A Study of the Safety and Effectiveness of ADX-N05 for Excessive Daytime Sleepiness in Subjects With Narcolepsy

NCT01681121 | Completed Phase 2 Results

• 1 other identifier: ADX-N05 202
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 28

Brief Summary

This is a study to evaluate the safety and effectiveness of ADX-N05 compared to placebo in the treatment of excessive daytime sleepiness in adults with narcolepsy.

Conditions

Narcolepsy

Outcome Measures

Primary Outcomes (2)

• Change From Baseline in the Average Sleep Latency Time (in Minutes) as Determined From the Maintenance of Wakefulness Test (MWT) for ADX-N05 300 mg vs. Placebo at Last Assessment.

  The MWT is a validated objective measure of the ability to stay awake for a defined period of time. The primary analysis was a comparison of treatments vs. control groups on change from Baseline to last available post-Baseline assessment (Week 12/Last Assessment) in the average sleep latency time (in minutes) averaged across the first four trials of the MWT using a two-sample t-test.

  Baseline up to Week 12/Last Assessment post-dose.

• Number of Participants With Improved Clinical Global Impression of Change (CGI-C) Scores for ADX-N05 vs. Placebo at Last Assessment

  The CGI-C scale rated the change in the participant's condition as compared to the Baseline visit on a 7-point scale ranging from a minimum of "Very much improved" to a maximum of "Very much worse." The proportion of subjects experiencing at least minimal improvement on the CGI-C was calculated and summarized for each of the treatment groups at Week 4 and the last available post-Baseline assessment (Week 12/Last Assessment). The CGI-C scale consists of the following ratings: 1-Very Much improved, 2-Much improved, 3-Minimally improved, 4-No change, 5-Minimally worse, 6-Much worse, 7-Very much worse; a rating of 1 indicates a better outcome, and a rating of 7 indicates a worse outcome. Improvement was defined as a CGI-rating of 1, 2, or 3.

  Week 12

Secondary Outcomes (8)

• Change From Baseline in the Average Sleep Latency Time (in Minutes) as Determined From the Maintenance of Wakefulness Test (MWT) (Average of the First Four Trials) Following Four Weeks of Treatment With ADX-N05 150 mg vs. Placebo

  Baseline up to Week 4 post-dose.

• Change From Baseline in Sleep Latency Time (in Minutes) as Determined From Each of the 5 Individual MWT Trials for ADX-N05 vs. Placebo at Week 4

  Baseline up to Week 4 post-dose.

• Change From Baseline in Sleep Latency Time (in Minutes) as Determined From Each of the 5 Individual MWT Trials for ADX-N05 vs. Placebo at Last Assessment

  Baseline up to Week 12/Last Assessment post-dose.

• Change From Baseline in Epworth Sleepiness Scale (ESS) Scores for ADX-N05 vs. Placebo at Week 4

  Baseline up to Week 4 post-dose.

• Change From Baseline in ESS Scores for ADX-N05 vs. Placebo at Last Assessment

  Baseline up to Week 12/Last Assessment post-dose.

Study Arms (2)

ADX-N05

EXPERIMENTAL

ADX-N05 to be taken once a day for 12 weeks

Drug: ADX-N05

Placebo

PLACEBO COMPARATOR

Placebo to match ADX-N05 to be taken once a day for 12 weeks

Drug: Placebo

Interventions

ADX-N05 DRUG

150 mg once a day for 4 weeks followed by 300 mg once a day for 8 weeks

ADX-N05

Placebo DRUG

One capsule placebo to match ADX-N05 to be taken for 4 weeks followed by 2 capsules placebo to match ADX-N05 to be taken for 8 weeks

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of narcolepsy
• Good general health
• Willing and able to comply with the study design and schedule and other requirements

You may not qualify if:

