Status EpilepticusPhase 3KETASER01NCT02431663
Ketamine in Refractory Convulsive Status Epilepticus
A Phase 3 study testing Ketamine in people with Status Epilepticus, run by Meyer Children's Hospital IRCCS at 1 site in Italy.
Trial summary
To evaluate the efficacy of intravenous administration of ketamine in the treatment of refractory convulsive status epilepticus in children compared to administration of midazolam at high doses, thiopental and / or propofol. Read more about this study
- Who is it for?
- Ages 1 month to 18 years
- Conditions the study is for
- Status Epilepticus
- What is being tested?
- Ketamine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteItaly
- Study dates
- Apr 2015to 31 Mar 2020
- 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 1 month to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Diagnosis and clinical EEGrafica of refractory convulsive status epilepticus
- Refractoriness of the drug I and II line
- Written informed consent from parents or legal guardian.
- Administration of rating scales in the risk of mortality (PIM III) and severity of SE (stess, status epilepticusseverity score) to be performed prior to randomization.
Who cannot join
- contraindications to the use of the medication/s in the study.
- pregnant or suspected pregnant.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Ketamine in Refractory Convulsive Status Epilepticus in Children: a Multicenter, Randomized, Controlled, Open-label, No-profit, With Sequential Design Study.
To evaluate the efficacy of intravenous administration of ketamine in the treatment of refractory convulsive status epilepticus in children compared to administration of midazolam at high doses, thiopental and / or propofol.
- Conditions
- Status Epilepticus
- Being tested
- Ketamine
- Keywords
- refractory convulsive status epilepticus, ketamine, conventional anesthetics, children
- Medical subject headings
- Status Epilepticus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetamineDrug
Also called KETAMINA MOLTENI, vials of 2 ml (50 mg/ml)
Intravenous administration in continuous
| Study group | Role | What they receive |
|---|---|---|
| ketamine up to 100 mcg/kg/min | Experimental | Two intravenous boluses of 2-3 mg/kg each of ketamine will be administered 5 minutes apart and immediately followed by a continuous infusion of 5-10 mcg/kg/min. Based on both clinical or electrographic responses, dosage will be increased every 10 minutes or longer, using 2 to 10 mcg/kg/ min increments, up to 60 mcg/kg/min. Maximum duration of infusion will be of 7 days. Receives: Drug: Ketamine |
| midazolam & thiopental & propofol | Active comparator | Midazolam intravenous will be increased every 5 minutes, using 2 mcg/kg/min increments, up to 12 mcg/kg/min and Thiopental intravenous will be increased every 30 minutes or longer, using 1 mg/kg/h increments, up to 6 mg/kg/h and Propofol intravenous will be increased every 5 minutes or longer, using 1 mg/kg/h increments, up to 5 mg/kg/h.
Maximum duration of infusion for each drug will be 48 hours. Receives: Drug: Ketamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with resolution of refractory convulsive status epilepticus
Measured: participant wil be followed for 24 hours after discontinuation of study drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2015 (estimated)
- Study startApr 2015
- Primary completion31 Mar 2020
- Study completion31 Mar 2020
Why it stopped: Futility
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Status EpilepticusStudies 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
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meyer Children's Hospital IRCCS
- Sponsor type
- University, hospital or other
- Collaborators
- Ospedali Riuniti Ancona, IRCCS Azienda Ospedaliero-Universitaria di Bologna, University of Padova, Bambino Gesù Hospital and Research Institute, Catholic University of the Sacred Heart, IRCCS Burlo Garofolo, Azienda Ospedaliera Universitaria Integrata Verona, Nuovo Regina Margherita Hospital, Vittore Buzzi Children's Hospital
- Responsible party
- Principal investigator, Anna Rosati, Meyer Children's Hospital IRCCS
- Investigators
- Anna Rosati, MD, PhD, Study chair, Children's Hospital A. Meyer of Firenze, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02431663
- Sponsor's protocol ID
- EudraCT number: 2013-004396-12
- Acronym
- KETASER01
- Status last verified
- Oct 2020
- First submitted
- 3 Apr 2015
- Last updated
- 8 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Rosati A, De Masi S, Guerrini R. Ketamine for Refractory Status Epilepticus: A Systematic Review. CNS Drugs. 2018 Nov;32(11):997-1009. doi: 10.1007/s40263-018-0569-6.
PubMed 30232735Rosati A, Ilvento L, L'Erario M, De Masi S, Biggeri A, Fabbro G, Bianchi R, Stoppa F, Fusco L, Pulitano S, Battaglia D, Pettenazzo A, Sartori S, Biban P, Fontana E, Cesaroni E, Mora D, Costa P, Meleleo R, Vittorini R, Conio A, Wolfler A, Mastrangelo M, Mondardini MC, Franzoni E, McGreevy KS, Di Simone L, Pugi A, Mirabile L, Vigevano F, Guerrini R. Efficacy of ketamine in refractory convulsive status epilepticus in children: a protocol for a sequential design, multicentre, randomised, controlled, open-label, non-profit trial (KETASER01). BMJ Open. 2016 Jun 15;6(6):e011565. doi: 10.1136/bmjopen-2016-011565.
