EpilepsyPhase 4Ketamin stdyNCT06741930
Pro-Epileptic Effects of IV Ketamine
A Phase 4 study testing Ketamine, Midazolam and Propofol in people with Epilepsy and Seizure, run by Haseki Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The investigators evaluated the safety and potential pro-epileptic effects of intravenous (IV) ketamine during procedural sedation in comparison with IV midazolam and IV propofol. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Ketamine, Midazolam and Propofol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2024to 30 Aug 2025
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged ≥18 years scheduled to undergo procedural sedation prior to esophagogastroduodenoscopy in the endoscopy unit were included in the study.
Who cannot join
- patients aged <18 years,
- pregnant or breastfeeding females,
- patients with a known history of epilepsy, previous status epilepticus, or neurological conditions such as head trauma, brain tumors, cerebrovascular events, meningitis, or encephalitis, as well as congenital or acquired structural brain anomalies.
- Individuals with a first-degree family history of epilepsy or who had used medications affecting the central nervous system (e.g., antidepressants, antipsychotics, sedatives, benzodiazepines, or opioids) within the previous month were also excluded.
- Patients were also excluded if they had a known allergy or hypersensitivity to the study drugs (IV ketamine, IV midazolam, IV propofol) or to adjunctive medications used for procedural sedation (e.g., IV fentanyl).
- Patients with a history of complications during anesthesia or previous surgical procedures, such as malignant hyperthermia or respiratory failure.
Show all 9Show fewer
- Patients with significant movement disorders, agitation, scalp lesions, or other conditions interfering with EEG recording.
- Patients with severe cardiovascular disease, including uncontrolled hypertension, advanced heart failure, or arrhythmias, as well as those with oxygen saturation <90%, a high risk of respiratory depression, or severe obstructive sleep apnea syndrome.
- Patients with severe hepatic or renal failure, or those who had undergone major surgery within the previous 6 months.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Haseki Training and Research Hospital
Istanbul, Istanbul, 34265
About this study
Official title: Potential Pro-Convulsive Properties of Ketamine and Its Effects on EEG During Procedural Sedation: A Comparative Evaluation With Midazolam and Propofol
The investigators evaluated the safety and potential pro-epileptic effects of intravenous (IV) ketamine during procedural sedation in comparison with IV midazolam and IV propofol. Specifically, the study hypothesizes that IV ketamine, at doses used for procedural sedation, exhibits pro-convulsive properties, lowers the epileptic seizure threshold, and may induce interictal epileptiform discharges and/or seizures. Additionally, the investigators assessed the effects of these sedative agents on electroencephalographic (EEG) activity during procedural sedation.
Read the detailed description
Patients were randomly assigned to one of three groups: the first group received IV ketamine at a titrated dose of 0.5-1.0 mg/kg, the second group received IV midazolam at a titrated dose of 0.15-0.40 mg/kg, and the third group received IV propofol at a titrated dose of 0.5-1.0 mg/kg. Procedural sedation in all groups was supplemented with IV fentanyl, administered in small incremental boluses of 25-50 mcg to ensure adequate analgesia. Baseline EEG recordings were obtained for all patients prior to the procedure. During the procedure, EEG recordings, vital parameters-including blood pressure, heart rate, and respiratory rate-and the depth of sedation were continuously monitored for all participants. The Modified Observer's Assessment of Alertness/Sedation (MOAA/S) Scale was used to evaluate the depth of sedation.
The MOAA/S scale was applied as follows:
Score 5: Alert; responds readily to name spoken in a normal tone. Score 4: Mild sedation; lethargic response to name spoken in a normal tone. Score 3: Moderate sedation; responds only after the name is spoken loudly and/or repeatedly.
Score 2: Deep sedation; responds only after mild prodding or shaking. Score 1: Very deep sedation; unresponsive to physical stimulation. The target sedation level for patients was maintained between 2 and 3, depending on the procedural requirements. If necessary, the drug dose was carefully adjusted to increase or decrease sedation while ensuring the depth of sedation did not drop to level 1.
EEG recordings for all patients were performed. Electrodes were placed on the scalp according to the International 10-20 system, with 19 electrodes and 1 reference electrode, and the impedance of each electrode was maintained below 5 kilo-ohms. EEG recordings began with a 5-minute baseline recording during wakefulness, followed by continuous monitoring during the induction phase (administration of sedative drugs), and an additional 10-minute recording after sedation was achieved. Upon completion of the procedural intervention, EEG recordings were repeated for 10 minutes during the awakening phase and calm wakefulness.
