CClinicalTrials.gg
CompletedNCT00908349Updated May 31, 2017Results posted

Safety and Tolerability of OXC XR as Adjunctive Therapy in Subjects With Refractory Partial Epilepsy

A Phase 3 interventional study of Oxcarbazepine XR in Partial Epilepsy, sponsored by Supernus Pharmaceuticals, Inc.. Completed at 58 sites in 8 countries. Open to participants aged 18 Years to 66 Years. Per ClinicalTrials.gov, last updated 2017-05-31.

Sponsored by Supernus Pharmaceuticals, Inc. · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
214
Allocation
Not applicable
Ages
18 Years to 66 Years
Sex
All
01

Study summary

Open-Label Extension Study to Evaluate the Long-Term Safety and Tolerability of Oxcarbazepine Extended-Release (OXC XR)

Read the detailed description

NAP

02

Conditions studied

  • Partial Epilepsy
03

In context

Epilepsy

1,805 studies on the registry are indexed under Epilepsy; 417 are open to participants now.

This study's enrollment of 214 is above the median of 50 across 1,206 interventional studies indexed under Epilepsy.

Browse Epilepsy studies →

Lead sponsor

Supernus Pharmaceuticals, Inc. is the lead sponsor of 61 studies on the registry; 6 are open to participants now.

Of its 31 completed or terminated interventional studies of FDA-regulated products, 25 (81%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 66 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Able to provide written informed consent and agree to comply with study procedures.
  2. Male or female aged 18 to 66 years, inclusive.
  3. Successful completion of the 804P301 study.
  4. Sexually active women, unless surgically sterile (at least 6 months prior to Study Medication [SM] administration) or at least 1 year post-menopausal, must use an effective method of avoiding pregnancy (including oral, transdermal, or implanted contraceptives [any hormonal method in conjunction with a secondary method], intrauterine device, female condom with spermicide, diaphragm with spermicide, cervical cap, abstinence, use of condom with spermicide by sexual partner or sterile [at least 6 months prior to SM administration] sexual partner) for at least four weeks prior to SM administration, and must agree to continue using such precautions through the End of Study visit. Cessation of birth control after this point should be discussed with a responsible physician.

Exclusion criteria

Exclusion Criteria

  1. Clinically significant change in health status that, in the opinion of the Investigator, would prevent the subject from participating in this study or successfully completing this study.
  2. Any reason which, in the opinion of the Investigator, would prevent the subject from participating in the study.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
214 participants (actual)

Study arms

  • Other
    Oxcarbazepine XR

    Open Label Study

    Drug: Oxcarbazepine XR

Interventions

  • DrugOxcarbazepine XR

    Open Label Study

    Also known as: SPN-804O

06

What researchers measure

Primary outcomes

  1. Percent Change in Seizure Rate

    Measured as change from baseline to end of study

    Time frame: one year

07

Results

Posted May 31, 2017

Participant flow

Participant flow — Overall Study
MilestoneOxcarbazepine XR
Started214
Completed179
Not completed35
Withdrew: Adverse event10
Withdrew: Withdrawal by subject9
Withdrew: Physician decision5
Withdrew: Lost to follow-up5
Withdrew: Various6

Outcome measures

PrimaryPercent Change in Seizure Rate

Measured as change from baseline to end of study

Time frame:
one year
Reported as:
Median · percentage of change in seizure rate
Percent Change in Seizure Rate
percentage of change in seizure rateOxcarbazepine XR
Percent Change in Seizure Rate-26.3 (-100.0 to 344.7)

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Oxcarbazepine XR—18/214 (8.4%)124/214 (57.9%)
Most frequent serious events
Showing 10 of 15
Most frequent serious events
EventOxcarbazepine XR
Grand Mal ConvulsionNervous system disorders2/214
Non-Cardiac Chest PainGeneral disorders2/214
EpilepsyNervous system disorders2/214
HypothermiaGeneral disorders1/214
Spinal FractureInjury, poisoning and procedural complications1/214
AtaxiaNervous system disorders1/214
Transient Ischaemic AttackNervous system disorders1/214
DizzinessNervous system disorders1/214
ConvulsionNervous system disorders1/214
Prostatic Specific Antigen IncreasedInvestigations1/214
Most frequent other events
Most frequent other events
EventOxcarbazepine XR
DizzinessNervous system disorders33/214
HeadacheNervous system disorders24/214
DiplopiaEye disorders20/214
NauseaGastrointestinal disorders16/214
VomitingGastrointestinal disorders13/214
SomnolenceNervous system disorders12/214
Balance DisorderNervous system disorders10/214
Upper respiratory tract infectionRespiratory, thoracic and mediastinal disorders10/214

Baseline characteristics

Age, Continuous
Age, Continuous(Years)Oxcarbazepine XR
Mean37.4 (18 to 67)
Sex: Female, Male
Sex: Female, Male(Participants)Oxcarbazepine XR
Female111
Male103
Region of Enrollment
Region of Enrollment(participants)Oxcarbazepine XR
United States43
Mexico30
Canada2
Poland31
Romania12
Croatia6
Russian Federation64
Bulgaria26
08

Study locations

58 sites
  • Huntsville, Alabama, United States
  • Northport, Alabama, United States
  • Phoenix, Arizona, United States
  • Tucson, Arizona, United States
  • Little Rock, Arkansas, United States
  • Riverside, California, United States
  • West Los Angeles, California, United States
  • Aurora, Colorado, United States
  • Jacksonville, Florida, United States
  • Miami, Florida, United States
  • Sarasota, Florida, United States
  • Springfield, Illinois, United States
  • Lexington, Kentucky, United States
  • Bethesda, Maryland, United States
  • Missoula, Montana, United States
  • New York, New York, United States
  • Oklahoma City, Oklahoma, United States
  • Nashville, Tennessee, United States
  • Baytown, Texas, United States
  • Temple, Texas, United States
  • Blagoevgrad, Bulgaria
  • Pleven, Bulgaria
  • Ruse, Bulgaria
  • Sofia, Bulgaria
  • Varna, Bulgaria
  • Calgary, Alberta, Canada
  • Greenfield Park, Quebec, Canada
  • Dubrovnik, Croatia
  • Zagreb, Croatia
  • Col. Las Palmas, Chihuahua, Mexico
  • Mexico City, DF, Mexico
  • Col. Guillermina, Durango, Mexico
  • Guadalajara, Jalisco, Mexico
  • Zapopan, Jalisco, Mexico
  • San Luis Potosi, San Luis Potosí, Mexico
  • Aguascalientes, Mexico
  • Puebla, Mexico
  • Gizycko, Poland
  • Katowice, Poland
  • Krakow, Poland
  • Lodz, Poland
  • Lublin, Poland
  • Warszawa, Poland
  • Wilkowice, Poland
  • Bucharest, Romania
  • Cluj-Napoca, Romania
  • Craiova, Romania
  • Câmpulung, Romania
  • Kazan, Russian Federation
  • Kirov, Russian Federation
  • Kursk, Russian Federation
  • Moscow, Russian Federation
  • Nizhny Novgorod, Russian Federation
  • Novosibirsk, Russian Federation
  • Pyatigorsk, Russian Federation
  • Saint-Petersburg, Russian Federation
  • Samara, Russian Federation
  • Smolensk, Russian Federation
09

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 31, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00908349
Lead sponsor
Supernus Pharmaceuticals, Inc.
Responsible party
Sponsor
First posted
May 25, 2009
Start date
Jun 2009
Primary completion
Nov 2011
Completion
Nov 2011
Results posted
May 31, 2017
Last update
May 31, 2017

Study contacts

Janet K Johnson, PhD
study director · Supernus Pharmaceuticals, Inc.

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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