PubMed 27311915
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Ketamine in Refractory Convulsive Status Epilepticus in Children: a Multicenter, Randomized, Controlled, Open-label, No-profit, With Sequential Design Study.
- ClinicalTrials.gov ID
- NCT02431663
- Acronym / sponsor ID
- KETASER01 / EudraCT number: 2013-004396-12
- Conditions
- Status Epilepticus
- Keywords
- refractory convulsive status epilepticus, ketamine, conventional anesthetics, children
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Futility
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Meyer Children's Hospital IRCCSUniversity, hospital or other
- Collaborators
- Ospedali Riuniti Ancona, IRCCS Azienda Ospedaliero-Universitaria di Bologna, University of Padova, Bambino Gesù Hospital and Research Institute, Catholic University of the Sacred Heart, IRCCS Burlo Garofolo, Azienda Ospedaliera Universitaria Integrata Verona, Nuovo Regina Margherita Hospital, Vittore Buzzi Children's Hospital
- Study start
- Apr 2015
- Primary completion
- 31 Mar 2020 (actual)
- Study completion
- 31 Mar 2020 (actual)
- First posted
- 1 May 2015 (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.
To evaluate the efficacy of intravenous administration of ketamine in the treatment of refractory convulsive status epilepticus in children compared to administration of midazolam at high doses, thiopental and / or propofol.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ketamine up to 100 mcg/kg/min | Experimental | Drug: KetamineTwo intravenous boluses of 2-3 mg/kg each of ketamine will be administered 5 minutes apart and immediately followed by a continuous infusion of 5-10 mcg/kg/min. Based on both clinical or electrographic responses, dosage will be increased every 10 minutes or longer, using 2 to 10 mcg/kg/ min increments, up to 60 mcg/kg/min. Maximum duration of infusion will be of 7 days. |
| midazolam & thiopental & propofol | Active comparator | Drug: KetamineMidazolam intravenous will be increased every 5 minutes, using 2 mcg/kg/min increments, up to 12 mcg/kg/min and Thiopental intravenous will be increased every 30 minutes or longer, using 1 mg/kg/h increments, up to 6 mg/kg/h and Propofol intravenous will be increased every 5 minutes or longer, using 1 mg/kg/h increments, up to 5 mg/kg/h. Maximum duration of infusion for each drug will be 48 hours. |
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Diagnosis and clinical EEGrafica of refractory convulsive status epilepticus
- Refractoriness of the drug I and II line
- Written informed consent from parents or legal guardian.
- Administration of rating scales in the risk of mortality (PIM III) and severity of SE (stess, status epilepticusseverity score) to be performed prior to randomization.
Key exclusion criteria (2 listed)
- contraindications to the use of the medication/s in the study.
- pregnant or suspected pregnant.
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 |
|---|---|---|
| KetamineAlso: KETAMINA MOLTENI, vials of 2 ml (50 mg/ml)Intravenous administration in continuous | Drug | ketamine up to 100 mcg/kg/min, midazolam & thiopental & propofol |
Primary outcome
Number of participants with resolution of refractory convulsive status epilepticus
Time frame: participant wil be followed for 24 hours after discontinuation of study drug
Results and safety
The study was stopped early (reason given: Futility). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2020.
- Derived from this study: PubMed 30232735Rosati A, De Masi S, Guerrini R. Ketamine for Refractory Status Epilepticus: A Systematic Review. CNS Drugs. 2018 Nov;32(11):997-1009. doi: 10.1007/s40263-018-0569-6.
- Derived from this study: PubMed 27311915Rosati A, Ilvento L, L'Erario M, De Masi S, Biggeri A, Fabbro G, Bianchi R, Stoppa F, Fusco L, Pulitano S, Battaglia D, Pettenazzo A, Sartori S, Biban P, Fontana E, Cesaroni E, Mora D, Costa P, Meleleo R, Vittorini R, Conio A, Wolfler A, Mastrangelo M, Mondardini MC, Franzoni E, McGreevy KS, Di Simone L, Pugi A, Mirabile L, Vigevano F, Guerrini R. Efficacy of ketamine in refractory convulsive status epilepticus in children: a protocol for a sequential design, multicentre, randomised, controlled, open-label, non-profit trial (KETASER01). BMJ Open. 2016 Jun 15;6(6):e011565. doi: 10.1136/bmjopen-2016-011565.
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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.
Anna Rosati, MD, PhD study chair
Children's Hospital A. Meyer of Firenze, Italy
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 Ketamine in people with Status Epilepticus, run by Meyer Children's Hospital IRCCS at 1 site in Italy.
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 2 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: stopped early, as of the sponsor's last update on 8 Oct 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 Italy. 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 stopped early (reason given: Futility). Results are not available in the source record.
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?
Number of participants with resolution of refractory convulsive status epilepticus (time frame: participant wil be followed for 24 hours after discontinuation of study drug). 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 NCT02431663, which also lists 2 linked publications.
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 8 Oct 2020.