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The Efficacy and Tolerability of NP101 Patch in the Treatment of Acute Migraine (NP101-007)

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ClinicalTrials.gov Identifier: NCT00724815
Recruitment Status : Completed
First Posted : July 30, 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 Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Migraine Disorders
Interventions Drug: NP101 - Sumatriptan iontophoretic transdermal patch
Drug: Placebo
Enrollment 530
Recruitment Details The study was initiated January 2009 and completed July 2009. Patients were enrolled from 38 investigative sites across the United States.
Pre-assignment Details  
Arm/Group Title NP101 Patch Placebo Patch
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 treat one migraine episode with moderate to severe headache pain. The study placebo patch contained sodium chloride instead of sumatriptan which was delivered over 4 hours. Patients were asked to treat one migraine episode with moderate to severe headache pain.
Period Title: Overall Study
Started 265 [1] 265 [1]
Completed 222 226
Not Completed 43 39
Reason Not Completed
Randomized, not treated             31             30
Adverse Event             5             3
Lost to Follow-up             4             1
Other Various             3             5
[1]
subjects randomized
Arm/Group Title NP101 Patch Placebo Patch Total
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 treat one migraine episode with moderate to severe headache pain. The study placebo patch contained sodium chloride instead of sumatriptan which was delivered over 4 hours. Patients were asked to treat one migraine episode with moderate to severe headache pain. Total of all reporting groups
Overall Number of Baseline Participants 234 235 469
Hide Baseline Analysis Population Description
Per protocol, the safety population was defined as subjects who applied a study patch. In each treatment group there were subjects who were randomized but not treated (NP101=31, placebo patch=30) and are therefore not included in the safety population.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 234 participants 235 participants 469 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
233
  99.6%
235
 100.0%
468
  99.8%
>=65 years
1
   0.4%
0
   0.0%
1
   0.2%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 234 participants 235 participants 469 participants
40.5  (11.20) 41.2  (11.06) 40.8  (11.12)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 234 participants 235 participants 469 participants
Female
197
  84.2%
201
  85.5%
398
  84.9%
Male
37
  15.8%
34
  14.5%
71
  15.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 234 participants 235 participants 469 participants
234 235 469
1.Primary Outcome
Title Pain Free at Two Hours
Hide Description Subjects whose headache severity score equaled zero (0) two hours post patch activation and who had not received any rescue medication before their two-hour assessment.
Time Frame 2 hours post patch activation
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol, the intent-to-treat population was assessed.
Arm/Group Title NP101 Patch Placebo Patch
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 treat one migraine episode with moderate to severe headache pain.
The study placebo patch contained sodium chloride instead of sumatriptan which was delivered over 4 hours. Patients were asked to treat one migraine episode with moderate to severe headache pain.
Overall Number of Participants Analyzed 226 228
Measure Type: Number
Unit of Measure: participants
40 21
2.Secondary Outcome
Title Photophobia Free at Two Hours
Hide Description Subjects who were photophobia free and who had not received any rescue medication before their two-hour assessment.
Time Frame 2 hours post patch activation
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol, the intent-to-treat population was assessed.
Arm/Group Title NP101 Patch Placebo Patch
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 treat one migraine episode with moderate to severe headache pain.
The study placebo patch contained sodium chloride instead of sumatriptan which was delivered over 4 hours. Patients were asked to treat one migraine episode with moderate to severe headache pain.
Overall Number of Participants Analyzed 226 228
Measure Type: Number
Unit of Measure: participants
116 83
3.Secondary Outcome
Title Phonophobia Free at Two Hours
Hide Description Subjects who were phonophobia free and who had not received any rescue medication before their two-hour assessment.
Time Frame 2 hours post patch activation
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol, the intent-to-treat population was assessed.
Arm/Group Title NP101 Patch Placebo Patch
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 treat one migraine episode with moderate to severe headache pain.
The study placebo patch contained sodium chloride instead of sumatriptan which was delivered over 4 hours. Patients were asked to treat one migraine episode with moderate to severe headache pain.
Overall Number of Participants Analyzed 226 228
Measure Type: Number
Unit of Measure: participants
125 89
4.Secondary Outcome
Title Nausea Free at Two Hours
Hide Description Number of subjects who were nausea free and who had not received any rescue medication before their two-hour assessment.
Time Frame 2 hours post patch activation
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol, the intent-to-treat population was assessed.
Arm/Group Title NP101 Patch Placebo Patch
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 treat one migraine episode with moderate to severe headache pain.
The study placebo patch contained sodium chloride instead of sumatriptan which was delivered over 4 hours. Patients were asked to treat one migraine episode with moderate to severe headache pain.
Overall Number of Participants Analyzed 226 228
Measure Type: Number
Unit of Measure: participants
189 144
Time Frame All Adverse Events were collected from study screening until 30 days post patch removal.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title NP101 Patch Placebo Patch
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 treat one migraine episode with moderate to severe headache pain. The study placebo patch contained sodium chloride instead of sumatriptan which was delivered over 4 hours. Patients were asked to treat one migraine episode with moderate to severe headache pain.
All-Cause Mortality
NP101 Patch Placebo Patch
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
NP101 Patch Placebo Patch
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/234 (0.00%)      0/235 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
NP101 Patch Placebo Patch
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   114/234 (48.72%)      100/235 (42.55%)    
General disorders     
Application site pain  1  54/234 (23.08%)  54 34/235 (14.47%)  34
Application site paraesthesia  1  28/234 (11.97%)  28 44/235 (18.72%)  44
Application site pruritus  1  18/234 (7.69%)  18 16/235 (6.81%)  16
Application site reaction  1  16/234 (6.84%)  16 13/235 (5.53%)  13
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
Name/Title: Mark Pierce, MD, PhD
Organization: NuPathe Inc.
Phone: 484-567-0130
Responsible Party: Teva Pharmaceutical Industries ( NuPathe Inc. )
ClinicalTrials.gov Identifier: NCT00724815     History of Changes
Other Study ID Numbers: PROT-15-NP101-007
First Submitted: July 28, 2008
First Posted: July 30, 2008
Results First Submitted: February 15, 2013
Results First Posted: May 7, 2013
Last Update Posted: February 4, 2016