ND0612 for Parkinson's Disease
(BouNDless Trial)
Trial Summary
What is the purpose of this trial?
This is a multi-center, randomized, double-blind, double-dummy, active controlled clinical Study. Following a screening period, eligible subjects will be enrolled to an open-label oral IR-LD/CD adjustment period; then an open-label ND0612 conversion period; then after optimization periods subjects will be randomized to receive either ND0612 or its matching Placebo with IR-LD/CD. Subjects can continue to an optional open-label extension period.
Research Team
Olivier Rascol, MD, PhD
Principal Investigator
Toulouse University Hospital, France
Alberto Espay, MD
Principal Investigator
University of Cincinnati OH, USA
Eligibility Criteria
This trial is for adults aged 30 or older with Parkinson's Disease who experience at least 2 hours of 'OFF' time daily, despite taking levodopa. They should not have had neurosurgery for PD, severe skin conditions, disabling dyskinesias, or used certain PD medications recently.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Oral IR-LD/CD Adjustment
Participants undergo an open-label oral IR-LD/CD adjustment period
ND0612 Conversion
Participants undergo an open-label ND0612 conversion period
Maintenance
Randomized double-blind, double-dummy active-controlled maintenance period
Open-label Extension (optional)
Participants may opt into continuation of treatment long-term
Safety Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Carbidopa and Levodopa 25mg/100mg
- ND0612 Solution
- Placebo for Carbidopa and Levodopa 25mg/100mg
- Placebo for ND0612 Solution
Find a Clinic Near You
Who Is Running the Clinical Trial?
NeuroDerm Ltd.
Lead Sponsor