Partial Onset SeizuresPhase 3NCT02072824

A Safety, Efficacy, and Tolerability Trial of Pregabalin as Add-On Treatment in Pediatric Subjects <4 Years of Age With Partial Onset Seizures.

A Phase 3 study testing Pregabalin Dose Level 1 and Pregabalin Dose Level 2 in people with Partial Onset Seizures, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 72 sites in 23 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 1 month to 3 years
Conditions the study is for: Partial Onset Seizures
What is being tested?: Pregabalin Dose Level 1 and Pregabalin Dose Level 2
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 175 participants
Where: 72 sitesin 23 countries
Study dates: 16 Sep 2014to 13 Mar 2018
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 3 years
All sexes
No healthy volunteers
Child

Who may be able to join

Subject must have 3 partial onset seizures in the month prior to screening.
Subject must have 2 partial onset seizures during the 48 hour baseline phase.
Signed Informed Consent.
On 1-3 stable anti-epileptic drugs at screening.

Who cannot join

Primary generalized seizures including clonic, tonic, clonic-tonic, absence, febrile seizures, and infantile spasms.
Lennox-Gasteau, BECTS, and Dravet's syndrome.
Status epliepticus within 1 year of screening.
Any change in AED regimen with 7 days of screening.
Progressive structural central nervous system (CNS) lesion or a progressive encephalopathy.
Progressive errors of metabolism.

Trial locations and contacts

72 sites in 23 countries.

Country

City, postcode or hospital

72 sites in 23 countries

Russia14 sites

FSFEI HE N.I. Pirogov RNRMU of Minzdrav of Russia
Moscow, 117997
FSFEI HE N.I. Pirogov RNRMU of Minzdrav of Russia
Moscow, 125412
Nizhmedklinika
Nizhny Novgorod, Nizhny Novgorod Oblast, 603159
Perm State Medical University n. a. acad. E.A. Vagner
Perm, Permskiy KRAY, 614000
Perm State Medical University n. a. acad. E.A. Vagner
Perm, 614990
LLC Medical Technologies
Saint Petersburg, 191025
LLC Medical Technologies
Saint Petersburg, 192148
St. Petersburg State Pediatric Medical University
Saint Petersburg, 194100
"Baltiyskaya Medicyna" LLC
Saint Petersburg, 194356
RSBHI Smolensk Regional Clinical Hospital
Smolensk, 214018
SHI Ulyanovsk Regional Children's Clinical Hospital n. a. Y.F.Goryachev
Ulyanovsk, 432011
SHI Central Clinical Medical Unit
Ulyanovsk, 432026
SHI Central Clinical Medical Unit
Ulyanovsk, 432045
MAI Children's City Clinical Hospital 9
Yekaterinburg, 620134

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Philippines7 sites

Cebu Doctors' University Hospital
Cebu City, CEBU, 6000
Perpetual Succour Hospital
Cebu City, CEBU, 6000
Manila Doctors Hospital
Manila, 1000
Metropolitan Medical Center
Manila, 1003
University of Santo Tomas Hospital
Manila, 1008
St. Luke's Medical Center
Quezon City, 1102
Philippine Children's Medical Center
Quezon City, 1105

Other trials in Philippines

Hungary6 sites

Dr. Kenessey Albert Korhaz es Rendelointezet
Balassagyarmat, H-2660
Szent János Kórház es Észak Budai Egyesitett Kórházak
Budapest, H-1023
Szent Margit Kórház
Budapest, H-1032
Semmelweis Egyetem, I. Sz. Gyermekgyogyaszati Klinika
Budapest, H-1083
Magyarorszagi Reformatus Egyhaz Bethesda Gyermekkorhaz, Gyermekneurologia
Budapest, H-1146
Debreceni Egyetem Klinikai Központ
Debrecen, H-4032

Other trials in Hungary

United States5 sites

The University of Texas Health Science Center at Houston
Houston, Texas, 77030
Pediatric Epilepsy Center of Central Florida
Orlando, Florida, 32819
Pediatric Neurology, PA
Orlando, Florida, 32819
Road Runner Research, Ltd.
San Antonio, Texas, 78249
Pediatric Epilepsy & Neurology Specialists, PA
Tampa, Florida, 33609

