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
  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: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Aerial BioPharma, LLC:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Other Outcome Measures:
  • 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 ]

Enrollment: 93
Study Start Date: September 2012
Study Completion Date: August 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ADX-N05
ADX-N05 to be taken once a day for 12 weeks
Drug: ADX-N05
150 mg once a day for 4 weeks followed by 300 mg once a day for 8 weeks
Placebo Comparator: Placebo
Placebo to match ADX-N05 to be taken once a day for 12 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

  Eligibility

Ages Eligible for Study:   18 Years to 70 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 2 years
  • Nicotine dependence that has an effect on sleep
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01681121

  Show 28 Study Locations
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: NCT01681121     History of Changes
Other Study ID Numbers: ADX-N05 202
Study First Received: September 5, 2012
Last Updated: September 9, 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 July 31, 2014