Partial Seizure DisorderPhase 3NCT00113815
Topiramate as Adjunctive Therapy in Infants 1-24 Months for the Control of Partial Onset Seizures
A Phase 3 study testing topiramate in people with Partial Seizure Disorder and Epilepsy, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. at 94 sites in 23 countries.
Trial summary
The purpose of this study is to evaluate the tolerability, safety and efficacy of topiramate in infants with refractory partial onset seizures (POS). Read more about this study
- Who is it for?
- Ages 1 month to 24 months
- Conditions the study is for
- Partial Seizure Disorder, Epilepsy, Seizures
- What is being tested?
- topiramate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 118 participants
- Where
- 94 sitesin 23 countries
- Study dates
- May 2005to Nov 2007
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 1 month to 24 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 1-24 months, inclusive
- Concurrent 1 or 2 antiepileptic drugs
- Receiving regular enteral feedings
- Weigh between 3.5 and 15 kg
- Clinical or EEG evidence of simple or complex POS
Who cannot join
- Exclusively breast fed and cannot take medicine by mouth
- Surgically implanted and functioning vagus nerve stimulator
- Renal stones
- Medically uncontrolled illnesses or conditions
- Infantile seizures as a result of a correctable medical condition
- Progressive neurologic disorder
Trial locations and contacts
94 sites in 23 countries.
94 sites in 23 countries
United States47 sites
Study site
Ann Arbor, Michigan
Study site
Augusta, Georgia
Study site
Birmingham, Alabama
Study site
Boston, Massachusetts
Study site
Buffalo, New York
Study site
Chapel Hill, North Carolina
Study site
Charleston, South Carolina
Study site
Cherry Hill, New Jersey
Study site
Chicago, Illinois
Study site
Cincinnati, Ohio
Study site
Cleveland, Ohio
Study site
Columbia, Missouri
Study site
Danville, Pennsylvania
Study site
Dearborn, Michigan
Study site
Denver, Colorado
Study site
Durham, North Carolina
Study site
Fort Worth, Texas
Study site
Germantown, Tennessee
Study site
Hershey, Pennsylvania
Study site
Kansas City, Missouri
Study site
Los Angeles, California
Study site
Louisville, Kentucky
Study site
Loxahatchee Groves, Florida
Study site
Madison, Wisconsin
Study site
Miami, Florida
Study site
Mineola, New York
Study site
Mobile, Alabama
Study site
New Haven, Connecticut
Study site
Newark, New Jersey
Study site
Norfolk, Virginia
Study site
Orlando, Florida
Study site
Park Ridge, Illinois
Study site
Pensacola, Florida
Study site
Philadelphia, Pennsylvania
Study site
Pittsburgh, Pennsylvania
Study site
Plano, Texas
Study site
Providence, Rhode Island
Study site
Rochester, New York
Study site
Saint Paul, Minnesota
Study site
Shreveport, Louisiana
Study site
Springfield, Missouri
Study site
St Louis, Missouri
Study site
Stony Brook, New York
Study site
Syracuse, New York
Study site
Tampa, Florida
Study site
Washington D.C., District of Columbia
Study site
Wilmington, Delaware
India6 sites
Study site
Chennai
Study site
Hyderabad Gpo
Study site
Kochi Ho
Study site
Mumbai
Study site
New Delhi
Study site
Pune
Argentina4 sites
Study site
Buenos Aires
Study site
Córdoba
Study site
Rio Negro
Study site
Santa Fe
Belgium4 sites
Study site
Antwerp
Study site
Ghent
Study site
Leuven
Study site
Pulderbos
Russia4 sites
Study site
Ekaterinburg Siberia
Study site
Moscow
Study site
Omsk Siberia
Study site
Samara
Australia3 sites
Study site
Heidelberg West
Study site
Melbourne
Study site
Subiaco
Canada2 sites
Study site
Saskatoon, Saskatchewan
Study site
St. John's, Newfoundland and Labrador
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Fixed Dose-Ranging Study to Assess the Safety, Tolerability, and Efficacy of Topiramate Oral Liquid and Sprinkle Formulations as an Adjunct to Concurrent Anticonvulsant Therapy for Infants (1-24 Months of Age) With Refractory Partial-Onset Seizures
The purpose of this study is to evaluate the tolerability, safety and efficacy of topiramate in infants with refractory partial onset seizures (POS).
