Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT02485899 · ClinicalTrials.gov registry record · Phase 1
An Extension Study to Evaluate the Long-Term Efficacy and Safety of BMN 190 in Patients With CLN2 Disease
A Phase 1 study, sponsored by BioMarin Pharmaceutical.
- Completed
- Registry status
- Phase 1
- Development phase
- 23
- Enrollment target
NCT02485899 is a Phase 1 study that has completed, run by BioMarin Pharmaceutical. The registered enrollment target is 23 participants.
The verdict
NCT02485899, a Phase 1 study, has completed, sponsored by BioMarin Pharmaceutical.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 23 participants
- Enrollment target
Study Summary
The Phase 1/2 study (190-201) evaluated the efficacy and safety of a 300 mg dose of BMN 190 administered every other week (qow) to patients with CLN2. The dose and regimen for this study (190-202) are based on the results of the 190-201 study. The rationale for this phase 2 extension study is to provide patients who complete the 190-201 study with the option to continue BMN 190 treatment. The 190-202 study is an open label extension protocol to assess long-term safety and efficacy.
Interventions
- BIOLOGICAL BMN 190
- DEVICE Intracerebroventricular (ICV) access device
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2015-02 |
| Est. Completion | 2020-12-10 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02485899
The ClinicalTrials.gov registry entry for NCT02485899 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 23 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is BioMarin Pharmaceutical, which has 80 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which BMN 190 is the first listed.
NCT02485899 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02485899 about?
NCT02485899 is a clinical study titled "An Extension Study to Evaluate the Long-Term Efficacy and Safety of BMN 190 in Patients With CLN2 Disease". The Phase 1/2 study (190-201) evaluated the efficacy and safety of a 300 mg dose of BMN 190 administered every other week (qow) to patients with CLN2. The dose and regimen for this study (190-202) are based on the results of the 190-201 study. The rationale for this phase 2 extension study is to pro...
What is the current status of trial NCT02485899?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 23 participants. The study started on 2015-02. Estimated completion is 2020-12-10.
What interventions are being tested in trial NCT02485899?
The interventions under investigation include: BMN 190 (BIOLOGICAL), Intracerebroventricular (ICV) access device (DEVICE).
Who is sponsoring clinical trial NCT02485899?
This trial is sponsored by BioMarin Pharmaceutical, which has 80 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.