Double-blind, randomised, placebo-controlled study to evaluate the efficacy and safety of OSU6162 in the treatment of residual symptoms after stroke
- Conditions
- StrokeTherapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2016-003888-19-SE
- Lead Sponsor
- A. Carlsson Research AB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 100
1. Signed written informed consent
2. Between 18-80 years
3. Stroke >12 months prior to the start of the study. Patients must have had the location of their stroke evaluated through a CT scan, noted in their hospital notes
4. Anamnestic evidence of post stroke residual symptoms at least 3 months prior to the start of the study
5. At least 10.5 points on Mental Fatigue scale at the screening visit (week -2)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 90
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10
1. Residual symptoms following other pathologies than stroke
2. Active substance abuse (drug screen taken at visit1)
3. Other serious somatic or psychiatric disease
4. Beck Depression Inventory >30 at visit1 and 2
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: 451 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 debiliated by their disease that they are not assumed to be able to perform the assessments or handle the instruments used for evaluation of effect
10. Current participation in other Clinical trials
11. Previous treatment with OSU6162
12. 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
13. 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.
14. Any surgical or medical condition which, in the opinion of the investigator, might interfere with the absorption, distribution, metabolism or excretion of the drug
15. Patients treated with Modiodal, Xyrem, Mirtazapine, Mianserin or metabolic enzyme inhibitors or inducers, or drugs with a narrow treatment window (e.g. warfarin, antiepileptics, cyclosporine) and individually modelled drugs such as lithium
16. Use of drugs capable of inducing hepatic enzyme metabolism (e.g., barbiturates, rifampicin, carbamazepine, phenytoin, primidone) within 30 days prior to the start of the study (or 5 half-lives of the inducing agent, whichever is longer)
17. Antipsychotic treatment
18. Patients treated with unstable therapies”, i.e., treatments that have not been at the same dose for at least 6 weeks prior to inclusion in this study. The treatment must also remain unchanged during the study period. Insomnia medication and other PRN medications are allowed
19. Use of acute or chronic medications for other medical conditions are allowed based on the investigator's judgement. Occasional use of over-the-counter (OTC) medication is allowed at the investigator's discretion
20. Supplements from Health food stors and naturopathic preparations are not allowed dusring the course of the study or 4 weeks fefore study start
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the efficacy and safety of OSU6162 with respect to treatment response in post stroke patients;Secondary Objective: Not applicable;Primary end point(s): The primary endpoints will be change from baseline in total score on Clinical Global Impression of Change (CGI-C) after 16 weeks of treatment with OSU6162or placebo, with data Collection at baseline, week 4, 8, 12 and 16.
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Mental Fatigue Scale (MFS)<br>Fatigue Severity Scale (FSS)<br>Becks Depression Inventory (BDI)<br>Frenchay Activity Index (FAI)<br>SF-36<br>Stroke Impact Scale (SIS)<br>after 4, 8, 12 and 16 weeks treatment.<br>- Plasmakoncentration of OSU6162 after 4 and 16 weeks treatment<br>- Vital signs and blood and urine samples at screening/baseline and after 4, 8, 12 and 16 weeks of treatment<br>- Physical and neurological examinations<br>- Adverse Event