Narcolepsy with Cataplexy
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CLINICAL_TRIALS trial_result · 2026-08-07Clinical Trial Results: Clarithromycin Mechanisms in Hypersomnia Syndromes [Phase 2]
Phase 2 trial results on clarithromycin mechanisms in hypersomnia syndromes including narcolepsy without cataplexy and idiopathic hypersomni…
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CLINICAL_TRIALS trial_result · 2026-06-30Clinical Trial Results: Narcolepsy Nightmare Study [NA]
Completed clinical trial results for Narcolepsy-related conditions; results posted.
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FDA approval · 2025-11-05FDA Approved: SODIUM OXYBATE — Original Application (Camber Pharmaceuticals, Inc.)
FDA approved Camber Pharmaceuticals' generic sodium oxybate under an original Abbreviated New Drug Application, enabling a generic option fo…
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FDA approval · 2025-09-10FDA Approved: SODIUM OXYBATE — Original Application (Amneal Pharmaceuticals LLC)
FDA approved the original ANDA for sodium oxybate by Amneal Pharmaceuticals LLC, establishing a generic version of the drug. The approved in…
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CLINICAL_TRIALS trial_result · 2025-07-16Clinical Trial Update: Clarithromycin Mechanisms in Hypersomnia Syndromes [Phase 2]
Phase 2 clinical trial examining clarithromycin mechanisms in hypersomnia syndromes has completed. The study enrolled individuals with narco…
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CLINICAL_TRIALS trial_result · 2024-09-19Clinical Trial Update: Efficacy and Safety of Pitolisant in Pediatric Narcoleptic Patients With or Without Cataplexy, Double-blind Study Followed by a Prolonged Open-label Period [Phase 3]
Phase 3 pediatric study assessing efficacy and safety of pitolisant in narcolepsy with and without cataplexy completed; results have been po…
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CLINICAL_TRIALS trial_result · 2024-06-12Clinical Trial Update: Narcolepsy Nightmare Study [NA]
A completed clinical trial update for the Narcolepsy Nightmare Study (NA) reported status as completed, with listed narcolepsy-related condi…
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CLINICAL_TRIALS research · 2024-05-21Clinical Trial Update: A Eight-Week Study of NLS-2 (Mazindol Extended Release) in Participants With Narcolepsy Type 1 [Phase 3]
This is a clinical trial update describing a Phase 3 study of NLS-2, mazindol extended release, for Narcolepsy Type 1 (with cataplexy), whic…
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CLINICAL_TRIALS trial_result · 2023-11-01Clinical Trial Update: Awareness and Self-Compassion Enhancing Narcolepsy Treatment [NA]
A completed clinical trial investigating awareness and self-compassion as a treatment approach for narcolepsy (including with and without ca…
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CLINICAL_TRIALS trial_result · 2023-03-13Clinical Trial Update: An Open Label Study of NLS-2 (Mazindol Extended Release) in Subjects With Narcolepsy [Phase 2]
Phase 2 open-label trial of mazindol extended release (NLS-2) in narcolepsy with and without cataplexy completed.
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CLINICAL_TRIALS trial_result · 2022-04-08Clinical Trial Update: Exploratory Clinical Study to Evaluate Sodium Oxybate (Xyrem) on Potential Endocrine Changes [Phase 1]
Phase 1 exploratory study evaluating potential endocrine changes with sodium oxybate (Xyrem) in narcolepsy with cataplexy.
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CLINICAL_TRIALS trial_result · 2021-03-23Clinical Trial Update: Xyrem and Brain Dopamine in Narcolepsy [Phase 4]
Phase 4 trial update on Xyrem and brain dopamine in narcolepsy with cataplexy; results posted after completion.
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CLINICAL_TRIALS trial_result · 2020-11-12Clinical Trial Update: A Study of the Efficacy and Safety of JZP-258 in Subjects With Narcolepsy With Cataplexy [Phase 3]
Phase 3 trial assessing the efficacy and safety of JZP-258 in narcolepsy with cataplexy has completed with results posted.
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CLINICAL_TRIALS trial_result · 2019-04-30Clinical Trial Update: A Multicenter Study of the Efficacy and Safety of Xyrem With an Open- Label Pharmacokinetic Evaluation and Safety Extension in Pediatric Subjects With Narcolepsy With Cataplexy [Phase 3]
Phase 3 multicenter trial assessing efficacy and safety of Xyrem with open-label pharmacokinetic evaluation and safety extension in pediatri…
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FDA approval · 2017-04-19FDA Approved: SODIUM OXYBATE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
FDA approved a supplemental application for sodium oxybate submitted by Hikma Pharmaceuticals USA Inc., marking an additional regulatory act…
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CLINICAL_TRIALS trial_result · 2016-08-31Clinical Trial Update: Pitolisant to Assess Weekly Frequency of Cataplexy Attacks and EDS in Narcoleptic Patients (HARMONY CTP) [Phase 3]
The Phase 3 HARMONY CTP trial evaluating pitolisant for narcolepsy with cataplexy and excessive daytime sleepiness has completed.
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FDA approval · 2012-12-17FDA Approved: SODIUM OXYBATE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
FDA approved a supplemental application for sodium oxybate submitted by Hikma Pharmaceuticals USA Inc., resulting in updated labeling.
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FDA approval · 2006-11-13FDA Approved: SODIUM OXYBATE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
FDA approved a supplemental application for sodium oxybate from Hikma Pharmaceuticals USA Inc.