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An Open-Label Study to Evaluate the Safety of NP101 in the Treatment of Acute Migraine Over 12 Months (NP101-008)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
NuPathe Inc.
ClinicalTrials.gov Identifier:
NCT00792103
First received: November 14, 2008
Last updated: March 26, 2013
Last verified: March 2013
Results First Received: February 15, 2013  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy 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 January 2009 and completed in September 2010. 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
This was an open-label study to assess the long-term safety of NP101. Subjects who continued to be in good health and received treatment with an NP101 patch for a qualifying migraine in the pivotal NP101-007 study were considered eligible for enrollment.

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 moderate or 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     198 [1]
COMPLETED     65  
NOT COMPLETED     133  
Enrolled, not treated                 15  
Lost to Follow-up                 17  
Adverse Event                 25  
Withdrawal by Subject                 52  
Protocol Violation                 10  
Did not apply 6 patches in 1st 3 mths                 14  
[1] 15 subjects were enrolled but did not treat for a total of 183 subjects in the safety population



  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.
Per protocol, the intent-to-treat (ITT) population was defined as all subjects who applied and activated at least one NP101 study patch and had at least one post baseline assessment for each migraine symptom (pain, photophobia, phonophobia, and nausea). Of the 183 subjects who applied at least one study patch, 181 subjects met the ITT criteria.

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 moderate or 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]
  183  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     183  
>=65 years     0  
Age  
[units: years]
Mean ± Standard Deviation
  42.0  ± 10.28  
Gender  
[units: participants]
 
Female     152  
Male     31  
Region of Enrollment  
[units: participants]
 
United States     183  



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

2.  Secondary:   Pain Relief   [ Time Frame: 2 hours ]

3.  Secondary:   Nausea Free   [ Time Frame: 2 hours ]

4.  Secondary:   Phonophobia Free   [ Time Frame: 2 hours ]

5.  Secondary:   Photophobia Free   [ Time Frame: 2 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: Mark Pierce, MD PhD
Organization: NuPathe Inc.
phone: 484-567-0130
e-mail: mpierce@nupathe.com


No publications provided by NuPathe Inc.

Publications automatically indexed to this study:

Responsible Party: NuPathe Inc.
ClinicalTrials.gov Identifier: NCT00792103     History of Changes
Other Study ID Numbers: PROT-15-NP101-008
Study First Received: November 14, 2008
Results First Received: February 15, 2013
Last Updated: March 26, 2013
Health Authority: United States: Food and Drug Administration