates. Participants were followed for up to 27 weeks.
|
|
Psychiatric disorders
Confusional state
|
5.6%
1/18 • Treatment-Emergent Adverse Events (TEAE) were collected, and includes all Adverse Events (AE) with a start date on or after Day 1 and within 15 Days of last dose, including AEs with missing start dates. Participants were followed for up to 27 weeks.
|
0.00%
0/33 • Treatment-Emergent Adverse Events (TEAE) were collected, and includes all Adverse Events (AE) with a start date on or after Day 1 and within 15 Days of last dose, including AEs with missing start dates. Participants were followed for up to 27 weeks.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/18 • Treatment-Emergent Adverse Events (TEAE) were collected, and includes all Adverse Events (AE) with a start date on or after Day 1 and within 15 Days of last dose, including AEs with missing start dates. Participants were followed for up to 27 weeks.
|
6.1%
2/33 • Treatment-Emergent Adverse Events (TEAE) were collected, and includes all Adverse Events (AE) with a start date on or after Day 1 and within 15 Days of last dose, including AEs with missing start dates. Participants were followed for up to 27 weeks.
|
|
Psychiatric disorders
Depression
|
5.6%
1/18 • Treatment-Emergent Adverse Events (TEAE) were collected, and includes all Adverse Events (AE) with a start date on or after Day 1 and within 15 Days of last dose, including AEs with missing start dates. Participants were followed for up to 27 weeks.
|
0.00%
0/33 • Treatment-Emergent Adverse Events (TEAE) were collected, and includes all Adverse Events (AE) with a start date on or after Day 1 and within 15 Days of last dose, including AEs with missing start dates. Participants were followed for up to 27 weeks.
|
|
Eye disorders
Diplopia
|
0.00%
0/18 • Treatment-Emergent Adverse Events (TEAE) were collected, and includes all Adverse Events (AE) with a start date on or after Day 1 and within 15 Days of last dose, including AEs with missing start dates. Participants were followed for up to 27 weeks.
|
6.1%
2/33 • Treatment-Emergent Adverse Events (TEAE) were collected, and includes all Adverse Events (AE) with a start date on or after Day 1 and within 15 Days of last dose, including AEs with missing start dates. Participants were followed for up to 27 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
5.6%
1/18 • Treatment-Emergent Adverse Events (TEAE) were collected, and includes all Adverse Events (AE) with a start date on or after Day 1 and within 15 Days of last dose, including AEs with missing start dates. Participants were followed for up to 27 weeks.
|
0.00%
0/33 • Treatment-Emergent Adverse Events (TEAE) were collected, and includes all Adverse Events (AE) with a start date on or after Day 1 and within 15 Days of last dose, including AEs with missing start dates. Participants were followed for up to 27 weeks.
|
|
Investigations
Gamma-glutamyltransferase increased
|
5.6%
1/18 • Treatment-Emergent Adverse Events (TEAE) were collected, and includes all Adverse Events (AE) with a start date on or after Day 1 and within 15 Days of last dose, including AEs with missing start dates. Participants were followed for up to 27 weeks.
|
0.00%
0/33 • Treatment-Emergent Adverse Events (TEAE) were collected, and includes all Adverse Events (AE) with a start date on or after Day 1 and within 15 Days of last dose, including AEs with missing start dates. Participants were followed for up to 27 weeks.
|
|
Gastrointestinal disorders
Gastritis
|
5.6%
1/18 • Treatment-Emergent Adverse Events (TEAE) were collected, and includes all Adverse Events (AE) with a start date on or after Day 1 and within 15 Days of last dose, including AEs with missing start dates. Participants were followed for up to 27 weeks.
|
0.00%
0/33 • Treatment-Emergent Adverse Events (TEAE) were collected, and includes all Adverse Events (AE) with a start date on or after Day 1 and within 15 Days of last dose, including AEs with missing start dates. Participants were followed for up to 27 weeks.
|
|
Nervous system disorders
Headache
|
0.00%
0/18 • Treatment-Emergent Adverse Events (TEAE) were collected, and includes all Adverse Events (AE) with a start date on or after Day 1 and within 15 Days of last dose, including AEs with missing start dates. Participants were followed for up to 27 weeks.
|
12.1%
4/33 • Treatment-Emergent Adverse Events (TEAE) were collected, and includes all Adverse Events (AE) with a start date on or after Day 1 and within 15 Days of last dose, including AEs with missing start dates. Participants were followed for up to 27 weeks.
|
|
Vascular disorders
Hypertension
|
11.1%
2/18 • Treatment-Emergent Adverse Events (TEAE) were collected, and includes all Adverse Events (AE) with a start date on or after Day 1 and within 15 Days of last dose, including AEs with missing start dates. Participants were followed for up to 27 weeks.
|
3.0%
1/33 • Treatment-Emergent Adverse Events (TEAE) were collected, and includes all Adverse Events (AE) with a start date on or after Day 1 and within 15 Days of last dose, including AEs with missing start dates. Participants were followed for up to 27 weeks.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/18 • Treatment-Emergent Adverse Events (TEAE) were collected, and includes all Adverse Events (AE) with a start date on or after Day 1 and within 15 Days of last dose, including AEs with missing start dates. Participants were followed for up to 27 weeks.
