Pharmaceutical Treatment of Fatigue After Aneurysmal Subarachnoid Hemorrhage

NCT03209830 | Completed Phase 2 DMC

• 1 other identifier: 2016/2214
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

mental fatigue; drug therapy; subarachnoid hemorrhage; stroke

Outcome Measures

Primary Outcomes (1)

• Change in Fatigue Severity Scale over time

  FSS - change

  Baseline, week 1, 4 12, and 20.

Secondary Outcomes (15)

• Beck Depression Inventory

  Baseline, week 4, 12, and 20.

• Beck Anxiety Inventory

  Baseline, week 4, 12, and 20.

• Mental Fatigue Scale

  Baseline, week 4, 12, and 20.

• Situational fatigue scale

  Baseline, week 4, 12, and 20.

• Short Form 36

  Baseline, week 4, 12, and 20.

Study Arms (2)

Arm A

EXPERIMENTAL

OSU6162, drug given to half of the patients after randomization

Drug: OSU 6162

Arm B

PLACEBO COMPARATOR

Placebo oral tablet, drug given to halv of the patients after randomization

Drug: Placebo Oral Tablet

Interventions

OSU 6162 DRUG

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.

Also known as: PNU-9639

Arm A

Placebo Oral Tablet DRUG

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.

Arm B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed written informed consent
• \> 18 years old
• Aneurysmal subarachnoid haemorrhage \>12 months prior to the start of the study.
• Diagnosed with post SAH syndrome/fatigue at ≥12 months after their hemorrhage
• 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)

You may not qualify if:

• Residual symptoms following other pathologies than aSAH
• Not adequately treated hydrocephalus secondary to aSAH
• Diagnosed with epilepsy, neurodegenerative disease, cerebral paresis, tumor cerebri, cerebral arterio-venous malformations
• Patients that have undergone brain surgery, have been hospitalized for head trauma, or suffered intracranial hemorrhage, stroke, or infectious brain diseases within the last 12 months
• Active substance abuse (drug screen taken at baseline)
• Current pregnancy or breast-feeding, or intention to become pregnant within 3 months after the last dose
• Women of childbearing age not using contraceptives
• Pathologic ECG, as assessed by the investigator. Max QTc-time on ECG in excess of 480 ms or any of these conditions that can increase QT related incidences: long QT syndrome or family history of long QT syndrome, hypothyreoidism, hypocalcemia, significant potassium deviations, type 1 diabetes with prolonged QT, and cardiac insufficiency
• Abnormal laboratory values of such severity that participation in the study, in the opinion of the investigator, is questionable
• 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
• Patients that speak so poorly Norwegian that they are not able to answer the questionnaires or undergo neuropsychological testing
• Previous treatment with OSU6162
• Clinically significant liver disease which may prevent the patient from completing the study and/or an elevation in either total bilirubin, alkaline phosphatase, LDH, SGOT of \>2 times the laboratory reference
• Clinically significant renal disease which may prevent the patient from completing the study and/or an elevation in serum creatinine of \>1.5 times the laboratory reference.
• Any surgical or medical condition which, in the opinion of the investigator, might interfere with the absorption, distribution, metabolism or excretion of OSU6162

Sponsors & Collaborators

• Oslo University Hospital: lead
• Göteborg University: collaborator
• Sahlgrenska University Hospital: collaborator

Study Sites (1)

Oslo University Hospital

Oslo, 0027, Norway

Location

MeSH Terms

Conditions

Subarachnoid Hemorrhage; Mental Fatigue; Stroke

Interventions

OSU 6162

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Fatigue; Signs and Symptoms; Behavioral Symptoms; Behavior

Study Officials

• Angelika Sorteberg, MD

  Oslo University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: Double-blind, randomised, placebo-controlled study

Study Record Dates

• First Submitted: June 28, 2017
• First Posted: July 6, 2017
• Study Start: September 5, 2017
• Primary Completion: September 13, 2019
• Study Completion: September 13, 2019
• Last Updated: November 22, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)