Acute MigrainePhase 1NCT02684409
Safety, Pharmacokinetic, and Tolerability Study of Zecuity® in Adolescent Subjects With a History of Acute Migraine
A Phase 1 study testing PROT-CL-NP101-015.01 in people with Acute Migraine, run by NuPathe Inc..
Trial summary
This will be a Phase 1, multiple center, open label, single-dose study in otherwise healthy adolescent subjects with a history of acute migraine. Subjects will each receive one Zecuity patch application. Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Acute Migraine
- What is being tested?
- PROT-CL-NP101-015.01
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- No sites listed yet
- Study dates
- Aug 2013to Nov 2014
- 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 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Subject has a diagnosis of migraine headache, with or without aura
- Subject and subject's parent or legal guardian are able to read and write English
- Subject must have a negative drug screen.
- Female subjects are eligible for participation provided they are of non-child bearing potential or if started menses; they are on a stable regimen of acceptable contraception
- Subject has one acceptable patch application site (left or right upper arm or thigh) that is relatively hair free and has no scars, tattoos, or abrasions
- Subject must have a body mass index of between the 5th and 84th percentile for age and sex
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- Subject must be nonsmokers
- Subject must have not consumed alcoholic beverages, poppy seeds, grapefruit, and/or grapefruit juice within 72 hours prior to admission to the clinic
- Additional criteria apply, please contact the investigator for more information
Who cannot join
- Subject has suspected or confirmed cardiovascular disease
- Subject has a history of epilepsy or conditions associated with a lowered seizure threshold
- Subject with Raynaud's disease
- Subject has a history of basilar or hemiplegic migraines
- Subject has a current diagnosis of a major depressive disorder
- Subject has taken non-triptan serotonergic drugs including selective serotonin reuptake inhibitors(SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs, including Wellbutrin), tricyclic antidepressants (TCAs), monoamine oxidase inhibitors (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 and through the End of Study visit
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- Subject with a history of a significant allergy or hypersensitivity to any component of the study patch used in this study
- Subject who has any generalized skin irritation or disease including eczema, psoriasis, melanoma, acne or contact dermatitis
- Subject is positive for hepatitis B, hepatitis C or human immunodeficiency virus (HIV)
- Female subjects who are pregnant, breast feeding, or if of childbearing potential, is not using or is unwilling to use an effective form of contraception
- Subject has known history of tolerability issues with sumatriptan
- 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 within 30 days of last study visit
- Subject is electrically sensitive (e.g., prior iontophoresis with adverse outcome related to the current delivered by the device).
- Additional criteria apply, please contact the investigator for more information
About this study
Official title: A Phase 1, Open Label, Single-Dose Safety, Pharmacokinetic, and Tolerability Study of Zecuity® in Adolescent Subjects With a History of Acute Migraine
This will be a Phase 1, multiple center, open label, single-dose study in otherwise healthy adolescent subjects with a history of acute migraine. Subjects will each receive one Zecuity patch application. Subjects will be admitted 2 hours prior to dosing on Day 1, and will remain in the clinical unit under supervision until the last pharmacokinetic (PK) sample is obtained. Blood will be obtained at prescribed times for PK analysis and safety assessments will be performed, including adverse event monitoring, 12-lead ECG test, patch adhesion evaluations, skin irritation evaluations, and vital signs.
- Conditions
- Acute Migraine
- Being tested
- PROT-CL-NP101-015.01
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PROT-CL-NP101-015.01Drug
Also called Zecuity®, Sumatriptan
| Study group | Role | What they receive |
|---|---|---|
| PROT-CL-NP101-015.01 | Experimental | Not described Receives: Drug: PROT-CL-NP101-015.01 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety- Percentage of Participants with Adverse Events
Measured: 30 days
Patch Adherence Evaluation
Adhesive Scoring Code- 0 (≥ 90% adhered (essentially no lift off of the skin)) through 4 (patch detached (patch completely off the skin))
Measured: 4 hours
Skin Irritation Examination
Skin Irritation Examination Scale- 0 (no erythema) through 4 (Intense erythema with edema and blistering/erosion)
Measured: 10 days
Area under the concentration versus time curve from time 0 to the last time point with measurable concentration (Ct) (AUC0-last)
Measured: 1 day
Area under the concentration versus time curve from time 0 to infinity (AUC0-∞); calculated as AUC0-last + Ct/λz2.
