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SDX for Idiopathic Hypersomnia
Study Summary
This trial studied if a drug was safe & effective for improving sleep in people with IH, & how the body processes the drug.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial 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 condition that causes abnormal behavior during sleep, such as sleepwalking or acting out dreams.Your body mass index (BMI) is less than or equal to 35 kilograms per square meter.You typically sleep for at least 7 hours each night, which will be confirmed during screening.Your body mass index (BMI) is less than or equal to 35 kg/m2.You depend on nicotine and it affects your sleep, like waking up at night to smoke.You have satisfactory physical and neurological health, as confirmed by the Investigator through examinations, vital signs, ECGs, medical history and laboratory tests at Screening.You must be at least 18 years old in order to participate in the study.You have a documented primary diagnosis of Insomnia Hyperarousal according to the International Classification of Sleep Disorders Third Edition criteria.You usually sleep for at least 7 hours every night, and this will be confirmed during the screening process.You usually go to bed after 1 AM more than once a week.You have a score of 11 or higher on the Epworth Sleepiness Scale during the screening and baseline visits.You have a score of 11 or more on the Epworth Sleepiness Scale during the Screening and Baseline visits.You have attempted suicide in the past or have expressed thoughts of wanting to harm yourself during the screening evaluation.You have excessive daytime sleepiness caused by another medical, behavioral, or psychiatric condition like depression, Parkinson's disease, multiple sclerosis, stroke, or narcolepsy.
- Group 1: Experimental: SDX
- Group 2: Active Comparator
- Screening: It may take up to 58 Days to process to see if you qualify in this trial.
- Treatment: You will receive the treatment for 4 Weeks
- Follow Ups: You may be asked to continue sharing information regarding the trial for 58 Months after you stop receiving the treatment.
Frequently Asked Questions
Has the FDA approved of Experimental: SDX for therapeutic use?
"Our team has rated Experimental: SDX with a score of 2, indicating that while there is some clinical data to suggest safety, efficacy remains unproven."
Are there any Canadian centers offering this trial opportunity?
"This experimental trial is gathering data from patients in Amr Daphne (Daphne, Arizona), Lakeview Clinical Research (Guntersville, California), and Mayo Clinic - Arizona (Phoenix, Colorado) as well as 35 other research clinics."
Is enrollment into this experiment currently available to participants?
"Affirmative. Information on clinicaltrials.gov demonstrates that the search for patients is in effect. This trial was first posted on December 22nd 2022 and updated lastly on December 29th of the same year. Currently, 48 individuals are being recruited from 35 sites across the country."
What is the main aim of this scientific research?
"As per the information provided by KemPharm, Inc., the primary outcome of this trial that will be measured over a 7-week period is safety parameters as assessed through AE's. In addition, secondary outcomes such as changes in brain fog scores, percentage of participants with increased clinical global impression severity ratings (CGI-S), and percentages of patients with greater patient global impressions of severities (PGI-S) from their baseline measurements shall also be evaluated."
What is the scope of this research project in terms of participant numbers?
"A total of 48 voluntary participants are required to effectively conduct the research. The sponsor, KemPharm Inc., has designated multiple sites across two states including Amr Daphne in Arizona and Lakeview Clinical Research in California."
Who else is applying?
What state do they live in?
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:
- Clinical Site Partners, LLC - Winter Park: < 48 hours
- Houston Clinical Research Associates: < 48 hours
- New Generation of Medical Trials: < 48 hours
Average response time
- < 2 Days
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