NCT03209830

Pharmaceutical Treatment of Fatigue After Aneurysmal Subarachnoid Hemorrhage

OSU6162 in the Treatment of Fatigue and Other Neuropsychological Sequelae After Aneurysmal Subarachnoid Hemorrhage - A Double-blind, Randomised, Placebo-controlled Study

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Oslo University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Many people who have undergone subarachnoid hemorrhage from an aneurysm (an artery of a vein in the brain) struggle with a pronounced fatigue as well as a number of other sequelae such as impaired concentration, memory deficits and emotional problems. Exhaustion is often permanent and can lead to a significant worsening of quality of life and be the cause of disability. This condition does not only have major consequences for the individual who is affected, but also for their families and for society. So far no effective treatment for fatigue has been found. The drug OSU6162 has shown a beneficial effect on fatigue and other impairments after stroke and after traumatic brain injury. There is good reason to believe that OSU6162 can also improve fatigue and other impairments after aneurysm bleeding and thus increase the chance of returning to the level of daily function they had before the bleeding. The study is double blinded and measures the effect of OSU6162 and placebo on fatigue and neuropsychological function.

Detailed description

The primary objective of this study is to evaluate the efficacy of OSU6162 with respect to sequela after aneurysmal subarachnoid haemorrhage with special emphasis on fatigue. The eventual aim is to find a cure for the debilitating fatigue, cognitive and emotional problems arising in many of the individuals that have suffered aSAH. Until now, no effective treatment exists and the final goal is to provide a medical treatment that alleviates these symptoms to such an extend that aSAH patients can regain a normal quality of live and resume their pre-morbid occupational status and level of social participation. The study is a phase II, double-blind, randomised, placebo-controlled study. Patients that have undergone aSAH from Health-region South-East. All aSAH patients in Health-region South-East are treated at Oslo University Hospital, Neuroclinic, at the Departments of Neurosurgery and the Department of Physical Medicine and Rehabilitation and will be recruited from there. 100 patients will be included in this trial (50 in each group). All patients will receive a dose of OSU6162 15 mg or placebo BID. The expected duration of therapy is 12 weeks. The primary endpoint will be change from baseline in Fatigue Severity Scale (FSS) after 12 weeks of treatment with OSU6162 or placebo, with data collection at weeks 1, 4, 12, and 20 (20=8 weeks after treatment). The secondary endpoints include change from baseline in total score on a number of questionnaires, with data collection at week 4, 12, and 20 (i.e. at 8 weeks after treatment). Secondary endpoints include change from baseline in vital signs, adverse events (+ week 4), physical examinations, blood and urine samples at week 1 and 12. Secondary endpoints include change from baseline on a number of neuropsychological tests, with data collection at week 12. Statistical analyses will be based on linear mixed models. A mixed model analysis uses all the available data to compensate for the data missing on a particular patient. Thus any imputation techniques for missing data points are not necessary. Adverse events (AEs) will be coded using Medical Dictionary for Regulatory Activities (MedDRA) and tabulated by System Organ Class (SOC) and preferred term. A data monitoring committee (DMC) will be established in order to enhance the safety aspect of the study and its primary function will be to review all registered side-effects at various points of time along the study and consider if there are indications for early stopping (either for futility or for positive efficacy). The study will be conducted in accordance with ethical principles that have their origin in the Declaration of Helsinki and are consistent with ICH/Good Clinical Practice and applicable regulatory requirements. Registration of patient data will be carried out in accordance with national personal data laws.

Conditions

• Aneurysmal Subarachnoid Hemorrhage

Interventions

Type	Name	Description
DRUG	OSU 6162	All patients will receive a dose of OSU6162 15 mg BID x 2 per day. The expected duration of therapy is 12 weeks. After 1 week of treatment, patients who do not respond to treatment will have their dose increased to maximum 30 mg BID x 2 per day.
DRUG	Placebo Oral Tablet	All patients will receive a dose of placebo 15 mg BID x 2 per day. The expected duration of therapy is 12 weeks. After 1 week of treatment, patients who do not respond to treatment will have their dose increased to maximum 30 mg BID x 2 per day.

Timeline

• Start date: 2017-09-05
• Primary completion: 2019-09-13
• Completion: 2019-09-13
• First posted: 2017-07-06
• Last updated: 2019-11-22

Locations

1 site across 1 country: Norway