EpilepsyPhase 1NCT01114854
A Conversion Study of Immediate Release (IR) and Modified Release (MR) Forms of Topiramate (TPM)
A Phase 1 study testing Topiramate IR and Topiramate ER in people with Epilepsy, run by Supernus Pharmaceuticals, Inc. at 9 sites in United States.
Trial summary
This multi-center, two-treatment study compares the pharmacokinetic profiles of Immediate Release (IR) and Modified Release (MR) formulations of Topiramate (TPM) in patients with epilepsy. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Epilepsy
- What is being tested?
- Topiramate IR and Topiramate ER
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 9 sitesUnited States
- Study dates
- Jun 2010to Jan 2011
- Phase
- Phase 1
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult male or female patients with epilepsy on stable doses of topiramate.
- Able to voluntarily provide written informed consent to participate in the study.
- Use of an effective form of birth control if of child-bearing potential.
Who cannot join
- Diagnosis of status epilepticus, non-epileptic seizures, or any progressive CNS disease.
- Recent or recurrent suicidal thoughts or ideation.
- Clinically significant medical condition that may affect the safety of the subject.
- Females who are pregnant or lactating.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
James Kiely
Atlanta, Georgia, 30342
Dr. Segal
Fort Lauderdale, Florida, 33308
Dr. Sackellares
Gainesville, Florida, 32607
Dr. Chumley
Lexington, Kentucky, 20513
Victor Biton
Little Rock, Arkansas, 72205
Mohammed Bari
National City, California, 91950
Dr. Fisher
Oklahoma City, Oklahoma, 73112
Kyle Patrick
Phoenix, Arizona, 85013
Bassem El-Nabbout
Wichita, Kansas, 67214
About this study
Official title: A Conversion Study to Determine the Relative Bioavailability of TPM MR vs TPM IR in Subjects With Epilepsy
This multi-center, two-treatment study compares the pharmacokinetic profiles of Immediate Release (IR) and Modified Release (MR) formulations of Topiramate (TPM) in patients with epilepsy.
- Conditions
- Epilepsy
- Being tested
- Topiramate IR, Topiramate ER
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topiramate IRDrug
Also called Topamax®
Topiramate ERDrug
Also called SPN-538T
| Study group | Role | What they receive |
|---|---|---|
| Topiramate IR followed by Topiramate ER | Other | Dosing with IR followed by dosing with ER Receives: Drug: Topiramate IR; Drug: Topiramate ER |
What is being measured
The primary outcome is the main question the study is designed to answer.
relative bioavailability at steady-state of TPM MR and TPM IR, as determined by TPM levels in plasma
Measured: 2 weeks
Secondary outcomes (1)
relative bioavailability of TPM MR immediately following switch from TPM IR, as determined by TPM levels in plasma
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2010 (estimated)
- Study startJun 2010
- Primary completionDec 2010
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Supernus Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Paolo Baroldi, MD, PhD, Study director, Supernus Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01114854
- Sponsor's protocol ID
- 538P108
- Status last verified
- May 2017
- First submitted
- 28 Apr 2010
- Last updated
- 18 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Conversion Study to Determine the Relative Bioavailability of TPM MR vs TPM IR in Subjects With Epilepsy
- ClinicalTrials.gov ID
- NCT01114854
- Acronym / sponsor ID
- 538P108
- Conditions
- Epilepsy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Supernus Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 3 May 2010 (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.
This multi-center, two-treatment study compares the pharmacokinetic profiles of Immediate Release (IR) and Modified Release (MR) formulations of Topiramate (TPM) in patients with epilepsy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Topiramate IR followed by Topiramate ER | Other | Drug: Topiramate IR, Drug: Topiramate ERDosing with IR followed by dosing with ER |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult male or female patients with epilepsy on stable doses of topiramate.
- Able to voluntarily provide written informed consent to participate in the study.
- Use of an effective form of birth control if of child-bearing potential.
Key exclusion criteria (4 listed)
- Diagnosis of status epilepticus, non-epileptic seizures, or any progressive CNS disease.
- Recent or recurrent suicidal thoughts or ideation.
- Clinically significant medical condition that may affect the safety of the subject.
- Females who are pregnant or lactating.
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 |
|---|---|---|
| Topiramate IRAlso: Topamax® | Drug | Topiramate IR followed by Topiramate ER |
| Topiramate ERAlso: SPN-538T | Drug | Topiramate IR followed by Topiramate ER |
Primary outcome
relative bioavailability at steady-state of TPM MR and TPM IR, as determined by TPM levels in plasma
Time frame: 2 weeks
1 secondary outcome
relative bioavailability of TPM MR immediately following switch from TPM IR, as determined by TPM levels in plasma
Time frame: 2 weeks
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 18 May 2017.
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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.
Paolo Baroldi, MD, PhD study director
Supernus Pharmaceuticals, Inc.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Topiramate IR and Topiramate ER in people with Epilepsy, run by Supernus Pharmaceuticals, Inc. at 9 sites in United States.
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 3 inclusion and 4 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 18 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
relative bioavailability at steady-state of TPM MR and TPM IR, as determined by TPM levels in plasma (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 May 2017; AzTrials last refreshed its copy on 29 Oct 2026.