An Open Label Study of NLS-2 (Mazindol Extended Release) in Subjects With Narcolepsy
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|ClinicalTrials.gov Identifier: NCT05055024|
Recruitment Status : Enrolling by invitation
First Posted : September 23, 2021
Last Update Posted : June 2, 2022
|Condition or disease||Intervention/treatment||Phase|
|Narcolepsy With Cataplexy Narcolepsy Narcolepsy Without Cataplexy||Drug: Mazindol||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A 6-Month Multicenter, Open-Labelled Extension of the Clinical Trial NLS-1021 in Narcoleptic Patients With and Without Cataplexy|
|Actual Study Start Date :||October 26, 2021|
|Estimated Primary Completion Date :||December 15, 2022|
|Estimated Study Completion Date :||December 15, 2022|
Experimental: NLS-2 (mazindol extended release)
NLS-2 (mazindol extended release) administered once a day.
- To evaluate the safety and tolerability of NLS-2 in adult subjects with narcolepsy type 1 (NT1) or narcolepsy type 2 (NT2) [ Time Frame: 24 weeks ]Summaries of the number and percentage of subjects who experienced Treatment Emergent Adverse Events (TEAEs), TEAEs related to study drug, SAEs, or discontinued study drug or withdrew from the study due to an AE.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05055024
|Study Director:||Carlos Camozzi, MD||NLS Pharmaceutics|