Clinical trial • Phase IV • Neurology

ESKETAMINE for Post-craniotomy headache | Temporal lobe epilepsy (drug-resistant)

Phase IV trial of ESKETAMINE for Post-craniotomy headache | Temporal lobe epilepsy (drug-resistant).

Overview

Trial Therapeutic Area
Neurology
Trial Disease
Post-craniotomy headache | Temporal lobe epilepsy (drug-resistant)
Trial Stage
Phase IV
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
11-10-2024
First CTIS Authorization Date
13-12-2024

Trial design

Randomised, placebo: sodium chloride intravenous infusion (intravenous cristallin fluid). dose/schedule not specified in source.-controlled Phase IV trial across 1 site in Netherlands.

Randomised
Yes
Comparator
Placebo: Sodium chloride intravenous infusion (intravenous cristallin fluid). Dose/schedule not specified in source.
Target Sample Size
62
Trial Duration For Participant
180

Eligibility

Recruits 62 No vulnerable population selected. Participants must be adults (Age > 18 years) and provide signed informed consent for trial participation..

Vulnerable Population
No vulnerable population selected. Participants must be adults (Age > 18 years) and provide signed informed consent for trial participation.

Inclusion criteria

  • {"criterion_text":"- Age > 18 years"}
  • {"criterion_text":"- Elective resective surgery for drug-resistant temporal lobe epilepsy"}
  • {"criterion_text":"- Drug-resistant epilepsy, based on: o chronic, focal epilepsy o not seizure free with antiepileptic medication o no medication options due to adverse effects"}
  • {"criterion_text":"- Signed informed consent for trial participation"}

Exclusion criteria

  • {"criterion_text":"- Declined informed consent"}
  • {"criterion_text":"- Allergy to any of the trial medications"}
  • {"criterion_text":"- Current chronic pain, such as, but not limiting to, migraine or other headaches."}
  • {"criterion_text":"- Chronic pain treatment with use of different kinds of pain medication."}
  • {"criterion_text":"- Alcohol, hard- or soft drug abuses"}
  • {"criterion_text":"- Inability to complete questionnaires or language barrier"}
  • {"criterion_text":"- History of psychiatric complaints for which treatment was performed"}
  • {"criterion_text":"- History of craniotomy or subdural electrode implantation"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- The primary endpoint is the total postoperative opioid consumption at the 7th postoperative day with interim measurements at 24, 48, 72 and 96 hours postoperatively.","definition_or_measurement_approach":"Total opioid consumption measured 5 times in the first 7 days after operation (interim measurements at 24, 48, 72 and 96 hours; primary assessment at day 7)."}

Secondary endpoints

  • {"endpoint_text":"- Secondary endpoints will be the length of hospital stay, patient health-related quality of life (RAND SF-36 questionnaire), psychological parameters (questionnaires below cited), adverse events, and postoperative pain scores (VAS+NRS) during the first 7 postoperative days.","definition_or_measurement_approach":"Postoperative pain scores measured with VAS and NRS during first 7 postoperative days and again at 3 and 6 months; health-related quality of life measured with RAND SF-36; psychological parameters via specified questionnaires; length of hospital stay and adverse events recorded."}

Recruitment

Planned Sample Size
62
Recruitment Window Months
88
Consent Approach
Signed informed consent required from participants. Participants must be adults (>18 years). Informed consent form document available (L1_SIS and ICF_NL_public). No details on multiple language versions provided in source.

Geography

Total Number Of Sites
1
Total Number Of Participants
62

Netherlands

Earliest CTIS Part Ii Submission Date
12-11-2024
Latest Decision Or Authorization Date
13-12-2024
Processing Time Days
31
Number Of Sites
1
Number Of Participants
62

Sites

Site Name
Maastricht University Medical Center+
Department Name
Neurosurgery
Contact Person Name
Olaf Schijns
Contact Person Email
o.schijns@mumc.nl

Sponsor

Primary sponsor

Full Name
Academisch Ziekenhuis Maastricht
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Netherlands

Investigational products

Investigational Product Name
ESKETAMINE
Active Substance
ESKETAMINE
Modality
Small molecule
Routes Of Administration
Intravenous infusion
Route
Intravenous infusion
Authorisation Status
Authorised
Maximum Dose
2.4 mg/Kg (max daily); 5.05 mg/Kg (max total)
Investigational Product Name
SODIUM CHLORIDE
Active Substance
SODIUM CHLORIDE
Modality
Small molecule
Routes Of Administration
Intravenous infusion
Route
Intravenous infusion
Maximum Dose
2.4 mg/Kg (max daily); 5.05 mg/Kg (max total)
Combination Treatment
Yes

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