Epilepsies, PartialPhase 3PROSPER1NCT00772603

Evaluation of Efficacy and Safety of OXC XR as Adjunctive Therapy for Partial Seizures

A Phase 3 study testing 2400mg SPN-804 and 1200mg SPN-804 in people with Epilepsies, Partial, run by Supernus Pharmaceuticals, Inc. at 71 sites in 8 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Evaluation of the safety and efficacy of Oxcarbazepine XR as adjunctive treatment for adults with partial onset seizures Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Epilepsies, Partial
What is being tested?: 2400mg SPN-804 and 1200mg SPN-804
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 366 participants
Where: 71 sitesin 8 countries
Study dates: Nov 2008to Nov 2010
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Capable of complying with the study procedures.
Able to provide written informed consent
Male or female aged 18 to 65 years, inclusive.
Diagnosis of partial onset seizures
Minimum of three seizures per 28 days
Receiving treatment with 1-3 AEDs

Show all 9Show fewer

Refractory to at least one AED
No progressive neurological conditions by recent MRI/CT
Adequate birth control in women of child-bearing potential

Who cannot join

Refractory to OXC for reasons of efficacy
Recent status epilepticus
Recent non-epileptic seizures
Current diagnosis of major depression
Recent suicidal plan or intent or more than one attempt
Current use of oxcarbazepine, felbamate for < 18 months, phenytoin with levels >15mcg/mL or frequent need for rescue benzodiazepines

Show all 12Show fewer

Current use of sodium-lowering non-seizure medications.
Clinically significant hepatic, renal, or cardiovascular function
History of recent substance abuse
Females who are pregnant or lactating.
Hypersensitivity to OXC or related drugs
Difficulty swallowing study medication

Trial locations and contacts

71 sites in 8 countries.

Country

City, postcode or hospital

71 sites in 8 countries

United States23 sites

Study site
Atlanta, Georgia
Study site
Aurora, Colorado
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Baytown, Texas
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Bethesda, Maryland
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Camden, New Jersey
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Huntsville, Alabama
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Jacksonville, Florida
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Lexington, Kentucky
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Little Rock, Arkansas
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Miami, Florida
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Missoula, Montana
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Nashville, Tennessee
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New York, New York
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Northport, Alabama
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Oklahoma City, Oklahoma
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Philadelphia, Pennsylvania
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Phoenix, Arizona
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Riverside, California
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Sarasota, Florida
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Springfield, Illinois
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Temple, Texas
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Tucson, Arizona
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West Los Angeles, California

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Russia12 sites

Study site
Kazan'
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Kirov
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Kursk
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Moscow
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Nizhny Novgorod
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Novosibirsk
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Pyatigorsk
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Saint Petersburg, Sestroretsk
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Saint Petersburg
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Samara
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Smolensk
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Yaroslavl

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Mexico11 sites

Study site
Aguascalientes, Aguascalientes
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Chihuahua City, Chihuahua
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Ciudad Juárez, Chihuahua
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Durango, Durango
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Guadalajara, Jalisco
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Mexico City, Mexico City
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Monterrey, Nuevo León
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Puebla City, Puebla
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San Luis Potosí City, San Luis Potosí
Study site
Toluca, State of Mexico
Study site
Zapopan, Jalisco

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Poland9 sites

Study site
Giżycko
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Gmina Końskie
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Katowice
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Krakow
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Lodz
Study site
Lublin
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Warsaw
Study site
Wilkowice
Study site
Zabrze

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Bulgaria6 sites

Study site
Blagoevgrad
Study site
Pleven
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Plovdiv
Study site
Rousse
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Sofia
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Varna

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Croatia4 sites

Study site
Dubrovnik
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Rijeka
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Zadar
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Zagreb

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Romania4 sites

Study site
Bucharest
Study site
Campulung Muscel
Study site
Cluj-Napoca
Study site
Craiova

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Canada2 sites

Study site
Edmonton, Alberta
Study site
Greenfield Park, Quebec

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About this study

Official title: Phase III Study to Evaluate the Efficacy and Safety of OXC XR as Adjunctive Therapy in Subjects With Refractory Partial Seizures

Evaluation of the safety and efficacy of Oxcarbazepine XR as adjunctive treatment for adults with partial onset seizures

Read the detailed description

Multicenter, double-blind, randomized, placebo-controlled, three-arm. parallel-group study of the efficacy and safety of extended-release oxcarbazepine in the treatment of adults with refractory partial onset epilepsy.