• If female, pregnant or lactating
• Customary bedtime later than midnight
• History of significant medical condition, behavioral, or psychiatric disorder (including suicidal ideation), or surgical history
• Any other clinically relevant medical, behavioral or psychiatric disorder other than narcolepsy that is associated with excessive sleepiness
• History of significant cardiovascular disease
• Body mass index \> 34
• Excessive caffeine use - \> 600 mg/day of caffeine or \> 6 cups of coffee/day
• History of alcohol or drug abuse within the past 2 years
• Nicotine dependence that has an effect on sleep

Sponsors & Collaborators

• Jazz Pharmaceuticals: lead

Study Sites (28)

Sleep Disorders Center of Alabama

Birmingham, Alabama, 35213, United States

Location

Pulmonary Associates

Phoenix, Arizona, 85006, United States

Location

Stanford Sleep Medicine Center

Redwood City, California, 94063, United States

Location

Pacific Research Network

San Diego, California, 92103, United States

Location

Sleep-Alertness Disorders Center

Aurora, Colorado, 80012, United States

Location

PAB Clinical Research

Brandon, Florida, 33511, United States

Location

Clinical Research Group of St. Petersburg

St. Petersburg, Florida, 33707, United States

Location

NeuroTrials Research, Inc.

Atlanta, Georgia, 30342, United States

Location

Sleep Disorders Center of Georgia

Atlanta, Georgia, 30342, United States

Location

SleepMed of Central Georgia

Macon, Georgia, 31201, United States

Location

Chicago Research Center

Chicago, Illinois, 60634, United States

Location

Community Research

Crestview Hills, Kentucky, 41017, United States

Location

Kentucky Research Group

Louisville, Kentucky, 40217, United States

Location

The Center for Sleep and Wake Disorders

Chevy Chase, Maryland, 20815, United States

Location

Pulmonary and Critical Care Associates of Baltimore

Towson, Maryland, 21204, United States

Location

Neurocare, Inc.

Newton, Massachusetts, 02459, United States

Location

Minnesota Lung Center and Sleep Institute

Edina, Minnesota, 55435, United States

Location

Washington University

St Louis, Missouri, 63108, United States

Location

Rex Sleep Disorders Center

Raleigh, North Carolina, 27607, United States

Location

Wake Research Associates

Raleigh, North Carolina, 27612, United States

Location

Mercy St. Vincent Medical Center

Toledo, Ohio, 43623, United States

Location

Center for Sleep Medicine

Philadelphia, Pennsylvania, 19118, United States

Location

SleepMed of South Carolina

Columbia, South Carolina, 29201, United States

Location

Future Search Trials of Neurology

Austin, Texas, 78731, United States

Location

Sleep Medicine Associates of Texas

Dallas, Texas, 75231, United States

Location

Todd J. Swick, MD, PA

Houston, Texas, 77063, United States

Location

Metroplex Pulmonary and Sleep Center

McKinney, Texas, 75069, United States

Location

Sleep Therapy and Research Center

San Antonio, Texas, 78229, United States

Location

Related Publications (1)

• Ruoff C, Swick TJ, Doekel R, Emsellem HA, Feldman NT, Rosenberg R, Bream G, Khayrallah MA, Lu Y, Black J. Effect of Oral JZP-110 (ADX-N05) on Wakefulness and Sleepiness in Adults with Narcolepsy: A Phase 2b Study. Sleep. 2016 Jul 1;39(7):1379-87. doi: 10.5665/sleep.5968.

  PMID: 27166238 DERIVED

MeSH Terms

Conditions

Narcolepsy

Interventions

solriamfetol

Condition Hierarchy (Ancestors)

Disorders of Excessive Somnolence; 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

215-970-7145

Study Officials

• David Ward, MD

  Aerial BioPharma, LLC

  STUDY DIRECTOR

Publication Agreements

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

Study Design

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

Study Record Dates

• First Submitted: September 5, 2012
• First Posted: September 7, 2012
• Study Start: September 1, 2012
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: May 28, 2021
• Results First Posted: September 11, 2014

Record last verified: 2021-05

Locations

US (28)