Pharmaceutical Treatment of Fatigue After Aneurysmal Subarachnoid Hemorrhage
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|ClinicalTrials.gov Identifier: NCT03209830|
Recruitment Status : Recruiting
First Posted : July 6, 2017
Last Update Posted : September 5, 2018
|Condition or disease||Intervention/treatment||Phase|
|Aneurysmal Subarachnoid Hemorrhage||Drug: OSU 6162 Drug: Placebo Oral Tablet||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Double-blind, randomised, placebo-controlled study|
|Masking:||Double (Participant, Investigator)|
|Official Title:||OSU6162 in the Treatment of Fatigue and Other Neuropsychological Sequelae After Aneurysmal Subarachnoid Hemorrhage - A Double-blind, Randomised, Placebo-controlled Study|
|Actual Study Start Date :||September 5, 2017|
|Estimated Primary Completion Date :||November 2019|
|Estimated Study Completion Date :||November 2019|
Experimental: Arm A
OSU6162, drug given to half of the patients after randomization
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.
Other Name: PNU-9639
Placebo Comparator: Arm B
Placebo oral tablet, drug given to halv of the patients after randomization
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.
- Change in Fatigue Severity Scale over time [ Time Frame: Baseline, week 1, 4 12, and 20. ]FSS - change
- Beck Depression Inventory [ Time Frame: Baseline, week 4, 12, and 20. ]BDI
- Beck Anxiety Inventory [ Time Frame: Baseline, week 4, 12, and 20. ]BAI
- Mental Fatigue Scale [ Time Frame: Baseline, week 4, 12, and 20. ]MFS
- Situational fatigue scale [ Time Frame: Baseline, week 4, 12, and 20. ]SFS
- Short Form 36 [ Time Frame: Baseline, week 4, 12, and 20. ]SF-36
- Resilience Scale for Adults [ Time Frame: Baseline, week 4, 12, and 20. ]RSA
- Brief COPE [ Time Frame: Baseline, week 4, 12, and 20. ]B-COPE
- Symptom Checklist 90 Revised [ Time Frame: Baseline, week 4, 12, and 20. ]SCL-90-R
- Post-traumatic stress symptom scale [ Time Frame: Baseline, week 4, 12, and 20. ]PTSS-10
- Connors Performance Test Version 3 [ Time Frame: Baseline and week 12 ]CPT-III
- Trail making Test (D-KEFS) [ Time Frame: Baseline and week 12 ]TMT
- Color-Word Interference Test (D-KEFS) [ Time Frame: Baseline and week 12 ]CWIT
- California Verbal Learning Test Version 2 [ Time Frame: Baseline and week 12 ]CVLT-II
- Digit Span (WAIS-IV) [ Time Frame: Baseline and week 12 ]DS
- Grooved Pegboard (Halstead-Reitan Battery) [ Time Frame: Baseline and week 12 ]PEG
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03209830
|Contact: Angelika Sorteberg, MDemail@example.com|
|Contact: Elin Western, PhDfirstname.lastname@example.org|
|Oslo University Hospital||Recruiting|
|Oslo, Norway, 0027|
|Contact: Angelika Sorteberg, MD,PhD +47 23070613 email@example.com|
|Principal Investigator:||Angelika Sorteberg, MD||Oslo University Hospital|