Trial Outcomes & Findings for Safety and Tolerability of OXC XR as Adjunctive Therapy in Subjects With Refractory Partial Epilepsy (NCT NCT00908349)
NCT ID: NCT00908349
Last Updated: 2017-05-31
Results Overview
Measured as change from baseline to end of study
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
214 participants
Primary outcome timeframe
one year
Results posted on
2017-05-31
Participant Flow
Participant milestones
| Measure |
Oxcarbazepine XR
Oxcarbazepine XR: Open Label Study 600mg to 2400mg of SPN-804O once daily.
|
|---|---|
|
Overall Study
STARTED
|
214
|
|
Overall Study
COMPLETED
|
179
|
|
Overall Study
NOT COMPLETED
|
35
|
Reasons for withdrawal
| Measure |
Oxcarbazepine XR
Oxcarbazepine XR: Open Label Study 600mg to 2400mg of SPN-804O once daily.
|
|---|---|
|
Overall Study
Adverse Event
|
10
|
|
Overall Study
Withdrawal by Subject
|
9
|
|
Overall Study
Physician Decision
|
5
|
|
Overall Study
Lost to Follow-up
|
5
|
|
Overall Study
Various
|
6
|
Baseline Characteristics
Safety and Tolerability of OXC XR as Adjunctive Therapy in Subjects With Refractory Partial Epilepsy
Baseline characteristics by cohort
| Measure |
Oxcarbazepine XR
n=214 Participants
Open Label Study
Oxcarbazepine XR: Open Label Study
|
|---|---|
|
Age, Continuous
|
37.4 Years
n=5 Participants
|
|
Sex: Female, Male
Female
|
111 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
103 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
43 participants
n=5 Participants
|
|
Region of Enrollment
Mexico
|
30 participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
2 participants
n=5 Participants
|
|
Region of Enrollment
Poland
|
31 participants
n=5 Participants
|
|
Region of Enrollment
Romania
|
12 participants
n=5 Participants
|
|
Region of Enrollment
Croatia
|
6 participants
n=5 Participants
|
|
Region of Enrollment
Russian Federation
|
64 participants
n=5 Participants
|
|
Region of Enrollment
Bulgaria
|
26 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: one yearMeasured as change from baseline to end of study
Outcome measures
| Measure |
Oxcarbazepine XR
n=214 Participants
Oxcarbazepine XR: Open Label Study 600mg to 2400mg of SPN-804O once daily.
|
|---|---|
|
Percent Change in Seizure Rate
|
-26.3 percentage of change in seizure rate
Interval -100.0 to 344.7
|
Adverse Events
Oxcarbazepine XR
Serious events: 18 serious events
Other events: 124 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Oxcarbazepine XR
n=214 participants at risk
Oxcarbazepine XR: Open Label Study 600mg to 2400mg of SPN-804O once daily.
|
|---|---|
|
General disorders
Hypothermia
|
0.47%
1/214 • Number of events 1
|
|
Injury, poisoning and procedural complications
Spinal Fracture
|
0.47%
1/214 • Number of events 1
|
|
Nervous system disorders
Ataxia
|
0.47%
1/214 • Number of events 1
|
|
Nervous system disorders
Transient Ischaemic Attack
|
0.47%
1/214 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
0.47%
1/214 • Number of events 1
|
|
Nervous system disorders
Convulsion
|
0.47%
1/214 • Number of events 1
|
|
Investigations
Prostatic Specific Antigen Increased
|
0.47%
1/214 • Number of events 1
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.47%
1/214 • Number of events 1
|
|
Nervous system disorders
Grand Mal Convulsion
|
0.93%
2/214 • Number of events 2
|
|
General disorders
Non-Cardiac Chest Pain
|
0.93%
2/214 • Number of events 2
|
|
Nervous system disorders
Epilepsy
|
0.93%
2/214 • Number of events 2
|
|
Psychiatric disorders
Suicidal Behaviour
|
0.47%
1/214 • Number of events 1
|
|
Nervous system disorders
Encephalopathy
|
0.47%
1/214 • Number of events 1
|
|
Infections and infestations
Pyelonephritis Acute
|
0.47%
1/214 • Number of events 1
|
|
Vascular disorders
Thrombosis
|
0.47%
1/214 • Number of events 1
|
Other adverse events
| Measure |
Oxcarbazepine XR
n=214 participants at risk
Oxcarbazepine XR: Open Label Study 600mg to 2400mg of SPN-804O once daily.
|
|---|---|
|
Nervous system disorders
Dizziness
|
15.4%
33/214
|
|
Nervous system disorders
Headache
|
11.2%
24/214
|
|
Eye disorders
Diplopia
|
9.3%
20/214
|
|
Gastrointestinal disorders
Nausea
|
7.5%
16/214
|
|
Gastrointestinal disorders
Vomiting
|
6.1%
13/214
|
|
Nervous system disorders
Somnolence
|
5.6%
12/214
|
|
Nervous system disorders
Balance Disorder
|
4.7%
10/214
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract infection
|
4.7%
10/214
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER