EpilepsyPhase 1/2NCT01284530
Evaluation of the Pharmacokinetics, Safety, and Tolerability of TPM XR as Adjunctive Therapy in Pediatric Subjects With Epilepsy
A Phase 1/2 study testing TPM XR in people with Epilepsy, run by Supernus Pharmaceuticals, Inc. at 10 sites in United States.
Trial summary
Multidose, Open-label, Multi-center Study to examine the steady state pharmacokinetics of TPM XR, as well as, safety and tolerability of repeated oral dosing in pediatric subjects with epilepsy. Read more about this study
- Who is it for?
- Ages 4 to 17 years
- Conditions the study is for
- Epilepsy
- What is being tested?
- TPM XR
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 10 sitesUnited States
- Study dates
- Jan 2011to Jun 2012
- Phase
- Phase 1/2
- 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 4 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Able to provide written IAF, as appropriate, with written informed permission (including ICF where required by regional laws or regulations) from the parent or LAR.
- Male or female aged 4 to 17 years, inclusive, with a current diagnosis of partial onset or primary generalized epilepsy.
- Current AED therapy including a stable dose of TPM IR as either adjunctive or monotherapy. All AED therapy (including a Vagal Nerve Stimulator) must have been initiated more than one month prior to Visit 1 and doses must be stable for at least two weeks prior to Visit 1.
- No diagnosis of a progressive neurological disorder based on previous imaging.
- Weight within the 25 - 80% weight-for-age percentiles based on the National Center for Health Statistics Growth Charts, and not less than 15.0kg.
- Able and willing to swallow whole capsules.
- FOCP should either be sexually inactive for two weeks prior to the first dose and throughout the study or, if sexually active, will be using an effective birth control method.
Who cannot join
- A documented history of status epilepticus in the past year or seizures secondary to conditions other than epilepsy.
- Use of either phenytoin or carbamazepine as current AEDs.
- Diagnosis or an electroencephalogram consistent with a diagnosis of seizure disorders other than partial onset or primary generalized epilepsy.
- Current diagnosis of Major Depressive Disorder or any history of suicide intent and/or attempt.
- History or presence of clinically significant, chronic medical condition which, in the opinion of the Investigator, would preclude the subject from entering the study.
- History of substance abuse or dependence.
- Females who are pregnant or lactating.
- Use of an investigational drug or device or participation in an investigational study within 30 days prior to the first dose of SM.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Study site
Akron, Ohio, 4308
Study site
Dallas, Texas, 75230
Study site
Hackensack, New Jersey, 07601
Study site
Louisville, Kentucky, 40202
Study site
Loxahatchee Groves, Florida, 33470
Study site
Miami, Florida, 33155
Study site
Norfolk, Virginia, 23510
Study site
Richmond, Virginia, 23219
Study site
Sacramento, California, 95815
Study site
Wichita, Kansas, 67214
About this study
Multidose, Open-label, Multi-center Study to examine the steady state pharmacokinetics of TPM XR, as well as, safety and tolerability of repeated oral dosing in pediatric subjects with epilepsy.
- Conditions
- Epilepsy
- Being tested
- TPM XR
- Keywords
- Epilepsy, Pediatrics, Young Adults
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TPM XRDrug
Equivalent TDD in XR form, QD, Day 1-14
| Study group | Role | What they receive |
|---|---|---|
| Conversion-25 | Experimental | 25 mg Receives: Drug: TPM XR |
| Conversion-50 | Experimental | 50 mg Receives: Drug: TPM XR |
| Conversion-100 | Experimental | 100 mg Receives: Drug: TPM XR |
| Conversion-200 | Experimental | 200 mg Receives: Drug: TPM XR |
What is being measured
The primary outcome is the main question the study is designed to answer.
steady-state pharmacokinetics (PK) of TPM XR and to assess the safety and tolerability
Relating to repeated oral dosing
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2011 (estimated)
- Study startJan 2011
- Primary completionJun 2012
- Study completionJun 2012
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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Supernus Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jennifer Stocks, Study director, Supernus Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01284530
- Sponsor's protocol ID
- 538P107
- Status last verified
- May 2016
- First submitted
- 25 Jan 2011
- Last updated
- 2 Jun 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Pharmacokinetics, Safety, and Tolerability of TPM XR as Adjunctive Therapy in Pediatric Subjects With Epilepsy
- ClinicalTrials.gov ID
- NCT01284530
- Acronym / sponsor ID
- 538P107
- Conditions
- Epilepsy
- Keywords
- Epilepsy, Pediatrics, Young Adults
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Supernus Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2011
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 27 Jan 2011 (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.
Multidose, Open-label, Multi-center Study to examine the steady state pharmacokinetics of TPM XR, as well as, safety and tolerability of repeated oral dosing in pediatric subjects with epilepsy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Conversion-25 | Experimental | Drug: TPM XR25 mg |
| Conversion-50 | Experimental | Drug: TPM XR50 mg |
| Conversion-100 | Experimental | Drug: TPM XR100 mg |
| Conversion-200 | Experimental | Drug: TPM XR200 mg |
Who may qualify
- Ages
- 4 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Able to provide written IAF, as appropriate, with written informed permission (including ICF where required by regional laws or regulations) from the parent or LAR.
- Male or female aged 4 to 17 years, inclusive, with a current diagnosis of partial onset or primary generalized epilepsy.
- Current AED therapy including a stable dose of TPM IR as either adjunctive or monotherapy. All AED therapy (including a Vagal Nerve Stimulator) must have been initiated more than one month prior to Visit 1 and doses must be stable for at least two weeks prior to Visit 1.
- No diagnosis of a progressive neurological disorder based on previous imaging.
- Weight within the 25 - 80% weight-for-age percentiles based on the National Center for Health Statistics Growth Charts, and not less than 15.0kg.
Key exclusion criteria (8 listed)
- A documented history of status epilepticus in the past year or seizures secondary to conditions other than epilepsy.
- Use of either phenytoin or carbamazepine as current AEDs.
- Diagnosis or an electroencephalogram consistent with a diagnosis of seizure disorders other than partial onset or primary generalized epilepsy.
- Current diagnosis of Major Depressive Disorder or any history of suicide intent and/or attempt.
- History or presence of clinically significant, chronic medical condition which, in the opinion of the Investigator, would preclude the subject from entering the study.
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 |
|---|---|---|
| TPM XREquivalent TDD in XR form, QD, Day 1-14 | Drug | Conversion-100, Conversion-200, Conversion-25, Conversion-50 |
Primary outcome
steady-state pharmacokinetics (PK) of TPM XR and to assess the safety and tolerability
Time frame: 14 days
Relating to repeated oral dosing
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 2 Jun 2016.
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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.
Jennifer Stocks study director
Supernus Pharmaceuticals, Inc.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing TPM XR in people with Epilepsy, run by Supernus Pharmaceuticals, Inc. at 10 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 7 inclusion and 8 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 2 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
steady-state pharmacokinetics (PK) of TPM XR and to assess the safety and tolerability (time frame: 14 days). 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 2 Jun 2016.