Conditions: Epilepsies, Partial
Being tested: Placebo, 2400mg SPN-804, 1200mg SPN-804
Keywords: Partial onset epilepsy, Partial onset seizures
Medical subject headings: Epilepsies, Partial

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PlaceboDrug
Also called sham treatment
Non-active tablet identical to study drug tablets
2400mg SPN-804Drug
Also called Oxcarbazepine extended-release, Oxtellar XR, Oxtellar
tablets containing 600mg OXC XR, identical to non-active tablets
1200mg SPN-804Drug
Also called Oxcarbazepine extended-release, Oxtellar XR, Oxtellar
two active tablets and two non-active tablets, all identical

Study groups in NCT00772603
Study group	Role	What they receive
Placebo	Placebo comparator	Placebo - four identical tablets taken orally once daily Receives: Drug: Placebo
2400 mg SPN-804	Active comparator	2400mg OXC XR taken orally once daily as four identical tablets Receives: Drug: 2400mg SPN-804
1200mg SPN-804	Active comparator	1200mg OXC XR taken orally once daily as four identical tablets Receives: Drug: 1200mg SPN-804

What is being measured

The primary outcome is the main question the study is designed to answer.

PCH(T), ITT
Percent change (PCH) in seizure frequency per 28d relative to Baseline, Treatment Phase (PCH[T]), Intent-to-Treat population.
Measured: Change at 16 weeks (4wks Titration + 12 wks Maintenance) compared to Baseline

Secondary outcomes (4)

PCH(M)- ITT
Percent change in seizure frequency per 28 days relative to Baseline, Maintenance Period (PCH[M]), Intent-to-Treat population
Measured: Change at 12 weeks (Maintenance Period) compared to Baseline
Responder Rate, ITT
Percent of patients with a positive response, defined as a 50% or greater reduction in seizure frequency per 28 days relative to Baseline, Treatment Phase, Intent-to-Treat population
Measured: At the end of 16 weeks (4 wks Titration + 12 wks Maintenance)
Seizure-Free Rates, ITT
Percent of patients seizure-free during Treatment Phase, Intent-to-Treat population
Measured: At the end of 16 weeks (4 wks Titration + 12 wks Maintenance)
Seizure Free Rate, ITT, (M)
Percent of patients seizure-free during Maintenance, Intent-to-Treat population
Measured: At the end of 12 weeks (Maintenance Period)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2008Nov 2010

First posted15 Oct 2008 (estimated)
Study startNov 2008
Primary completionApr 2010
Study completionNov 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Epilepsies, PartialStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 366 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00772603
Sponsor's protocol ID: 804P301
Acronym: PROSPER1
Status last verified: Dec 2013
First submitted: 10 Oct 2008
Last updated: 11 Feb 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 3
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures
Focal Seizure, Epilepsy
RecruitingPhase 3
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures FOCUS-1
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Active, not recruitingPhase 2
A Study to Evaluate XEN1101 as Adjunctive Therapy in Focal Epilepsy
Focal Epilepsy
Not yet recruiting
Electrophysiological Dose-Response to Anterior Thalamic Deep Brain Stimulation in Drug-Resistant Focal Epilepsy
Drug Resistant Epilepsy, Focal Epilepsy
Enrolling by invitationPhase 3
An Open-label Study of XEN1101 in Epilepsy
Focal Epilepsy, Tonic-Clonic Seizures

All Epilepsies, Partial trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase III Study to Evaluate the Efficacy and Safety of OXC XR as Adjunctive Therapy in Subjects With Refractory Partial Seizures
ClinicalTrials.gov ID: NCT00772603
Acronym / sponsor ID: PROSPER1 / 804P301
Conditions: Epilepsies, Partial
Keywords: Partial onset epilepsy, Partial onset seizures
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 366 participants (actual)
Lead sponsor: Supernus Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
Collaborators: Parexel
Study start: Nov 2008
Primary completion: Apr 2010 (actual)
Study completion: Nov 2010 (actual)
First posted: 15 Oct 2008 (estimated)
Results: Posted 11 Feb 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Evaluation of the safety and efficacy of Oxcarbazepine XR as adjunctive treatment for adults with partial onset seizures

