The Efficacy and Tolerability of NP101 Patch in the Treatment of Acute Migraine (NP101-007)
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| ClinicalTrials.gov Identifier: NCT00724815 |
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Recruitment Status :
Completed
First Posted : July 30, 2008
Results First Posted : May 7, 2013
Last Update Posted : February 4, 2016
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Sponsor:
NuPathe Inc.
Information provided by (Responsible Party):
Teva Branded Pharmaceutical Products R&D, Inc. ( NuPathe Inc. )
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| 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 |
Participant Flow
| 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 |
|---|---|---|
 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 |
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[1]
subjects randomized
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Baseline Characteristics
| Arm/Group Title | NP101 Patch | Placebo Patch | Total | |
|---|---|---|---|---|
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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 | |
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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.
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 234 participants | 235 participants | 469 participants | |
| <=18 years |
0 0.0%
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0 0.0%
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0 0.0%
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| Between 18 and 65 years |
233 99.6%
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235 100.0%
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468 99.8%
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| >=65 years |
1 0.4%
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0 0.0%
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1 0.2%
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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| Number Analyzed | 234 participants | 235 participants | 469 participants | |
| 40.5 (11.20) | 41.2 (11.06) | 40.8 (11.12) | ||
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 234 participants | 235 participants | 469 participants | |
| Female |
197 84.2%
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201 85.5%
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398 84.9%
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| Male |
37 15.8%
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34 14.5%
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71 15.1%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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| United States | Number Analyzed | 234 participants | 235 participants | 469 participants |
| 234 | 235 | 469 | ||
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
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 |
| EMail: | mpierce@nupathe.com |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Teva Branded Pharmaceutical Products R&D, Inc. ( NuPathe Inc. ) |
| ClinicalTrials.gov Identifier: | NCT00724815 |
| 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 |