Polaris Clinical Development Program
The POLARIS clinical development program is being conducted by NLS Pharmaceutics. The investigational study drug, Mazindol ER, is a special extended-release (ER) formulation of mazindol and is being tested in this program to evaluate how well it works when given to adult subjects with narcolepsy with or without cataplexy. Additionally, the program is being conducted to determine the drug’s safety, tolerability, and how it is absorbed and processed in the body. A benefit of taking part in this clinical development program is that you and other people with narcolepsy may benefit from the outcome of the POLARIS studies.
The overall POLARIS clinical development program includes:
• NLS-1021, a Four-week, Double-blind, Placebo-controlled trial, where the drug is given orally once-a-day;
• NLS-1022, an Open Label Extension Study available to Individuals who choose to continue to take the study treatment following the completion of the four-week treatment cycle in the NLS-1021 study. This Open Label Extension study offers participants the possibility to take Mazindol ER once daily (in the morning) as an oral tablet for up to 6 months.
Clinical Study NLS-1021
Frequently asked questions
Who can participate to the NLS-1021 study?
You may qualify for the study if you:
• are 18-65 years old,
• have a formal diagnosis of either narcolepsy type 1 or type 2,
• meet additional requirements as determined by a screening process.
After completion of the initial tests and procedures known as Screening Assessments, it will be decided if you are eligible to take part in the study NLS-1021. Baseline procedures and test will be conducted as well to confirm eligibility, prior to the administration of study treatment. Once enrolled in the study there is no guarantee that you will receive the treatment described above, you will be randomly selected to received Mazindol ER or the placebo (pill with no active drug).
About 60 subjects with narcolepsy type 1 or type 2 will take part in this Study at specialized medical sites in the United States and/or in Europe.
The study NLS-1021 will be double-blind, which means that neither you nor the Study Doctor will know which study medication – Mazindol ER or placebo – you will receive. In an emergency, this information can be obtained.
What happens to me if I agree to take part in this research?
You will be asked to first review and sign an “informed consent form” to take part in this study and before any study procedures or tests are performed. The document will be thoroughly reviewed by a qualified professional and detail all aspects of the study.
The Study Schedule will consist of the following:
1) Visit 1: Screening Visit and Tests
2) Visit 2: Baseline Visit (Day -1)
3) Visit 3: (end of Week 1),
4) Visit 4: (end of Week 2),
5) Visit 5: (end of Week 3)
6) Visit 6: (end of Week 4) (at the end of the visit you will be enrolled into the NLS-1022 if you agreed to do so and if you meet the criteria).
7) Visit 7: Follow-up Phone Call*
* if you choose not to participate in the Open Label Extension study (NLS-1022) at the end of week 4 (visit 6).
During the study, the Study Doctor or Study Team will provide you with information about an optional extension study (NLS-1022) in which participating subjects will receive the active study medication, Mazindol ER, for 24-weeks. If you are interested, you will be provided with an additional “informed consent document”. If you agree to participate, you will begin the 24-week extension study immediately following your last visit (Visit 6) of week 4 of the double-blind study (NLS-1021). You are not obliged to participate in the Open Label Extension study. You can take part in this Open Label Extension study only if you agree to do so.
How long should I expect to be in the NLS-1021 study?
The duration of NLS-1021 is about 9 weeks. This includes up to 4-weeks for the initial assessments (Screening), the double blind 4-week dosing period, and a 1-week follow-up period if you decline to participate in the Open Label Extension (OLE) study (NLS-1022).
If you opt to participate in the OLE study, treatment will continue up to 6 months.
What would be my responsibilities if I take part in this research?
If you take part in this research, you will be responsible for:
• Following the instructions of the Study Doctor and Study Team
• Taking the study treatment once daily and completing the assigned study diaries and questionnaires as instructed
• Attending all your study visits outlined in the Informed Consent Form
• Informing the Study Doctor or Study Team about any side effects, doctor visits, or hospitalizations that may occur during study participation
• Informing the Study Doctor or Study Team about any prescribed or over the counter medications not prescribed by your Study Doctor.
What happens if I agree to participate in this study, but I change my mind later?
Entering a research study is completely voluntary. You can agree to take part and later change your mind. If you start the study, you may stop at any time. You do not need to give a reason. There will be no penalty or loss of benefits. Additionally, if receiving standard of care treatment associated with this disorder at the time of discontinuation, this treatment will not be affected.
Upon taking part in this research, you may receive compensation for travel expenses. The study drug and all tests, procedures, and visits required by the study are provided at no cost to you. The sponsor will pay for them.
Expenses for travel may be reimbursed, after receipts for the payments are provided, and in agreement with the Study Doctor and Sponsor. You may ask your Study Doctor about which expenses will be reimbursed ahead of time.
If you do not complete the study, you will only receive compensation for travel expenses that accrued for the visits that you completed.
Clinical Study NLS-1022
You may opt to participate in the study NLS-1022. You can participate in this Open Label Extension (OLE) study once you successfully completed the study NLS-1021 and read and sign the new informed consent form for the OLE study. Immediately after the last visit (visit 6) of the study NLS-1021, you can be enrolled in the OLE study. You will receive the investigational active product (Mazindol ER) for 24 weeks. There will be one visit per month (every 4 weeks). Evaluations and tests are like those completed in NLS-1021. The quantity of the Investigational Product, Mazindol ER, provided during NLS-1022 will be increased to cover your treatment until the next visit in 4 weeks. There will be an additional visit 4 weeks after the last treatment visit of the OLE study