Modafinil In Debilitating Fatigue After Stroke 2

INTERVENTION: Study Drug: Modafinil Dose: 200mg taken once a day for 56 days followed by open‐label non‐randomised observational phase for 10 months. Route: oral tablet Time of administration; Modafinil is ideally to be taken with breakfast. Treatment adherence will be monitored by drug tablet return. CONDITION: Post Stroke Fatigue PRIMARY OUTCOME: Change in the Quality of life of participants on Modanifil compared to placebo assessed by an increase of 10 or more points on the self‐reported quality of life using the 36‐item Short Form Survey (SF‐36). SECONDARY OUTCOME: Change in carer burden on the Oberst Caregiving Burden Scale and Caregiver Strain Index. Change in the Depressive Anxiety and Stress Scale (DASS 42) compared between study groups ‐ Modafinil and Placebo Change in the EuroQol five dimensions questionnaire (EQ‐5D) compared between study groups ‐ Modafinil and placebo ; Change in the Fatigue Severity Scale (FSS) compared between study groups‐ Modafinil and placebo (Tertiary Endpoint) ; Change in the Modified Ranking Scale (mRS) compared between study groups‐ Modafinil and placebo (Tertiary Endpoint) ; Change in the Montreal Cognitive Assessment (MoCA) compared between study groups ‐ Modafinil and Placebo ; ; Change in the Multidimensional Fatigue Inventory (MFI) compared between study groups _ Modafinil and Placebo ; ; ; ; ; ; Change in the Quality of life of participants on Modanifil compared to placebo assessed by an increase of 5 or more points on the self‐reported quality of life using the 36‐item Short Form Survey (SF‐36). ; Change in the Trail Making A and B test compared between study groups‐ Modafinil and Placebo Safety Endpoint 1: Number of severe adverse events between modafinil and placebo assessed by the Investigator and designated study personnel monitoring each subject for adverse events during the study. ; Safety Endpoint 2: Number of rash complications compared between study groups‐ Modafinil and Placebo assessed by adverse event review by the investigator and designated study personnel for each subject during the study. INCLUSION CRITERIA: Participant: • 18 years of age or older • have suffered a stroke (ischaemic/ Haemorrhagic) at least 3 months ago • have persistent self‐reported fatigue with MFI score of 60 or more • modified Rankin Score (mRS) of 3 or less • can speak reasonable English, understand instructions and be able to complete tests and questionnaires on their own or with minimal support • able to give informed consent to participate in the study, in accordance with the ICH GCP guidelines, and local regulations, before initiating any study related procedures Caregiver: • have the consent of the study participant for whom they care for, to take part in the research • meets the definition of a ‘caregiver’ to participate in the research. They must be a reliable and capable person, who either lives in the same household with the participant or interacts with the participant at least 10 hours per week and will be available to attend all clinic visit