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

NCT01485770 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2021-07-06

Study results available
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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.

Conditions

Interventions

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 once a day for 2 consecutive weeks

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-12-31
Primary Completion
2012-05-31
Completion
2012-05-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01485770 on ClinicalTrials.gov