|
6.1%
2/33 • Treatment-Emergent Adverse Events (TEAE) were collected, and includes all Adverse Events (AE) with a start date on or after Day 1 and within 15 Days of last dose, including AEs with missing start dates. Participants were followed for up to 27 weeks.
|
|
Cardiac disorders
Palpitations
|
5.6%
1/18 • Treatment-Emergent Adverse Events (TEAE) were collected, and includes all Adverse Events (AE) with a start date on or after Day 1 and within 15 Days of last dose, including AEs with missing start dates. Participants were followed for up to 27 weeks.
|
0.00%
0/33 • Treatment-Emergent Adverse Events (TEAE) were collected, and includes all Adverse Events (AE) with a start date on or after Day 1 and within 15 Days of last dose, including AEs with missing start dates. Participants were followed for up to 27 weeks.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.6%
1/18 • Treatment-Emergent Adverse Events (TEAE) were collected, and includes all Adverse Events (AE) with a start date on or after Day 1 and within 15 Days of last dose, including AEs with missing start dates. Participants were followed for up to 27 weeks.
|
9.1%
3/33 • Treatment-Emergent Adverse Events (TEAE) were collected, and includes all Adverse Events (AE) with a start date on or after Day 1 and within 15 Days of last dose, including AEs with missing start dates. Participants were followed for up to 27 weeks.
|
|
Nervous system disorders
Radicular syndrome
|
5.6%
1/18 • Treatment-Emergent Adverse Events (TEAE) were collected, and includes all Adverse Events (AE) with a start date on or after Day 1 and within 15 Days of last dose, including AEs with missing start dates. Participants were followed for up to 27 weeks.
|
0.00%
0/33 • Treatment-Emergent Adverse Events (TEAE) were collected, and includes all Adverse Events (AE) with a start date on or after Day 1 and within 15 Days of last dose, including AEs with missing start dates. Participants were followed for up to 27 weeks.
|
|
Nervous system disorders
Sciatica
|
5.6%
1/18 • Treatment-Emergent Adverse Events (TEAE) were collected, and includes all Adverse Events (AE) with a start date on or after Day 1 and within 15 Days of last dose, including AEs with missing start dates. Participants were followed for up to 27 weeks.
|
0.00%
0/33 • Treatment-Emergent Adverse Events (TEAE) were collected, and includes all Adverse Events (AE) with a start date on or after Day 1 and within 15 Days of last dose, including AEs with missing start dates. Participants were followed for up to 27 weeks.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/18 • Treatment-Emergent Adverse Events (TEAE) were collected, and includes all Adverse Events (AE) with a start date on or after Day 1 and within 15 Days of last dose, including AEs with missing start dates. Participants were followed for up to 27 weeks.
|
15.2%
5/33 • Treatment-Emergent Adverse Events (TEAE) were collected, and includes all Adverse Events (AE) with a start date on or after Day 1 and within 15 Days of last dose, including AEs with missing start dates. Participants were followed for up to 27 weeks.
|
|
Infections and infestations
Upper respiratory tract infection
|
5.6%
1/18 • Treatment-Emergent Adverse Events (TEAE) were collected, and includes all Adverse Events (AE) with a start date on or after Day 1 and within 15 Days of last dose, including AEs with missing start dates. Participants were followed for up to 27 weeks.
|
0.00%
0/33 • Treatment-Emergent Adverse Events (TEAE) were collected, and includes all Adverse Events (AE) with a start date on or after Day 1 and within 15 Days of last dose, including AEs with missing start dates. Participants were followed for up to 27 weeks.
|
|
Ear and labyrinth disorders
Vertigo
|
5.6%
1/18 • Treatment-Emergent Adverse Events (TEAE) were collected, and includes all Adverse Events (AE) with a start date on or after Day 1 and within 15 Days of last dose, including AEs with missing start dates. Participants were followed for up to 27 weeks.
|
3.0%
1/33 • Treatment-Emergent Adverse Events (TEAE) were collected, and includes all Adverse Events (AE) with a start date on or after Day 1 and within 15 Days of last dose, including AEs with missing start dates. Participants were followed for up to 27 weeks.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/18 • Treatment-Emergent Adverse Events (TEAE) were collected, and includes all Adverse Events (AE) with a start date on or after Day 1 and within 15 Days of last dose, including AEs with missing start dates. Participants were followed for up to 27 weeks.
|
9.1%
3/33 • Treatment-Emergent Adverse Events (TEAE) were collected, and includes all Adverse Events (AE) with a start date on or after Day 1 and within 15 Days of last dose, including AEs with missing start dates. Participants were followed for up to 27 weeks.
|
|
Investigations
Alanine aminotransferase increased
|
5.6%
1/18 • Treatment-Emergent Adverse Events (TEAE) were collected, and includes all Adverse Events (AE) with a start date on or after Day 1 and within 15 Days of last dose, including AEs with missing start dates. Participants were followed for up to 27 weeks.
|
0.00%
0/33 • Treatment-Emergent Adverse Events (TEAE) were collected, and includes all Adverse Events (AE) with a start date on or after Day 1 and within 15 Days of last dose, including AEs with missing start dates. Participants were followed for up to 27 weeks.
|
Additional Information
Eisai Inc.
Eisai Call Center
Phone: 888-422-4743
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place