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

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:

Genetics Home Reference related topics: narcolepsy

U.S. FDA Resources

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 ]

Estimated Enrollment:	90
Study Start Date:	September 2012
Estimated Study Completion Date:	June 2013
Estimated Primary Completion Date:	June 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

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

Show 32 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:	May 7, 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 16, 2013