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Ukraine5 sites

Komunalnyi zaklad "Dnipropetrovska dytiacha miska klinichna likarnia #5"
Dnipro, 49027
Komunalnyi zaklad "Dnipropetrovska oblasna dytiacha klinichna likarnia"
Dnipro, 49100
Ivano-Frankivska oblasna dytiacha klinichna likarnia
Ivano-Frankivsk, 76018
DZ "Ukrainskyi medychnyi tsentr reabilitatsii ditei z orhanichnym urazhenniam
Kyiv, 04209
Oblasnyi klinichnyi tsentr neirokhirurhii ta nevrolohii,viddilennia neirokhirurhii #2
Uzhhorod, 88018

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Israel4 sites

Pharmacy of The E. Wolfson Medical Center
Holon, 5810001
The E. Wolfson Medical Center
Holon, 5810001
Pharmacy of Tel Aviv Sourasky Medical Center
Tel Aviv, 6423906
Tel Aviv Sourasky Medical Center
Tel Aviv, 6423906

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China3 sites

Beijing Children's Hospital
Beijing, 100045
The First Bethune Hospital of Jilin University
Changchun, Jilin, 130021
Children's Hospital of Fudan University
Shanghai, Shanghai Municipality, 201102

Other trials in China

Serbia3 sites

Mother and Child Healthcare Institute Dr Vukan Cupic
Belgrade, 11000
University Children's Hospital Belgrade
Belgrade, 11000
Institute for Child and Youth Healthcare of Vojvodina
Novi Sad, Vojvodina, 21000

Other trials in Serbia

Taiwan3 sites

Chang Gung Memorial Hospital- Kaohsiung branch
Kaohsiung City, 833
China Medical University Hospital
Taichung, 40447
National Taiwan University Hospital
Taipei, 100

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Turkey (Türkiye)3 sites

Eskisehir Osmangazi Universitesi Tip Fakultesi
Eskişehir, 26480
Izmir Tepecik Training and Research Hospital
Izmir, Konak, 35120
Karadeniz Teknik Universitesi Tip Fakultesi Farabi Hastanesi
Trabzon, 61080

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Bulgaria2 sites

UMHAT Dr. Georgi Stranski Ltd.
Pleven, 5800
UMHAT "Sveti Georgi" Ltd.
Plovdiv, 4002

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Greece2 sites

University General Hospital Attikon
Athens, 12462
General Hospital of Thessaloniki Ippokratio
Thessaloniki, 54642

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Lebanon2 sites

American University of Beirut Medical Center
Beirut
Saint George Hospital - University Medical Center
Beirut

Other trials in Lebanon

Romania2 sites

Centrul Medical Unirea
Bucharest, 013766
Spitalul Clinic de Urgente pentru Copii "Sf. Maria"
Iași, 700309

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South Korea2 sites

Seoul National University Hospital
Seoul, 03080
Samsung Medical Center
Seoul, 06351

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Thailand2 sites

Siriraj Hospital, Faculty of Medicine, Mahidol University
Bangkoknoi, Bangkok, 10700
Phramongkutklao Hospital
Ratchathevee, Bangkok, 10400

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Belarus1 site

GU Republican Scientific and Practical Center Mother and Child
Minsk, 220053

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Belgium1 site

UZ Brussel
Brussels, Brussels Capital, 1090

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Bosnia and Herzegovina1 site

University Clinical Centre of the Republic of Srpska
Banja Luka, 78000

Other trials in Bosnia and Herzegovina

France1 site

Hopital Raymond Poincare
Garches, 92380

Other trials in France

Germany1 site

Universitaetsklinikum Jena
Jena, Thuringia, 07747

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Malaysia1 site

Hospital Raja Perempuan Zainab II
Kota Bharu, Kelantan, 15586

Other trials in Malaysia

Spain1 site

Hospital Universitario Miguel Servet
Zaragoza, 50009

Other trials in Spain

About this study

Official title: A Double-blind, Placebo-controlled, Parallel-group, Multicenter Study Of The Efficacy And Safety Of Pregabalin As Adjunctive Therapy In Children 1 Month Through <4 Years Of Age With Partial Onset Seizures

This study is designed to evaluate the effectiveness of 2 doses of pregabalin to reduce seizure frequency as an add on therapy in pediatric subjects 1 month to <4 years of age with refractory partial onset seizures. It is hypothesized that both doses of pregabalin will demonstrate superior efficacy when compared to placebo by reducing the partial onset seizure frequency and that pregabalin will be safe and well tolerated.

