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

Jazz Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Narcolepsy

Treatments: Drug: ADX-N05; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01681121

ADX-N05 202

Details and patient eligibility

About

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.

Enrollment: 93 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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93 participants in 2 patient groups, including a placebo group

ADX-N05

Experimental group

Description:

ADX-N05 to be taken once a day for 12 weeks

Treatment:

Drug: ADX-N05

Placebo

Placebo Comparator group

Description:

Placebo to match ADX-N05 to be taken once a day for 12 weeks

Treatment:

Drug: Placebo