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NCT02577523 · ClinicalTrials.gov registry record · Phase 2
A Clinical Study of Efficacy, Safety, Tolerability and PK of ND0612H in Subjects With Advanced Parkinson's Disease
A Phase 2 study, sponsored by NeuroDerm.
- Completed
- Registry status
- Phase 2
- Development phase
- 38
- Enrollment target
NCT02577523 is a Phase 2 study that has completed, run by NeuroDerm. The registered enrollment target is 38 participants.
The verdict
NCT02577523, a Phase 2 study, has completed, sponsored by NeuroDerm.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 38 participants
- Enrollment target
Study Summary
This is a multicenter, parallel-group, rater-blinded, randomized clinical study in subjects with advanced PD investigating the efficacy, PK, safety and tolerability of continuous SC infusion of 2 dosing regimens of ND0612H, a solution of LD/CD delivered via a pump system as a continuous SC infusion, compared to standard oral LD/CD. After screening, subjects will undergo 1 day of standard oral LD/CD inpatient dosing followed by 2 days of inpatient treatment with 1 of 2 randomly allocated (1:1 randomization ratio) dosing regimens of ND0612H continuous SC infusion. Subjects will then continue on a maintenance dose of the assigned ND0612H dosing regimen for the next 25 days. A safety visit will be performed 4 weeks after the last SC administration of the study drug for a total of about 2.5 months of participation for each subject enrolled into the trial.
Interventions
- DRUG ND0612 (Levodopa/Carbidopa solution)
- DRUG ND0612 (Levodopa/Carbidopa solution) + morning oral IR-LD/CD
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2015-12-29 |
| Est. Completion | 2017-01-31 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02577523
The ClinicalTrials.gov registry entry for NCT02577523 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 38 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is NeuroDerm, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which ND0612 (Levodopa/Carbidopa solution) is the first listed.
NCT02577523 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02577523 about?
NCT02577523 is a clinical study titled "A Clinical Study of Efficacy, Safety, Tolerability and PK of ND0612H in Subjects With Advanced Parkinson's Disease". This is a multicenter, parallel-group, rater-blinded, randomized clinical study in subjects with advanced PD investigating the efficacy, PK, safety and tolerability of continuous SC infusion of 2 dosing regimens of ND0612H, a solution of LD/CD delivered via a pump system as a continuous SC infusion,...
What is the current status of trial NCT02577523?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 38 participants. The study started on 2015-12-29. Estimated completion is 2017-01-31.
What interventions are being tested in trial NCT02577523?
The interventions under investigation include: ND0612 (Levodopa/Carbidopa solution) (DRUG), ND0612 (Levodopa/Carbidopa solution) + morning oral IR-LD/CD (DRUG).
Who is sponsoring clinical trial NCT02577523?
This trial is sponsored by NeuroDerm, which has 3 total clinical trials registered on ClinicalTrials.gov.
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