Nonconvulsive SeizuresPhase 2TRENdSNCT01458522

Intravenous Lacosamide Compared With Fosphenytoin in the Treatment of Patients With Frequent Nonconvulsive Seizures

A Phase 2 study testing fPHT and LCM in people with Nonconvulsive Seizures, run by Aatif Husain at 11 sites 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

Who is it for?: Ages 18 years and older
Conditions the study is for: Nonconvulsive Seizures
What is being tested?: fPHT and LCM
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 74 participants
Where: 11 sitesUnited States
Study dates: May 2012to Jul 2015
Phase: Phase 2
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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Have the capacity to understand and sign an institutional review board (IRB)-approved informed consent form (ICF) or have a legally authorized representative (LAR) available to sign on behalf of the subject.
Are undergoing cEEG monitoring in the neurologic intensive care unit (NICU) or other closely monitored environment.
Are experiencing NCSs according to the following criteria:
At least 1 ESz lasting at least 10 seconds, with or without clinical correlates, occurring within the last 6 hours of cEEG monitoring.
If a new AED has been started, ESzs must have occurred per the preceding bullet point at least 2 hours after starting that AED.
If individual ESzs are not well defined, ESz time is at least 10 seconds and less than 30 minutes per hour of cEEG recording.
Are being considered for treatment with an IV AED.
Are at least 18 years old.

Who cannot join

Treatment with PHT, fPHT, or LCM in the last 7 days.
Contraindication for the use of fPHT or LCM.
Ongoing generalized convulsive status epilepticus (SE) (more than 2 generalized tonic-clonic seizures within 30 minutes without recovery to baseline or 1 seizure lasting longer than 10 minutes).
Episodes of SE, defined as at least 30 minutes of ESz activity in 1 hour, in the last 6 hours.
Encephalopathic event secondary to acute anoxic/hypoxic event.
Undergoing therapeutic hypothermia protocol.

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Continuous EEG monitoring showing only periodic discharges or rhythmic delta activity without clear ESzs (for definitions of periodic discharges, rhythmic delta activity, and ESzs, see the Manual of Operations).
Electroencephalographic seizures consistent with typical absence seizures.
Evaluation for spell characterization or surgical treatment for epilepsy.
Pregnancy.

Trial locations and contacts

11 sites in 1 country.

City, postcode or hospital

11 sites in 1 country

United States11 sites

Mission Hospital
Asheville, North Carolina, 28801
Emory University School of Medicine
Atlanta, Georgia, 30307
Massachusetts General Hospital
Boston, Massachusetts, 02214
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Brigham and Woman's Hospital
Boston, Massachusetts, 02215
Medical University of South Carolina
Charleston, South Carolina, 29425
University of Texas Southwestern Medical Center Dallas
Dallas, Texas, 75390-8589
Duke University Medical Center
Durham, North Carolina, 27710
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Yale University School of Medicine
New Haven, Connecticut, 06520
Huntington Memorial Hospital
Pasadena, California, 91109

Other trials in United States

About this study

Official title: Utility of Intravenous Lacosamide Compared With Fosphenytoin in the Treatment of Patients With Frequent Nonconvulsive Seizures

This a phase 2 study comparing the efficacy of intravenous (IV) lacosamide (LCM) with IV fosphenytoin (fPHT) in controlling frequent nonconvulsive seizures (NCSs), the Adverse Events profile of LCM compared with fPHT when used to treat frequent NCSs, and length of stay in an intensive care unit for subjects treated with LCM versus subjects treated with fPHT. The trial will include a preacute-treatment period, an acute-treatment period, a postacute-treatment period, and a long-term follow-up period.

Read the detailed description

Exploratory, prospective, multicenter, open-label, randomized study, in which the physicians who are interpreting cEEGs for treatment purposes and the central reviewers who are providing final cEEG interpretation for study purposes are all blinded to treatment.

Initial LCM/maintenance doses: Subjects will receive a 400-mg IV initial bolus over 30 minutes, followed by a 2-hour post-dose observation-only period. If a breakthrough seizure occurs in the 6 hours following the 2-hour post-dose observation-only period, the subject will receive a 200-mg rebolus over 30 minutes. Regardless of whether a rebolus was administered, a maintenance dose of LCM will be started 12 hours after the initial bolus, and it will continue every 12 hours throughout the acute-treatment period. The daily maintenance dose will be equivalent to the total IV bolus per day (400 mg if no rebolus was administered or 600 mg if a rebolus was administered), divided into 2 doses. After completion of the acute-treatment period, daily maintenance with an AED will be at the discretion of the treating physician.

Initial fPHT/maintenance doses: Subjects will receive a 20-mg PE/kg IV initial bolus at a rate no greater than 75 mg PE/minute, followed by a 2-hour post-dose observation-only period. If a breakthrough seizure occurs in the 6 hours following the 2-hour post-dose observation-only period, the subject will receive a 5-mg PE/kg IV rebolus at a rate no greater than 75 mg PE/minute. Regardless of whether a rebolus was administered, a maintenance dose of fPHT will be started 12 hours after the initial bolus, and it will continue every 12 hours throughout the acute-treatment period. The daily maintenance dose will be 5 mg PE/kg, divided into 2 doses. After completion of the acute-treatment period, daily maintenance with an AED will be at the discretion of the treating physician.

Crossover/maintenance doses: If a subject does not receive a rebolus but has a seizure within 24 hours following the 2-hour post-initial-dose observation-only period, he or she will "cross over" and begin receiving the other drug, ie, the one not originally administered. If a subject does receive a rebolus and has another seizure within 24 hours following the 2-hour post-rebolus observation-only period, he or she will also cross over to the other drug. If crossover occurs, the subject will "start over" with the second drug, going through the same observation-only period and rebolusing, if necessary. If a subject crosses over and starts receiving the second drug, in addition to receiving every-12-hours maintenance doses of the drug originally administered, the subject will also receive maintenance doses of the second drug every 12 hours, beginning 12 hours after the first dose of the second drug.

Conditions: Nonconvulsive Seizures
Being tested: fPHT, LCM
Keywords: Nonconvulsive Seizures

What participants receive

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

fPHTDrug
Also called Cerebyx, Fosphenytoin
If after initial treatment with fPHT any of the following occurs, the subject will have reached the end of the first treatment arm and will "cross over" and begin receiving the other drug, ie, the one not originally administered: the subject subsequently has another seizure within 24 hours following the 2-hour post-rebolus observation-only period; the subject does not receive a rebolus but has a seizure within 24 hours following the 2 hour post-bolus observation-only period; the subject experiences an AE that precludes further use of the first study drug.
If crossover occurs, the subject will "start over" with the second drug, going through the same observation-only period, rebolusing (if necessary), and study assessments with the second drug, beginning with the Baseline assessments.
LCMDrug
Also called Vimpat, Lacosamide
If after initial treatment with LCM any of the following occurs, the subject will have reached the end of the first treatment arm and will "cross over" and begin receiving the other drug, ie, the one not originally administered: the subject subsequently has another seizure within 24 hours following the 2-hour post-rebolus observation-only period; the subject does not receive a rebolus but has a seizure within 24 hours following the 2 hour post-bolus observation-only period; the subject experiences an AE that precludes further use of the first study drug.
If crossover occurs, the subject will "start over" with the second drug, going through the same observation-only period, rebolusing (if necessary), and study assessments with the second drug, beginning with the Baseline assessments.

Study groups in NCT01458522
Study group	Role	What they receive
fPHT 20mg	Active comparator	fPHT treatment arm, a bolus of 20 mg PE/kg will be administered at a rate of no greater than 75 mg PE/minute. If a further bolus is required, 5 mg PE/kg will be administered. The daily maintenance dose for fPHT will be 5 mg PE/kg divided into 2 doses. Receives: Drug: fPHT; Drug: LCM
LCM 400mg	Experimental	LCM treatment arm, a bolus of 400 mg will be administered over 30 minutes. If a further bolus is required, 200 mg will be administered. Regardless of whether the subject received a rebolus, he or she will begin receiving a maintenance dose 12 hours after the initial dose. The daily maintenance dose will be the same as the total bolus (400 mg or 600 mg) divided into 2 doses. Receives: Drug: fPHT; Drug: LCM

What is being measured

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

Percentage of Subjects Who Experience no Nonconvulsive Seizures (NCS) for 24 Hours Following Treatment With LCM vs. fPHT, as Measured by Continuous Electroencephalography (cEEG) Monitoring.
Percentage of subjects who experience no nonconvulsive seizures (NCS) for 24 hours (after the 2-hour observation-only period) following treatment with LCM vs. fPHT, as measured by continuous electroencephalography (cEEG) monitoring with blinded review.
Measured: 24 hours

