What are the risks related to ND0612 clinical studies?

  • Though the investigational medication has been studied before, and was found to be tolerable, it is possible you could experience side effects. Because research studies can affect the health and safety of participants, you will be closely monitored during the study if you participate in these studies.
  • To date, 138 people (healthy volunteers and patients with Parkinson’s Disease) were treated with continuous subcutaneous infusion of the study drug.
    • The most commonly reported adverse effects were local skin infusion site reactions. Nearly all subjects reported subcutaneous nodules at the infusion sites, which were generally not associated with pain. The nodules resolved spontaneously within an average of 2-3 months. Approximately 50% of patients reported mild and transient pain, erythema (superficial reddening of the skin) and edema (a condition characterized by an excess of watery fluid collecting in the cavities), at the infusion sites, which resolved spontaneously.
    • Other common adverse events included local hemorrhage (bruising) at the infusion sites and headache.
    • The study drug contains levodopa and carbidopa which are known to be associated with adverse events, the most common being dyskinesia (abnormal involuntary movements), nausea, vomiting, dizziness, low blood pressure upon rising, headache, sleeplessness, dry mouth, anxiety and constipation.
    • Serious side effects that are known to be associated with LD/CD medications are hallucinations and delusions, unexpected falling asleep (e.g. during driving), unusual urges and high fever and confusion related to medication withdrawal.