Migraine DisordersPhase 3NP101-009NCT00806546
An Open-Label Study to Evaluate the Safety of NP101 in the Treatment of Acute Migraine Over Twelve Months
A Phase 3 study testing NP101 in people with Migraine Disorders, run by NuPathe Inc. at 31 sites in United States.
Trial summary
This study will use an open-label design to evaluate the safety of NP101. Adult subjects who meet the enrollment criteria will be treated with NP101 (sumatriptan succinate iontophoretic transdermal patch) for acute migraine attacks over a 12 month period. 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
- 514 participants
- Where
- 31 sitesUnited States
- Study dates
- Feb 2009to May 2011
- 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 is an adult male or female, age range 18 years to 65 years.
- Subject has a diagnosis of migraine headache, with or without aura, as defined in the ICHD-II and the diagnosis was made before the age of 50.
- Subject experiences mild to severe headaches during a migraine attack based on subject testimony.
- Subject has at least a one year history of migraine based upon subject testimony.
- Subject typically experiences at least two migraine headaches per month based on subject testimony.
- Subject will be judged to be in good health, based upon the results of a medical history, physical examination, vital signs, ECG and laboratory profile. Subjects will not have any clinically significant abnormal laboratory parameters, vital signs or ECG parameters in order to qualify for enrollment.
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- Female subject of childbearing potential (not surgically sterile or 2 years postmenopausal) must have a negative pregnancy test at screening and prior to enrollment.
- Subject must have a negative drug screen.
- Subject must be capable of reading and understanding either English or Spanish subject information materials. Be able to successfully apply a practice patch, carry-out all subject procedures, and be able to voluntarily sign and date an IC agreement approved by an IRB.
- Subject has at least two acceptable patch application sites (upper arms or upper thighs) that are relatively hair free and has no scars, tattoos, scratches or bruises.
- In the investigator's opinion the subject is on a stable medication regimen.
Who cannot join
- Subject has more than 15 headache days per month for any of the three months prior to screening.
- Subject has suspected or confirmed cardiovascular disease that contraindicates study participation.
- Subject has a history of epilepsy or condition associated with a lowered seizure threshold.
- Subject has Raynaud's disease.
- Subject has a history of basilar or hemiplegic migraines.
- Subject has a history (within 1 year) or current evidence of drug or alcohol abuse or dependence.
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- Subject has taken non-triptan serotonergic drugs including SSRIs (including Wellbutrin), SNRIs, TCAs, MAOIs or preparations containing St. John's Wort within 1 month prior to screening and/or is planning to start any of these medications during the study.
- Subject is unwilling to discontinue use of a PD5 inhibitor (e.g. Viagra®, Levitra®, or Cialis®) through the Final Visit.
- Subject has a history of a significant allergy or hypersensitivity to any component of the study patch used in this study.
- Subject has any generalized skin irritation or disease including eczema, psoriasis, melanoma, or contact dermatitis that would affect transdermal absorption of sumatriptan and / or affect the subjects ability to assess skin irritation.
- Subject has clinically significant abnormal laboratory parameters, vital signs or ECG parameters.
- Subject is known to be hepatitis B, hepatitis C or HIV positive.
- Subject has a diagnosis of bipolar disorder or current major depressive disorder, or has any other medical or psychiatric condition, that in the investigator's opinion would make the subject unsuitable for enrollment / participation in the study.
- Subject has hepatic dysfunction defined as SGOT/AST or SGPT/ALT ≥ 2 times the upper limit of normal (ULN) range, or alkaline phosphatase or total bilirubin ≥ 1.5 times the ULN range or if in the opinion of the Investigator the subject's history, physical examination or other laboratory tests suggest hepatic dysfunction.
- Female subject who is pregnant, breast feeding, or if of childbearing potential, is not using or is unwilling to use an effective form of contraception during the study and for a period of 30 days following dosing.
