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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Aerial BioPharma, LLC
ClinicalTrials.gov Identifier:
NCT01681121
First received: September 5, 2012
Last updated: September 9, 2013
Last verified: September 2013

September 5, 2012
September 9, 2013
September 2012
August 2013   (final data collection date for primary outcome measure)
  • Evaluate the change from Baseline in the average sleep latency time (in minutes) as determined from the Maintenance of Wakefulness Test for ADX-N05 vs. placebo at last assessment. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Evaluate the Clinical Global Impression-Change scores for ADX-N05 vs. placebo at last assessment [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01681121 on ClinicalTrials.gov Archive Site
  • Evaluate the change from Baseline in Epworth Sleepiness Scale scores for ADX-N05 vs. placebo at Week 4 [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Evaluate the change from Baseline in Epworth Sleepiness Scale scores for ADX-N05 vs. placebo at last assessment [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Evaluate the change from Baseline in the average sleep latency time (in minutes) as determined from the Maintenance of Wakefulness Test (average of the first four trials) following four weeks of treatment with ADX-N05 150 mg vs. placebo [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Evaluate the change from Baseline in sleep latency time (in minutes) as determined from each of the 5 individual Maintenance of Wakefulness Test trials for ADX-N05 vs. placebo at Week 4 [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Evaluate the change from Baseline in sleep latency time (in minutes) as determined from each of the 5 individual Maintenance of Wakefulness Test trials for ADX-N05 vs. placebo at last assessment [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Evaluate the Clinical Global Impression-Change scores for ADX-N05 vs. placebo at Week 4 [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Evaluate the Patient Global Impression-Change scores for ADX-N05 vs. placebo at Week 4 [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Evaluate the Patient Global Impression-Change scores for ADX-N05 vs. placebo at last assessment [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Evaluate the safety and tolerability of ADX-N05 vs placebo in adults with narcolepsy by assessing treatment emergent adverse events, vital signs, laboratory results, ECGs, and physical exams. [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
Same as current
  • Evaluate the change from Baseline in the median number of cataplectic attacks per week for the subset of subjects with cataplexy for ADX-N05 vs. placebo at Week 4 [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Evaluate the change from Baseline in the median number of cataplectic attacks per week for the subset of subjects with cataplexy for ADX-N05 vs. placebo at last assessment [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Same as current
 
A Study of the Safety and Effectiveness of ADX-N05 for Excessive Daytime Sleepiness in Subjects With Narcolepsy
A Twelve-week, Double-blind, Placebo-controlled, Randomized, Parallel-group, Multi-center Study of the Safety and Efficacy of ADX-N05 in the Treatment of Excessive Daytime Sleepiness in Subjects With Narcolepsy

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Narcolepsy
  • Drug: ADX-N05
    150 mg once a day for 4 weeks followed by 300 mg once a day for 8 weeks
  • Drug: Placebo
    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
  • Experimental: ADX-N05
    ADX-N05 to be taken once a day for 12 weeks
    Intervention: Drug: ADX-N05
  • Placebo Comparator: Placebo
    Placebo to match ADX-N05 to be taken once a day for 12 weeks
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
93
August 2013
August 2013   (final data collection date for primary outcome measure)

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 2 years
  • Nicotine dependence that has an effect on sleep
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01681121
ADX-N05 202
No
Aerial BioPharma, LLC
Aerial BioPharma, LLC
Not Provided
Study Director: David Ward, MD Aerial BioPharma, LLC
Aerial BioPharma, LLC
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP