EpilepsyPhase 1NCT01332513

An Open Label, Randomised, Repeat Dose Study to Assess the Pharmacokinetic Performance of Five Ezogabine/Retigabine Modified Release (MR) Formulations at Steady State Compared to the Immediate Release (IR) Formulation.

A Phase 1 study testing Investigational Medicinal Product (MR1), Investigational Medicinal Product (MR2) and Investigational Medicinal Product (MR3) in people with Epilepsy, run by GlaxoSmithKline at 1 site in United States.

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

This is an open-label, single centre, repeat dose, up- titration study in healthy male and female subjects to assess the pharmacokinetic (PK) performance of five prototypes of ezogabine modified release tablet formulations. Read more about this study

Who is it for?: Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for: Epilepsy
What is being tested?: Investigational Medicinal Product (MR1), Investigational Medicinal Product (MR2) and Investigational Medicinal Product (MR3)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 36 participants
Where: 1 siteUnited States
Study dates: 10 Feb 2011to 23 May 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 60 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Healthy as determined by a responsible and experienced physician
Male or female between 18 and 60 years of age inclusive, at the time of signing the informed consent.
A female subject is eligible to participate if she is of:
Non-childbearing potential defined
Child-bearing potential and agrees to use one of the contraception methods listed
Male subjects must agree to use one of the contraception methods listed

Show all 13Show fewer

Body weight > 50 kg and body mass index (BMI) within the range of 18 - 30kg/m2 (inclusive).
Normal or High Normal blood pressure
24hr holter with no clinically significant findings.
QTcB or QTcF < 450 msec at screening and pre-dose.
Creatinine Clearance within the normal range at screening and pre-dose.
Liver function test within normal limits at screening and pre-dose.
Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.

Who cannot join

A subject will not be eligible for inclusion in this study if any of the following criteria apply:
Subjects who are vegetarian or vegan, or for any other reason be unwilling to consume a high fat meal.
The subject has either a previous disease or current medical condition
Has made a suicide attempt in the past or, in the investigator's judgment, poses significant suicide risk.
Presence of clinically significant proteinuria or hematuria or other clinically significant findings in urinalysis.
Subjects with symptoms of urinary dysfunction.

Show all 23Show fewer

Subjects whose ECG shows PR interval is >220 msec, or presence of intraventricular conduction disturbances (complete or incomplete BBB), at screening or prior to dosing.
Presence of clinically significant arrhythmias.
A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening.
Current or chronic liver disease or biliary abnormalities. Medical history positive for biliary signs and symptoms (cholecystectomy is acceptable).
History of regular alcohol consumption within 6 months of the study.
A positive drug/alcohol screen at screening and / or pre-dose.
A positive test for HIV antibody.
The subjects smokes more than 10 cigarettes per week.
The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).
Exposure to more than four new chemical entities within 12 months prior to the first dosing day.
Use of prescription or non-prescription drugs.
History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy.
Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period.
Pregnant females as determined by positive serum hCG test at screening or prior to dosing.
Lactating females.
Unwillingness or inability to follow the procedures outlined in the protocol.
Subject is mentally or legally incapacitated.

Trial locations and contacts

1 site in 1 country.

United States1 site

GSK Investigational Site
Baltimore, Maryland, 21225

Other trials in United States

About this study

The study will consist of a screening period, a treatment phase (consisting of a titration phase, bioavailability phase and food effect phase) and a post-treatment follow-up visit. The study duration from screening to follow up will be approximately 7 weeks. No study procedures will start before informed consent is obtained. Subjects will remain in the clinical unit for the duration of the treatment period (35 days).

Subjects will receive repeat doses of ezogabine for up to 34 days starting at a dose of 100 mg IR TID (300mg TDD) with a standard meal (to be consumed 30 min prior to dosing) for Days 1-3, on days 4-6 subjects will receive 150mg IR TID (450mg TDD). On Day 7 through to the end of the study subjects will receive ezogabine (Mr or IR) at a dose of 600mgTDD.

On Day 7 subjects will enter into a 6-way cross over period to investigate the 5 MR formulations being tested (each at 300mg BID) and the single IR formulation (at 200mg TID). Subjects will receive each formulaition for 4 days and blood samples for pharmacokinetic analysis will be collected up to 24 hours post dose on each 4th day (PK days).

On Day 31 subjects will enter into a food effect phase to investigate the 5 MR formulations being tested (each at 600mg QD). Subjects in this period will have a PK day on Day 33 (following a standard breakfast), and on Day 34 (following a high fat breakfast) to investigate a food effect on the PK profile of ezogabine.

