Aneurysmal subarachnoid haemorrhage Cerebral vasospasm Ischaemic stroke MedDRA version: 16.0 Level: LLT Classification code 10047164 Term: Vasospasm cerebral System Organ Class: 10029205 - Nervous system disorders MedDRA version: 16.0 Level: PT Classification code 10061256 Term: Ischaemic stroke System Organ Class: 10029205 - Nervous system disorders MedDRA version: 16.0 Level: LLT Classification code 10055845 Term: Haemorrhage subarachnoid System Organ Class: 10029205 - Nervous system disord
Conditions
Interventions
Trade Name: Aricept Evess
Product Name: Aricept Evess
Pharmaceutical Form: Dispersible tablet
INN or Proposed INN: Donepezil hydrochloride
CAS Number: 120011-70-3
Concentration unit: mg milligram(s)
C
Sponsors
St George's University of London
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients aged 18-85 admitted to St George's Hospital neurosurgical service with confirmed aneurysmal subarachnoid haemorrhage (brain bleeding from an aneurysm). 2. Amount of blood: Fisher score = 2 or greater (blood load on CT scan) 3. Able to be enroled within 12-72 hours of brain bleeding symptom onset. 4. Index aneurysm suitable for endovascular occlusion (coiling) Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 76 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 24
Exclusion criteria
Exclusion criteria: 1. Allergy to donepezil or other piperidine derivatives. 2. Pregnancy. 3. Lactating or breast feeding women 4. Male or female participants that are unwilling to use an effective method of birth control (hormonal or barrier method of birth control; abstinence from time consent is signed until 6 weeks after the last dose of Donepezil 5. Known dementia. 6. Severe hepatic impairment (Child-Pugh Class C) 7. Patients with ‘sick sinus syndrome’ or other supraventricular cardiac conduction conditions such as sino-atrial or atrioventricular block. 8. Patients with a history of brittle asthma or obstructive pulmonary disease, requiring regular steroid (inhalers or tablet) for control.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: The first XeCT scan is performed under general anaesthetic immediately prior to the administration of the first dose of donepezil. It is expected that this would occur within the first 24 hours after enrolment. The second XeCT scan would be performed as soon as possible after the treatment of the participant's aneurysm (but not less than 3 hours after the first XeCT scan (timescale in protocol: 3-24h).;Main Objective: Does donepezil improve brain blood flow after brain bleeding from aneurysms (subarachnoid haemorrhage)?;Secondary Objective: Is donepezil safe and well tolerated in patients with acute brain bleeding (subarachnoid haemorrhage)?;Primary end point(s): Changes in regional cerebral blood flow (mL/100g/min) measured by two Xenon CT perfusion scans, one performed before the administration of a loading dose of donepezil, and the other after this dose. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Modified Rankin Score at 6 months. 2. Evidence of brain infarction on imaging (CT or MRI) not related to aneurysm occlusion treatment. 3. Delayed clinical neurological deficits. 4. Number of hospital days. 5. Need for endovascular treatment of large vessel spasm ;Timepoint(s) of evaluation of this end point: Modified Rankin Score - 6 months after admission. All other secondary outcomes would be evaluated during the participant's acute admission for subarachnoid haemorrhage (usually 1-4 weeks). | — |
Countries
United Kingdom
Contacts
Public ContactDr Jeremy B Madigan
St George's Hospital NHS Trust
Outcome results
None listed