A Phase 3 interventional study of ND0612 Solution for SC infusion and Placebo for SC infusion in Parkinson's Disease, sponsored by NeuroDerm Ltd.. Active, not recruiting at 103 sites in 16 countries. Open to participants aged 30 Years and older. Per ClinicalTrials.gov, last updated 2025-05-21.
Sponsored by NeuroDerm Ltd. · Phase 3, Interventional, and Treatment
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.
This is a phase III multi-center, randomized, active-controlled, double-blind, double-dummy (DBDD), parallel group clinical trial, investigating the efficacy, safety, and tolerability of continuous subcutaneous (SC) ND0612 infusion in comparison to oral IR-LD/CD in subjects with Parkinson's disease (PD) experiencing motor fluctuations.
This study is comprised of 6 periods:
4,487 studies on the registry are indexed under Parkinson Disease; 1,082 are open to participants now.
This study's enrollment of 381 is above the median of 40 across 3,294 interventional studies indexed under Parkinson Disease.
Browse Parkinson Disease studies →NeuroDerm Ltd. is the lead sponsor of 14 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
ND0612 continuous SC infusion + Active IR-LD/CD (grey capsules) + Placebo IR-LD/CD (white capsules). Randomized DBDD Maintenance Treatment for 12 weeks.
Combination Product: ND0612 Solution for SC infusion · Drug: Oral IR-LD/CD · Drug: Placebo for Oral IR-LD/CD
Placebo for ND0612 continuous SC infusion + Placebo IR-LD/CD (grey capsules) + Active IR-LD/CD (white capsules). Randomized DBDD Maintenance Treatment for 12 weeks.
Combination Product: Placebo for SC infusion · Drug: Oral IR-LD/CD · Drug: Placebo for Oral IR-LD/CD
Active IR-LD/CD (white capsules). Open-label Treatment in Run-in 1 for 4-6 weeks.
Drug: Oral IR-LD/CD
ND0612 continuous SC infusion + Active IR-LD/CD (grey capsules). Open-label Treatment in Run-in 2 for 4-6 weeks.
Combination Product: ND0612 Solution for SC infusion · Drug: Oral IR-LD/CD
ND0612 continuous SC infusion + Standard of care LD/dopa-decarboxylase inhibitor. Open-label Treatment in Extension for up to 54 months.
Combination Product: ND0612 Solution for SC infusion
Levodopa/Carbidopa (LD/CD) solution administered SC via infusion pump
Placebo solution administered SC via infusion pump
Encapsulated LD/CD 100mg/25mg
Also known as: IR-LD/CD
Encapsulated Placebo for LD/CD 100mg/25mg
Also known as: Placebo for IR-LD/CD
The change in daily ON time without troublesome dyskinesia
ON time without troublesome dyskinesia is the sum of ON time without dyskinesia and ON time with non-troublesome dyskinesia per patient diary
Time frame: Baseline to the end of DBDD Maintenance Period (12 weeks)
The change in daily OFF time
OFF time per patient diary
Time frame: Baseline to the end of DBDD Maintenance Period (12 weeks)
Showing the first 100 of 103 sites across 16 countries.
This study is active, not recruiting, as verified in May 2025. You cannot join it, but the record below documents what was studied.
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NeuroDerm Ltd.