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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02684409
Recruitment Status : Completed
First Posted : February 18, 2016
Last Update Posted : February 18, 2016
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( NuPathe Inc. )

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.

Condition or disease Intervention/treatment Phase
Acute Migraine Drug: PROT-CL-NP101-015.01 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : August 2013
Actual Primary Completion Date : November 2014
Actual Study Completion Date : November 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Migraine

Arm Intervention/treatment
Experimental: PROT-CL-NP101-015.01 Drug: PROT-CL-NP101-015.01
Other Names:
  • Zecuity®
  • Sumatriptan

Primary Outcome Measures :
  1. Safety- Percentage of Participants with Adverse Events [ Time Frame: 30 days ]
  2. 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))

  3. Skin Irritation Examination [ Time Frame: 10 days ]
    Skin Irritation Examination Scale- 0 (no erythema) through 4 (Intense erythema with edema and blistering/erosion)

  4. 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 ]
  5. Area under the concentration versus time curve from time 0 to infinity (AUC0-∞); calculated as AUC0-last + Ct/λz2. [ Time Frame: 1 day ]
  6. Maximum observed drug concentration (Cmax) [ Time Frame: 1 day ]
  7. Time of maximum drug concentration (Tmax) [ Time Frame: 1 day ]
  8. The terminal elimination rate constant (λz); calculated using non-linear regression Analysis [ Time Frame: 1 day ]
  9. Terminal elimination half-life (t1/2); calculated as 0.693/λz2 [ Time Frame: 1 day ]

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02684409

Sponsors and Collaborators
NuPathe Inc.
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Study Director: Teva Medical Expert, MD Teva Pharmaceuticals USA

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Responsible Party: NuPathe Inc. Identifier: NCT02684409    
Other Study ID Numbers: PROT-CL-NP101-015.01
First Posted: February 18, 2016    Key Record Dates
Last Update Posted: February 18, 2016
Last Verified: February 2016
Additional relevant MeSH terms:
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Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vasoconstrictor Agents
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs