Four-week Study of the Safety and Efficacy of NLS-2 (Mazindol Extended Release) in the Treatment of Narcolepsy
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|ClinicalTrials.gov Identifier: NCT04923594|
Recruitment Status : Completed
First Posted : June 11, 2021
Last Update Posted : August 12, 2022
|Condition or disease||Intervention/treatment||Phase|
|Narcolepsy Excessive Daytime Sleepiness Cataplexy Narcolepsy||Drug: mazindol extended release Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||67 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Four-week, Double-blind, Placebo-controlled, Randomized, Multicenter, Parallel-group Study of the Safety and Efficacy of NLS-2 (Mazindol Extended Release) in Adults for the Treatment of Narcolepsy|
|Actual Study Start Date :||September 13, 2021|
|Actual Primary Completion Date :||June 30, 2022|
|Actual Study Completion Date :||June 30, 2022|
Active Comparator: NLS-2 (mazindol extended release)
2 mg dosed orally, once daily for 1 week; followed by 3 mg dosed orally, once daily for up to 3 weeks (total of 4 weeks)
Drug: mazindol extended release
Dosed orally, once daily for up to 3 weeks
Other Name: NLS-2
Placebo Comparator: Placebo
Dosed orally, once daily for up to 4 weeks
Dosed orally, once daily for up to 4 weeks.
- Change in ESS Score From Baseline to Week 4 [ Time Frame: Baseline to Week 4 ]
Change in Epworth Sleepiness Scale (ESS) score from Baseline to Week 4. A negative change from baseline represents improvement in excessive sleepiness.
The ESS is a self-administered questionnaire with 8 questions. Each activity is scored on a scale ranging from 0-3, with 0 = would never fall asleep, and 3 = high chance of falling asleep. The total score ranges from 0-24, with a higher number representing an increased propensity for sleepiness.
- Subjects Reported Improved on the Patient Global Impression of Change (PGIc) at Week 4 [ Time Frame: Baseline to Week 4 ]Percentage of subjects reported as improved (minimally, much, or very much) on the PGIc at Week 4. PGIc is rated by subjects and measures the change in their condition since treatment starts on a 7-point scale ranging from 1= very much improved to 7= very much worse
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): NCT04923594
|Study Director:||Carlos Camozzi, MD||NLS Pharmaceutics|