Migraine DisordersPhase 1NP101-011NCT00723983
Phase I, Open Label, Single-Dose, Four Way Crossover Study to Compare the PK of NP101 With Oral Imitrex® (50mg) in Migraine Subjects During an Acute Migraine Attack and During a Non-Migraine Period
A Phase 1 study testing Sumatriptan succinate and NP101 Study Patch in people with Migraine Disorders, run by NuPathe Inc. at 1 site in United States.
Trial summary
To compare the pharmacokinetics of NP101 with a currently approved oral formulation of Imitrex® (50 mg) in migraine subjects both during an acute migraine attack and during a non-migraine 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?
- Sumatriptan succinate and NP101 Study Patch
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2008to Sep 2009
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Adult male and female subjects, between the ages of 18 to 65 years.
- Subjects with 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.
- The majority of a subject's headaches during a migraine attack are moderate to severe in intensity.
- Subject has history of regularly occuring migraines, accompanied by nausea or vomiting.
- Subject has at least one year history of migraine based upon 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.
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- Subjects must voluntarily sign and date and Informed Consent agreement approved by an IRB.
- Subject must have a negative drug screen and re-screen.
- Female subjects of childbearing potential must have a negative pregnancy test at Screening and Re-Screening.
- Subject has two acceptable patch application sites.
Who cannot join
- Subject has or plans to start stop, or change treatment (including dose change) of any medication within one month prior to the subject screening date and through the end of study.
- Subject has less than 2 migraines per month or subject has more than 15 headache days/month for any of the 3 months prior ot screening.
- Subject who has suspected or confirmed cardiovascular disease that contraindicates study participation.
- Subject has history of epilepsy or conditions associated with lower seizure threshold.
- Subject with Raynaud's disease.
- Subject with hemiplegic or basilar migraine.
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- Subject with a current diagnosis of major depressive disorder.
- Subject who has taken non-triptan serotonergic drugs including SSRI's, SNRI, TCAs or MAOI's or preparations containing St. John's Wort within month prior to screening and/or is planning to start any of these medications during the study and through the End of Study Visit.
- Subject is unwilling to discontinue use of PD5 inhibitors (eg. Viagra, Levitra, Cialis) from screening through End of Study Visit.
- Subject with a history of significant allergy or hypersensitivity to any component of the NP101 study patch.
- Subject who has any generalized skin irritation or disease including eczema, psoriasis, melanoma, acne or contact dermatitis.
- Subject has a positive test result for hepatitis B, hepatitis C or is known to be HIV positive.
- Subjects with moderate or severe hepatic dysfunction defined as SGOT/AST or SGPT/ALT ≥ 2 times the upper limit of normal range, or alkaline phosphatase or total bilirubin ≥ 1.5 times the upper limit of normal range or if in the opinion of the investigator, the subject's history, physical examination or other laboratory tests suggest hepatic dysfunction.
- Female subjects who are pregnant, breast feeding, or if not 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 final dosing.
- Subjects with a known history of tolerability issues with sumatriptan.
- Subject who is considered by the investigator or NuPathe to be an unsuitable candidate for this study.
- Subject has a history (within 1 year) or current evidence of drug or alcohol abuse or dependence.
- Subject has participated in a clinical study within 30 days of Screening or is planning to participate in another clinical study.
- Subject has clinically significant abnormal labs, vital signs or ECG
- Subject is electrically sensitive or who has an implantable electronic device.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Open Label, Single-Dose, Four-Way Crossover Study Comparing the Pharmacokinetics of NP101 (Sumatriptan Iontophoretic Transdermal Patch) With an Oral Formulation of Imitrex® (50mg) in Migraine Subjects During an Acute Migraine Attack and During a Non-Migraine Period
To compare the pharmacokinetics of NP101 with a currently approved oral formulation of Imitrex® (50 mg) in migraine subjects both during an acute migraine attack and during a non-migraine period.
- Conditions
- Migraine Disorders
- Being tested
- Sumatriptan succinate, NP101 Study Patch
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sumatriptan succinateDrug
Sumatriptan succinate 50 mg taken orally
NP101 Study PatchDrug
NP101 study patch 4 hour application
| Study group | Role | What they receive |
|---|---|---|
| Period 1 | Active comparator | Subject dosed with oral sumatriptan succinate during an acute migraine attack. Receives: Drug: Sumatriptan succinate |
| Period 2 | Active comparator | Subject dosed with oral sumatriptan during a non-migraine period. Receives: Drug: Sumatriptan succinate |
| Period 3 and Period 6 | Experimental | Subject dosed with NP101 during an acute migraine attack. Receives: Drug: NP101 Study Patch |
| Period 4 and Period 5 | Experimental | Subject dosed with NP101 study patch during a non-migraine period. Receives: Drug: NP101 Study Patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare the pharmacokinetics of NP101 with a currently approved formulation of Imitrex in migraine subjects during an acute migraine attack and during a non-migraine period.
