Migraine DisordersPhase 3NP101-008NCT00792103
An Open-Label Study to Evaluate the Safety of NP101 in the Treatment of Acute Migraine Over 12 Months
A Phase 3 study testing NP101 in people with Migraine Disorders, run by NuPathe Inc. at 34 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Migraine Disorders
- What is being tested?
- NP101
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 198 participants
- Where
- 34 sitesUnited States
- Study dates
- Jan 2009to Sep 2010
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
34 sites in 1 country.
34 sites in 1 country
United States34 sites
Study site
Alexandria, Virginia
Study site
Ann Arbor, Michigan
Study site
Atlanta, Georgia
Study site
Chicago, Illinois
Study site
Columbus, Georgia
Study site
Dallas, Texas
Study site
Decatur, Georgia
Study site
Fairfield, Connecticut
Study site
Greensboro, North Carolina
Study site
Houston, Texas
Study site
Kalamazoo, Michigan
Study site
Little Rock, Arkansas
Study site
Memphis, Tennessee
Study site
Mount Vernon, New York
Study site
Nashville, Tennessee
Study site
Newport Beach, California
Study site
Ocala, Florida
Study site
Oklahoma City, Oklahoma
Study site
Palm Beach Gardens, Florida
Study site
Philadelphia, Pennsylvania
Study site
Phoenix, Arizona
Study site
Pittsburgh, Pennsylvania
Study site
Plainview, New York
Study site
San Antonio, Texas
Study site
San Francisco, California
Study site
Santa Monica, California
Study site
Savannah, Georgia
Study site
Seattle, Washington
Study site
Springfield, Missouri
Study site
St Louis, Missouri
Study site
Sunrise, Florida
Study site
Virginia Beach, Virginia
Study site
West Chester, Ohio
Study site
Wynnewood, Pennsylvania
About this study
Official title: An Open-Label Study to Evaluate the Safety of NP101, a Sumatriptan Iontophoretic Transdermal Patch, in the Treatment of Acute Migraine Over 12 Months
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
Read more
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.
- Conditions
- Migraine Disorders
- Being tested
- NP101
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NP101Drug
NP101 study patch 4 hour application
| Study group | Role | What they receive |
|---|---|---|
| NP101 | Experimental | sumatriptan iontophoretic transdermal patch Receives: Drug: NP101 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 24 hours post patch activation
Secondary outcomes (4)
Pain Relief
Headache pain relief (no pain or mild headache pain) at two hours post activation of NP101.
Measured: 2 hours
Nausea Free
Nausea free at two hours after patch activation.
Measured: 2 hours
Phonophobia Free
Phonophobia free at two hours after patch activation.
Measured: 2 hours
Photophobia Free
Photophobia free at two hours after patch activation.
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2008 (estimated)
- Study startJan 2009
- Primary completionSep 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Migraine DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 198 participants (actual)
Sponsor and investigators
- Lead sponsor
- NuPathe Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mark Pierce, MD PhD, Study chair, NuPathe Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00792103
- Sponsor's protocol ID
- PROT-15-NP101-008
- Acronym
- NP101-008
- Status last verified
- Feb 2016
- First submitted
- 14 Nov 2008
- Last updated
- 4 Feb 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Smith TR, Goldstein J, Singer R, Pugach N, Silberstein S, Pierce MW. Twelve-month tolerability and efficacy study of NP101, the sumatriptan iontophoretic transdermal system. Headache. 2012 Apr;52(4):612-24. doi: 10.1111/j.1526-4610.2012.02094.x. Epub 2012 Feb 21.
PubMed 22352764
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Study to Evaluate the Safety of NP101, a Sumatriptan Iontophoretic Transdermal Patch, in the Treatment of Acute Migraine Over 12 Months
- ClinicalTrials.gov ID
- NCT00792103
- Acronym / sponsor ID
- NP101-008 / PROT-15-NP101-008
- Conditions
- Migraine Disorders
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 198 participants (actual)
- Lead sponsor
- NuPathe Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2009
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 17 Nov 2008 (estimated)
- Results
- Posted 7 May 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NP101 | Experimental | Drug: NP101sumatriptan iontophoretic transdermal patch |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NP101NP101 study patch 4 hour application | Drug | NP101 |
Primary outcome
Subject Self-examination of Skin Irritation
Time frame: 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).
4 secondary outcomes
Pain Relief
Time frame: 2 hours
Nausea Free
Time frame: 2 hours
Phonophobia Free
Time frame: 2 hours
Photophobia Free
Time frame: 2 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 22352764Smith TR, Goldstein J, Singer R, Pugach N, Silberstein S, Pierce MW. Twelve-month tolerability and efficacy study of NP101, the sumatriptan iontophoretic transdermal system. Headache. 2012 Apr;52(4):612-24. doi: 10.1111/j.1526-4610.2012.02094.x. Epub 2012 Feb 21.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Pierce, MD PhD study chair
NuPathe Inc.
34 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing NP101 in people with Migraine Disorders, run by NuPathe Inc. at 34 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 34 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 May 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subject Self-examination of Skin Irritation (time frame: 24 hours post patch activation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00792103, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2016.