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Daridorexant for Insomnia
Study Summary
This trial will study the effects of a new drug on insomnia and nighttime urination in people with both conditions.
Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2020 Phase 3 trial • 924 Patients • NCT03575104Trial Design
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Logistics
Travel, including flights, are covered
Your expenses for travel tickets for this trial will be reimbursed.
Other reimbursement is provided
Other forms of reimbursement are provided for this trial.
Who is running the clinical trial?
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- You have a score of 13 or higher on the ISI© at Visit 1.You have signed and dated the ICF prior to any study-mandated procedure.I can communicate clearly and understand the study's needs.I am 55 years old or older.I own a smartphone.I have trouble sleeping and have complained about it.I have been getting up to urinate at least 3 times every night for the past month.I am 54 years old or older.You drink caffeinated beverages regularly after 4 pm.I have had trouble sleeping for at least 3 months.I go to the bathroom to urinate 3 or more times a night for at least a month.
- Group 1: 50 mg daridorexant
- Group 2: Placebo
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 21 Weeks to process to see if you qualify in this trial.
- Treatment: You will receive the treatment for 3 Months
- Follow Ups: You may be asked to continue sharing information regarding the trial for 10 Months after you stop receiving the treatment.
Frequently Asked Questions
How many healthcare facilities are actively involved in this research?
"Currently, the study is running at 5 sites across multiple cities: Hialeah, San Bernardino and New york among others. For those interested in participating, it's beneficial to select a location that requires minimal travel."
Has the FDA sanctioned a dosage of 50mg for daridorexant?
"The safety of 50 mg daridorexant was determined to be a 3, as this is an approved Phase 4 trial."
Are there any opportunities for prospective participants to partake in this clinical trial?
"Contrary to current expectations, clinicaltrials.gov indicates that this medical trial is no longer signing up patients; the original posting date was December 15th 2022 and it has since been edited on November 15th 2022. Despite this fact, 220 other trials are still accepting participants at present."
Who else is applying?
What state do they live in?
How old are they?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
What questions have other patients asked about this trial?
Why did patients apply to this trial?
How responsive is this trial?
Typically responds via
Most responsive sites:
- Urology Research Network: < 24 hours
- Clinical Research Center of Florida: < 24 hours
Average response time
- < 2 Days
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