NarcolepsyPhase 2NCT04923594
Four-week Study of the Safety and Efficacy of NLS-2 (Mazindol Extended Release) in the Treatment of Narcolepsy
A Phase 2 study testing mazindol extended release in people with Narcolepsy and Excessive Daytime Sleepiness, run by NLS Pharmaceutics at 22 sites in United States.
Trial summary
This is a double-blind, randomized, placebo-controlled, multicenter trial of NLS-2 in adult patients with narcolepsy. The study will enroll approximately 60 patients and eligible patients will be treated to receive either NLS-2 or placebo for 4-weeks. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Narcolepsy, Excessive Daytime Sleepiness, Cataplexy Narcolepsy
- What is being tested?
- mazindol extended release
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 67 participants
- Where
- 22 sitesUnited States
- Study dates
- 13 Sep 2021to 30 Jun 2022
- 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
- Males and females between 18 and 65 years of age, inclusive
- Diagnosis of narcolepsy according to ICSD-3 (International Classification of Sleep Disorders, 3rd Edition) or Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria
- Body mass index from 18 to 40 kg/m2, inclusive
- Consent to use a medically acceptable method of contraception
- Willing and able to provide written informed consent
Who cannot join
- Female subjects who are pregnant, nursing, or lactating
- Any other clinically relevant medical, behavioral, or psychiatric disorder other than narcolepsy that is associated with excessive sleepiness
- History or presence of bipolar disorder, bipolar related disorders, schizophrenia, schizophrenia spectrum disorders, or other psychotic disorders according to DSM-5 criteria
- Use of any over-the-counter (OTC) or prescription medications that could affect the evaluation of excessive sleepiness
- Use of any medications that could affect the evaluation of cataplexy
- Received an investigational drug in the past 30 days or five half-lives (whichever is longer)
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 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
This is a double-blind, randomized, placebo-controlled, multicenter trial of NLS-2 in adult patients with narcolepsy. The study will enroll approximately 60 patients and eligible patients will be treated to receive either NLS-2 or placebo for 4-weeks.
- Being tested
- mazindol extended release, Placebo
- Medical subject headings
- Narcolepsy, Disorders of Excessive Somnolence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mazindol extended releaseDrug
Also called NLS-2
Dosed orally, once daily for up to 3 weeks
PlaceboDrug
Dosed orally, once daily for up to 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| NLS-2 (mazindol extended release) | Active comparator | 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) Receives: Drug: mazindol extended release |
| Placebo | Placebo comparator | Dosed orally, once daily for up to 4 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in ESS Score From 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.
Measured: Baseline to Week 4
Secondary outcomes (1)
Subjects Reported Improved on the Patient Global Impression of Change (PGIc) at 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
Measured: Baseline to Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2021
- Study start13 Sep 2021
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NarcolepsyStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 67 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
- NCT04923594
- Sponsor's protocol ID
- NLS-1021
- Status last verified
- Aug 2022
- First submitted
- 9 Jun 2021
- Last updated
- 12 Aug 2022
- 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 12 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04923594
- Acronym / sponsor ID
- NLS-1021
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- NLS PharmaceuticsIndustry (pharma, biotech, devices)
- Study start
- 13 Sep 2021 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 11 Jun 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 double-blind, randomized, placebo-controlled, multicenter trial of NLS-2 in adult patients with narcolepsy. The study will enroll approximately 60 patients and eligible patients will be treated to receive either NLS-2 or placebo for 4-weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NLS-2 (mazindol extended release) | Active comparator | Drug: mazindol extended release2 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) |
| Placebo | Placebo comparator | Drug: PlaceboDosed orally, once daily for up to 4 weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Males and females between 18 and 65 years of age, inclusive
- Diagnosis of narcolepsy according to ICSD-3 (International Classification of Sleep Disorders, 3rd Edition) or Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria
- Body mass index from 18 to 40 kg/m2, inclusive
- Consent to use a medically acceptable method of contraception
- Willing and able to provide written informed consent
Key exclusion criteria (6 listed)
- Female subjects who are pregnant, nursing, or lactating
- Any other clinically relevant medical, behavioral, or psychiatric disorder other than narcolepsy that is associated with excessive sleepiness
- History or presence of bipolar disorder, bipolar related disorders, schizophrenia, schizophrenia spectrum disorders, or other psychotic disorders according to DSM-5 criteria
- Use of any over-the-counter (OTC) or prescription medications that could affect the evaluation of excessive sleepiness
- Use of any medications that could affect the evaluation of cataplexy
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 |
|---|---|---|
| mazindol extended releaseAlso: NLS-2Dosed orally, once daily for up to 3 weeks | Drug | NLS-2 (mazindol extended release) |
| PlaceboDosed orally, once daily for up to 4 weeks. | Drug | Placebo |
Primary outcome
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.
1 secondary outcome
Subjects Reported Improved on the Patient Global Impression of Change (PGIc) at Week 4
Time frame: Baseline to Week 4
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 12 Aug 2022.
- 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 extended release in people with Narcolepsy and Excessive Daytime Sleepiness, 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 6 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 12 Aug 2022. 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. Some participants in this study may receive a placebo. 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?
Change in ESS Score From Baseline to Week 4 (time frame: Baseline to Week 4). 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 12 Aug 2022.