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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01681121
Recruitment Status : Completed
First Posted : September 7, 2012
Results First Posted : September 11, 2014
Last Update Posted : September 29, 2014
Sponsor:
Information provided by (Responsible Party):
Jazz Pharmaceuticals

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Narcolepsy
Interventions Drug: ADX-N05
Drug: Placebo
Enrollment 93
Recruitment Details  
Pre-assignment Details  
Arm/Group Title ADX-N05 Placebo
Hide Arm/Group Description

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

ADX-N05: 150 mg once a day for 4 weeks followed by 300 mg once a day for 8 weeks

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

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

Period Title: Overall Study
Started 44 49
Completed 36 38
Not Completed 8 11
Arm/Group Title ADX-N05 Placebo Total
Hide Arm/Group Description

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

ADX-N05: 150 mg once a day for 4 weeks followed by 300 mg once a day for 8 weeks

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

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

Total of all reporting groups
Overall Number of Baseline Participants 44 49 93
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 44 participants 49 participants 93 participants
41  (12.33) 36.7  (11.71) 38.7  (12.13)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 44 participants 49 participants 93 participants
Female
30
  68.2%
30
  61.2%
60
  64.5%
Male
14
  31.8%
19
  38.8%
33
  35.5%
1.Primary Outcome
Title 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.
Hide Description Sleep Latency - The primary analysis was a comparison of treatments vs. control groups on change from Baseline to last available post-Baseline assessment (Week 12/Last Assessment) in the average sleep latency time (in minutes) averaged across the first four trials of the MWT using a two-sample t-test.
Time Frame Baseline and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
93 subject were randomly assigned to a treatment group; 90 subjects (43 on ADX-N05 and 47 on Placebo) had at least one post-Basdeline efficacy assessment (Intent-to-treat [ITT] Population). For the primary endpoint analysis (40 on ADX-N05 and 45 on Placebo) have assessment week 12/last assessment
Arm/Group Title ADX-N05 Placebo
Hide Arm/Group Description:

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

ADX-N05: 150 mg once a day for 4 weeks followed by 300 mg once a day for 8 weeks

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

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

Overall Number of Participants Analyzed 40 45
Mean (Standard Deviation)
Unit of Measure: Minutes
12.8  (10.28) 2.1  (7.88)
2.Primary Outcome
Title Evaluate the Clinical Global Impression-Change Scores for ADX-N05 vs. Placebo at Last Assessment
Hide Description [Not Specified]
Time Frame 12 weeks
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Evaluate the Change From Baseline in Epworth Sleepiness Scale Scores for ADX-N05 vs. Placebo at Week 4
Hide Description [Not Specified]
Time Frame 4 weeks
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Evaluate the Change From Baseline in Epworth Sleepiness Scale Scores for ADX-N05 vs. Placebo at Last Assessment
Hide Description [Not Specified]
Time Frame 12 weeks
Outcome Measure Data Not Reported
5.Secondary Outcome
Title 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
Hide Description [Not Specified]
Time Frame 4 weeks
Outcome Measure Data Not Reported
6.Secondary Outcome
Title 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
Hide Description [Not Specified]
Time Frame 4 weeks
Outcome Measure Data Not Reported
7.Secondary Outcome
Title 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
Hide Description [Not Specified]
Time Frame 12 weeks
Outcome Measure Data Not Reported
8.Secondary Outcome
Title Evaluate the Clinical Global Impression-Change Scores for ADX-N05 vs. Placebo at Week 4
Hide Description [Not Specified]
Time Frame 4 weeks
Outcome Measure Data Not Reported
9.Secondary Outcome
Title Evaluate the Patient Global Impression-Change Scores for ADX-N05 vs. Placebo at Week 4
Hide Description [Not Specified]
Time Frame 4 weeks
Outcome Measure Data Not Reported
10.Secondary Outcome
Title Evaluate the Patient Global Impression-Change Scores for ADX-N05 vs. Placebo at Last Assessment
Hide Description [Not Specified]
Time Frame 12 weeks
Outcome Measure Data Not Reported
11.Secondary Outcome
Title 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.
Hide Description [Not Specified]
Time Frame 12 weeks
Outcome Measure Data Not Reported
12.Other Pre-specified Outcome
Title 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
Hide Description [Not Specified]
Time Frame 4 weeks
Outcome Measure Data Not Reported
13.Other Pre-specified Outcome
Title 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
Hide Description [Not Specified]
Time Frame 12 weeks
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title ADX-N05 Placebo
Hide Arm/Group Description

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

ADX-N05: 150 mg once a day for 4 weeks followed by 300 mg once a day for 8 weeks

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

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

All-Cause Mortality
ADX-N05 Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
ADX-N05 Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/44 (4.55%)      0/49 (0.00%)    
Hepatobiliary disorders     
Cholecystitis Acute  1/44 (2.27%)  1 0/49 (0.00%)  0
Psychiatric disorders     
Conversion Disorder  1/44 (2.27%)  1 0/49 (0.00%)  0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
ADX-N05 Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   21/44 (47.73%)      12/49 (24.49%)    
Gastrointestinal disorders     
Nausea  6/44 (13.64%)  3/49 (6.12%) 
Diarrhoea  5/44 (11.36%)  3/49 (6.12%) 
Infections and infestations     
Upper Respirstory Tract Infection  2/44 (4.55%)  4/49 (8.16%) 
Nasophanyngitis  2/44 (4.55%)  1/49 (2.04%) 
Nervous system disorders     
Headache  7/44 (15.91%)  5/49 (10.20%) 
Insomnia  6/44 (13.64%)  1/49 (2.04%) 
Dizziness  3/44 (6.82%)  1/49 (2.04%) 
Initial Insomnia  2/44 (4.55%)  2/49 (4.08%) 
Middle Insomnia  2/44 (4.55%)  0/49 (0.00%) 
Psychiatric disorders     
Anxiety  5/44 (11.36%)  0/49 (0.00%) 
Agitation  3/44 (6.82%)  0/49 (0.00%) 
Bruxism  3/44 (6.82%)  0/49 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
 
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Yuan Lu, MS
Organization: Jazz Pharmaceuticals
Phone: 650 496 2855
EMail: yuan.lu@jazzpharma.com
Layout table for additonal information
Responsible Party: Jazz Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01681121    
Other Study ID Numbers: ADX-N05 202
First Submitted: September 5, 2012
First Posted: September 7, 2012
Results First Submitted: September 4, 2014
Results First Posted: September 11, 2014
Last Update Posted: September 29, 2014