Read the detailed description
This is a world wide, multicenter, randomized, double-blind, placebo-controlled study to evaluate the tolerability, safety and efficacy of 3 target doses (5, 15, and 25 mg/kg/day) of topiramate compared with placebo as an adjunct therapy in infants with refractory partial onset seizures (POS). There are 4 phases to the study, a screening phase of 3 days, a double blind treatment phase of 20 days, a one year open label extension phase and a posttreatment (taper and withdrawal) phase. The oral liquid formulation will also be assessed during this study, as it is investigational, unlike the marketed sprinkle formulation. 5, 15, 25 mg/kg/day of topriramate sprinkle and oral liquid formulation will be administered during the four phases of the study.
- Conditions
- Partial Seizure Disorder, Epilepsy, Seizures
- Being tested
- topiramate, placebo
- Keywords
- Partial seizure disorder, Topiramate, Epilepsy, Infants
- Medical subject headings
- Epilepsies, Partial, Epilepsy, Seizures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
topiramateDrug
15 mg/kg/day
topiramateDrug
5 mg/kg/day
topiramateDrug
25 mg/kg/day
placeboDrug
placebo
| Study group | Role | What they receive |
|---|---|---|
| 003 | Experimental | topiramate 25 mg/kg/day Receives: Drug: topiramate |
| 002 | Experimental | topiramate 15 mg/kg/day Receives: Drug: topiramate |
| 001 | Experimental | topiramate 5 mg/kg/day Receives: Drug: topiramate |
| 004 | Experimental | placebo placebo Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Video-recorded EEG was primary efficacy measure. Baseline vEEG and the vEEG at Visit 4 (Days 19 to 20; end point DB treatment phase or early withdrawal) will be read by a blinded central reader
Measured: Video-recorded EEG was primary efficacy measure. Baseline vEEG and the vEEG at Visit 4 (Days 19 to 20; end point DB treatment phase or early withdrawal) will be read by a blinded central reader
Secondary outcomes (1)
Percent treatment responders >=50% reduction seizure rate. ·Percentage change in seizure rate recorded on subject take-home records. Percentage change in seizure rates for all seizure types recorded on VEEG.
Measured: Baseline to endpoint of double blind phase
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2005 (estimated)
- Study startMay 2005
- Primary completionJun 2007
- Study completionNov 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Partial Seizure DisorderStudies 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
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial, Study director, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00113815
- Sponsor's protocol ID
- CR002233
- Status last verified
- Mar 2014
- First submitted
- 10 Jun 2005
- Last updated
- 26 Mar 2014
- Results posted
- No
Publications
Novotny E, Renfroe B, Yardi N, Nordli D, Ness S, Wang S, Weber T, Kurland CL, Yuen E, Eerdekens M, Venkatraman L, Nye JS, Ford L. Randomized trial of adjunctive topiramate therapy in infants with refractory partial seizures. Neurology. 2010 Mar 2;74(9):714-20. doi: 10.1212/WNL.0b013e3181d1cd4c. Epub 2010 Jan 20.
PubMed 20089937Ness S, Todd MJ, Wang S, Eerdekens M, Nye JS, Ford L. Adaptive behavior outcomes in infants treated with adjunctive topiramate. Pediatr Neurol. 2012 Jun;46(6):350-8. doi: 10.1016/j.pediatrneurol.2012.02.028.
PubMed 22633629Puri V, Ness S, Sattaluri SJ, Wang S, Todd M, Yuen E, Eerdekens M, Nye JS, Manitpisitkul P, Shalayda K, Ford L. Long-term open-label study of adjunctive topiramate in infants with refractory partial-onset seizures. J Child Neurol. 2011 Oct;26(10):1271-83. doi: 10.1177/0883073811406982. Epub 2011 Jun 14.
PubMed 21673279
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Fixed Dose-Ranging Study to Assess the Safety, Tolerability, and Efficacy of Topiramate Oral Liquid and Sprinkle Formulations as an Adjunct to Concurrent Anticonvulsant Therapy for Infants (1-24 Months of Age) With Refractory Partial-Onset Seizures
- ClinicalTrials.gov ID
- NCT00113815
- Acronym / sponsor ID
- CR002233
- Conditions
- Partial Seizure Disorder, Epilepsy, Seizures
- Keywords
- Partial seizure disorder, Topiramate, Epilepsy, Infants
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.Industry (pharma, biotech, devices)
- Study start
- May 2005
- Primary completion
- Jun 2007 (actual)
- Study completion
- Nov 2007 (actual)
- First posted
- 13 Jun 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the tolerability, safety and efficacy of topiramate in infants with refractory partial onset seizures (POS).
