Refractory Partial SeizuresPhase 3NCT04558580
Safety Study of Rufinamide Given as an add-on Therapy to Treat Patients With Seizures
A Phase 3 study testing Rufinamide in people with Refractory Partial Seizures, run by University of South Alabama at 1 site in United States.
Trial summary
This study will evaluate the efficacy and safety of Rufinamide in reducing seizure frequency in subjects with partial seizures not fully controlled despite treatment with 1 to 3 concomitant antiepileptic drugs. Read more about this study
- Who is it for?
- Ages 12 to 80 years
- Conditions the study is for
- Refractory Partial Seizures
- What is being tested?
- Rufinamide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2006to Dec 2008
- 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 12 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Male and Female patients between 12 and 80 years of age
- Dx of epilepsy with partial onset seizures woth or woth out secondarily generalized seizures
- Non controlled partial seizures despite treatment with 2 different AEDs for at least 2 years
- must have 6 seizures during baseline
- current treatment with maximum of 3 AEDs
- stable dose of AED(s)for at least 1 month
- if patient has VNS, must have been implanted 6 months prior to randomization
Who cannot join
- Participation in any investigational product for at least 1 month prior to visit 1
- Presence of non-motor simple partial seizures only
- presence of generalized epilepsies
- Evidence of clinically significant disease
- Clinically significant ECG
- Psychogenic seizure in previous year
Show all 13Show fewer
- History of drug/alcohol abuse
- History of suicide attempt
- Multiple drug allergies
- Concomitant felbamate use
- Need for frequent rescue benzodiazepines
- Concomitant use of vigabatrin
- All patients diagnosed with congenital short QT syndrome
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-Blind, Placebo-Controlled, Parallel-Group Study of Rufinamide Given as Adjunctive Therapy in Patients With Refractory Partial Seizures
This study will evaluate the efficacy and safety of Rufinamide in reducing seizure frequency in subjects with partial seizures not fully controlled despite treatment with 1 to 3 concomitant antiepileptic drugs.
- Conditions
- Refractory Partial Seizures
- Being tested
- Rufinamide
- Keywords
- Seizure, Seizures, Epilepsy
- Medical subject headings
- Seizures, Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RufinamideDrug
Rufinamide
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | No intervention | Not described |
| Rufinamide | Experimental | Not described Receives: Drug: Rufinamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage change in total partial seizure frequency from baseline.
Measured: 22 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2020
- Study startApr 2006
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractory Partial SeizuresStudies 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Alabama
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paul Maertens, MD, Principal investigator, University of South Alabama
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04558580
- Sponsor's protocol ID
- E2080-A001-301
- Status last verified
- Sep 2020
- First submitted
- 15 Sep 2020
- Last updated
- 22 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Placebo-Controlled, Parallel-Group Study of Rufinamide Given as Adjunctive Therapy in Patients With Refractory Partial Seizures
- ClinicalTrials.gov ID
- NCT04558580
- Acronym / sponsor ID
- E2080-A001-301
- Conditions
- Refractory Partial Seizures
- Keywords
- Seizure, Seizures, Epilepsy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of South AlabamaUniversity, hospital or other
- Study start
- Apr 2006 (actual)
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 22 Sep 2020 (actual)
- 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 study will evaluate the efficacy and safety of Rufinamide in reducing seizure frequency in subjects with partial seizures not fully controlled despite treatment with 1 to 3 concomitant antiepileptic drugs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | No intervention | – |
| Rufinamide | Experimental | Drug: Rufinamide |
Who may qualify
- Ages
- 12 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Male and Female patients between 12 and 80 years of age
- Dx of epilepsy with partial onset seizures woth or woth out secondarily generalized seizures
- Non controlled partial seizures despite treatment with 2 different AEDs for at least 2 years
- must have 6 seizures during baseline
- current treatment with maximum of 3 AEDs
Key exclusion criteria (13 listed)
- Participation in any investigational product for at least 1 month prior to visit 1
- Presence of non-motor simple partial seizures only
- presence of generalized epilepsies
- Evidence of clinically significant disease
- Clinically significant ECG
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 |
|---|---|---|
| RufinamideRufinamide | Drug | Rufinamide |
Primary outcome
Percentage change in total partial seizure frequency from baseline.
Time frame: 22 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2020.
Related trials for Refractory Partial Seizures
RecruitingEarly Phase 1
Optimizing Therapy in Epilepsy Using Seizure Forecasts Via EEG and Wearables
Focal Epilepsy, Generalized Seizure
Recruiting
Non-Invasive Low Intensity Focused Ultrasound Stimulation for Drug-Resistant Epilepsy
Drug-Resistant Epilepsy, Epilepsy
RecruitingPhase 2
A Long-term Study of the Safety and Effectiveness of RAP-219 in Adults With Focal Onset Seizures
Focal Epilepsy, Epilepsy
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.
Paul Maertens, MD principal investigator
University of South Alabama
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Rufinamide in people with Refractory Partial Seizures, run by University of South Alabama at 1 site 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 13 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: withdrawn, as of the sponsor's last update on 22 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 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 was withdrawn before enrolling participants, so there are no results.
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?
Percentage change in total partial seizure frequency from baseline. (time frame: 22 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 22 Sep 2020; AzTrials last refreshed its copy on 6 Nov 2026.