After data collection, all EEG recordings were visually analyzed by a clinical neurophysiologist blinded to the administered drugs. EEG signals were evaluated using filters set between 0.5-70 Hz and a bipolar montage (double banana). Large-amplitude waves (>100 μV) were considered artifacts, and artifacts caused by eyelid or ocular movements were excluded from the analysis.
The recordings were analyzed for basic EEG activity, including alpha (8-12 Hz), beta (13-25 Hz), theta (4-7 Hz), delta (0.5-3.5 Hz), and gamma (25-40 Hz) rhythms, suppression-burst patterns, and their topographies. The presence of interictal epileptiform discharges, such as focal and/or generalized spike-wave, sharp wave, spike-slow wave, sharp-slow wave, and multiple spike-slow wave patterns, was noted. Additionally, clinical and/or subclinical ictal activity was documented.
Demographic data, including age, sex, comorbidities, and body weight, as well as vital parameters recorded before and during the procedure, EEG findings, and adverse effects following IV treatment, were systematically recorded.
- Keywords
- ketamine, midazolam, propofol, epilepsy, Procedural Sedation, Pro-Convulsive Effects
- Medical subject headings
- Epilepsy, Seizures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetamineDrug
The Ketamine group received IV ketamine at a titrated dose of 0.5-1.0 mg/kg with IV fentanyl, administered in small incremental boluses of 25-50 mcg to ensure adequate analgesia.
MidazolamDrug
The Midazolam group received IV midazolam at a titrated dose of 0.15-0.40 mg/kg with IV fentanyl, administered in small incremental boluses of 25-50 mcg to ensure adequate analgesia.
PropofolDrug
The Propofol group received IV propofol at a titrated dose of 0.5-1.0 mg/kg with IV fentanyl, administered in small incremental boluses of 25-50 mcg to ensure adequate analgesia.
| Study group | Role | What they receive |
|---|---|---|
| Ketamine group | Active comparator | The Ketamine group received IV ketamine at a dosage of 0.5-1.0 mg/kg. Receives: Drug: Ketamine |
| Midazolam group | Active comparator | The Midazolam group received IV midazolam at a dosage of 0.15-0.40 mg/kg. Receives: Drug: Midazolam |
| Propofol group | Active comparator | The Propofol group received IV propofol at a dosage of 0.5-1.0 mg/kg. Receives: Drug: Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rates of interictal epileptiform discharges on EEG
The investigators assessed the rates of interictal epileptiform discharges on EEG, including focal and/or generalized spike-wave, sharp wave, spike-slow wave, and sharp-slow wave patterns, induced by IV ketamine.
Measured: 0, 5, and 30 min following the initial administration.
Rates of interictal epileptiform discharges on EEG
The investigators assessed the rates of interictal epileptiform discharges on EEG, including focal and/or generalized spike-wave, sharp wave, spike-slow wave, and sharp-slow wave patterns, induced by IV midazolam.
Measured: 0, 5, and 30 min following the initial administration.
Rates of interictal epileptiform discharges on EEG
The investigators assessed the rates of interictal epileptiform discharges on EEG, including focal and/or generalized spike-wave, sharp wave, spike-slow wave, and sharp-slow wave patterns, induced by IV propofol.
Measured: 0, 5, and 30 min following the initial administration.
Secondary outcomes (3)
Presence of subclinical seizure activity
The investigators assessed the presence of subclinical seizure activity (ictal activity) on EEG within the ketamine group.
Measured: 0, 5, and 30 min following the initial administration.
Presence of subclinical seizure activity
The investigators assessed the presence of subclinical seizure activity (ictal activity) on EEG within the midazolam group.
Measured: 0, 5, and 30 min following the initial administration.
Presence of subclinical seizure activity
The investigators assessed the presence of subclinical seizure activity (ictal activity) on EEG within the propofol group.
