At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 24 enrolled
Drug / intervention
BMN 190biological
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.
A Phase 1/2 Open-Label Dose-Escalation Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Efficacy of Intracerebroventricular BMN 190 in Patients With Late-Infantile Neuronal Ceroid Lipofuscinosis Type 2 (CLN2) Disease
In Brief
A Phase 2 clinical trial evaluating BMN 190 for Jansky-Bielschowsky Disease and 3 related conditions. Completed, enrolled 24 participants across 5 sites in 4 countries.
Detailed Summary
The purpose of this study is to determine whether BMN 190 is safe and effective in the treatment of patients with Late-Infantile Neuronal Ceroid Lipofuscinosis Type 2 (CLN2) disease.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsJansky-Bielschowsky Disease, Batten Disease, Late-Infantile Neuronal Ceroid Lipofuscinosis Type 2, CLN2 Disease
CountriesGermany, Italy, United Kingdom, United States
Collaborators--
Timeline
Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJul 2013
Enrollment StartSep 2013
Primary CompletionNov 2015
TodayJul 2026
First PostedJul 24, 2013
Enrollment StartSep 1, 2013
Primary CompletionNov 1, 2015
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 12.9 years ago
Interventions
BMN 190biological
30-300 mg ICV infusion administered every other week for at least 48 weeks.