OSU6162 IN THE TREATMENT OF FATIGUE AND OTHER NEUROPSYCHOLOGICAL SEQUELAE AFTER ANEURYSMAL SUBARACHNOIDAL HEMORRHAGE - A DOUBLE-BLIND, RANDOMISED, PLACEBO-CONTROLLED STUDY

Oslo University Hospital0 sites100 target enrollmentFebruary 1, 2017

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Fatigue and neuropsychological dysfunction after aneurysmal brain hemorrhage
Sponsor: Oslo University Hospital
Enrollment: 100
Status: Active, not recruiting
Last Updated: 4 years ago

No summary available.

Registry

who.int

Start Date

February 1, 2017

End Date

TBD

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

Oslo University Hospital

•1\.Signed written informed consent
•2\.\> 18 years old
•3\.Aneurysmal subarachnoid haemorrhage \>12 months prior to the start of the study.
•4\.Diagnosed with post SAH syndrome/fatigue at \=12 months after their hemorrhage
•5\.Post\-menopausal or using adequate contraceptive measures
•\-Female patients of childbearing potential using a highly efficient method of contraception (i.e. a method with a failure rate of less than 1% \[e.g. sterilisation, hormone implants, hormone injections, some intrauterine devices, or vasectomy in partner])
•\-Male patients agreeing to use condoms during the study and for 3 months after the end of the study/last dose of the investigational medicinal product, or male patients with a partner who is using a highly efficient method of contraception (as described above)
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1\.2 Adults (18\-64 years) yes

•1\.Residual symptoms following other pathologies than aSAH
•2\.Not adequately treated hydrocephalus secondary to aSAH
•3\.Diagnosed with neurodegenerative disease
•4\.Active substance abuse (drug screen taken at baseline)
•5\.Current pregnancy or breast\-feeding, or intention to become pregnant within 3 months after the last dose
•6\.Women of childbearing age not using contraceptives
•7\.Pathologic ECG, as assessed by the investigator. Max QTc\-time on ECG: 450 ms in men and 460 ms in women
•8\.Abnormal laboratory values of such severity that participation in the study, in the opinion of the investigator, is questionable
•9\.Patients who are so debilitated by their disease that they are not assumed to be able to perform the assessments or handle the instruments used for evaluation of effect and/or are not able to consent
•10\.Patients that speak so poorly Norwegian that they are not able to answer the questionnaires or undergo neuropsychological testing