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

Tracking Information

First Received Date ^ICMJE

December 2, 2011

Last Updated Date

March 8, 2013

Start Date ^ICMJE

December 2011

Primary Completion Date

May 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01485770 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Narcolepsy

Intervention ^ICMJE

Drug: ADX-N05
150 mg once a day for seven days followed by 300 mg once a day for seven days
Drug: Placebo
Placebo to match ADX-N05 to be taken for 2 consecutive weeks during 4 week study treatment period

Study Arm (s)

Experimental: ADX-N05
ADX-N05 to be taken once a day for 2 consecutive weeks during 4 week study treatment period

Intervention: Drug: ADX-N05
Placebo Comparator: Placebo
Placebo to match ADX-N05 to be taken once a day for 2 consecutive weeks during 4 week study treatment period

Intervention: Drug: Placebo

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

May 2012

Primary Completion Date

May 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01485770

Other Study ID Numbers ^ICMJE

ADX-N05 201

Has Data Monitoring Committee

Responsible Party

Aerial BioPharma, LLC

Study Sponsor ^ICMJE

Aerial BioPharma, LLC

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

David Ward, MD

Aerial BioPharma, LLC

Information Provided By

Aerial BioPharma, LLC

Verification Date

March 2013

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

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