Conditions: Epilepsy
Being tested: Investigational Medicinal Product (MR1), Investigational Medicinal Product (MR2), Investigational Medicinal Product (MR3), Investigational Medicinal Product (MR4), Investigational Medicinal Product (MR5)
Keywords: Healthy Volunteers
Medical subject headings: Epilepsy

What participants receive

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

Investigational Medicinal Product (MR1)Drug
Ezogabine MR1 at a dose strength of 300 mg will be orally administered with approximately 250 milliliter (mL) of water to group A subjects during the bioavailability phase. For the food effect phase subjects in group G will be orally administered MR1 tablets at a dose strength of 600 mg.
Investigational Medicinal Product (MR2)Drug
Ezogabine MR2 at a dose strength of 300 mg will be orally administered to group B subjects with approximately 250 mL of water during the bioavailability phase. For the food effect phase subjects in group H will be orally administered MR2 tablets at a dose strength of 600 mg.
Investigational Medicinal Product (MR3)Drug
Ezogabine MR3 will be orally administered with approximately 250 mL of water to group C subjects during the bioavailability phase. For the food effect phase subjects in group I will be orally administered MR3 tablets at a dose strength of 600 mg.
Investigational Medicinal Product (MR4)Drug
Ezogabine MR4 will be orally administered with approximately 250 mL of water to group D subjects during the bioavailability phase. For the food effect phase subjects in group J will be orally administered MR4 tablets at a dose strength of 600 mg.
Investigational Medicinal Product (MR5)Drug
Ezogabine MR5 will be orally administered with approximately 250 mL of water to group E subjects during the bioavailability phase. For the food effect phase subjects in group K will be orally administered MR5 tablets at a dose strength of 600 mg.
Investigational Medicinal Product (IR)Drug
Ezogabine IR at dose strengths of 50 mg and 200 mg will be orally administered with approximately 250 mL of water.

Study groups in NCT01332513
Study group	Role	What they receive
ABFCED sequence	Experimental	Each subject will participate in six study periods in the bioavailability phase, wherein the subjects will receive a 300 milligram (mg) twice daily (BID) dosing of ezogabine modified release (MR) tablet in periods A, B, C, D and E and will receive 200 mg three times daily (TID) dosing of ezogabine immediate release (IR) tablet in period F. Following the completion of the crossover phase, subjects will be re-randomized to one of five cohorts receiving 600 mg doses of either G, H, I, J or K for the food effect phase. Receives: Drug: Investigational Medicinal Product (MR1); Drug: Investigational Medicinal Product (MR2); Drug: Investigational Medicinal Product (MR3); Drug: Investigational Medicinal Product (MR4); Drug: Investigational Medicinal Product (MR5); Drug: Investigational Medicinal Product (IR)
BCADFE sequence	Experimental	Each subject will participate in six study periods in the bioavailability phase, wherein the subjects will receive a 300 mg BID dosing of ezogabine MR in periods A, B, C, D and E and will receive 200 mg TID dosing of ezogabine IR in period F. Following the completion of the crossover phase, subjects will be re-randomized to one of five cohorts receiving 600 mg doses of either G, H, I, J or K for the food effect phase. Receives: Drug: Investigational Medicinal Product (MR1); Drug: Investigational Medicinal Product (MR2); Drug: Investigational Medicinal Product (MR3); Drug: Investigational Medicinal Product (MR4); Drug: Investigational Medicinal Product (MR5); Drug: Investigational Medicinal Product (IR)
CDBEAF sequence	Experimental	Each subject will participate in six study periods in the bioavailability phase, wherein the subjects will receive a 300 mg BID dosing of ezogabine MR in periods A, B, C, D and E and will receive 200 mg TID dosing of ezogabine IR in period F. Following the completion of the crossover phase, subjects will be re-randomized to one of five cohorts receiving 600 mg doses of either G, H, I, J or K for the food effect phase. Receives: Drug: Investigational Medicinal Product (MR1); Drug: Investigational Medicinal Product (MR2); Drug: Investigational Medicinal Product (MR3); Drug: Investigational Medicinal Product (MR4); Drug: Investigational Medicinal Product (MR5); Drug: Investigational Medicinal Product (IR)
DECFBA sequence	Experimental	Each subject will participate in six study periods in the bioavailability phase, wherein the subjects will receive a 300 mg BID dosing of ezogabine MR in periods A, B, C, D and E and will receive 200 mg TID dosing of ezogabine IR in period F. Following the completion of the crossover phase, subjects will be re-randomized to one of five cohorts receiving 600 mg doses of either G, H, I, J or K for the food effect phase. Receives: Drug: Investigational Medicinal Product (MR1); Drug: Investigational Medicinal Product (MR2); Drug: Investigational Medicinal Product (MR3); Drug: Investigational Medicinal Product (MR4); Drug: Investigational Medicinal Product (MR5); Drug: Investigational Medicinal Product (IR)
EFDACB sequence	Experimental	Each subject will participate in six study periods in the bioavailability phase, wherein the subjects will receive a 300 mg BID dosing of ezogabine MR in periods A, B, C, D and E and will receive 200 mg TID dosing of ezogabine IR in period F. Following the completion of the crossover phase, subjects will be re-randomized to one of five cohorts receiving 600 mg doses of either G, H, I, J or K for the food effect phase. Receives: Drug: Investigational Medicinal Product (MR1); Drug: Investigational Medicinal Product (MR2); Drug: Investigational Medicinal Product (MR3); Drug: Investigational Medicinal Product (MR4); Drug: Investigational Medicinal Product (MR5); Drug: Investigational Medicinal Product (IR)
FAEBDC sequence	Experimental	Each subject will participate in six study periods in the bioavailability phase, wherein the subjects will receive a 300 mg BID dosing of ezogabine MR in periods A, B, C, D and E and will receive 200 mg TID dosing of ezogabine IR in period F. Following the completion of the crossover phase, subjects will be re-randomized to one of five cohorts receiving 600 mg doses of either G, H, I, J or K for the food effect phase. Receives: Drug: Investigational Medicinal Product (MR1); Drug: Investigational Medicinal Product (MR2); Drug: Investigational Medicinal Product (MR3); Drug: Investigational Medicinal Product (MR4); Drug: Investigational Medicinal Product (MR5); Drug: Investigational Medicinal Product (IR)

