Recruiting PHASE2 Idiopathic Hypersomnia

Tests treatment safety and results for Idiopathic Hypersomnia

Official title A Study to Evaluate the Safety and Effectiveness of ALKS 2680 in Subjects With Idiopathic Hypersomnia

ClinicalTrials.gov ID: NCT06843590

What this study is testing

What is ALKS 2680?

ALKS 2680 is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for idiopathic hypersomnia.

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 the safety and decrease in daytime sleepiness in subjects with Idiopathic Hypersomnia when taking ALKS 2680 tablets compared with placebo tablets
  • Phase 2: a mid-size study of how well it works
  • 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

  • Is willing and able, in the opinion of the Investigator, to understand and comply with protocol requirements, including: lifestyle considerations and...
  • Meets the diagnostic criteria of Idiopathic Hypersomnia according to ICSD-3-TR guidelines, confirmed by the diagnostic evaluations...

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 clinical study or used any investigational drug or device within 30 days prior to Visit 1
  • 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
  • Phoenix, Arizona, United States
  • Little Rock, Arkansas, United States
  • Los Angeles, California, United States
  • Redwood City, California, United States
  • San Francisco, California, United States
  • Boulder, Colorado, United States
  • Colorado Springs, Colorado, United States
  • Brandon, Florida, United States
  • Miami, Florida, United States
  • Winter Park, Florida, United States
  • Atlanta, Georgia, United States
  • Macon, Georgia, United States
  • Stockbridge, Georgia, United States
  • Peoria, Illinois, United States
  • Kansas City, Kansas, United States
  • Boston, Massachusetts, United States
  • Lansing, Michigan, United States
  • Lincoln, Nebraska, United States
  • Middletown, New Jersey, United States

+ 29 more site(s).

Compensation & support

Compensation mentioned.

ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.

Questions & answers

Do participants get paid in this trial?

This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.

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; Phoenix, Arizona, United States; Little Rock, Arkansas, United States; Los Angeles, California, United States; Redwood City, California, United States; San Francisco, California, United States and 43 more location(s). Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

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.