Measured: 1 day
Maximum observed drug concentration (Cmax)
Measured: 1 day
Time of maximum drug concentration (Tmax)
Measured: 1 day
The terminal elimination rate constant (λz); calculated using non-linear regression Analysis
Measured: 1 day
Terminal elimination half-life (t1/2); calculated as 0.693/λz2
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2016 (estimated)
- Study startAug 2013
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute MigraineStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- NuPathe Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Teva Medical Expert, MD, Study director, Teva Pharmaceuticals USA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02684409
- Sponsor's protocol ID
- PROT-CL-NP101-015.01
- Status last verified
- Feb 2016
- First submitted
- 2 Feb 2016
- Last updated
- 18 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open Label, Single-Dose Safety, Pharmacokinetic, and Tolerability Study of Zecuity® in Adolescent Subjects With a History of Acute Migraine
- ClinicalTrials.gov ID
- NCT02684409
- Acronym / sponsor ID
- PROT-CL-NP101-015.01
- Conditions
- Acute Migraine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- NuPathe Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2013
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 18 Feb 2016 (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.
This will be a Phase 1, multiple center, open label, single-dose study in otherwise healthy adolescent subjects with a history of acute migraine. Subjects will each receive one Zecuity patch application. Subjects will be admitted 2 hours prior to dosing on Day 1, and will remain in the clinical unit under supervision until the last pharmacokinetic (PK) sample is obtained. Blood will be obtained at prescribed times for PK analysis and safety assessments will be performed, including adverse event monitoring, 12-lead ECG test, patch adhesion evaluations, skin irritation evaluations, and vital signs.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PROT-CL-NP101-015.01 | Experimental | Drug: PROT-CL-NP101-015.01 |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- Subject has a diagnosis of migraine headache, with or without aura
- Subject and subject's parent or legal guardian are able to read and write English
- Subject must have a negative drug screen.
- Female subjects are eligible for participation provided they are of non-child bearing potential or if started menses; they are on a stable regimen of acceptable contraception
- Subject has one acceptable patch application site (left or right upper arm or thigh) that is relatively hair free and has no scars, tattoos, or abrasions
Key exclusion criteria (15 listed)
- Subject has suspected or confirmed cardiovascular disease
- Subject has a history of epilepsy or conditions associated with a lowered seizure threshold
- Subject with Raynaud's disease
- Subject has a history of basilar or hemiplegic migraines
- Subject has a current diagnosis of a major depressive disorder
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 |
|---|---|---|
| PROT-CL-NP101-015.01Also: Zecuity®, Sumatriptan | Drug | PROT-CL-NP101-015.01 |
Primary outcome
Safety- Percentage of Participants with Adverse Events
Time frame: 30 days
Patch Adherence Evaluation
Time frame: 4 hours
Adhesive Scoring Code- 0 (≥ 90% adhered (essentially no lift off of the skin)) through 4 (patch detached (patch completely off the skin))
Skin Irritation Examination
Time frame: 10 days
Skin Irritation Examination Scale- 0 (no erythema) through 4 (Intense erythema with edema and blistering/erosion)
Area under the concentration versus time curve from time 0 to the last time point with measurable concentration (Ct) (AUC0-last)
Time frame: 1 day
Area under the concentration versus time curve from time 0 to infinity (AUC0-∞); calculated as AUC0-last + Ct/λz2.
Time frame: 1 day
Maximum observed drug concentration (Cmax)
Time frame: 1 day
Time of maximum drug concentration (Tmax)
Time frame: 1 day
The terminal elimination rate constant (λz); calculated using non-linear regression Analysis
Time frame: 1 day
Terminal elimination half-life (t1/2); calculated as 0.693/λz2
Time frame: 1 day
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 18 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.
Teva Medical Expert, MD study director
Teva Pharmaceuticals USA
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PROT-CL-NP101-015.01 in people with Acute Migraine, run by NuPathe Inc..
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 9 inclusion and 15 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 18 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Safety- Percentage of Participants with Adverse Events (time frame: 30 days). The study lists 9 primary outcomes in all. 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 18 Feb 2016.