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An Open-Label Study to Evaluate the Safety of NP101 in the Treatment of Acute Migraine Over Twelve Months (NP101-009)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
NuPathe Inc.
ClinicalTrials.gov Identifier:
NCT00806546
First received: December 10, 2008
Last updated: March 26, 2013
Last verified: March 2013
History of Changes
Results First Received: February 15, 2013  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Migraine Disorders
Intervention: Drug: NP101

  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
The study was initiated March 2009 and completed in May 2011. Patients were enrolled from 34 investigative sites across the United States.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Not applicable.

Reporting Groups
  Description
NP101 The NP101 patch contained 86 mg of sumatriptan and was designed to deliver approximately 6.5 mg of sumatriptan over 4 hours. Patients were asked to use study patches to treat migraine episodes with mild to severe headache pain for up to 12 months, during which they were permitted to apply (to the upper arms or thighs) a maximum of 6 patches within a 30-day period.

Participant Flow:   Overall Study
    NP101  
STARTED     514 [1]
COMPLETED     207  
NOT COMPLETED     307  
Enrolled, not treated                 35  
Lost to Follow-up                 32  
Adverse Event                 74  
Withdrawal by Subject                 75  
Protocol Violation                 49  
Various                 42  
[1] 35 subjects were enrolled but did not treat for a total of 479 subjects in the safety population



  Baseline Characteristics
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Reporting Groups
  Description
NP101 The NP101 patch contained 86 mg of sumatriptan and was designed to deliver approximately 6.5 mg of sumatriptan over 4 hours. Patients were asked to use study patches to treat migraine episodes with mild to severe headache pain for up to 12 months, during which they were permitted to apply (to the upper arms or thighs) a maximum of 6 patches within a 30-day period.

Baseline Measures
    NP101  
Number of Participants  
[units: participants]
 		  479  
Age  
[units: participants]
 		 
<=18 years     0  
Between 18 and 65 years     479  
>=65 years     0  
Age  
[units: years]
Mean ± Standard Deviation 		  41.7  ± 11.85  
Gender  
[units: participants]
 		 
Female     392  
Male     87  
Region of Enrollment  
[units: participants]
 		 
United States     479  



  Outcome Measures

1.  Primary:   Subject Self-examination of Skin Irritation   [ Time Frame: 24 hours post patch application ]
  Show Outcome Measure 1


  Serious Adverse Events
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  Other Adverse Events
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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.


Limitations and Caveats
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.  


Results Point of Contact:  
Name/Title: Mark Pierce, MD, PhD
Organization: NuPathe Inc.
phone: 484-567-0130
e-mail: mpierce@nupathe.com


No publications provided


Responsible Party: NuPathe Inc.
ClinicalTrials.gov Identifier: NCT00806546     History of Changes
Other Study ID Numbers: PROT-15-NP101-009
Study First Received: December 10, 2008
Results First Received: February 15, 2013
Last Updated: March 26, 2013
Health Authority: United States: Food and Drug Administration