Study Assessing Effects of JZP-110 on Driving Performance in the Treatment of Excessive Sleepiness in Narcolepsy

Jazz Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Excessive Sleepiness; Narcolepsy

Treatments: Drug: Placebo; Drug: JZP-110

Study type: Interventional

Funder types: Industry

Identifiers

NCT02806908

15-005

Details and patient eligibility

About

This trial is a randomized, double-blind, placebo-controlled, crossover study to evaluate the effect of JZP-110 on driving performance in subjects with excessive sleepiness due to narcolepsy.

Enrollment: 24 patients

Sex: All

Ages: 21 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Male or female, age 21 to 65 years inclusive
2. Diagnosis of narcolepsy per International Classification of Sleep Disorders (ICSD-3) or Diagnostic and Statistical Manual of Mental Disorders 5th Edition (DSM-5)
3. BMI 18 to <40 kg/m2
4. Willing and able to provide written informed consent

Exclusion criteria

1. Female subjects who are pregnant, nursing, or lactating
2. Moderate or severe sleep apnea
3. Any other clinically relevant medical, behavioral, or psychiatric disorder other than narcolepsy that is associated with excessive sleepiness
4. History or presence of bipolar disorder, bipolar related disorders, schizophrenia, schizophrenia spectrum disorders, or other psychotic disorders according to DSM-5 criteria
5. 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
6. History of bariatric surgery within the past year or a history of any gastric bypass procedure
7. Presence or history of significant cardiovascular disease
8. Unable to washout or refrain from taking any over-the-counter (OTC) or prescription medications that could affect sleep-wake function

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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24 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Once daily dosing

Treatment:

Drug: Placebo

JZP-110

Active Comparator group

Description:

150 mg/day for first 3 days and 300 mg/day for next 4 days

Treatment:

Drug: JZP-110