All potential medicines can cause side effects.
The compound has been studied extensively in the laboratory and in animals. Based on the way this study compound works, the following side effects could occur:
- Infections of the skin that may require medical intervention such as the use of an antibiotic or antifungal.
- Infection of the central nervous system, such as:
- Meningitis is an infection associated with inflammation of the fluid and membranes that cover the brain and spinal cord.
- Encephalitis, an inflammatory reaction in the brain that could be triggered by infection from a virus or bacteria.
- Temporary change to your mood, memory and learning ability.
- Allergic reaction.
- Skin symptoms, such as itching or a rash.
In Part A, healthy subjects received the study compound as single infusion. Of the 42 healthy subjects that participated in Part A, 27 subjects received the study compound and 15 subjects received placebo. Mild to moderate itching was observed in 7 subjects. The itching was judged to be possibly related to the study treatments. As it is not yet known which subject received the study compound and who received placebo, it cannot yet be determined if these effects are related to the study compound or placebo.
You should take into account that side effects may occur that are still unknown. In addition to unknown side effects, there is a (small) chance that an allergic reaction will occur. This can be caused by the study compound or other ingredients that are used to prepare the formulation. During the study, you will be under strict medical supervision. The doctors and investigators of ICON are always well-informed about the compound being studied. With this knowledge they can estimate the effects and side effects reasonably well.
During the study you will undergo a lumbar puncture (LP). The procedure will be carried out by trained medical personnel using a technique that minimizes risks and you will be monitored closely. Before the CSF collection, you will undergo tests to check if it is safe to carry out the CSF collection (for example blood test and neurological examination).
The lumbar puncture procedure could cause pain, nausea (feeling sick), headache, discomfort, bruising, stiffness, bleeding, and, rarely, an infection. Occasionally, during needle insertion, a spinal nerve might be touched, causing pain to spread to the buttock or leg. This usually lasts only a short time. Rarely, participants may experience bleeding into the spinal canal, or spinal canal nerve damage. Headache after lumbar puncture can be accompanied by dizziness, nausea and ringing in the ears (tinnitus). If you develop a headache, you will be encouraged to lie down in a comfortable position. In most cases headache can be alleviated with bed rest, drinking enough water, and simple painkillers if needed. Most headaches last for several hours to two days; in extremely rare cases, headaches persisting for a full week have been reported. If the headache does not go away, a second procedure called a blood patch may be necessary to treat it. This involves taking a sample of your blood and injecting it in your back.