Measured: 0, 5, and 30 min following the initial administration.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2024
- Study start1 Dec 2024
- Primary completion30 Aug 2025
- Study completion30 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for EpilepsyStudies 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 4
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Single center
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haseki Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adem Az, Haseki Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06741930
- Sponsor's protocol ID
- 35-2024
- Acronym
- Ketamin stdy
- Status last verified
- Dec 2025
- First submitted
- 18 Dec 2024
- Last updated
- 15 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Stored in non-publicly available Available on request
Publications
Az A, Dogan Y. Unexpected consequences: A case of ketamine-induced seizure in procedural sedation. Turk J Emerg Med. 2024 Oct 1;24(4):259-261. doi: 10.4103/tjem.tjem_67_24. eCollection 2024 Oct-Dec.
PubMed 39564442Kim JH, Lee CK, Yu SH, Min BD, Chung CE, Kim DC. Ketamine-induced generalized convulsive seizure during procedural sedation. Arch Craniofac Surg. 2021 Apr;22(2):119-121. doi: 10.7181/acfs.2021.00094. Epub 2021 Apr 20.
PubMed 33957739Shehata IM, Kohaf NA, ElSayed MW, Latifi K, Aboutaleb AM, Kaye AD. Ketamine: Pro or antiepileptic agent? A systematic review. Heliyon. 2024 Jan 10;10(2):e24433. doi: 10.1016/j.heliyon.2024.e24433. eCollection 2024 Jan 30.
PubMed 38293492Besha A, Adamu Y, Mulugeta H, Zemedkun A, Destaw B. Evidence-based guideline on management of status epilepticus in adult intensive care unit in resource-limited settings: a review article. Ann Med Surg (Lond). 2023 Apr 17;85(6):2714-2720. doi: 10.1097/MS9.0000000000000625. eCollection 2023 Jun.
PubMed 37363462Cohen SP, Bhatia A, Buvanendran A, Schwenk ES, Wasan AD, Hurley RW, Viscusi ER, Narouze S, Davis FN, Ritchie EC, Lubenow TR, Hooten WM. Consensus Guidelines on the Use of Intravenous Ketamine Infusions for Chronic Pain From the American Society of Regional Anesthesia and Pain Medicine, the American Academy of Pain Medicine, and the American Society of Anesthesiologists. Reg Anesth Pain Med. 2018 Jul;43(5):521-546. doi: 10.1097/AAP.0000000000000808.
PubMed 29870458Zanos P, Moaddel R, Morris PJ, Riggs LM, Highland JN, Georgiou P, Pereira EFR, Albuquerque EX, Thomas CJ, Zarate CA Jr, Gould TD. Ketamine and Ketamine Metabolite Pharmacology: Insights into Therapeutic Mechanisms. Pharmacol Rev. 2018 Jul;70(3):621-660. doi: 10.1124/pr.117.015198.
PubMed 29945898
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Potential Pro-Convulsive Properties of Ketamine and Its Effects on EEG During Procedural Sedation: A Comparative Evaluation With Midazolam and Propofol
- ClinicalTrials.gov ID
- NCT06741930
- Acronym / sponsor ID
- Ketamin stdy / 35-2024
- Keywords
- ketamine, midazolam, propofol, epilepsy, Procedural Sedation, Pro-Convulsive Effects
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Haseki Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 30 Aug 2025 (actual)
- Study completion
- 30 Aug 2025 (actual)
- First posted
- 19 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators evaluated the safety and potential pro-epileptic effects of intravenous (IV) ketamine during procedural sedation in comparison with IV midazolam and IV propofol. Specifically, the study hypothesizes that IV ketamine, at doses used for procedural sedation, exhibits pro-convulsive properties, lowers the epileptic seizure threshold, and may induce interictal epileptiform discharges and/or seizures. Additionally, the investigators assessed the effects of these sedative agents on electroencephalographic (EEG) activity during procedural sedation.
Detailed description
Patients were randomly assigned to one of three groups: the first group received IV ketamine at a titrated dose of 0.5-1.0 mg/kg, the second group received IV midazolam at a titrated dose of 0.15-0.40 mg/kg, and the third group received IV propofol at a titrated dose of 0.5-1.0 mg/kg. Procedural sedation in all groups was supplemented with IV fentanyl, administered in small incremental boluses of 25-50 mcg to ensure adequate analgesia. Baseline EEG recordings were obtained for all patients prior to the procedure. During the procedure, EEG recordings, vital parameters-including blood pressure, heart rate, and respiratory rate-and the depth of sedation were continuously monitored for all participants. The Modified Observer's Assessment of Alertness/Sedation (MOAA/S) Scale was used to evaluate the depth of sedation.