Secondary outcomes (10)

Percentage of Subjects Who Require a Rebolus of the Initial Antiepileptic Drugs (AED) to Control Nonconvulsive Seizures (NCS) in the LCM vs fPHT Arms.
The percentage of subjects who require a rebolus of the initial antiepileptic drug (AED) to control nonconvulsive seizures (NCS) in the LCM vs fPHT arms.
Measured: 24 hours
Number of Subjects Who Required a Second Antiepileptic Drug (AED) to Control Nonconvulsive Seizures (NCS)
Number of subjects who required a second antiepileptic drug (AED) to control nonconvulsive seizures (NCS)
Measured: 24-26 hours
Seizure Burden Change From Baseline to End of Initial Treatment
Absolute change in seizure time (defined as the number of minutes of electrographic seizure (ESz) activity per hour) before treatment and at the end of the first treatment arm. If less than 1 hour of recording time is available, seizure time will be extrapolated to 1 hour. The maximum amount of time that can be used to determine baseline seizure time is 6 hours.
Measured: Baseline, 24 hours
Seizure Burden Change From Baseline to End of Crossover, Excluding Initial Treatment Arm
Absolute change defined as the number of minutes of ESz activity per hour before treatment and at the end of the second treatment arm. This measure does not evaluate seizure activity in the first treatment arm. If less than 1 hour of recording time is available, seizure time will be extrapolated to 1 hour.
Measured: baseline, 26-68 hours
Time of First Bolus to End of Seizures After Initial Treatment Arm, Time From Crossover to End of Seizures in Crossover Treatment Arm
Time of first bolus to end of seizures after initial treatment arm, time from crossover to end of seizures in crossover treatment arm
Measured: time of first bolus to end of seizures after initial treatment arm, time from crossover to end of seizures in crossover treatment arm
Number of Predefined Adverse Events (AE) After Treatment Arm 1 Administration
Number of predefined adverse events (AE) after treatment arm 1 administration. These predefined adverse events include Patients with at least one AE of interest, Cardiac disorders, investigations, suspected hypersensitivity reactions, vascular disorders, and hypotension.
Measured: 24 hours
Percentage of Subjects in Whom Study Drug is Withdrawn Early After Treatment With Treatment Arm 1
Percentage of subjects in whom study drug is withdrawn early after treatment with treatment arm 1
Measured: baseline to end of treatment arm 1
Days in the Intensive Care Unit/Hospital
Data was acquired in a manner consistent with determining if one treatment arm (LCM first, then fPHT versus fPHT first, then LCM) resulted in more days of hospitalization than the other over the course of the study.
Measured: initial bolus to end of study
Change in Functional Status as Measured by the Functional Disability Scale at Day 7 to 9 Postrandomization and Day 30 Post-randomization in the LCM vs fPHT Arms.
Change in functional status as measured by the Functional Disability Scale, using a 0-29 rating (0=w/o disability; 29=extreme vegetative state) at Day 7 to 9 postrandomization and Day 30 post-randomization in the LCM first, then fPHT versus fPHT first, then LCM arms. Data was analyzed in a manner consistent with determining if one treatment arm resulted in a greater change in functional status than the other.
Measured: Baseline to day 7-9, baseline to day 30
Percentage of All Subjects Who Have Had a Seizure, Are on Antiepileptic Drug (AED) Therapy, and Are Alive/Dead at Day 30
Percentage of all subjects who have had a seizure, are on antiepileptic drug (AED) therapy, and are alive and dead at day 30. Data was acquired in a manner consistent with determining if one treatment arm (LCM first, then fPHT versus fPHT first, then LCM) resulted in a greater effect on seizures, antiepileptic drug (AED) use, and survival at day 30 after the acute treatment period. The acute treatment period could range from 6 to 30 hours.
Measured: both acute treatment periods to 30 days

Timeline

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

May 2012Jul 2015

First posted25 Oct 2011 (estimated)
Study startMay 2012
Primary completionJul 2014
Study completionJul 2015