What is being measured

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

Area under the curve from zero to 24 hours at steady-state of ezogabine
Measured: Days 10, 14, 18, 22, 26 and 30

Secondary outcomes (6)

Area under the curve of ezogabine from zero to 24 hours at steady-state
Measured: Days 33 and 34
Cmax of ezogabine at steady state
Measured: Days 10, 14, 18, 22, 26, 30, 33 and 34
Tmax of ezogabine at steady-state
Measured: Days 10, 14, 18, 22, 26, 30, 33 and 34
Cmin of ezogabine at steady state
Measured: Days 10, 14, 18, 22, 26, 30, 33 and 34
Cmax:Cmin Ratio of ezogabine
Measured: Days 10, 14, 18, 22, 26, 30, 33 and 34
Fluctuation Index (FI) of ezogabine
Measured: Days 10, 14, 18, 22, 26, 30, 33 and 34

Timeline

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

10 Feb 201123 May 2011

First posted11 Apr 2011 (estimated)
Study start10 Feb 2011
Primary completion23 May 2011
Study completion23 May 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.
More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
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: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 36 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01332513
Sponsor's protocol ID: 114552
Status last verified: Jun 2018
First submitted: 7 Apr 2011
Last updated: 19 Jun 2018
Results posted: No
Data monitoring committee: No
Individual data sharing: Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

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

Enrolling by invitation
An Examination of Cognitive and Sensorimotor Processes in Patients With Epilepsy
Epilepsy
RecruitingObservational study
Surgery as a Treatment for Medically Intractable Epilepsy
Epilepsy, Epilepsy, Temporal Lobe
RecruitingObservational study
Tumor Related Epilepsy
Epilepsy, Cancer
RecruitingObservational study
Investigating Epilepsy: Screening and Evaluation
Seizures, Epilepsy
Recruiting
Optimizing Brain Stimulation Parameters
Epilepsy; Seizure

All Epilepsy trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open Label, Randomised, Repeat Dose Study to Assess the Pharmacokinetic Performance of Five Ezogabine/Retigabine Modified Release (MR) Formulations at Steady State Compared to the Immediate Release (IR) Formulation.
ClinicalTrials.gov ID: NCT01332513
Acronym / sponsor ID: 114552
Conditions: Epilepsy
Keywords: Healthy Volunteers
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 36 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 10 Feb 2011 (actual)
Primary completion: 23 May 2011 (actual)
Study completion: 23 May 2011 (actual)
First posted: 11 Apr 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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 6