Detailed description
This is a world wide, multicenter, randomized, double-blind, placebo-controlled study to evaluate the tolerability, safety and efficacy of 3 target doses (5, 15, and 25 mg/kg/day) of topiramate compared with placebo as an adjunct therapy in infants with refractory partial onset seizures (POS). There are 4 phases to the study, a screening phase of 3 days, a double blind treatment phase of 20 days, a one year open label extension phase and a posttreatment (taper and withdrawal) phase. The oral liquid formulation will also be assessed during this study, as it is investigational, unlike the marketed sprinkle formulation. 5, 15, 25 mg/kg/day of topriramate sprinkle and oral liquid formulation will be administered during the four phases of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 003 | Experimental | Drug: topiramatetopiramate 25 mg/kg/day |
| 002 | Experimental | Drug: topiramatetopiramate 15 mg/kg/day |
| 001 | Experimental | Drug: topiramatetopiramate 5 mg/kg/day |
| 004 | Experimental | Drug: placeboplacebo placebo |
Who may qualify
- Ages
- 1 month to 24 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 1-24 months, inclusive
- Concurrent 1 or 2 antiepileptic drugs
- Receiving regular enteral feedings
- Weigh between 3.5 and 15 kg
- Clinical or EEG evidence of simple or complex POS
Key exclusion criteria (6 listed)
- Exclusively breast fed and cannot take medicine by mouth
- Surgically implanted and functioning vagus nerve stimulator
- Renal stones
- Medically uncontrolled illnesses or conditions
- Infantile seizures as a result of a correctable medical condition
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 |
|---|---|---|
| topiramate15 mg/kg/day | Drug | 002 |
| topiramate5 mg/kg/day | Drug | 001 |
| topiramate25 mg/kg/day | Drug | 003 |
| placeboplacebo | Drug | 004 |
Primary outcome
Video-recorded EEG was primary efficacy measure. Baseline vEEG and the vEEG at Visit 4 (Days 19 to 20; end point DB treatment phase or early withdrawal) will be read by a blinded central reader
Time frame: Video-recorded EEG was primary efficacy measure. Baseline vEEG and the vEEG at Visit 4 (Days 19 to 20; end point DB treatment phase or early withdrawal) will be read by a blinded central reader
1 secondary outcome
Percent treatment responders >=50% reduction seizure rate. ·Percentage change in seizure rate recorded on subject take-home records. Percentage change in seizure rates for all seizure types recorded on VEEG.
Time frame: Baseline to endpoint of double blind phase
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2014.
- Results publication: PubMed 20089937Novotny E, Renfroe B, Yardi N, Nordli D, Ness S, Wang S, Weber T, Kurland CL, Yuen E, Eerdekens M, Venkatraman L, Nye JS, Ford L. Randomized trial of adjunctive topiramate therapy in infants with refractory partial seizures. Neurology. 2010 Mar 2;74(9):714-20. doi: 10.1212/WNL.0b013e3181d1cd4c. Epub 2010 Jan 20.
- Derived from this study: PubMed 22633629Ness S, Todd MJ, Wang S, Eerdekens M, Nye JS, Ford L. Adaptive behavior outcomes in infants treated with adjunctive topiramate. Pediatr Neurol. 2012 Jun;46(6):350-8. doi: 10.1016/j.pediatrneurol.2012.02.028.
- Derived from this study: PubMed 21673279Puri V, Ness S, Sattaluri SJ, Wang S, Todd M, Yuen E, Eerdekens M, Nye JS, Manitpisitkul P, Shalayda K, Ford L. Long-term open-label study of adjunctive topiramate in infants with refractory partial-onset seizures. J Child Neurol. 2011 Oct;26(10):1271-83. doi: 10.1177/0883073811406982. Epub 2011 Jun 14.
- Topiramate as Adjunctive Therapy in Infants 1-24 Months for the Control of Partial Onset SeizuresLink provided by the sponsor.
Related trials for Partial Seizure Disorder
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
Focal Seizure, Epilepsy
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
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.
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial study director
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
94 sites in 23 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing topiramate in people with Partial Seizure Disorder and Epilepsy, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. at 94 sites in 23 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 5 inclusion and 6 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 26 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 94 sites in United States, India, Argentina, Belgium, Russia and 18 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Video-recorded EEG was primary efficacy measure. Baseline vEEG and the vEEG at Visit 4 (Days 19 to 20; end point DB treatment phase or early withdrawal) will be read by a blinded central reader (time frame: Video-recorded EEG was primary efficacy measure. Baseline vEEG and the vEEG at Visit 4 (Days 19 to 20; end point DB treatment phase or early withdrawal) will be read by a blinded central reader). 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 NCT00113815, which also lists 3 linked publications.
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 26 Mar 2014.