Conditions: Partial Onset Seizures
Being tested: Pregabalin Dose Level 1, Pregabalin Dose Level 2, Placebo
Keywords: Partial Onset Seizures, Epilepsy, Safety, Efficacy, Tolerability, Pregabalin, Lyrica, Adjunctive treatment, Placebo controlled, blinded, Eligibility Criteria
Medical subject headings: Epilepsy

What participants receive

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

Pregabalin Dose Level 1Drug
Pregabalin liquid dosed daily three times a day in equally divided doses escalated to 7.0 mg/kg/day beginning at Randomization through Taper Phase then tapered to 3.5 mg/kg/day during 1 week Taper Phase
Pregabalin Dose Level 2Drug
Pregabalin liquid dosed daily three times a day in equally divided doses escalated to 14.0 mg/kg/day beginning at Randomization through Taper Phase then tapered to 3.5 mg/kg/day during 1 week Taper Phase
PlaceboDrug
Placebo Liquid dosed three times daily beginning at Randomization through Taper Phase

Study groups in NCT02072824
Study group	Role	What they receive
Study Drug Level 1	Experimental	Not described Receives: Drug: Pregabalin Dose Level 1
Study Drug Level 2	Experimental	Not described Receives: Drug: Pregabalin Dose Level 2
Placebo	Placebo comparator	Not described Receives: Drug: Placebo

What is being measured

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

Log Transformed 24-Hour Seizure Rate for All Partial Onset Seizures During the Double-Blind Treatment Phase
All partial onset seizures experienced during treatment phase were recorded by central reader during the 48 to 72 hour video-electroencephalogram (EEG). Double Blind 24 hour EEG seizure rate for all partial onset seizures = ([Number of seizures in double blind 48 to 72 hour EEG assessment] divided by [number of hours of video-EEG monitoring])*24. The EEG assessment was done at the end of the fixed dose treatment. For log-transformation, the quantity 1 was added to the double blind 24 hour EEG seizure rate for all participants to account for any possible "0" seizure incidence. This resulted in final calculation as: log transformed (double-blind 24-hour EEG seizure rate + 1).
Measured: Day 1 up to Day 14

Secondary outcomes (1)

Responder Rate: Percentage of Participants With at Least 50 Percent (%) or Greater Reduction From Baseline in 24-Hour Seizure Rate for All Partial Onset Seizures During the Double-Blind Treatment Phase
Responder Rate was defined as percentage of participants who had a 50% or greater reduction from baseline in 24-hour seizure rate during the double-blind treatment phase. Double Blind 24 hour EEG seizure rate for all partial onset seizures = ([Number of seizures in double blind 48 to 72 hour EEG assessment] divided by [number of hours of video-EEG monitoring])*24. The EEG assessment was done at the end of the fixed dose treatment.
Measured: Day 1 up to Day 14

Timeline

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

16 Sep 201413 Mar 2018

First posted27 Feb 2014 (estimated)
Study start16 Sep 2014
Primary completion13 Mar 2018
Study completion13 Mar 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Partial Onset 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: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 175 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02072824
Sponsor's protocol ID: A0081042
Other IDs: 2013-003420-37
Status last verified: Sep 2018
First submitted: 25 Feb 2014
Last updated: 20 Jan 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

Mann D, Antinew J, Knapp L, Almas M, Liu J, Scavone J, Yang R, Modequillo M, Makedonska I, Ortiz M, Kyrychenko A, Nordli D, Farkas V, Farkas MK; A0081042 study group. Pregabalin adjunctive therapy for focal onset seizures in children 1 month to <4 years of age: A double-blind, placebo-controlled, video-electroencephalographic trial. Epilepsia. 2020 Apr;61(4):617-626. doi: 10.1111/epi.16466. Epub 2020 Mar 18.
PubMed 32189338

