Narcolepsy With CataplexyPhase 2NCT05055024
An Open Label Study of NLS-2 (Mazindol Extended Release) in Subjects With Narcolepsy
A Phase 2 study testing Mazindol in people with Narcolepsy With Cataplexy and Narcolepsy, run by NLS Pharmaceutics at 22 sites in United States.
Trial summary
This is a multicenter, open-label extension of the clinical study NLS-1021, evaluating long-term safety, tolerability, pharmacokinetics (PK), and therapeutic response to treatment with NLS-2 in adult subjects with narcolepsy. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Narcolepsy With Cataplexy, Narcolepsy, Narcolepsy Without Cataplexy
- What is being tested?
- Mazindol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 22 sitesUnited States
- Study dates
- 26 Oct 2021to 19 Jan 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The subject must complete all Study NLS-1021 study requirements and assessments up to Visit 6;
- The subject is able, in the opinion of the Investigator, to receive NLS-2 for the 24-week Treatment Phase of this study;
- Biological females of childbearing potential must agree to use a medically acceptable double-barrier method of contraception for at least 30 days prior to Day 1 and until completion of the study;
- The subject is able to comply with the open-labelled extension design schedule and other study requirements;
- The subject provides written informed consent for the open-label extension study.
Who cannot join
- The subject meets any Exclusion Criteria for Study NLS-1021 at Visit 6 of that study;
- The subject receives any investigational drug (other than the COVID-19 vaccine) that is not NLS-2.
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
United States22 sites
Treken Primary care
Atlanta, Georgia, 30315
NeuroTrials Research
Atlanta, Georgia, 30328
Sleep Disorders Center of Alabama
Birmingham, Alabama, 35213
The Center For Sleep & Wake Disorders
Chevy Chase, Maryland, 20815
Intrepid Research
Cincinnati, Ohio, 45245
St. Francis Sleep Allergy and Lung Institute
Clearwater, Florida, 33765
Neurology and Sleep Disorders Clinic
Columbia, Missouri, 65212
Bogan Sleep Consultants
Columbia, South Carolina, 29201
Carolinas Sleep Specialists
Concord, North Carolina, 28025
Dharma PA d/b/a Southwest Family Medicine Associates
Dallas, Texas, 75235
Ohio Sleep Medicine Institute
Dublin, Ohio, 43017
Superior Clinical Research, LLC
Goldsboro, North Carolina, 27534
Hawaii Pacific Neuroscience Clinical Research Center
Honolulu, Hawaii, 96817
Advanced Respiratory and Sleep Medicine
Huntersville, North Carolina, 28078
Sleep Medicine Specialists of South Florida
Miami, Florida, 33126
Ivetmar Medical Group
Miami, Florida, 33155
The Angel Medical Research Corporation
Miami Lakes, Florida, 33016
Stanford Sleep Medicine Center
Redwood City, California, 94063
Sleep Therapy & Research Center
San Antonio, Texas, 78229
Pacific Research Network
San Diego, California, 92103
Sleep and Attention Disorders
Sterling Heights, Michigan, 48314
Clinical Research Institute
Stockbridge, Georgia, 30281
About this study
Official title: A 6-Month Multicenter, Open-Labelled Extension of the Clinical Trial NLS-1021 in Narcoleptic Patients With and Without Cataplexy
This is a multicenter, open-label extension of the clinical study NLS-1021, evaluating long-term safety, tolerability, pharmacokinetics (PK), and therapeutic response to treatment with NLS-2 in adult subjects with narcolepsy.
- Being tested
- Mazindol
- Medical subject headings
- Narcolepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MazindolDrug
Also called NLS-2, mazindol extended release
Drug: NLS-2
| Study group | Role | What they receive |
|---|---|---|
| NLS-2 (mazindol extended release) | Experimental | NLS-2 (mazindol extended release) administered once a day. Receives: Drug: Mazindol |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the safety and tolerability of NLS-2 in adult subjects with narcolepsy type 1 (NT1) or narcolepsy type 2 (NT2)
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.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2021
- Study start26 Oct 2021
- Primary completion19 Jan 2023
- Study completion19 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Narcolepsy With CataplexyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- NLS Pharmaceutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Carlos Camozzi, MD, Study director, NLS Pharmaceutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05055024
- Sponsor's protocol ID
- NLS-1022
- Status last verified
- Mar 2023
- First submitted
- 1 Sep 2021
- Last updated
- 13 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 6-Month Multicenter, Open-Labelled Extension of the Clinical Trial NLS-1021 in Narcoleptic Patients With and Without Cataplexy
- ClinicalTrials.gov ID
- NCT05055024
- Acronym / sponsor ID
- NLS-1022
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- NLS PharmaceuticsIndustry (pharma, biotech, devices)
- Study start
- 26 Oct 2021 (actual)
- Primary completion
- 19 Jan 2023 (actual)
- Study completion
- 19 Jan 2023 (actual)
- First posted
- 23 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multicenter, open-label extension of the clinical study NLS-1021, evaluating long-term safety, tolerability, pharmacokinetics (PK), and therapeutic response to treatment with NLS-2 in adult subjects with narcolepsy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NLS-2 (mazindol extended release) | Experimental | Drug: MazindolNLS-2 (mazindol extended release) administered once a day. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- The subject must complete all Study NLS-1021 study requirements and assessments up to Visit 6;
- The subject is able, in the opinion of the Investigator, to receive NLS-2 for the 24-week Treatment Phase of this study;
- Biological females of childbearing potential must agree to use a medically acceptable double-barrier method of contraception for at least 30 days prior to Day 1 and until completion of the study;
- The subject is able to comply with the open-labelled extension design schedule and other study requirements;
- The subject provides written informed consent for the open-label extension study.
Key exclusion criteria (2 listed)
- The subject meets any Exclusion Criteria for Study NLS-1021 at Visit 6 of that study;
- The subject receives any investigational drug (other than the COVID-19 vaccine) that is not NLS-2.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MazindolAlso: NLS-2, mazindol extended releaseDrug: NLS-2 | Drug | NLS-2 (mazindol extended release) |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carlos Camozzi, MD study director
NLS Pharmaceutics
22 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Mazindol in people with Narcolepsy With Cataplexy and Narcolepsy, run by NLS Pharmaceutics at 22 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2023.