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A Study of the Safety and Effectiveness of ADX-N05 in the Treatment of Excessive Daytime Sleepiness

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Aerial BioPharma, LLC
ClinicalTrials.gov Identifier:
NCT01485770
First received: December 2, 2011
Last updated: March 8, 2013
Last verified: March 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Narcolepsy
 Drug: ADX-N05
Drug: Placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Four-week, Double-blind, Placebo-controlled, Randomized, Cross-over Study of the Safety and Efficacy of ADX-N05 in the Treatment of Excessive Daytime Sleepiness

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Aerial BioPharma, LLC:

Primary Outcome Measures:
  • Evaluate the effectiveness of ADX-N05 compared to baseline in adults with narcolepsy as determined by the Maintenance of Wakefulness Test following 2 weeks of treatment with ADX-N05 vs. 2 weeks of treatment with placebo [ Time Frame: To determine efficacy after 2 weeks of dosing with ADX-N05 vs 2 weeks of dosing with placebo ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Evaluate the effectiveness of ADX-N05 compared to baseline in adults with narcolepsy as determined by the Epworth Sleepiness Scale following 2 weeks of treatment with ADX-N05 vs. 2 weeks of treatment with placebo [ Time Frame: To determine efficacy after 2 weeks of dosing with ADX-N05 vs 2 weeks of dosing with placebo ] [ Designated as safety issue: No ]
  • Evaluate the effectiveness of ADX-N05 compared to baseline in adults with narcolepsy as determined by the Clinical Global Impression-Change score following 2 weeks of treatment with ADX-N05 vs. 2 weeks of treatment with placebo [ Time Frame: To determine efficacy after 2 weeks of dosing with ADX-N05 vs 2 weeks of dosing with placebo ] [ Designated as safety issue: No ]
  • Evaluate the safety and tolerability of ADX-N05 in adults with narcolepsy by assessing treatment emergent adverse events, vital signs, laboratory results,and ECGs [ Time Frame: To determine safety after 2 weeks of dosing with ADX-N05 vs. 2 weeks of dosing with placebo ] [ Designated as safety issue: Yes ]

Enrollment: 33
Study Start Date: December 2011
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ADX-N05
ADX-N05 to be taken once a day for 2 consecutive weeks during 4 week study treatment period
 Drug: ADX-N05
150 mg once a day for seven days followed by 300 mg once a day for seven days
Placebo Comparator: Placebo
Placebo to match ADX-N05 to be taken once a day for 2 consecutive weeks during 4 week study treatment period
 Drug: Placebo
Placebo to match ADX-N05 to be taken for 2 consecutive weeks during 4 week study treatment period

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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 two years
  • Nicotine dependence that has an affect on sleep
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01485770

Locations
United States, Arizona
Pulmonary Associates
Phoenix, Arizona, United States, 85006
United States, Florida
Clinical Research Group of St. Petersburg
St. Petersburg, Florida, United States, 33707
United States, Georgia
Sleep Disorders Center of Georgia
Atlanta, Georgia, United States, 30342
Neurotrials Research, Inc.
Atlanta, Georgia, United States, 30342
SleepMed of Central Georgia
Macon, Georgia, United States, 31201
United States, Maryland
The Center for Sleep and Wake Disorders
Chevy Chase, Maryland, United States, 20815
United States, Ohio
Mercy St. Anne Sleep Disorders Center
Toledo, Ohio, United States, 43623
United States, South Carolina
SleepMed of South Carolina
Columbia, South Carolina, United States, 29201
United States, Texas
Future Search Trials of Neurology
Austin, Texas, United States, 78731
Sleep Medicine Associates of Texas
Dallas, Texas, United States, 75231
Sponsors and Collaborators
Aerial BioPharma, LLC
Investigators
Study Director: David Ward, MD Aerial BioPharma, LLC
  More Information

No publications provided

Responsible Party: Aerial BioPharma, LLC
ClinicalTrials.gov Identifier: NCT01485770     History of Changes
Other Study ID Numbers: ADX-N05 201
Study First Received: December 2, 2011
Last Updated: March 8, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Narcolepsy
Disorders of Excessive Somnolence
Sleep Disorders, Intrinsic
Dyssomnias
 Sleep Disorders
Nervous System Diseases
Mental Disorders

ClinicalTrials.gov processed this record on May 22, 2013