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

Acute Migraine Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02684409
• Other study ID #: PROT-CL-NP101-015.01
• Status: Completed
• Phase: Phase 1
• First received: February 2, 2016
• Last updated: February 16, 2016
• Start date: August 2013
• Est. completion date: November 2014

Study information

• Verified date: February 2016
• Source: Teva Pharmaceutical Industries
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 17 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Migraine
• Migraine Disorders

Intervention

Drug:
• PROT-CL-NP101-015.01

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
NuPathe Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety- Percentage of Participants with Adverse Events		30 days	Yes
Primary	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))	4 hours	No
Primary	Skin Irritation Examination	Skin Irritation Examination Scale- 0 (no erythema) through 4 (Intense erythema with edema and blistering/erosion)	10 days	No
Primary	Area under the concentration versus time curve from time 0 to the last time point with measurable concentration (Ct) (AUC0-last)		1 day	No
Primary	Area under the concentration versus time curve from time 0 to infinity (AUC0-8); calculated as AUC0-last + Ct/?z2.		1 day	No
Primary	Maximum observed drug concentration (Cmax)		1 day	No
Primary	Time of maximum drug concentration (Tmax)		1 day	No
Primary	The terminal elimination rate constant (?z); calculated using non-linear regression Analysis		1 day	No
Primary	Terminal elimination half-life (t1/2); calculated as 0.693/?z2		1 day	No