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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.
 
ClinicalTrials.gov Identifier: NCT02684409
Recruitment Status : Completed
First Posted : February 18, 2016
Last Update Posted : February 18, 2016
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( NuPathe Inc. )

Tracking Information
First Submitted Date  ICMJE February 2, 2016
First Posted Date  ICMJE February 18, 2016
Last Update Posted Date February 18, 2016
Study Start Date  ICMJE August 2013
Actual Primary Completion Date November 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 16, 2016)
  • 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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety, Pharmacokinetic, and Tolerability Study of Zecuity® in Adolescent Subjects With a History of Acute Migraine
Official Title  ICMJE A Phase 1, Open Label, Single-Dose Safety, Pharmacokinetic, and Tolerability Study of Zecuity® in Adolescent Subjects With a History of Acute Migraine
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Acute Migraine
Intervention  ICMJE Drug: PROT-CL-NP101-015.01
Other Names:
  • Zecuity®
  • Sumatriptan
Study Arms  ICMJE Experimental: PROT-CL-NP101-015.01
Intervention: Drug: PROT-CL-NP101-015.01
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 16, 2016)
37
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2014
Actual Primary Completion Date November 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02684409
Other Study ID Numbers  ICMJE PROT-CL-NP101-015.01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Teva Pharmaceutical Industries ( NuPathe Inc. )
Study Sponsor  ICMJE NuPathe Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Teva Medical Expert, MD Teva Pharmaceuticals USA
PRS Account Teva Pharmaceutical Industries
Verification Date February 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP