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

NCT02806908 | Completed Phase 2 Results

• 1 other identifier: 15-005
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Narcolepsy; Excessive Sleepiness

Keywords

Driving

Outcome Measures

Primary Outcomes (1)

• Standard Deviation of Lateral Position (SDLP) at 2 Hours Post-dose (Approximately at Tmax)

  Subjects were instructed to drive with steady lateral position between the delineated boundaries of the slower (right) traffic lane, while maintaining a constant speed of 95 kilometers (km) per hour (hr). Deviation was measured by the vehicle's speed and lateral distance to the left lane line and was continuously recorded. Individual improvement was defined as a decrease in SDLP below the negative value of threshold; individual impairment was defined as an increase in SDLP above the threshold or failure to complete the driving test due to sleepiness or subjects related safety concerns.

  2 hours post-dose

Secondary Outcomes (26)

• SDLP at 6 Hours Post-dose

  6 hours post-dose

• Number of Subjects With Improved or Impaired Driving at a Threshold 1 Centimeter (cm) on JZP-110 Compared to Placebo 2 Hours Post-dose

  2 hours post-dose

• Number of Subjects With Improved or Impaired Driving at a Threshold 1.5 cm on JZP-110 Compared to Placebo 2 Hours Post-dose

  2 hours post-dose

• Number of Subjects With Improved or Impaired Driving at a Threshold 2.0 cm on JZP-110 Compared to Placebo 2 Hours Post-dose

  2 hours post-dose

• Number of Subjects With Improved or Impaired Driving at a Threshold 2.5 cm on JZP-110 Compared to Placebo 2 Hours Post-dose

  2 hours post-dose

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Once daily dosing

Drug: Placebo

JZP-110

ACTIVE COMPARATOR

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

Drug: JZP-110

Interventions

JZP-110 DRUG

Also known as: solriamfetol

JZP-110

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Jazz Pharmaceuticals: lead

Study Sites (1)

Maastricht University

Maastricht, Limburg, 6229, Netherlands

Location

Related Publications (1)

• 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.

  PMID: 36494591 DERIVED

MeSH Terms

Conditions

Narcolepsy; Disorders of Excessive Somnolence

Interventions

solriamfetol

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Results Point of Contact

• Title: Director, Disclosure & Transparency
• Organization: Jazz Pharmaceuticals

ClinicalTrialDisclosure@JazzPharma.com

2158709177

Study Officials

• Grace Wang, MD

  Jazz Pharmaceuticals

  STUDY DIRECTOR

• Jan Ramaekers, PhD

  Maastricht University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2016
• First Posted: June 21, 2016
• Study Start: June 1, 2016
• Primary Completion: May 19, 2019
• Study Completion: May 19, 2019
• Last Updated: January 13, 2021
• Results First Posted: January 13, 2021

Record last verified: 2020-12

Locations

NL (1)