Migraine Disorders
Conditions
Brief summary
The primary objective is to evaluate the safety of long-term treatment with NP101 as assessed by: * Subject self-examination skin irritation scores * Adverse events * Changes in vital signs and ECG parameters The secondary objective is to evaluate the long term efficacy of NP101 as assessed by: * Headache pain free at two hours after patch activation for all initial acute migraine attacks treated with NP101 * Headache pain relief at two hours after patch activation for all initial acute migraine attacks treated with NP101 * Nausea free at two hours after patch activation for all initial acute migraine attacks treated with NP101 * Phonophobia free at two hours after patch activation for all initial acute migraine attacks treated with NP101 * Photophobia free at two hours after patch activation for all initial acute migraine attacks treated with NP101 * Migraine free at two hours after patch activation for all initial acute migraine attacks treated with NP101 This study will use an open-label design to assess the long term safety of NP101 (sumatriptan iontophoretic transdermal patch). Subjects who continue to be in good health (use of a triptan or use of an NP101 patch is not contraindicated) and received treatment (patch activation) with the study patch for a qualifying migraine under study NP101-007 will be considered eligible for enrollment into the open-label study. Subjects will be expected to remain in the study for up to 12 months.
Interventions
DRUGNP101
NP101 study patch 4 hour application
Sponsors
NuPathe Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Subject was previously enrolled in study NP101-007 and treated (patch activation) a qualifying migraine. * Subject will be judged to be in good health, based upon the results of a medical history, physical examination, vital signs, and ECG. Subjects will not have any clinically significant abnormal vital signs or ECG parameters in order to qualify for enrollment. ECG must be done at enrollment for NP101-008 unless ECG for the Final Visit of study NP101-007 was conducted within 30 days. * Female subjects of childbearing potential (not surgically sterile or 2 years post menopausal) must have a negative pregnancy test at enrollment.
Exclusion criteria
* Subject has less than two potential skin application sites. * Subject has clinically significant abnormal vital signs or ECG parameters or had an adverse event while participating in NP101-007 that would preclude the continued treatment with the NP101 patch. * Subject has had changes in their medical history or medication use that would preclude their use of sumatriptan as per the approved Imitrex® product Prescribing Information (PI) or their safe use of NP101 as per the NP101 Investigator's Brochure. * Subject has or plans to start, stop, change treatment or dose of any of the following within 3 months prior to the subject's study Enrollment date and through the Final Visit: anxiolytics, lithium and other mood stabilizers such as valproate, carbamazepine or lamotrigine, hypnotics or antipsychotics. * Subject has taken non-triptan serotonergic drugs including selective serotonin reuptake inhibitor (SSRI), serotonin and norepinephrine reuptake inhibitor (SNRI), tricyclic antidepressants (TCAs), monoamine oxidase inhibitor (MAOI) or preparations containing St. John's Wort within 1 month prior to enrollment and/or is planning to start any of these medications during the study (through Final Visit). * Female subjects who are pregnant, breast feeding, or of childbearing potential, and are not using or are unwilling to use an effective form of contraception during the study and for a period of 30 days following Final Visit. Acceptable methods of contraception include barrier method with spermicide, intrauterine device (IUD), steroidal contraceptive (oral, transdermal, implanted or injected) or abstinence. If the exclusive male partner is surgically sterile, this will be acceptable. * Subject has participated in a clinical study within 30 days of enrollment (excluding NP101-007) or is planning to participate in another clinical study for the duration of NP101-008.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Subject Self-examination of Skin Irritation | 24 hours post patch activation | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Relief | 2 hours | Headache pain relief (no pain or mild headache pain) at two hours post activation of NP101. |
| Nausea Free | 2 hours | Nausea free at two hours after patch activation. |
| Phonophobia Free | 2 hours | Phonophobia free at two hours after patch activation. |
| Photophobia Free | 2 hours | Photophobia free at two hours after patch activation. |
Countries
United States
Participant flow
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 183 |
| Total | 183 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 25 |
| Overall Study | Did not apply 6 patches in 1st 3 mths | 14 |
| Overall Study | Enrolled, not treated | 15 |
| Overall Study | Lost to Follow-up | 17 |
| Overall Study | Protocol Violation | 10 |
| Overall Study | Withdrawal by Subject | 52 |
Baseline characteristics
| Characteristic | NP101 |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 183 Participants |
| Age, Continuous | 42.0 years STANDARD_DEVIATION 10.28 |
| Region of Enrollment United States | 183 participants |
| Sex: Female, Male Female | 152 Participants |
| Sex: Female, Male Male | 31 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 66 / 183 |
| serious Total, serious adverse events | 2 / 183 |
Outcome results
Primary
Subject Self-examination of Skin Irritation
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
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NP101 | Subject Self-examination of Skin Irritation | 1.0 scores on a scale | Standard Deviation 0.96 |
Secondary
Nausea Free
Nausea free at two hours after patch activation.
Time frame: 2 hours
Population: 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 | Measure | Value (NUMBER) |
|---|---|---|
| NP101 | Nausea Free | 143 participants |
Secondary
Pain Relief
Headache pain relief (no pain or mild headache pain) at two hours post activation of NP101.
Time frame: 2 hours
Population: 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 | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| NP101 | Pain Relief | 105 participants | 0.341 |
Secondary
Phonophobia Free
Phonophobia free at two hours after patch activation.
Time frame: 2 hours
Population: 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 | Measure | Value (NUMBER) |
|---|---|---|
| NP101 | Phonophobia Free | 109 participants |
Secondary
Photophobia Free
Photophobia free at two hours after patch activation.
Time frame: 2 hours
Population: 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 | Measure | Value (NUMBER) |
|---|---|---|
| NP101 | Photophobia Free | 97 participant |