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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-30

Study Completion Date

2019-05-19

Brief Summary

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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.

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Detailed Description

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Conditions

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Narcolepsy Excessive Sleepiness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Placebo

Once daily dosing

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

JZP-110

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

Group Type ACTIVE_COMPARATOR

JZP-110

Intervention Type DRUG

Interventions

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JZP-110

Intervention Type DRUG

Placebo

Intervention Type DRUG

Other Intervention Names

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solriamfetol

Eligibility Criteria

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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

Minimum Eligible Age

21 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No