- Subject has known history of failure to respond to sumatriptan (ineffective or poorly tolerated).
- Subject has participated in a clinical study within 30 days of screening or is planning to participate in another clinical study.
- Subject has been previously enrolled in NP101-008.
- Subject is electrically sensitive (e.g., prior iontophoresis with adverse outcome related to the current delivered by the device) or who have electrically sensitive support systems (e.g., pacemaker) or other medical condition that in the investigator's opinion would make the subject unsuitable for enrollment in the study.
- Subject who is considered by investigator or NuPathe, for any reason, to be an unsuitable candidate for this study.
Trial locations and contacts
31 sites in 1 country.
31 sites in 1 country
United States31 sites
Study site
Alexandria, Virginia
Study site
Ann Arbor, Michigan
Study site
Atlanta, Georgia
Study site
Cincinnati, Ohio
Study site
Clarksville, Tennessee
Study site
Cleveland, Ohio
Study site
Crestview Hills, Kentucky
Study site
Dallas, Texas
Study site
Decatur, Georgia
Study site
Fairfield, Connecticut
Study site
Greensboro, North Carolina
Study site
Hallandale, Florida
Study site
Irvine, California
Study site
Mount Vernon, New York
Study site
Newport Beach, California
Study site
Ocala, Florida
Study site
Oklahoma City, Oklahoma
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
Scottsdale, Arizona
Study site
Seattle, Washington
Study site
St Louis, Missouri
Study site
Sunrise, Florida
Study site
Virginia Beach, Virginia
Study site
Walnut Creek, California
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
This study will use an open-label design to evaluate the safety of NP101. Adult subjects who meet the enrollment criteria will be treated with NP101 (sumatriptan succinate iontophoretic transdermal patch) for acute migraine attacks over a 12 month period.
- 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 four 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 application
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2008 (estimated)
- Study startFeb 2009
- Primary completionMay 2011
- Study completionMay 2011
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.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 514 participants (actual)
Sponsor and investigators
- Lead sponsor
- NuPathe Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mark Pierce, M.D., PhD., Study director, NuPathe Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00806546
- Sponsor's protocol ID
- PROT-15-NP101-009
- Acronym
- NP101-009
- Status last verified
- Feb 2016
- First submitted
- 10 Dec 2008
- Last updated
- 4 Feb 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
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
- NCT00806546
- Acronym / sponsor ID
- NP101-009 / PROT-15-NP101-009
- Conditions
- Migraine Disorders
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 514 participants (actual)
- Lead sponsor
- NuPathe Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2009
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 11 Dec 2008 (estimated)
- Results
- Posted 20 Mar 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will use an open-label design to evaluate the safety of NP101. Adult subjects who meet the enrollment criteria will be treated with NP101 (sumatriptan succinate iontophoretic transdermal patch) for acute migraine attacks over a 12 month period.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- 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 (11 listed)
- Subject is an adult male or female, age range 18 years to 65 years.
- Subject has a diagnosis of migraine headache, with or without aura, as defined in the ICHD-II and the diagnosis was made before the age of 50.
- Subject experiences mild to severe headaches during a migraine attack based on subject testimony.
- Subject has at least a one year history of migraine based upon subject testimony.
- Subject typically experiences at least two migraine headaches per month based on subject testimony.
Key exclusion criteria (20 listed)
- Subject has more than 15 headache days per month for any of the three months prior to screening.
- Subject has suspected or confirmed cardiovascular disease that contraindicates study participation.
- Subject has a history of epilepsy or condition associated with a lowered seizure threshold.
- Subject has Raynaud's disease.
- Subject has a history of basilar or hemiplegic migraines.
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 four hour application | Drug | NP101 |
Primary outcome
Subject Self-examination of Skin Irritation
Time frame: 24 hours post patch application
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).
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.
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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, M.D., PhD. study director
NuPathe Inc.
31 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 31 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 11 inclusion and 20 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 31 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 20 Mar 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 application). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.