Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04006210 · ClinicalTrials.gov registry record · Phase 3
Efficacy, Safety and Tolerability Study of ND0612 vs. Oral Immediate Release Levodopa/Carbidopa (IR-LD/CD) in Subjects With Parkinson's Disease Experiencing Motor Fluctuations
A Phase 3 study of Parkinson's Disease, sponsored by NeuroDerm.
- Active
- Registry status
- Phase 3
- Development phase
- 381
- Enrollment target
- 20
- Study locations
NCT04006210: Active Phase 3 study of Parkinson's Disease, sponsored by NeuroDerm.
NCT04006210 is a Phase 3 study of Parkinson's Disease that is active but no longer recruiting, run by NeuroDerm. The registered enrollment target is 381 participants, below the 633-participant average among 158 other Parkinson's Disease trials with a reported enrollment target (40% lower). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04006210, a Phase 3 study of Parkinson's Disease, is active but no longer recruiting, sponsored by NeuroDerm.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 381 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Primary Outcome
ON time without troublesome dyskinesia is the sum of ON time without dyskinesia and ON time with non-troublesome dyskinesia per patient diary
Conditions Studied
Interventions
- COMBINATION_PRODUCT ND0612 Solution for SC infusion
- COMBINATION_PRODUCT Placebo for SC infusion
- DRUG Oral IR-LD/CD
- DRUG Placebo for Oral IR-LD/CD
Study Locations (20)
Florida
- Visionary Investigators Network - Aventura
- Parkinsons Disease and Movement Disorders Center of Boca Raton - Boca Raton
- University of Florida Norman Fixel Institute for Neurological Diseases - Gainesville
- Neurology Associates PA - Maitland
- USF Parkinson's Disease and Movement Disorders Center - Tampa
- Neurology One - Winter Park
California
- Cedar- Sinai Medical Center Department of Neurology - Los Angeles
- SC3 Research - Reseda - Reseda
- University of California San Francisco - San Francisco
Georgia
- Emory University - Brain Health Center - Atlanta
- NeuroStudies - Decatur
Arizona
- Xenoscience - Phoenix
Arkansas
- University of Arkansas for Medical Sciences - Little Rock
Colorado
- Rocky Mountain Movement Disorders Center - Englewood
Connecticut
- Hartford Healthcare Chase Family Movement Disorders Center - Vernon
Hawaii
- Hawaii Pacific Neuroscience - Honolulu
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 381 participants |
| Start Date | 2019-09-30 |
| Est. Completion | 2027-02 |
| Phase | Phase 3 |
What the registry record for NCT04006210 still lists
NCT04006210 is an interventional study that assigns participants to a tested intervention. The registered 381 participants enrollment target is mid-sized for trials with a published cap, below the 633-participant average among 158 other Parkinson's Disease trials with a reported enrollment target (40% lower).
The record links to 1 condition, with Parkinson's Disease appearing as the primary indexed condition, and to 4 interventions - of which ND0612 Solution for SC infusion is the first listed.
NCT04006210 names 20 study sites across 12 states, led by Florida, California, Georgia.
Frequently Asked Questions
What is clinical trial NCT04006210 about?
NCT04006210 is a clinical study titled "Efficacy, Safety and Tolerability Study of ND0612 vs. Oral Immediate Release Levodopa/Carbidopa (IR-LD/CD) in Subjects With Parkinson's Disease Experiencing Motor Fluctuations". 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 w...
What is the current status of trial NCT04006210?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 381 participants. The study started on 2019-09-30. Estimated completion is 2027-02.
What conditions does trial NCT04006210 study?
This clinical trial studies the following conditions: Parkinson's Disease.
What interventions are being tested in trial NCT04006210?
The interventions under investigation include: ND0612 Solution for SC infusion (COMBINATION_PRODUCT), Placebo for SC infusion (COMBINATION_PRODUCT), Oral IR-LD/CD (DRUG), Placebo for Oral IR-LD/CD (DRUG).
Who is sponsoring clinical trial NCT04006210?
This trial is sponsored by NeuroDerm, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04006210 being conducted?
This trial has 20 study locations across Arizona, Arkansas, California, Colorado, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Parkinson's Disease
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04006210's enrollment target sits among peer trials
381 21st of 158 higher than 138 of 158 other Parkinson's Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Parkinson's Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
A Study to Evaluate the Efficacy and Safety of Intravenous (IV) Prasinezumab in Participants With Early-Stage Parkinson's Disease
RECRUITING · Phase 3
-
Deep Brain Stimulation for Parkinson's Disease Trial
COMPLETED · Phase 3
-
An Open Label Extension Study of the Safety and Clinical Utility of IPX066 in Subjects With Parkinson's Disease
COMPLETED · Phase 3
-
Study of KW-6002 (Istradefylline) in Parkinson's Disease in Patients With Motor Response Complications on Levodopa
COMPLETED · Phase 3
-
An Open-label Continuation Study Evaluating the Long-term Safety of Extended Release Ropinirole XL (Formerly CR) in Parkinson''s Disease
COMPLETED · Phase 3
-
A Study to Compare IPX066 and Carbidopa/Levodopa/Entacapone (CLE) Followed by an Open-Label Safety Study of IPX066
COMPLETED · Phase 3
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT05677490 · 382 participants · Phase 3
mFOLFIRINOX Versus mFOLFOX With or Without Nivolumab for the Treatment of Advanced, Unresectable, or Metastatic HER2 Negative Esophageal, Gastroesophageal Junction, and Gastric Adenocarcinoma
- NCT06196008 · 382 participants · NA
Telephone-based Physical Activity Coaching or Self Monitored Physical Activity to Improve Physical Function in Older Adults Who Are Undergoing Surgery for Lung Cancer and Their Caregivers
- NCT07100990 · 382 participants · Phase 3
Treatment of Inflammatory Myelitis and Optic Neuritis With Early vs Rescue Plasma Exchange (TIMELY-PLEX)
- NCT04560673 · 380 participants · Phase 2
Duloxetine and Neurofeedback Training for the Treatment of Chemotherapy Induced Peripheral Neuropathy
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI