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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)

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ClinicalTrials.gov Identifier: NCT00806546
Recruitment Status : Completed
First Posted : December 11, 2008
Results First Posted : March 20, 2013
Last Update Posted : February 4, 2016
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( NuPathe Inc. )

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Migraine Disorders
Intervention Drug: NP101
Enrollment 514
Recruitment Details 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  
Arm/Group Title NP101
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 514 [1]
Completed 207
Not Completed 307
Reason Not Completed
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
Arm/Group Title NP101
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 479
Hide Baseline Analysis Population Description
Patients were asked to use study patches to treat migraine episodes with mild to severe headache pain for up to 12 months. The safety population included all subjects who applied at least one NP101 patch. Of the 514 subjects enrolled, 35 subjects did not treat for a total of 479 subjects in the safety population.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 479 participants
<=18 years
0
   0.0%
Between 18 and 65 years
479
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 479 participants
41.7  (11.85)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 479 participants
Female
392
  81.8%
Male
87
  18.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 479 participants
479
1.Primary Outcome
Title Subject Self-examination of Skin Irritation
Hide Description For each patch application, subjects performed a self-examination of skin irritation using a 5-point scale (0=no redness; 1=minimal skin redness; 2=moderate skin redness with sharp borders; 3=intense skin redness with or without swelling; 4=intense skin redness with blisters or broken skin).
Time Frame 24 hours post patch application
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol, all subjects who applied at least one NP101 study patch were included in the safety population.
Arm/Group Title NP101
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 479
Overall Number of Units Analyzed
Type of Units Analyzed: Patches
7395
Mean (Standard Deviation)
Unit of Measure: scores on a scale
0.6  (0.86)
Time Frame All adverse events were collected from Screening until 30 days after the last study visit.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title NP101
Hide Arm/Group Description 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.
All-Cause Mortality
NP101
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
NP101
Affected / at Risk (%) # Events
Total   9/479 (1.88%)    
Cardiac disorders   
Atrial fibrillation  1  1/479 (0.21%)  1
Supraventricular tachycardia  1  1/479 (0.21%)  1
Endocrine disorders   
Goiter  1  1/479 (0.21%)  1
Hepatobiliary disorders   
Bile duct stone  1  1/479 (0.21%)  1
Cholelithiasis  1  1/479 (0.21%)  1
Musculoskeletal and connective tissue disorders   
Back pain  1  1/479 (0.21%)  1
Nervous system disorders   
Headache  1  1/479 (0.21%)  1
Syncope  1  1/479 (0.21%)  1
Pregnancy, puerperium and perinatal conditions   
Ruptured ectopic pregnancy  1  1/479 (0.21%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (10.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
NP101
Affected / at Risk (%) # Events
Total   177/479 (36.95%)    
General disorders   
Application site discoloration  1  28/479 (5.85%)  28
Application site dryness  1  27/479 (5.64%)  27
Application site pain  1  93/479 (19.42%)  93
Application site paraesthesia  1  26/479 (5.43%)  26
Application site pruritus  1  67/479 (13.99%)  67
Application site reaction  1  29/479 (6.05%)  29
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (10.0)
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.
Per the study agreement, Investigators shall have the right to publish or present information and/or data arising from the study, provided the text of any such publication or presentation is submitted for review at least thirty days prior to submission for publication or other disclosure and NuPathe shall have the right to request the removal of any confidential information
Results Point of Contact
Name/Title: Mark Pierce, MD, PhD
Organization: NuPathe Inc.
Phone: 484-567-0130
Responsible Party: Teva Pharmaceutical Industries ( NuPathe Inc. )
ClinicalTrials.gov Identifier: NCT00806546     History of Changes
Other Study ID Numbers: PROT-15-NP101-009
First Submitted: December 10, 2008
First Posted: December 11, 2008
Results First Submitted: February 15, 2013
Results First Posted: March 20, 2013
Last Update Posted: February 4, 2016