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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jazz Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01681121
First received: September 5, 2012
Last updated: September 15, 2014
Last verified: September 2014
Results First Received: September 4, 2014  
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
Condition: Narcolepsy
Interventions: Drug: ADX-N05
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
ADX-N05

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

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


Participant Flow:   Overall Study
    ADX-N05     Placebo  
STARTED     44     49  
COMPLETED     36     38  
NOT COMPLETED     8     11  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
ADX-N05

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

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 Total of all reporting groups

Baseline Measures
    ADX-N05     Placebo     Total  
Number of Participants  
[units: participants]
  44     49     93  
Age  
[units: Years]
Mean ± Standard Deviation
  41  ± 12.33     36.7  ± 11.71     38.7  ± 12.13  
Gender  
[units: participants]
     
Female     30     30     60  
Male     14     19     33  



  Outcome Measures

1.  Primary:   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: Baseline and 12 weeks ]

2.  Primary:   Evaluate the Clinical Global Impression-Change Scores for ADX-N05 vs. Placebo at Last Assessment   [ Time Frame: 12 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

3.  Secondary:   Evaluate the Change From Baseline in Epworth Sleepiness Scale Scores for ADX-N05 vs. Placebo at Week 4   [ Time Frame: 4 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

4.  Secondary:   Evaluate the Change From Baseline in Epworth Sleepiness Scale Scores for ADX-N05 vs. Placebo at Last Assessment   [ Time Frame: 12 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

5.  Secondary:   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 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

6.  Secondary:   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 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

7.  Secondary:   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 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

8.  Secondary:   Evaluate the Clinical Global Impression-Change Scores for ADX-N05 vs. Placebo at Week 4   [ Time Frame: 4 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

9.  Secondary:   Evaluate the Patient Global Impression-Change Scores for ADX-N05 vs. Placebo at Week 4   [ Time Frame: 4 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

10.  Secondary:   Evaluate the Patient Global Impression-Change Scores for ADX-N05 vs. Placebo at Last Assessment   [ Time Frame: 12 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

11.  Secondary:   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 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes

12.  Other Pre-specified:   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 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

13.  Other Pre-specified:   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 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Yuan Lu, MS
Organization: Jazz Pharmaceuticals
phone: 650 496 2855
e-mail: yuan.lu@jazzpharma.com


No publications provided


Responsible Party: Jazz Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01681121     History of Changes
Other Study ID Numbers: ADX-N05 202
Study First Received: September 5, 2012
Results First Received: September 4, 2014
Last Updated: September 15, 2014
Health Authority: United States: Food and Drug Administration