The MOAA/S scale was applied as follows:
Score 5: Alert; responds readily to name spoken in a normal tone. Score 4: Mild sedation; lethargic response to name spoken in a normal tone. Score 3: Moderate sedation; responds only after the name is spoken loudly and/or repeatedly.
Score 2: Deep sedation; responds only after mild prodding or shaking. Score 1: Very deep sedation; unresponsive to physical stimulation. The target sedation level for patients was maintained between 2 and 3, depending on the procedural requirements. If necessary, the drug dose was carefully adjusted to increase or decrease sedation while ensuring the depth of sedation did not drop to level 1.
EEG recordings for all patients were performed. Electrodes were placed on the scalp according to the International 10-20 system, with 19 electrodes and 1 reference electrode, and the impedance of each electrode was maintained below 5 kilo-ohms. EEG recordings began with a 5-minute baseline recording during wakefulness, followed by continuous monitoring during the induction phase (administration of sedative drugs), and an additional 10-minute recording after sedation was achieved. Upon completion of the procedural intervention, EEG recordings were repeated for 10 minutes during the awakening phase and calm wakefulness.
After data collection, all EEG recordings were visually analyzed by a clinical neurophysiologist blinded to the administered drugs. EEG signals were evaluated using filters set between 0.5-70 Hz and a bipolar montage (double banana). Large-amplitude waves (>100 μV) were considered artifacts, and artifacts caused by eyelid or ocular movements were excluded from the analysis.
The recordings were analyzed for basic EEG activity, including alpha (8-12 Hz), beta (13-25 Hz), theta (4-7 Hz), delta (0.5-3.5 Hz), and gamma (25-40 Hz) rhythms, suppression-burst patterns, and their topographies. The presence of interictal epileptiform discharges, such as focal and/or generalized spike-wave, sharp wave, spike-slow wave, sharp-slow wave, and multiple spike-slow wave patterns, was noted. Additionally, clinical and/or subclinical ictal activity was documented.
Demographic data, including age, sex, comorbidities, and body weight, as well as vital parameters recorded before and during the procedure, EEG findings, and adverse effects following IV treatment, were systematically recorded.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- Single center
| Arm | Type | Receives |
|---|---|---|
| Ketamine group | Active comparator | Drug: KetamineThe Ketamine group received IV ketamine at a dosage of 0.5-1.0 mg/kg. |
| Midazolam group | Active comparator | Drug: MidazolamThe Midazolam group received IV midazolam at a dosage of 0.15-0.40 mg/kg. |
| Propofol group | Active comparator | Drug: PropofolThe Propofol group received IV propofol at a dosage of 0.5-1.0 mg/kg. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults aged ≥18 years scheduled to undergo procedural sedation prior to esophagogastroduodenoscopy in the endoscopy unit were included in the study.
Key exclusion criteria (9 listed)
- patients aged <18 years,
- pregnant or breastfeeding females,
- patients with a known history of epilepsy, previous status epilepticus, or neurological conditions such as head trauma, brain tumors, cerebrovascular events, meningitis, or encephalitis, as well as congenital or acquired structural brain anomalies.
- Individuals with a first-degree family history of epilepsy or who had used medications affecting the central nervous system (e.g., antidepressants, antipsychotics, sedatives, benzodiazepines, or opioids) within the previous month were also excluded.
- Patients were also excluded if they had a known allergy or hypersensitivity to the study drugs (IV ketamine, IV midazolam, IV propofol) or to adjunctive medications used for procedural sedation (e.g., IV fentanyl).
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 |
|---|---|---|
| KetamineThe Ketamine group received IV ketamine at a titrated dose of 0.5-1.0 mg/kg with IV fentanyl, administered in small incremental boluses of 25-50 mcg to ensure adequate analgesia. | Drug | Ketamine group |
| MidazolamThe Midazolam group received IV midazolam at a titrated dose of 0.15-0.40 mg/kg with IV fentanyl, administered in small incremental boluses of 25-50 mcg to ensure adequate analgesia. | Drug | Midazolam group |
| PropofolThe Propofol group received IV propofol at a titrated dose of 0.5-1.0 mg/kg with IV fentanyl, administered in small incremental boluses of 25-50 mcg to ensure adequate analgesia. | Drug | Propofol group |
Primary outcome
Rates of interictal epileptiform discharges on EEG
Time frame: 0, 5, and 30 min following the initial administration.
The investigators assessed the rates of interictal epileptiform discharges on EEG, including focal and/or generalized spike-wave, sharp wave, spike-slow wave, and sharp-slow wave patterns, induced by IV ketamine.
Rates of interictal epileptiform discharges on EEG
Time frame: 0, 5, and 30 min following the initial administration.
The investigators assessed the rates of interictal epileptiform discharges on EEG, including focal and/or generalized spike-wave, sharp wave, spike-slow wave, and sharp-slow wave patterns, induced by IV midazolam.
Rates of interictal epileptiform discharges on EEG
Time frame: 0, 5, and 30 min following the initial administration.
The investigators assessed the rates of interictal epileptiform discharges on EEG, including focal and/or generalized spike-wave, sharp wave, spike-slow wave, and sharp-slow wave patterns, induced by IV propofol.
3 secondary outcomes
Presence of subclinical seizure activity
Time frame: 0, 5, and 30 min following the initial administration.
Presence of subclinical seizure activity
Time frame: 0, 5, and 30 min following the initial administration.
Presence of subclinical seizure activity
Time frame: 0, 5, and 30 min following the initial administration.
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 15 Dec 2025.
- Results publication: PubMed 39564442Az A, Dogan Y. Unexpected consequences: A case of ketamine-induced seizure in procedural sedation. Turk J Emerg Med. 2024 Oct 1;24(4):259-261. doi: 10.4103/tjem.tjem_67_24. eCollection 2024 Oct-Dec.
- Results publication: PubMed 33957739Kim JH, Lee CK, Yu SH, Min BD, Chung CE, Kim DC. Ketamine-induced generalized convulsive seizure during procedural sedation. Arch Craniofac Surg. 2021 Apr;22(2):119-121. doi: 10.7181/acfs.2021.00094. Epub 2021 Apr 20.
- Results publication: PubMed 38293492Shehata IM, Kohaf NA, ElSayed MW, Latifi K, Aboutaleb AM, Kaye AD. Ketamine: Pro or antiepileptic agent? A systematic review. Heliyon. 2024 Jan 10;10(2):e24433. doi: 10.1016/j.heliyon.2024.e24433. eCollection 2024 Jan 30.
- Results publication: PubMed 37363462Besha A, Adamu Y, Mulugeta H, Zemedkun A, Destaw B. Evidence-based guideline on management of status epilepticus in adult intensive care unit in resource-limited settings: a review article. Ann Med Surg (Lond). 2023 Apr 17;85(6):2714-2720. doi: 10.1097/MS9.0000000000000625. eCollection 2023 Jun.
- Results publication: PubMed 29870458Cohen SP, Bhatia A, Buvanendran A, Schwenk ES, Wasan AD, Hurley RW, Viscusi ER, Narouze S, Davis FN, Ritchie EC, Lubenow TR, Hooten WM. Consensus Guidelines on the Use of Intravenous Ketamine Infusions for Chronic Pain From the American Society of Regional Anesthesia and Pain Medicine, the American Academy of Pain Medicine, and the American Society of Anesthesiologists. Reg Anesth Pain Med. 2018 Jul;43(5):521-546. doi: 10.1097/AAP.0000000000000808.
- Results publication: PubMed 29945898Zanos P, Moaddel R, Morris PJ, Riggs LM, Highland JN, Georgiou P, Pereira EFR, Albuquerque EX, Thomas CJ, Zarate CA Jr, Gould TD. Ketamine and Ketamine Metabolite Pharmacology: Insights into Therapeutic Mechanisms. Pharmacol Rev. 2018 Jul;70(3):621-660. doi: 10.1124/pr.117.015198.
- Individual participant dataSharing planned: No. Stored in non-publicly available Available on request
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ketamine, Midazolam and Propofol in people with Epilepsy and Seizure, run by Haseki Training and Research Hospital at 1 site in Turkey (Türkiye).
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 1 inclusion and 9 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 15 Dec 2025. 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 Turkey (Türkiye). 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Rates of interictal epileptiform discharges on EEG (time frame: 0, 5, and 30 min following the initial administration.). The study lists 3 primary outcomes in all. 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 NCT06741930, which also lists 6 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 15 Dec 2025.