A Safety, Tolerability and Levodopa Pharmacokinetics Study of Repeated ND0612 in Parkinson's Disease Patients
Phase 2
Completed
NCT01883505
| Condition | Parkinson's Disease |
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| Phase | Phase 2 |
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| Sponsor | NeuroDerm Ltd. |
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| Status | Completed |
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| Enrollment | 30 participants |
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| Interventions | ND0612, Entacapone |
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| Start date | Jan 6, 2014 |
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| Completion date | Apr 26, 2015 |
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| Results posted | Jul 9, 2026 |
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Summary
This is a randomized, placebo-controlled, double-blind, 2-period study evaluating the safety and pharmacokinetics (PK) of ND0612 in Parkinson's disease (PD) patients on an optimized oral levodopa (LD) regimen and experiencing ≥2 h/day of OFF time. Safety and tolerability, PK profile, pump usability, and the potential clinical effect of ND0612 will be explored in subjects with PD and motor fluctuations.
Maximum Dermal Rating Score: Draize Score
14 days (Period 1) · score
| Period 1. ND0612 | 1.6 ± 1.38 score |
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| Period 1. Placebo | 1.0 ± 1.41 score |
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Maximum Dermal Rating Score: Erythema and Eschar Formation
14 days (Period 1) · score
| Period 1. ND0612 | 1.0 ± 0.88 score |
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| Period 1. Placebo | 0.36 ± 0.81 score |
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Maximum Dermal Rating Score: Edema
14 days (Period 1) · score
| Period 1. ND0612 | 0.82 ± 1.08 score |
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| Period 1. Placebo | 1.2 ± 1.79 score |
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Open in BENITIONS
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