Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Orion Corporation, Orion Pharma
Age
18–120
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Written or verbal informed consent (IC) for participation in the study
Subjects who completed 48 weeks of treatment according to the REFALS study protocol
Able to swallow study treatment capsules at the time of completing 48 weeks dosing in the REFALS study
You may not be if
Development (or significant worsening from baseline of the REFALS study) of serious cardiovascular disease (e.g.: myocardial infarction, heart failure, arrhythmia, stroke, or second or third degree atrioventricular (AV) block)
Pulse/heart rate repeatedly \>100 bpm after 5-minute rest at baseline. If the pulse/heart rate is \>100 bpm in the first recording, then a second recording must be done after another 5 min rest to confirm pulse/heart rate \>100 bpm
Systolic blood pressure (SBP) \<90 mmHg
Severe renal impairment (creatinine clearance \< 30ml/min or creatine \>170 µmol/l at 48 week visit of the REFALS study, or on dialysis
Severe hepatic impairment at the discretion of the investigator
Women of reproductive age without a negative pregnancy test and without a commitment to using a highly effective method of contraception (e.g.: oral hormonal contraceptive associated with inhibition of ovulation, intrauterine devices and long acting progestin agent), if sexually active during the study, and for 1 month after the last dose of the study treatment. Women who are postmenopausal (1 year since last menstrual cycle), surgically sterilised or who have undergone a hysterectomy are considered not to be reproductive and can be included
Subject judged to be actively suicidal by the investigator
Any other clinical significant cardiovascular, gastrointestinal, hepatic, renal, neurological or psychiatric disorder or any other major concurrent illness that in the opinion of the investigator could interfere with the interpretation of the study results or constitute a health risk for the subject if he/she took part in the study
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