A Phase 2a, Randomized, Double-blind, Placebo-controlled Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ORX750 in Subjects With Narcolepsy and Idiopathic Hypersomnia (CRYSTAL-1)

Status: Recruiting
Location: See all (28) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

Narcolepsy Type 1 (NT1), Narcolepsy Type 2 (NT2), and Idiopathic Hypersomnia (IH) are rare conditions that make people feel very sleepy during the day (often referred to as excessive daytime sleepiness \[EDS\]). People living with these conditions might find it hard to stay alert and pay attention when they are at school, working, driving, or performing other daily activities. While all conditions result in feeling sleepy, there are some differences in other common symptoms: * NT1: People with NT1 often feel very tired during the day and experience cataplexy. Cataplexy is a sudden loss of muscle strength, which can cause someone to collapse or lose control of their muscles for a short time. This is often triggered by strong emotions, such as laughter or surprise. They may also have trouble sleeping well at night. * NT2: People with NT2 feel sleepy during the day, just like NT1, but they do not have cataplexy. * IH: People with IH feel tired during the day, even after sleeping a lot at night. They may sleep for long periods, take long naps, and find it hard to wake up. Orexin is a protein in the brain that helps coordinate a system that plays an important role in helping people to stay awake during the daytime. ORX750 is designed to mimic the action of orexin. The purpose of this study is to see how safe and tolerable ORX750 is in NT1, NT2, and IH, and learn about what the drug does to the body. Another goal of the study is to see if ORX750 can help people with NT1, NT2, and IH feel less sleepy and make other symptoms better.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• 18-65 years of age

• BMI ≥17 and ≤37 kg/m2

• Meets the diagnostic criteria of Narcolepsy Type 1 (NT1), Type 2 (NT2) or Idiopathic Hypersomnia (IH) according to ICSD-3-TR criteria

• Is willing and able to discontinue all medications used for the treatment of narcolepsy or idiopathic hypersomnia

• Is willing and able to adhere to additional protocol requirements

Locations
United States
Alabama
Auburn, Alabama
RECRUITING
Auburn
Arizona
Chandler, Arizona
RECRUITING
Chandler
Scottsdale, Arizona
RECRUITING
Scottsdale
California
Long Beach, California
RECRUITING
Long Beach
Santa Ana, California
RECRUITING
Santa Ana
Florida
Brandon, Florida
RECRUITING
Brandon
Miami, Florida
RECRUITING
Miami
Miami, Florida
RECRUITING
Miami
Orlando, FL
RECRUITING
Orlando
Winter Park, Florida
RECRUITING
Winter Park
Georgia
Atlanta, Georgia
RECRUITING
Atlanta
Atlanta, Georgia
RECRUITING
Atlanta
Riverdale, Georgia
RECRUITING
Riverdale
Louisiana
New Orleans, Louisiana
RECRUITING
New Orleans
Massachusetts
Newton, Massachusetts
RECRUITING
Newton
Michigan
Southfield, Michigan
RECRUITING
Southfield
Sterling Heights, Michigan
RECRUITING
Sterling Heights
North Carolina
Denver, North Carolina
RECRUITING
Denver
Huntersville, North Carolina
RECRUITING
Huntersville
Nevada
Henderson, Nevada
RECRUITING
Henderson
Ohio
Cincinnati, Ohio
RECRUITING
Cincinnati
Dublin, Ohio
RECRUITING
Dublin
Pennsylvania
Willow Grove, Pennsylvania
RECRUITING
Willow Grove
South Carolina
Columbia, South Carolina
RECRUITING
Columbia
North Charleston, South Carolina
RECRUITING
North Charleston
Texas
Austin, Texas
RECRUITING
Austin
San Antonio, Texas
RECRUITING
San Antonio
Other Locations
Canada
Toronto, Ontario
RECRUITING
Toronto
Contact Information
Primary
Centessa Pharmaceuticals
CRYSTAL-1@centessa.com
+1 617-468-5770
Time Frame
Start Date: 2024-12-23
Estimated Completion Date: 2025-12
Participants
Target number of participants: 96
Treatments
Experimental: Narcolepsy Type 1: ORX750 and Placebo
Experimental: Narcolepsy Type 2: ORX750 and Placebo
Experimental: Idiopathic Hypersomnia: ORX750 and Placebo
Sponsors
Leads: Centessa Pharmaceuticals (UK) Limited

This content was sourced from clinicaltrials.gov

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