A Phase I/IIa Study of Safety, Tolerability and Plasma Concentration of Subcutaneous Continuously-delivered Levodopa/Carbidopa Solution (ND0612) in PD Patients
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|ClinicalTrials.gov Identifier: NCT01725802|
Recruitment Status : Completed
First Posted : November 14, 2012
Last Update Posted : April 1, 2016
|Condition or disease||Intervention/treatment||Phase|
|Parkinson's Disease||Drug: levodopa and carbidopa solution for SC administration Drug: Placebo||Phase 1 Phase 2|
Design: single center, double-blind, randomized, placebo-controlled, crossover study.
Study Drug: Subcutaneous (SC), ND0612 (LD/CD solution) or placebo (saline) to be administered via a continuously via the CRONO Five SC pump. A 1-week washout period will apply between the treatments.
Population: Eight (8) PD subjects.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||8 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Phase I/IIa, Single Dose, Single-centre, Randomized, Crossover, Double-blind, Placebo-controlled Study Evaluating Safety, Tolerability and Levodopa Plasma Concentration Following Administration of Subcutaneous Continuously-delivered Levodopa/Carbidopa Solution (ND0612) in PD Patients|
|Study Start Date :||December 2012|
|Actual Primary Completion Date :||August 2013|
|Actual Study Completion Date :||September 2013|
Experimental: levodopa and carbidopa
levodopa and carbidopa solution
Drug: levodopa and carbidopa solution for SC administration
Placebo Comparator: placebo to levodopa and carbidopa
Other Name: Saline
- Incidence and frequency of adverse events [ Time Frame: up to 8 weeks ]
- Incidence and frequency of adverse events
- Adverse events reporting related to the ND0612 application, local safety score
- Withdrawal rate [ Time Frame: 2 days ]Withdrawal rates and discontinuations due to adverse events
- LD Half life (t½ ), time of LD plasma concentrations maintained above 1000 ng/ml, trough levels, Cmax, Tmax and AUC [ Time Frame: Up to 2 days ]LD PK profile after oral LD dosing administered with or without ND0612:
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01725802
|Hadassah Medical Center|