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Tests treatment safety and results for Narcolepsy Type 1
Official title A Study to Evaluate the Efficacy and Safety of ALKS 2680 in Adults With Narcolepsy Type 1
ClinicalTrials.gov ID: NCT07455383
What this study is testing
What is ALKS 2680 Dose 1?
ALKS 2680 Dose 1 is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for narcolepsy type 1.
Also referred to as Alixorexton.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this study is to measure decreases in daytime sleepiness, cataplexy (sudden loss of muscle tone), and disease symptoms in participants with NT1 when taking ALKS 2680 tablets compared with placebo tablets.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- Meets the diagnostic criteria of NT1 according to ICSD-3-TR guidelines, confirmed by diagnostic evaluations (either PSG/MSLT\ or CSF hypocretin-1...
You likely can't join if
- Has another comorbid sleep disorder or condition that may influence the sleep-wake cycle.
- Has a history or presence at Visit 1 of other clinically significant (treated or untreated) illness, disease, abnormality, or surgical procedure...
- Is currently enrolled in another treatment clinical trial or has received any investigational drug or used any treatment investigational device...
- Is currently pregnant, breastfeeding, or is planning to become pregnant during the study
The study team makes the final eligibility decision.
Where it's taking place
- Cullman, Alabama, United States
- Los Angeles, California, United States
- Boulder, Colorado, United States
- Brandon, Florida, United States
- Miami, Florida, United States
- Winter Park, Florida, United States
- Macon, Georgia, United States
- Kansas City, Kansas, United States
- Newton, Massachusetts, United States
- Lansing, Michigan, United States
- St Louis, Missouri, United States
- Middletown, New Jersey, United States
- Cincinnati, Ohio, United States
- Wyomissing, Pennsylvania, United States
- Columbia, South Carolina, United States
- Austin, Texas, United States
- San Antonio, Texas, United States
- Sugar Land, Texas, United States
- Macquarie Park, New South Wales, Australia
- Markham, Ontario, Canada
+ 2 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Cullman, Alabama, United States; Los Angeles, California, United States; Boulder, Colorado, United States; Brandon, Florida, United States; Miami, Florida, United States; Winter Park, Florida, United States and 16 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.