Condition: Parkinson’s disease
Key Inclusion Criteria:
- Individuals with Parkinson’s disease (PD) who are at least 30 years old. Parkinson’s disease diagnosis must be consistent with the UK Brain Bank Criteria.
- Modified Hoehn and Yahr Scale in “ON” state ≤3
- Must experience motor fluctuations and experience an average of at least 2.5 hours daily (with a minimum of 2 hours every day) in the “OFF” state during the waking hours as confirmed by an adequately completed ”ON/OFF” diary over 3 days
Key Exclusion Criteria:
- Atypical or secondary Parkinsonism
- Acute psychosis or troublesome hallucinations in the past 6 months
- Clinically significant or unstable medical, surgical, or psychiatric condition or laboratory abnormalities that represent a safety risk, make the individual unsuitable for study entry or potentially unable to complete all aspects of the study
A Multicenter, Randomized, Active-Controlled, Double-Blind, Double-Dummy, Parallel Group Clinical Trial, Investigating the Efficacy, Safety, and Tolerability of Continuous Subcutaneous ND0612 Infusion in Comparison to Oral IR-LD/CD in Subjects With Parkinson’s Disease Experiencing Motor Fluctuations (Boundless) (IRB no. 00000805)
This study focuses on individuals who have Parkinson’s disease with poorly controlled or involuntary movement symptoms. The purpose of the study is to evaluate the effectiveness and safety of an investigational drug called ND0612, delivered under the skin, as a possible treatment for Parkinson’s disease. ND0612 is a solution of levodopa/carbidopa (LD/CD) delivered as a continuous, subcutaneous (under the skin) infusion through a pump system to treat Parkinson’s disease. It is not yet known how well the infusion treatment works compared with standard treatment (with tablets).
In this study, oral LD/CD will be given on top of the infusion as needed. Researchers hope that the administration of LD and CD as a continuous infusion will result in more constant drug levels in the patient’s blood, which may reduce Parkinson’s symptoms more effectively than current standard treatment.