Measured: PK samples at pre and 0.25, 0.5, 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 10, 12 and 24 hours post each dose/period for Periods 1, 2, 3, and 4 [24 hour PK will not be done for Periods 5 and 6]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2008 (estimated)
- Study startNov 2008
- Primary completionSep 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- NuPathe Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kerri L Wilks, MD, CPI, Principal investigator, MD clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00723983
- Sponsor's protocol ID
- PROT-15-NP101-011
- Acronym
- NP101-011
- Status last verified
- Feb 2016
- First submitted
- 25 Jul 2008
- Last updated
- 3 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open Label, Single-Dose, Four-Way Crossover Study Comparing the Pharmacokinetics of NP101 (Sumatriptan Iontophoretic Transdermal Patch) With an Oral Formulation of Imitrex® (50mg) in Migraine Subjects During an Acute Migraine Attack and During a Non-Migraine Period
- ClinicalTrials.gov ID
- NCT00723983
- Acronym / sponsor ID
- NP101-011 / PROT-15-NP101-011
- Conditions
- Migraine Disorders
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- NuPathe Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2008
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 29 Jul 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To compare the pharmacokinetics of NP101 with a currently approved oral formulation of Imitrex® (50 mg) in migraine subjects both during an acute migraine attack and during a non-migraine period.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Period 1 | Active comparator | Drug: Sumatriptan succinateSubject dosed with oral sumatriptan succinate during an acute migraine attack. |
| Period 2 | Active comparator | Drug: Sumatriptan succinateSubject dosed with oral sumatriptan during a non-migraine period. |
| Period 3 and Period 6 | Experimental | Drug: NP101 Study PatchSubject dosed with NP101 during an acute migraine attack. |
| Period 4 and Period 5 | Experimental | Drug: NP101 Study PatchSubject dosed with NP101 study patch during a non-migraine period. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Adult male and female subjects, between the ages of 18 to 65 years.
- Subjects with 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.
- The majority of a subject's headaches during a migraine attack are moderate to severe in intensity.
- Subject has history of regularly occuring migraines, accompanied by nausea or vomiting.
- Subject has at least one year history of migraine based upon subject testimony.
Key exclusion criteria (20 listed)
- Subject has or plans to start stop, or change treatment (including dose change) of any medication within one month prior to the subject screening date and through the end of study.
- Subject has less than 2 migraines per month or subject has more than 15 headache days/month for any of the 3 months prior ot screening.
- Subject who has suspected or confirmed cardiovascular disease that contraindicates study participation.
- Subject has history of epilepsy or conditions associated with lower seizure threshold.
- Subject with Raynaud's disease.
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 |
|---|---|---|
| Sumatriptan succinateSumatriptan succinate 50 mg taken orally | Drug | Period 1, Period 2 |
| NP101 Study PatchNP101 study patch 4 hour application | Drug | Period 3 and Period 6, Period 4 and Period 5 |
Primary outcome
Compare the pharmacokinetics of NP101 with a currently approved formulation of Imitrex in migraine subjects during an acute migraine attack and during a non-migraine period.
Time frame: PK samples at pre and 0.25, 0.5, 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 10, 12 and 24 hours post each dose/period for Periods 1, 2, 3, and 4 [24 hour PK will not be done for Periods 5 and 6]
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2016.
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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.
Kerri L Wilks, MD, CPI principal investigator
MD clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Sumatriptan succinate and NP101 Study Patch in people with Migraine Disorders, run by NuPathe Inc. at 1 site 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 10 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 3 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 1 site 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Compare the pharmacokinetics of NP101 with a currently approved formulation of Imitrex in migraine subjects during an acute migraine attack and during a non-migraine period. (time frame: PK samples at pre and 0.25, 0.5, 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 10, 12 and 24 hours post each dose/period for Periods 1, 2, 3, and 4 [24 hour PK will not be done for Periods 5 and 6]). 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 3 Feb 2016.