Post-acute Infectious Syndrome - Aripiprazole Symptom Evaluation (PAIS-AriSE)
Study Details
- Unmapped
- Drug: Aripiprazole (low-dose, 1mg)
- Drug: Placebo
- Male, female or diverse adult who is 18 years or older at the time of informed consent
- Potential participant is willing, understanding and able to provide informed consent
- Signed informed consent prior to initiation of any trial-related measure
- History of confirmed or suspected (PCR or serology or rapid antigen detection, certificate of attending physician, sick note) infectious disease
- Ongoing symptoms of PAIS/PCC for ≥ 3 months
- Self-reported neuropsychiatric symptoms at screening
- For women of childbearing potential (WOCBP):
- Confirmed post-menopausal state, defined as amenorrhea for at least 12 months, or
- If being of childbearing potential: Negative highly sensitive urine or serum pregnancy test before randomization, and practicing a highly effective birth control method (failure rate of less than 1%)
- Prior chronic neuroimmunological or neurodegenerative disease
- Severe psychiatric disease (psychosis, bipolar disorder, severe major depression with inpatient treatment) within the last 10 years
- Current malignant disease (including space-occupying brain tumors)
- Concomitant antipsychotic medication
- Patient is allergic or has contraindication to Aripiprazole or lactulose and cellulose
- Patient is pregnant or breastfeeding
- WOCBP who are unwilling to use an effective method of contraception as defined in inclusion criterion above
- Bell disability scale \< 30
- Participation in another interventional clinical trial within the last 3 months or within five half-lives of the investigational product (whichever is longer)
- Patient is institutionalized by order of court or public authority
- Patient who might be dependent on the sponsor, the investigator or the trial site
- Place of living does not allow the potential participant to attend the planned study visits
- Other conditions that are likely to affect the safety of the study treatment (e.g. severely impaired immune status)
Protocol Summary
This study is looking at how safe it is to switch from emicizumab to Mim8, in people with haemophilia A. Mim8 is a new medicine that is used to prevent bleeding episodes in people with haemophilia A. Mim8 works by replacing the function of the missing clotting factor VIII (FVIII). Mim8 will be injected under the skin using a pen-injector either once every week, once every two weeks or once every month. The participants will be trained in using the pen injector. The participants can choose themselves, in collaboration with the study doctor how often they get Mim8 in this study. When the participant will get their first Mim8 injection depends on their current treatment with emicizumab. The participants will get their first Mim8 injection at Visit 2. Participants will have between 6 and 27 Mim8 injections. The total number of injections participants will have depends on their dosing frequency. The study will last for about 6-12 months. While taking part in this study, there are some restrictions about what medicine participant can use. The study doctor will tell the participants more about this. In case the participants experience bleeds, these can be treated with additional haemostatic medicine as agreed with the study doctor. Female participants cannot take part if they are pregnant, breast-feeding or plan to get pregnant during the study period.