Overview
Sponsor-declared trial summary
Post-craniotomy headache
The aim of this study is to investigate the effect of adding s-ketamine to a multimodal pain approach of acetaminophen and opioids compared to placebo with the same multimodal pain approach, on total opioid consumption after craniotomy in patients with drug-resistant temporal lobe epilepsy. The total opioid consumption…
Key facts
- Sponsor
- Academisch Ziekenhuis Maastricht
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nervous System Diseases [C10]
- Trial duration
- 14 Mar 2018 → ongoing
- Decision date (initial)
- 2024-12-13
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-514020-16-00
- EudraCT number
- 2017-002616-13
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Therapy
The aim of this study is to investigate the effect of adding s-ketamine to a multimodal pain approach of acetaminophen and opioids compared to placebo with the same multimodal pain approach, on total opioid consumption after craniotomy in patients with drug-resistant temporal lobe epilepsy. The total opioid consumption will be measured 5 times in the first 7 days after operation.
Secondary objectives 1
- Secondary endpoints in this study will be postoperative pain scores measured with the VAS and Numeric Rating Scale (NRS), whereby they will be measured the first 7 days after operation and again after 3 and 6 months, length of hospital stay, different psychological parameters (see questionnaires below under 3), patient health-related quality of life and adverse events.
Conditions and MedDRA coding
Post-craniotomy headache
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- Age > 18 years
- Elective resective surgery for drug-resistant temporal lobe epilepsy
- Drug-resistant epilepsy, based on: o chronic, focal epilepsy o not seizure free with antiepileptic medication o no medication options due to adverse effects
- Signed informed consent for trial participation
Exclusion criteria 8
- Declined informed consent
- Allergy to any of the trial medications
- Current chronic pain, such as, but not limiting to, migraine or other headaches.
- Chronic pain treatment with use of different kinds of pain medication.
- Alcohol, hard- or soft drug abuses
- Inability to complete questionnaires or language barrier
- History of psychiatric complaints for which treatment was performed
- History of craniotomy or subdural electrode implantation
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- 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.
Secondary endpoints 1
- 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.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
SUB25825 · Substance
- Active substance
- Esketamine
- Pharmaceutical form
- SOLUTION FOR INJECTION/INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 2.4 mg/Kg milligram(s)/kilogram
- Max total dose
- 5.05 mg/Kg milligram(s)/kilogram
- Max treatment duration
- 2 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Placebo 1
SUB12581MIG · Substance
- Active substance
- Sodium Chloride
- Pharmaceutical form
- SOLUTION FOR INJECTION/INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 2.4 mg/Kg milligram(s)/kilogram
- Max total dose
- 5.05 mg/Kg milligram(s)/kilogram
- Max treatment duration
- 2 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Academisch Ziekenhuis Maastricht
- Sponsor organisation
- Academisch Ziekenhuis Maastricht
- Address
- P Debyelaan 25
- City
- Maastricht
- Postcode
- 6229 HX
- Country
- Netherlands
Scientific contact point
- Organisation
- Academisch Ziekenhuis Maastricht
- Contact name
- Secretariaat Neurochirurgie MUMC+
Public contact point
- Organisation
- Academisch Ziekenhuis Maastricht
- Contact name
- Secretariaat Neurochirurgie MUMC+
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ongoing, recruiting | 62 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Netherlands | 2018-03-14 | 2024-12-13 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 4 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_2024-514020-16_public | 6 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_Placeholder Document | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_NL_public | 4 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Esketiv | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-10-11 | Netherlands | Acceptable 2024-12-13
|
2024-12-13 |