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NLS-2

Phase 3

Narcolepsy Type 1 | Small molecule | Neurology |NewcelX Ltd.|Last Updated: May 21, 2024

Success Probability

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment48

FDA Designations

No designations recorded

Clinical trial landscape

NLS-2 · 1 trial · 2 indications

Phase 3 1
NCT05914194A Eight-Week Study of NLS-2 (Mazindol Extended Release) in Participants With Narcolepsy Type 1Narcolepsy Type 1
NOT YET_RECRUITING48 Analytics
PHASE3NOT YET_RECRUITING
A Eight-Week Study of NLS-2 (Mazindol Extended Release) in Participants With Narcolepsy Type 1
Narcolepsy Type 1
NCT0591419448
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Study Endpoints

Primary Endpoints

Number of cataplexy episodes at Week 8
8 weeks

Cataplexy episodes is a clinical outcome measure that assesses the frequency of cataplexy episodes.

Secondary Endpoints

Patient Reported Outcomes Measurement Information System-Sleep Related Impairment (PROMIS-SRI): change from baseline
8 weeks
Patient Reported Outcomes Measurement Information System-Sleep Disturbance (PROMIS-SD): change from baseline
8 weeks
Epworth Sleepiness Scale (ESS): change from baseline
8 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
NLS-2EXPERIMENTALParticipants will receive a single NLS-2 tablet orally once daily from Day 1 to Day 56 (until the end of Week 8).
PlaceboPLACEBO_COMPARATORParticipants will receive a single NLS-2 placebo matching tablet orally once daily from Day 1 to Day 56 (until the end of Week 8).

Interventions

NameTypeDescription
NLS-2DRUGParticipants will receive NLS-2 tablets orally.
PlaceboDRUGParticipants will receive NLS-2 matching placebo tablets orally.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo

Key Inclusion Criteria: * Adults ≥ 18 years of age at the time of signing the informed consent. * Documented primary diagnosis of Narcolepsy Type 1 (NT1) according to the International Classification of Sleep Disorders-Third Edition (ICSD-3) criteria. * Willing and able to safely discontinue all pr...

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Frequently asked questions about NLS-2

What is NLS-2 used for?

NLS-2 is an investigational small molecule being developed for the treatment of narcolepsy type 1, also known as narcolepsy with cataplexy. It is currently in Phase 3 clinical development and has not been approved by regulatory authorities.

What does NLS-2 target?

NLS-2 is a small molecule, but its specific molecular target has not been disclosed in available information. It is being studied for its effects on symptoms of narcolepsy type 1, including excessive daytime sleepiness and cataplexy.

Who is developing NLS-2?

NLS-2 is being developed by NewcelX Ltd., a biopharmaceutical company. The company is conducting a Phase 3 clinical trial to evaluate the drug's safety and efficacy in patients with narcolepsy type 1.

What phase is NLS-2 in?

NLS-2 is currently in Phase 3 clinical development. It is an investigational drug and has not yet received regulatory approval for any indication. The ongoing Phase 3 trial is designed to assess its effects in participants with narcolepsy type 1.

What clinical trials is NLS-2 in?

NLS-2 is being evaluated in a Phase 3 clinical trial registered as NCT05914194. This eight-week study is a randomized, double-blind, placebo-controlled trial enrolling approximately 48 participants aged 18 years and older with narcolepsy type 1 or narcolepsy with cataplexy.

Is NLS-2 the same as mazindol?

NLS-2 is described as mazindol extended release in the clinical trial title. It is a formulation of mazindol designed for extended release, being studied for the treatment of narcolepsy type 1.