Arm	Type	Receives
ABFCED sequence	Experimental	Drug: Investigational Medicinal Product (MR1), Drug: Investigational Medicinal Product (MR2), Drug: Investigational Medicinal Product (MR3), Drug: Investigational Medicinal Product (MR4), Drug: Investigational Medicinal Product (MR5), Drug: Investigational Medicinal Product (IR)Each subject will participate in six study periods in the bioavailability phase, wherein the subjects will receive a 300 milligram (mg) twice daily (BID) dosing of ezogabine modified release (MR) tablet in periods A, B, C, D and E and will receive 200 mg three times daily (TID) dosing of ezogabine immediate release (IR) tablet in period F. Following the completion of the crossover phase, subjects will be re-randomized to one of five cohorts receiving 600 mg doses of either G, H, I, J or K for the food effect phase.
BCADFE sequence	Experimental	Drug: Investigational Medicinal Product (MR1), Drug: Investigational Medicinal Product (MR2), Drug: Investigational Medicinal Product (MR3), Drug: Investigational Medicinal Product (MR4), Drug: Investigational Medicinal Product (MR5), Drug: Investigational Medicinal Product (IR)Each subject will participate in six study periods in the bioavailability phase, wherein the subjects will receive a 300 mg BID dosing of ezogabine MR in periods A, B, C, D and E and will receive 200 mg TID dosing of ezogabine IR in period F. Following the completion of the crossover phase, subjects will be re-randomized to one of five cohorts receiving 600 mg doses of either G, H, I, J or K for the food effect phase.
CDBEAF sequence	Experimental	Drug: Investigational Medicinal Product (MR1), Drug: Investigational Medicinal Product (MR2), Drug: Investigational Medicinal Product (MR3), Drug: Investigational Medicinal Product (MR4), Drug: Investigational Medicinal Product (MR5), Drug: Investigational Medicinal Product (IR)Each subject will participate in six study periods in the bioavailability phase, wherein the subjects will receive a 300 mg BID dosing of ezogabine MR in periods A, B, C, D and E and will receive 200 mg TID dosing of ezogabine IR in period F. Following the completion of the crossover phase, subjects will be re-randomized to one of five cohorts receiving 600 mg doses of either G, H, I, J or K for the food effect phase.
DECFBA sequence	Experimental	Drug: Investigational Medicinal Product (MR1), Drug: Investigational Medicinal Product (MR2), Drug: Investigational Medicinal Product (MR3), Drug: Investigational Medicinal Product (MR4), Drug: Investigational Medicinal Product (MR5), Drug: Investigational Medicinal Product (IR)Each subject will participate in six study periods in the bioavailability phase, wherein the subjects will receive a 300 mg BID dosing of ezogabine MR in periods A, B, C, D and E and will receive 200 mg TID dosing of ezogabine IR in period F. Following the completion of the crossover phase, subjects will be re-randomized to one of five cohorts receiving 600 mg doses of either G, H, I, J or K for the food effect phase.
EFDACB sequence	Experimental	Drug: Investigational Medicinal Product (MR1), Drug: Investigational Medicinal Product (MR2), Drug: Investigational Medicinal Product (MR3), Drug: Investigational Medicinal Product (MR4), Drug: Investigational Medicinal Product (MR5), Drug: Investigational Medicinal Product (IR)Each subject will participate in six study periods in the bioavailability phase, wherein the subjects will receive a 300 mg BID dosing of ezogabine MR in periods A, B, C, D and E and will receive 200 mg TID dosing of ezogabine IR in period F. Following the completion of the crossover phase, subjects will be re-randomized to one of five cohorts receiving 600 mg doses of either G, H, I, J or K for the food effect phase.
FAEBDC sequence	Experimental	Drug: Investigational Medicinal Product (MR1), Drug: Investigational Medicinal Product (MR2), Drug: Investigational Medicinal Product (MR3), Drug: Investigational Medicinal Product (MR4), Drug: Investigational Medicinal Product (MR5), Drug: Investigational Medicinal Product (IR)Each subject will participate in six study periods in the bioavailability phase, wherein the subjects will receive a 300 mg BID dosing of ezogabine MR in periods A, B, C, D and E and will receive 200 mg TID dosing of ezogabine IR in period F. Following the completion of the crossover phase, subjects will be re-randomized to one of five cohorts receiving 600 mg doses of either G, H, I, J or K for the food effect phase.

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (13 listed)

Healthy as determined by a responsible and experienced physician
Male or female between 18 and 60 years of age inclusive, at the time of signing the informed consent.
A female subject is eligible to participate if she is of:
Male subjects must agree to use one of the contraception methods listed
Body weight > 50 kg and body mass index (BMI) within the range of 18 - 30kg/m2 (inclusive).

Key exclusion criteria (23 listed)

A subject will not be eligible for inclusion in this study if any of the following criteria apply:
Subjects who are vegetarian or vegan, or for any other reason be unwilling to consume a high fat meal.
The subject has either a previous disease or current medical condition
Has made a suicide attempt in the past or, in the investigator's judgment, poses significant suicide risk.
Presence of clinically significant proteinuria or hematuria or other clinically significant findings in urinalysis.

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
Investigational Medicinal Product (MR1)Ezogabine MR1 at a dose strength of 300 mg will be orally administered with approximately 250 milliliter (mL) of water to group A subjects during the bioavailability phase. For the food effect phase subjects in group G will be orally administered MR1 tablets at a dose strength of 600 mg.	Drug	ABFCED sequence, BCADFE sequence, CDBEAF sequence, DECFBA sequence, EFDACB sequence, FAEBDC sequence
Investigational Medicinal Product (MR2)Ezogabine MR2 at a dose strength of 300 mg will be orally administered to group B subjects with approximately 250 mL of water during the bioavailability phase. For the food effect phase subjects in group H will be orally administered MR2 tablets at a dose strength of 600 mg.	Drug	ABFCED sequence, BCADFE sequence, CDBEAF sequence, DECFBA sequence, EFDACB sequence, FAEBDC sequence
Investigational Medicinal Product (MR3)Ezogabine MR3 will be orally administered with approximately 250 mL of water to group C subjects during the bioavailability phase. For the food effect phase subjects in group I will be orally administered MR3 tablets at a dose strength of 600 mg.	Drug	ABFCED sequence, BCADFE sequence, CDBEAF sequence, DECFBA sequence, EFDACB sequence, FAEBDC sequence
Investigational Medicinal Product (MR4)Ezogabine MR4 will be orally administered with approximately 250 mL of water to group D subjects during the bioavailability phase. For the food effect phase subjects in group J will be orally administered MR4 tablets at a dose strength of 600 mg.	Drug	ABFCED sequence, BCADFE sequence, CDBEAF sequence, DECFBA sequence, EFDACB sequence, FAEBDC sequence
Investigational Medicinal Product (MR5)Ezogabine MR5 will be orally administered with approximately 250 mL of water to group E subjects during the bioavailability phase. For the food effect phase subjects in group K will be orally administered MR5 tablets at a dose strength of 600 mg.	Drug	ABFCED sequence, BCADFE sequence, CDBEAF sequence, DECFBA sequence, EFDACB sequence, FAEBDC sequence
Investigational Medicinal Product (IR)Ezogabine IR at dose strengths of 50 mg and 200 mg will be orally administered with approximately 250 mL of water.	Drug	ABFCED sequence, BCADFE sequence, CDBEAF sequence, DECFBA sequence, EFDACB sequence, FAEBDC sequence

Primary outcome

Area under the curve from zero to 24 hours at steady-state of ezogabine
Time frame: Days 10, 14, 18, 22, 26 and 30

6 secondary outcomes

Area under the curve of ezogabine from zero to 24 hours at steady-state
Time frame: Days 33 and 34
Cmax of ezogabine at steady state
Time frame: Days 10, 14, 18, 22, 26, 30, 33 and 34
Tmax of ezogabine at steady-state
Time frame: Days 10, 14, 18, 22, 26, 30, 33 and 34
Cmin of ezogabine at steady state
Time frame: Days 10, 14, 18, 22, 26, 30, 33 and 34
Cmax:Cmin Ratio of ezogabine
Time frame: Days 10, 14, 18, 22, 26, 30, 33 and 34
Fluctuation Index (FI) of ezogabine
Time frame: Days 10, 14, 18, 22, 26, 30, 33 and 34

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 19 Jun 2018.
Results for study 114552 can be found on the GSK Clinical Study Register.Link provided by the sponsor.
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Related trials for Epilepsy

Enrolling by invitation
An Examination of Cognitive and Sensorimotor Processes in Patients With Epilepsy
Epilepsy
RecruitingObservational study
Surgery as a Treatment for Medically Intractable Epilepsy
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Investigating Epilepsy: Screening and Evaluation
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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.

GSK Clinical Trials study director

GlaxoSmithKline

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 13 inclusion and 23 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 19 Jun 2018. 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 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?

Area under the curve from zero to 24 hours at steady-state of ezogabine (time frame: Days 10, 14, 18, 22, 26 and 30). 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 NCT01332513.

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 19 Jun 2018; AzTrials last refreshed its copy on 26 Oct 2026.