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 Nonconvulsive 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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind
Who is masked: Investigator
Enrolment: 74 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01458522
Sponsor's protocol ID: Pro00033295
Other IDs: Pro00037794, DCRI-CEMC101.01
Acronym: TRENdS
Status last verified: May 2018
First submitted: 20 Oct 2011
Last updated: 11 Jun 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Belcastro V, Vidale S, Pierguidi L, Sironi L, Tancredi L, Striano P, Taborelli A, Arnaboldi M. Intravenous lacosamide as treatment option in post-stroke non convulsive status epilepticus in the elderly: a proof-of-concept, observational study. Seizure. 2013 Dec;22(10):905-7. doi: 10.1016/j.seizure.2013.07.011. Epub 2013 Aug 13.
PubMed 23953988

Study at a glance

From the registry record, last updated by the sponsor on 11 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Utility of Intravenous Lacosamide Compared With Fosphenytoin in the Treatment of Patients With Frequent Nonconvulsive Seizures
ClinicalTrials.gov ID: NCT01458522
Acronym / sponsor ID: TRENdS / Pro00033295
Conditions: Nonconvulsive Seizures
Keywords: Nonconvulsive Seizures
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 74 participants (actual)
Lead sponsor: Aatif HusainUniversity, hospital or other
Collaborators: UCB Pharma
Study start: May 2012
Primary completion: Jul 2014 (actual)
Study completion: Jul 2015 (actual)
First posted: 25 Oct 2011 (estimated)
Results: Posted 11 Jun 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (investigator)
Number of arms: 2

Arm	Type	Receives
fPHT 20mg	Active comparator	Drug: fPHT, Drug: LCMfPHT treatment arm, a bolus of 20 mg PE/kg will be administered at a rate of no greater than 75 mg PE/minute. If a further bolus is required, 5 mg PE/kg will be administered. The daily maintenance dose for fPHT will be 5 mg PE/kg divided into 2 doses.
LCM 400mg	Experimental	Drug: fPHT, Drug: LCMLCM treatment arm, a bolus of 400 mg will be administered over 30 minutes. If a further bolus is required, 200 mg will be administered. Regardless of whether the subject received a rebolus, he or she will begin receiving a maintenance dose 12 hours after the initial dose. The daily maintenance dose will be the same as the total bolus (400 mg or 600 mg) divided into 2 doses.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Have the capacity to understand and sign an institutional review board (IRB)-approved informed consent form (ICF) or have a legally authorized representative (LAR) available to sign on behalf of the subject.
Are undergoing cEEG monitoring in the neurologic intensive care unit (NICU) or other closely monitored environment.
Are experiencing NCSs according to the following criteria:
Are being considered for treatment with an IV AED.
Are at least 18 years old.

Key exclusion criteria (10 listed)

Treatment with PHT, fPHT, or LCM in the last 7 days.
Contraindication for the use of fPHT or LCM.
Ongoing generalized convulsive status epilepticus (SE) (more than 2 generalized tonic-clonic seizures within 30 minutes without recovery to baseline or 1 seizure lasting longer than 10 minutes).
Episodes of SE, defined as at least 30 minutes of ESz activity in 1 hour, in the last 6 hours.
Encephalopathic event secondary to acute anoxic/hypoxic event.

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
fPHTAlso: Cerebyx, FosphenytoinIf after initial treatment with fPHT any of the following occurs, the subject will have reached the end of the first treatment arm and will "cross over" and begin receiving the other drug, ie, the one not originally administered: the subject subsequently has another seizure within 24 hours following the 2-hour post-rebolus observation-only period; the subject does not receive a rebolus but has a seizure within 24 hours following the 2 hour post-bolus observation-only period; the subject experiences an AE that precludes further use of the first study drug. If crossover occurs, the subject will "start over" with the second drug, going through the same observation-only period, rebolusing (if necessary), and study assessments with the second drug, beginning with the Baseline assessments.	Drug	LCM 400mg, fPHT 20mg
LCMAlso: Vimpat, LacosamideIf after initial treatment with LCM any of the following occurs, the subject will have reached the end of the first treatment arm and will "cross over" and begin receiving the other drug, ie, the one not originally administered: the subject subsequently has another seizure within 24 hours following the 2-hour post-rebolus observation-only period; the subject does not receive a rebolus but has a seizure within 24 hours following the 2 hour post-bolus observation-only period; the subject experiences an AE that precludes further use of the first study drug. If crossover occurs, the subject will "start over" with the second drug, going through the same observation-only period, rebolusing (if necessary), and study assessments with the second drug, beginning with the Baseline assessments.	Drug	LCM 400mg, fPHT 20mg

Primary outcome

Percentage of Subjects Who Experience no Nonconvulsive Seizures (NCS) for 24 Hours Following Treatment With LCM vs. fPHT, as Measured by Continuous Electroencephalography (cEEG) Monitoring.
Time frame: 24 hours
Percentage of subjects who experience no nonconvulsive seizures (NCS) for 24 hours (after the 2-hour observation-only period) following treatment with LCM vs. fPHT, as measured by continuous electroencephalography (cEEG) monitoring with blinded review.