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Placebo	Placebo comparator	Drug: PlaceboPlacebo - four identical tablets taken orally once daily
2400 mg SPN-804	Active comparator	Drug: 2400mg SPN-8042400mg OXC XR taken orally once daily as four identical tablets
1200mg SPN-804	Active comparator	Drug: 1200mg SPN-8041200mg OXC XR taken orally once daily as four identical tablets

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

Capable of complying with the study procedures.
Able to provide written informed consent
Male or female aged 18 to 65 years, inclusive.
Diagnosis of partial onset seizures
Minimum of three seizures per 28 days

Key exclusion criteria (12 listed)

Refractory to OXC for reasons of efficacy
Recent status epilepticus
Recent non-epileptic seizures
Current diagnosis of major depression
Recent suicidal plan or intent or more than one attempt

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PlaceboAlso: sham treatmentNon-active tablet identical to study drug tablets	Drug	Placebo
2400mg SPN-804Also: Oxcarbazepine extended-release, Oxtellar XR, Oxtellartablets containing 600mg OXC XR, identical to non-active tablets	Drug	2400 mg SPN-804
1200mg SPN-804Also: Oxcarbazepine extended-release, Oxtellar XR, Oxtellartwo active tablets and two non-active tablets, all identical	Drug	1200mg SPN-804

Primary outcome

PCH(T), ITT
Time frame: Change at 16 weeks (4wks Titration + 12 wks Maintenance) compared to Baseline
Percent change (PCH) in seizure frequency per 28d relative to Baseline, Treatment Phase (PCH[T]), Intent-to-Treat population.

4 secondary outcomes

PCH(M)- ITT
Time frame: Change at 12 weeks (Maintenance Period) compared to Baseline
Responder Rate, ITT
Time frame: At the end of 16 weeks (4 wks Titration + 12 wks Maintenance)
Seizure-Free Rates, ITT
Time frame: At the end of 16 weeks (4 wks Titration + 12 wks Maintenance)
Seizure Free Rate, ITT, (M)
Time frame: At the end of 12 weeks (Maintenance Period)

Results and safety

Results posted to the registry on 11 Feb 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
2400mg/Day SPN-804	123	71
1200mg/Day SPN-804	122	82
Placebo	121	95

Primary outcome: PCH(T), ITT

Time frame: Change at 16 weeks (4wks Titration + 12 wks Maintenance) compared to Baseline. Median (Full Range). Unit: percentage of change

Measure	2400mg/Day SPN-804 n = 111	1200mg/Day SPN-804 n = 109	Placebo n = 117
Value	-42.90 (53.11)	-38.20 (69.84)	-28.70 (67.34)

2400mg/Day SPN-804 vs Placebo: Median Difference (Net): -18.30 (95% CI -30.40 to -5.80), p =0.003, Wilcoxon (Mann-Whitney)
1200mg/Day SPN-804 vs Placebo: Median Difference (Net): -10.30 (95% CI -22.30 to 1.20), p =0.078, Wilcoxon (Mann-Whitney)

Population analysed: All safety population subjects with baseline Seizure Diary data and at least one visit during the Treatment Phase (ITT population). Subjects must have had at least 3 consecutive weeks of Seizure Diary data (SDD) in the Baseline Phase and at least 14 consecutive days of SDD after starting study drug.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: All randomized subjects who took at least one dose of study drug.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
2400mg/Day SPN-804	10 of 123 (8.1%)	69 of 123 (56.1%)	Not reported
1200mg/Day SPN-804	7 of 122 (5.7%)	57 of 122 (46.7%)	Not reported
Placebo	7 of 121 (5.8%)	55 of 121 (45.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Epilepsies, Partial

RecruitingPhase 3
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Janet K Johnson, PhD study director

Supernus Pharmaceuticals, Inc.

71 sites in 8 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing 2400mg SPN-804 and 1200mg SPN-804 in people with Epilepsies, Partial, run by Supernus Pharmaceuticals, Inc. at 71 sites in 8 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 71 sites in United States, Russia, Mexico, Poland, Bulgaria and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Feb 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PCH(T), ITT (time frame: Change at 16 weeks (4wks Titration + 12 wks Maintenance) compared to Baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00772603.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2014.