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Pharmaceutical Treatment of Fatigue After Aneurysmal Subarachnoid Hemorrhage

NCT03209830 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2019-11-22

No results posted yet for this study

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.

Conditions

  • Aneurysmal Subarachnoid Hemorrhage

Interventions

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.

Sponsors & Collaborators

  • Göteborg University

    collaborator OTHER

  • Sahlgrenska University Hospital

    collaborator OTHER

  • Oslo University Hospital

    lead OTHER

Principal Investigators

  • Angelika Sorteberg, MD · Oslo University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-05
Primary Completion
2019-09-13
Completion
2019-09-13

Countries

  • Norway

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03209830 on ClinicalTrials.gov