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 invitationPhase 2
SPN-817 Open-Label Extension Study in Adults With Focal Onset Seizures
Focal Onset Seizures
Active, not recruitingPhase 4
Open-label Study of Cenobamate Monotherapy in Adult Subjects With Newly Diagnosed or Recurrent Partial-Onset Epilepsy
Focal Onset Seizure
RecruitingPhase 3
A Study to Evaluate the Safety, Efficacy, and PK of ONO-2017 in Japanese Patients With POS 2 to 17 Year Olds
Partial Epilepsy
Active, not recruiting
A Pilot Study: Focused Ultrasound Thalamotomy for the Prevention of Secondary Generalization in Focal Onset Epilepsy
Partial Seizures With Secondary Generalization, Focal Epilepsy With Secondary Generalization
RecruitingPhase 2
RENAISSANCE 2: SPN-817 Phase 2, Double-Blind, Placebo-Controlled Study in Adults With Focal Onset Seizures
Focal Onset Seizures

All Partial Onset Seizures trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Double-blind, Placebo-controlled, Parallel-group, Multicenter Study Of The Efficacy And Safety Of Pregabalin As Adjunctive Therapy In Children 1 Month Through <4 Years Of Age With Partial Onset Seizures
ClinicalTrials.gov ID: NCT02072824
Acronym / sponsor ID: A0081042
Conditions: Partial Onset Seizures
Keywords: Partial Onset Seizures, Epilepsy, Safety, Efficacy, Tolerability, Pregabalin, Lyrica, Adjunctive treatment
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 175 participants (actual)
Lead sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
Study start: 16 Sep 2014 (actual)
Primary completion: 13 Mar 2018 (actual)
Study completion: 13 Mar 2018 (actual)
First posted: 27 Feb 2014 (estimated)
Results: Posted 9 Oct 2018

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: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 3

Arm	Type	Receives
Study Drug Level 1	Experimental	Drug: Pregabalin Dose Level 1
Study Drug Level 2	Experimental	Drug: Pregabalin Dose Level 2
Placebo	Placebo comparator	Drug: Placebo

Who may qualify

Ages: 1 month to 3 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (4 listed)

Subject must have 3 partial onset seizures in the month prior to screening.
Subject must have 2 partial onset seizures during the 48 hour baseline phase.
Signed Informed Consent.
On 1-3 stable anti-epileptic drugs at screening.

Key exclusion criteria (6 listed)

Primary generalized seizures including clonic, tonic, clonic-tonic, absence, febrile seizures, and infantile spasms.
Lennox-Gasteau, BECTS, and Dravet's syndrome.
Status epliepticus within 1 year of screening.
Any change in AED regimen with 7 days of screening.
Progressive structural central nervous system (CNS) lesion or a progressive encephalopathy.

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
Pregabalin Dose Level 1Pregabalin liquid dosed daily three times a day in equally divided doses escalated to 7.0 mg/kg/day beginning at Randomization through Taper Phase then tapered to 3.5 mg/kg/day during 1 week Taper Phase	Drug	Study Drug Level 1
Pregabalin Dose Level 2Pregabalin liquid dosed daily three times a day in equally divided doses escalated to 14.0 mg/kg/day beginning at Randomization through Taper Phase then tapered to 3.5 mg/kg/day during 1 week Taper Phase	Drug	Study Drug Level 2
PlaceboPlacebo Liquid dosed three times daily beginning at Randomization through Taper Phase	Drug	Placebo

Primary outcome

Log Transformed 24-Hour Seizure Rate for All Partial Onset Seizures During the Double-Blind Treatment Phase
Time frame: Day 1 up to Day 14
All partial onset seizures experienced during treatment phase were recorded by central reader during the 48 to 72 hour video-electroencephalogram (EEG). Double Blind 24 hour EEG seizure rate for all partial onset seizures = ([Number of seizures in double blind 48 to 72 hour EEG assessment] divided by [number of hours of video-EEG monitoring])*24. The EEG assessment was done at the end of the fixed dose treatment. For log-transformation, the quantity 1 was added to the double blind 24 hour EEG seizure rate for all participants to account for any possible "0" seizure incidence. This resulted in final calculation as: log transformed (double-blind 24-hour EEG seizure rate + 1).

