Clinical Trial Results:
Multicenter, Open-Label Extension Study to Evaluate the Long-Term Safety and Tolerability of Oxcarbazepine Extended-Release (OXC XR) as Adjunctive Therapy in Subjects with Refractory Partial Epilepsy on up to Three Concomitant Anti-epileptic Medications
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Summary
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EudraCT number |
2008-003334-19 |
Trial protocol |
BG |
Global end of trial date |
30 Nov 2011
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Results information
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Results version number |
v1(current) |
This version publication date |
26 Jun 2022
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First version publication date |
26 Jun 2022
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Other versions |
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Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
804P302
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT00908349 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Supernus Pharmaceuticals, Inc.
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Sponsor organisation address |
9715 Key West Avenue, Rockville, MD, United States, 20850
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Public contact |
Jonathan Rubin, MD, Supernus Pharmaceuticals, Inc., jrubin@supernus.com
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Scientific contact |
Joseph T. Hull, PhD, Supernus Pharmaceuticals, Inc., jhull@supernus.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
26 Jun 2012
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
26 Nov 2011
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Global end of trial reached? |
Yes
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Global end of trial date |
30 Nov 2011
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
The primary objective of this study is to evaluate the safety and tolerability of long-term administration of adjunctive oxcarbazepine extended-release (OXC XR) in the treatment of seizures of partial origin in adult subjects with refractory epilepsy receiving up to three concomitant anti-epileptic drugs (AEDs).
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Protection of trial subjects |
All potential study participants provided informed consent. Subjects who completed the randomized, double-blind, placebo-control trial (804P301) and who continued to meet the inclusion/exclusion criteria were eligible to participate for this open-label extension (OLE) safety trial (804P302). Eligible subjects who enrolled and received study medication in this OLE trial were monitored for safety and tolerability throughout the study. During treatment at study visits and/or at the end of study (or early discontinuation) visit, the following clinical assessments were performed: physical and neurological exam, vital signs (blood pressure, pulse rate, respiratory rate, temperature), weight, clinical laboratory testing (hematology/chemistry), 12-lead electrocardiogram, urine pregnancy test (women of childbearing potential only), review of subject's concomitant medications and assess/record adverse events.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
19 Nov 2009
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Poland: 31
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Country: Number of subjects enrolled |
Romania: 12
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Country: Number of subjects enrolled |
Bulgaria: 26
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Country: Number of subjects enrolled |
United States: 43
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Country: Number of subjects enrolled |
Canada: 2
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Country: Number of subjects enrolled |
Mexico: 30
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Country: Number of subjects enrolled |
Croatia: 6
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Country: Number of subjects enrolled |
Russian Federation: 64
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Worldwide total number of subjects |
214
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EEA total number of subjects |
75
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
213
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From 65 to 84 years |
1
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85 years and over |
0
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Recruitment
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Recruitment details |
Subjects who completed the Phase 3, randomized, double-blind, placebo-control trial (804P301) and met the inclusion/exclusion criteria for this trial (804P302) were eligible to participate in this open-label extension safety trial. | ||||||||||||||||||||||
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Pre-assignment
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Screening details |
Subjects who completed the Phase 3, randomized, double-blind, placebo-control trial (804P301) and met the inclusion/exclusion criteria for this trial (804P302) were eligible to participate in this open-label extension safety trial. | ||||||||||||||||||||||
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Period 1
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Period 1 title |
Open-Label Extension (OLE) (overall period)
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Is this the baseline period? |
Yes | ||||||||||||||||||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||||||||||||||||||
Blinding implementation details |
Intervention Model: Single Group Assignment; Masking: None (Open Label)
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Arms
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Arm title
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Oxcarbazepine extended-release (OXC XR) | ||||||||||||||||||||||
Arm description |
Subjects who received at least one dose of Oxcarbazepine extended-release (OXC XR) and had at least 3 weeks of seizure diary data between Week 4 and Week 48 of treatment | ||||||||||||||||||||||
Arm type |
Open-Label | ||||||||||||||||||||||
Investigational medicinal product name |
Oxcarbazepine extended-release (OXC XR)
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Investigational medicinal product code |
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Other name |
SPN-804
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
Oxcarbazepine extended-release (OXC XR) was supplied in 300mg and 600mg tablets. For the first 4 weeks (Day 1 to Day 28) of treatment, subjects took 1200mg OXC XR (two 600mg OXC XR tablets) once daily. From Week 5 to Week 48 (Day 29 to Day 337), the total daily dose of OXC XR could be titrated up or tapered down in increments/decrements of 300mg or 600mg every 3 days between a minimum total daily dose of 600mg/day and maximum total daily dose of 2400mg/day. From Week 49 to Week 52 (Day 338 to 365), subject's total daily dose of OXC XR was then tapered down in decrements of 600mg/day per week until subject is tapered off OXC XR. In addition, during the 52 weeks (12 months) of treatment, subjects continued their adjunctive anti-epileptic drug (AED) treatment(s) (one to three AEDs).
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Baseline characteristics reporting groups
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Reporting group title |
Open-Label Extension (OLE)
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Reporting group description |
Subjects who received at least one dose of Oxcarbazepine extended-release (OXC XR) | |||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Oxcarbazepine extended-release (OXC XR)
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Reporting group description |
Subjects who received at least one dose of Oxcarbazepine extended-release (OXC XR) and had at least 3 weeks of seizure diary data between Week 4 and Week 48 of treatment | ||
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End point title |
Percent Seizure Change in Monthly (28-Day) Seizure Frequency (PCH) [1] | ||||||||
End point description |
Efficacy was measured as median percent change from baseline monthly 28-day seizure frequency (PCH) to the End of Treatment (EOT, Visit 5, start of OXC XR taper)
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End point type |
Primary
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End point timeframe |
Treatment Period Visits 1-5, Days 0-337
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| Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: There are no statistical data to report other than descriptive statistics (median, minimum and maximum percent change). Since this is an open-label extension trial, there is only one arm. Therefore, no group comparisons are possible. In addition, no statistical comparison(s) between treatment period and baseline were prespecified. |
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| No statistical analyses for this end point | |||||||||
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Adverse events information
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Timeframe for reporting adverse events |
12 months of open-label extension trial
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Adverse event reporting additional description |
Number of subjects is based on the Safety Population (defined as subjects who took at least one dose of study medication).
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
11.1
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Reporting groups
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Reporting group title |
Oxcarbazepine extended-release (OXC XR)
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Reporting group description |
The number of subjects reported in each treatment arm for serious adverse events and non-serious adverse events is based on the Safety Population, defined as all enrolled subjects who took at least one dose of Oxcarbazepine extended-release (OXC XR). | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
