CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 23 enrolled
Drug / intervention
BMN 190 +1 morebiological
Likely dose
BMN 190 300 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02485899
NCT02485899Phase 2Completed
CompareCT.gov

A Multicenter, Multinational, Extension Study to Evaluate the Long-Term Efficacy and Safety of BMN 190 in Patients With CLN2 Disease

BioMarin Pharmaceutical·interventional·Posted Jun 30, 2015·Updated Aug 24, 2022

In Brief

A Phase 2 clinical trial evaluating BMN 190 and Intracerebroventricular (ICV) access device for Jansky-Bielschowsky Disease and 4 related conditions. Completed, enrolled 23 participants across 4 sites in 4 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsJansky-Bielschowsky Disease, Batten Disease, Late-Infantile Neuronal Ceroid Lipofuscinosis Type 2, CLN2 Disease, CLN2 Disorder
CountriesGermany, Italy, United Kingdom, United States
Collaborators--

Timeline

Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedJun 30, 2015
Enrollment StartFeb 1, 2015
Primary CompletionDec 10, 2020
TodayJul 2, 2026
Enrollment to primary: 5.9 yearsPosted 11.0 years ago

Interventions

BMN 190biological

300 mg Intracerebroventricular (ICV) infusion administered every other week for up to 240 weeks

Intracerebroventricular (ICV) access devicedevice

Surgical implantation of an MRI compatible ICV access device in the lateral ventricle of the right hemisphere is required for administration of study drug.