10 secondary outcomes

Percentage of Subjects Who Require a Rebolus of the Initial Antiepileptic Drugs (AED) to Control Nonconvulsive Seizures (NCS) in the LCM vs fPHT Arms.
Time frame: 24 hours
Number of Subjects Who Required a Second Antiepileptic Drug (AED) to Control Nonconvulsive Seizures (NCS)
Time frame: 24-26 hours
Seizure Burden Change From Baseline to End of Initial Treatment
Time frame: Baseline, 24 hours
Seizure Burden Change From Baseline to End of Crossover, Excluding Initial Treatment Arm
Time frame: baseline, 26-68 hours
Time of First Bolus to End of Seizures After Initial Treatment Arm, Time From Crossover to End of Seizures in Crossover Treatment Arm
Time frame: time of first bolus to end of seizures after initial treatment arm, time from crossover to end of seizures in crossover treatment arm
Number of Predefined Adverse Events (AE) After Treatment Arm 1 Administration
Time frame: 24 hours
Percentage of Subjects in Whom Study Drug is Withdrawn Early After Treatment With Treatment Arm 1
Time frame: baseline to end of treatment arm 1
Days in the Intensive Care Unit/Hospital
Time frame: initial bolus to end of study
Change in Functional Status as Measured by the Functional Disability Scale at Day 7 to 9 Postrandomization and Day 30 Post-randomization in the LCM vs fPHT Arms.
Time frame: Baseline to day 7-9, baseline to day 30
Percentage of All Subjects Who Have Had a Seizure, Are on Antiepileptic Drug (AED) Therapy, and Are Alive/Dead at Day 30
Time frame: both acute treatment periods to 30 days

Results and safety

Results posted to the registry on 11 Jun 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
LCM First, Then fPHT	37	34
fPHT First, Then LCM	37	26

Primary outcome: Percentage of Subjects Who Experience no Nonconvulsive Seizures (NCS) for 24 Hours Following Treatment With LCM vs. fPHT, as Measured by Continuous Electroencephalography (cEEG) Monitoring.

Time frame: 24 hours. Count of participants. Unit: Participants

Measure	LCM 400mg n = 35	fPHT 20mg PE/kg n = 35
Value	19	22

Population analysed: Data are reported for the percentage of participants without a nonconvulsive seizure event in the period prior to crossover.

10 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse event data was collected for 30 days after last dose of study drug (approximately 30-32 days). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
All Participants Receiving LCM 400mg	10 of 45 (22.2%)	22 of 45 (48.9%)	7 of 45
All Participants Receiving fPHT 20mg PE/kg	13 of 50 (26%)	27 of 50 (54%)	8 of 50

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 23953988Belcastro V, Vidale S, Pierguidi L, Sironi L, Tancredi L, Striano P, Taborelli A, Arnaboldi M. Intravenous lacosamide as treatment option in post-stroke non convulsive status epilepticus in the elderly: a proof-of-concept, observational study. Seizure. 2013 Dec;22(10):905-7. doi: 10.1016/j.seizure.2013.07.011. Epub 2013 Aug 13.

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.

Aatif Husain, MD principal investigator

Duke Clinical Research Institute

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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing fPHT and LCM in people with Nonconvulsive Seizures, run by Aatif Husain at 11 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 8 inclusion and 10 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 11 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 11 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 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?

Yes. Results are posted in the registry (first posted 11 Jun 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?

Percentage of Subjects Who Experience no Nonconvulsive Seizures (NCS) for 24 Hours Following Treatment With LCM vs. fPHT, as Measured by Continuous Electroencephalography (cEEG) Monitoring. (time frame: 24 hours). 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 NCT01458522, 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 11 Jun 2018.