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Study of the Safety and Effectiveness of NXN-188 for the Treatment of Migraine Headache Without Aura

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
NeurAxon Inc.
ClinicalTrials.gov Identifier:
NCT00959751
First received: August 14, 2009
Last updated: July 12, 2014
Last verified: July 2014
Results First Received: May 8, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Migraine Without Aura
Interventions: Drug: NXN-188
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
Study Period - 6 months. First subject screened 28 July 2009, Last subject completed the study 9 February 2010.

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
Placebo 3 x capsules, PRN
NXN-188 600 mg 3 x 200 mg capsules, PRN

Participant Flow:   Overall Study
    Placebo   NXN-188 600 mg
STARTED   97   98 
COMPLETED   88   86 
NOT COMPLETED   9   12 
Lost to Follow-up                2                3 
Consent Withdrawn                0                1 
Non-compliance to Study Procedures                0                1 
No migraine headache without aura                7                7 



  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.
Of the 195 subjects randomized, 174 subjects received study drug: the 174 subjects constitute the Safety Population.

Reporting Groups
  Description
NXN-188 3 x 200 mg capsules
Placebo 3 x 0 mg capsules
Total Total of all reporting groups

Baseline Measures
   NXN-188   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 86   88   174 
Age 
[Units: Years]
Mean (Standard Deviation)
 40.2  (12.34)   38.4  (12.63)   39.3  (12.49) 
Gender 
[Units: Participants]
     
Female   66   74   140 
Male   20   14   34 
Ethnicity (NIH/OMB) 
[Units: Participants]
     
Hispanic or Latino   21   13   34 
Not Hispanic or Latino   65   75   140 
Unknown or Not Reported   0   0   0 
Race (NIH/OMB) 
[Units: Participants]
     
American Indian or Alaska Native   0   0   0 
Asian   0   1   1 
Native Hawaiian or Other Pacific Islander   0   0   0 
Black or African American   13   19   32 
White   72   66   138 
More than one race   1   2   3 
Unknown or Not Reported   0   0   0 
Weight 
[Units: Kg]
Mean (Standard Deviation)
 74.94  (14.695)   74.74  (17.066)   74.84  (15.893) 
Height 
[Units: Cm]
Mean (Standard Deviation)
 168.33  (8.502)   165.91  (9.960)   167.10  (9.321) 
Body Mass Index (BMI) 
[Units: Kg/m^2]
Mean (Standard Deviation)
 26.2  (4.09)   27.2  (5.28)   26.7  (4.74) 
Type of Migraine [1] 
[Units: Participants]
     
Without Aura   86   88   174 
With Aura   0   0   0 
[1] Subjects are counted once within each type where at least one migraine is recorded.
Number of Previous Migraines [1] 
[Units: Migraine episodes]
Mean (Standard Deviation)
 1.1  (0.30)   1.1  (0.23)   1.1  (0.27) 
[1] Previous Migraines for each subject was based on the total number of migraine entries reported on the Migraine History CRF


  Outcome Measures
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1.  Primary:   Headache Relief (Modified LOCF - Efficacy Evaluable Analysis Set)   [ Time Frame: 2 hours ]

2.  Primary:   Headache Recurrence (Modified LOCF - Efficacy Evaluable Analysis Set)   [ Time Frame: 4 hours ]

3.  Secondary:   Headache Relief Based on a 2-Point Reduction From Baseline (Modified LOCF - Efficacy Evaluable Analysis Set)   [ Time Frame: 72 hours ]

4.  Secondary:   Headache Relief Based on a 1-Point Reduction From Baseline (Modified LOCF - Efficacy Evaluable Analysis Set)   [ Time Frame: 72 hours ]

5.  Secondary:   Complete Headache Relief (Efficacy Evaluable Analysis Set)   [ Time Frame: 72 hours ]

6.  Secondary:   Time (Hours) to First Use of Rescue Medication (Full Analysis Set)   [ Time Frame: 24 Hours ]

7.  Secondary:   Overall Evaluation of Study Medication at 24 Hours Post Administration (Full Analysis Set)   [ Time Frame: 24 hours ]

8.  Post-Hoc:   Sustained Complete Headache Relief (Efficacy Evaluable Analysis Set)   [ Time Frame: 2 - 48 hours ]


  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
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  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: Thomas Lategan, PhD
Organization: NeurAxon, Inc.
phone: 417-673-6697
e-mail: tlategan@neuraxon.com



Responsible Party: NeurAxon Inc.
ClinicalTrials.gov Identifier: NCT00959751     History of Changes
Other Study ID Numbers: NXN-188-204
Study First Received: August 14, 2009
Results First Received: May 8, 2013
Last Updated: July 12, 2014
Health Authority: United States: Food and Drug Administration
Canada: Health Canada