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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)

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ClinicalTrials.gov Identifier: NCT00792103
Recruitment Status : Completed
First Posted : November 17, 2008
Results First Posted : May 7, 2013
Last Update Posted : February 4, 2016
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( NuPathe Inc. )

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Migraine Disorders
Intervention Drug: NP101
Enrollment 198
Recruitment Details 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 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.
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 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.
Period Title: Overall Study
Started 198 [1]
Completed 65
Not Completed 133
Reason Not Completed
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
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 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.
Overall Number of Baseline Participants 183
Hide Baseline Analysis Population Description
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.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 183 participants
<=18 years
0
   0.0%
Between 18 and 65 years
183
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 183 participants
42.0  (10.28)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 183 participants
Female
152
  83.1%
Male
31
  16.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 183 participants
183
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 activation
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol, the intent-to-treat 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).
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 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.
Overall Number of Participants Analyzed 183
Overall Number of Units Analyzed
Type of Units Analyzed: NP101 Patches
1917
Mean (Standard Deviation)
Unit of Measure: scores on a scale
1.0  (0.96)
2.Secondary Outcome
Title Pain Relief
Hide Description Headache pain relief (no pain or mild headache pain) at two hours post activation of NP101.
Time Frame 2 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol, the intent-to-treat 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). Two treated subjects in the safety population did not meet this criteria.
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 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.
Overall Number of Participants Analyzed 181
Measure Type: Number
Unit of Measure: participants
105
3.Secondary Outcome
Title Nausea Free
Hide Description Nausea free at two hours after patch activation.
Time Frame 2 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol, the intent-to-treat 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). Two treated subjects in the safety population did not meet this criteria.
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 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.
Overall Number of Participants Analyzed 181
Measure Type: Number
Unit of Measure: participants
143
4.Secondary Outcome
Title Phonophobia Free
Hide Description Phonophobia free at two hours after patch activation.
Time Frame 2 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol, the intent-to-treat 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). Two treated subjects in the safety population did not meet this criteria.
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 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.
Overall Number of Participants Analyzed 181
Measure Type: Number
Unit of Measure: participants
109
5.Secondary Outcome
Title Photophobia Free
Hide Description Photophobia free at two hours after patch activation.
Time Frame 2 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol, the intent-to-treat 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). Two treated subjects in the safety population did not meet this criteria.
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 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.
Overall Number of Participants Analyzed 181
Measure Type: Number
Unit of Measure: participant
97
Time Frame All adverse events were collected from study enrollment until 30 days after the last patch application.
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 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.
All-Cause Mortality
NP101
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
NP101
Affected / at Risk (%) # Events
Total   2/183 (1.09%)    
Ear and labyrinth disorders   
Vertigo  1  1/183 (0.55%)  1
Metabolism and nutrition disorders   
Dehydration  1  1/183 (0.55%)  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   66/183 (36.07%)    
General disorders   
Application site hypersensitivity  1  11/183 (6.01%)  11
Application Site Pain  1  39/183 (21.31%)  39
Application site pruritus  1  40/183 (21.86%)  40
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 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
Layout table for Results Point of Contact information
Name/Title: Mark Pierce, MD PhD
Organization: NuPathe Inc.
Phone: 484-567-0130
EMail: mpierce@nupathe.com
Layout table for additonal information
Responsible Party: Teva Pharmaceutical Industries ( NuPathe Inc. )
ClinicalTrials.gov Identifier: NCT00792103     History of Changes
Other Study ID Numbers: PROT-15-NP101-008
First Submitted: November 14, 2008
First Posted: November 17, 2008
Results First Submitted: February 15, 2013
Results First Posted: May 7, 2013
Last Update Posted: February 4, 2016