Study Assessing Effects of JZP-110 on Driving Performance in the Treatment of Excessive Sleepiness in OSA
NCT ID: NCT02806895
Last Updated: 2021-01-14
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
34 participants
INTERVENTIONAL
2016-07-05
2019-05-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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Placebo
Once daily dosing
Placebo
JZP-110
150 mg/day for first 3 days and 300 mg/day for next 4 days
JZP-110
Interventions
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JZP-110
Placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Diagnosis of obstructive sleep apnea (OSA) per International Classification of Sleep Disorders (ICSD-3)
3. BMI 18 to \<40 kg/m2
4. Willing and able to provide written informed consent
Exclusion Criteria
2. Any other clinically relevant medical, behavioral, or psychiatric disorder other than OSA that is associated with excessive sleepiness
3. History or presence of bipolar disorder, bipolar related disorders, schizophrenia, schizophrenia spectrum disorders, or other psychotic disorders according to Diagnostic and Statistical Manual of Mental Disorders 5th Edition (DSM-5) criteria
4. History or presence of any unstable medical condition, behavioral or psychiatric disorder (including active suicidal ideation), or surgical history that could affect the safety of the subject or interfere with study efficacy and/or safety assessments per the judgment of the investigator
5. History of bariatric surgery within the past year or a history of any gastric bypass procedure
6. Presence or history of significant cardiovascular disease
7. Unable to washout or refrain from taking any over-the-counter (OTC) or prescription medications that could affect sleep-wake function
21 Years
65 Years
ALL
No
Sponsors
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Jazz Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Grace Wang, MD
Role: STUDY_DIRECTOR
Jazz Pharmaceuticals
Jan Ramaekers, PhD
Role: PRINCIPAL_INVESTIGATOR
Maastricht University
Locations
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Maastricht University
Maastricht, Limburg, Netherlands
Countries
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References
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Devine JK, Schwartz L, Hursh S, Asin J, de Vries N, Vonk PE, Vermeeren A, Donjacour CEHM, Vinckenbosch F, Ramaekers JG, Janssen H, Wang G, Chen D, Carter LP, Overeem S, Lammers GJ. Psychomotor Vigilance Performance in Participants with Excessive Daytime Sleepiness in Obstructive Sleep Apnea or Narcolepsy Compared with SAFTE-FAST Model Predictions. Neurol Ther. 2023 Feb;12(1):249-265. doi: 10.1007/s40120-022-00425-w. Epub 2022 Dec 10.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2015-003930-28
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
15-004
Identifier Type: -
Identifier Source: org_study_id
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