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Safety, Pharmacokinetic, and Tolerability Study of Zecuity® in Adolescent Subjects With a History of Acute Migraine

Primary Purpose

Acute Migraine

Status

Completed

Phase

Phase 1

Locations

Study Type

Interventional

Intervention

PROT-CL-NP101-015.01

About this trial

This is an interventional treatment trial for Acute Migraine

Eligibility Criteria

12 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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
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

Exclusion Criteria:

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
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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

PROT-CL-NP101-015.01

Arm Description

Outcomes

Primary Outcome Measures

Safety- Percentage of Participants with Adverse Events

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))

Skin Irritation Examination

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)

Area under the concentration versus time curve from time 0 to infinity (AUC0-∞); calculated as AUC0-last + Ct/λz2.

Maximum observed drug concentration (Cmax)

Time of maximum drug concentration (Tmax)

The terminal elimination rate constant (λz); calculated using non-linear regression Analysis

Terminal elimination half-life (t1/2); calculated as 0.693/λz2

Secondary Outcome Measures

Full Information

NCT ID

NCT02684409

First Posted

February 2, 2016

Last Updated

February 16, 2016

Sponsor

NuPathe Inc.

1. Study Identification

Unique Protocol Identification Number

NCT02684409

Brief Title

Safety, Pharmacokinetic, and Tolerability Study of Zecuity® in Adolescent Subjects With a History of Acute Migraine

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2016

Overall Recruitment Status

Completed

Study Start Date

August 2013 (undefined)

Primary Completion Date

November 2014 (Actual)

Study Completion Date

November 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

NuPathe Inc.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Migraine

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

37 (Actual)

8. Arms, Groups, and Interventions

Arm Title

PROT-CL-NP101-015.01

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

PROT-CL-NP101-015.01

Other Intervention Name(s)

Zecuity®, Sumatriptan

Primary Outcome Measure Information:

Title

Safety- Percentage of Participants with Adverse Events

Time Frame

30 days

Title

Patch Adherence Evaluation

Description

Adhesive Scoring Code- 0 (≥ 90% adhered (essentially no lift off of the skin)) through 4 (patch detached (patch completely off the skin))

Time Frame

4 hours

Title

Skin Irritation Examination

Description

Skin Irritation Examination Scale- 0 (no erythema) through 4 (Intense erythema with edema and blistering/erosion)

Time Frame

10 days

Title

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

Title

Area under the concentration versus time curve from time 0 to infinity (AUC0-∞); calculated as AUC0-last + Ct/λz2.

Time Frame

1 day

Title

Maximum observed drug concentration (Cmax)

Time Frame

1 day

Title

Time of maximum drug concentration (Tmax)

Time Frame

1 day

Title

The terminal elimination rate constant (λz); calculated using non-linear regression Analysis

Time Frame

1 day

Title

Terminal elimination half-life (t1/2); calculated as 0.693/λz2

Time Frame

1 day

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Maximum Age & Unit of Time

17 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 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 Exclusion Criteria: 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 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Teva Medical Expert, MD

Organizational Affiliation

Teva Pharmaceuticals USA

Official's Role

Study Director

12. IPD Sharing Statement

Learn more about this trial

Safety, Pharmacokinetic, and Tolerability Study of Zecuity® in Adolescent Subjects With a History of Acute Migraine

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