NCT02485899
CLN2, Late-Infantile Neuronal Ceroid Lipofuscinosis Type 2, Jansky-Bielschowsky Disease, Batten Disease, CLN2 Disease, CLN2 Disorder
The below information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc. and has not been edited.
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.
All
3 Years to 16 Years
No
BMN 190, Intracerebroventricular (ICV) access device
Phase 1/Phase 2
Interventional
23
2015-02
2022-08-24
Columbus, Ohio, United States
Hamburg, , Germany
Rome, Piazza, Italy
London, , United Kingdom
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