1 secondary outcome

Responder Rate: Percentage of Participants With at Least 50 Percent (%) or Greater Reduction From Baseline in 24-Hour Seizure Rate for All Partial Onset Seizures During the Double-Blind Treatment Phase
Time frame: Day 1 up to Day 14

Results and safety

Results posted to the registry on 9 Oct 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Pregabalin 7 mg/kg/Day or 6 mg/kg/Day	71	69
Pregabalin 14 mg/kg/Day or 12 mg/kg/Day	34	33
Placebo	70	67

Primary outcome: Log Transformed 24-Hour Seizure Rate for All Partial Onset Seizures During the Double-Blind Treatment Phase

Time frame: Day 1 up to Day 14. Least squares mean (Standard Error). Unit: seizures per 24 hours

Measure	Pregabalin 7 mg/kg/Day or 6 mg/kg/Day n = 59	Pregabalin 14 mg/kg/Day or 12 mg/kg/Day n = 28	Placebo n = 53
Value	1.69 (0.115)	1.15 (0.163)	1.58 (0.129)

Pregabalin 7 mg/kg/Day or 6 mg/kg/Day vs Placebo: Least Square Mean Difference: 0.11 (95% CI -0.19 to 0.42), p = 0.4606, ANCOVA
Pregabalin 14 mg/kg/Day or 12 mg/kg/Day vs Placebo: Least Square Mean Difference: -0.43 (95% CI -0.80 to -0.06), p = 0.0223, ANCOVA

Population analysed: Modified intent-to-treat (mITT) population included all randomized participants who took at least one dose of study drug during the double-blind treatment phase, had a baseline with at least one partial onset seizure identified by video-EEG (at least 24 hours of evaluable monitoring) and a treatment phase video-EEG.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Day 1 up to End of Study (maximum Day 25). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Pregabalin 7 mg/kg/Day or 6 mg/kg/Day	0 of 71 (0%)	32 of 71 (45.1%)	0 of 71
Pregabalin 14 mg/kg/Day or 12 mg/kg/Day	1 of 34 (2.9%)	16 of 34 (47.1%)	0 of 34
Placebo	4 of 70 (5.7%)	37 of 70 (52.9%)	0 of 70

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 32189338Mann D, Antinew J, Knapp L, Almas M, Liu J, Scavone J, Yang R, Modequillo M, Makedonska I, Ortiz M, Kyrychenko A, Nordli D, Farkas V, Farkas MK; A0081042 study group. Pregabalin adjunctive therapy for focal onset seizures in children 1 month to <4 years of age: A double-blind, placebo-controlled, video-electroencephalographic trial. Epilepsia. 2020 Apr;61(4):617-626. doi: 10.1111/epi.16466. Epub 2020 Mar 18.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.

Related trials for Partial Onset Seizures

Enrolling by invitationPhase 2
SPN-817 Open-Label Extension Study in Adults With Focal Onset Seizures
Focal Onset Seizures
Active, not recruitingPhase 4
Open-label Study of Cenobamate Monotherapy in Adult Subjects With Newly Diagnosed or Recurrent Partial-Onset Epilepsy
Focal Onset Seizure
RecruitingPhase 3
A Study to Evaluate the Safety, Efficacy, and PK of ONO-2017 in Japanese Patients With POS 2 to 17 Year Olds
Partial Epilepsy
Active, not recruiting
A Pilot Study: Focused Ultrasound Thalamotomy for the Prevention of Secondary Generalization in Focal Onset Epilepsy
Partial Seizures With Secondary Generalization, Focal Epilepsy With Secondary Generalization
RecruitingPhase 2
RENAISSANCE 2: SPN-817 Phase 2, Double-Blind, Placebo-Controlled Study in Adults With Focal Onset Seizures
Focal Onset 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.

Pfizer CT.gov Call Center study director

Pfizer

72 sites in 23 countries: 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 4 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 20 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 72 sites in Russia, Philippines, Hungary, United States, Ukraine 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. Some participants in this study may receive a placebo. 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?

Yes. Results are posted in the registry (first posted 9 Oct 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Log Transformed 24-Hour Seizure Rate for All Partial Onset Seizures During the Double-Blind Treatment Phase (time frame: Day 1 up to Day 14). 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 NCT02072824, which also lists 1 linked publication.

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 20 Jan 2021.