The Efficacy and Tolerability of NP101 Patch in the Treatment of Acute Migraine

Condition(s) targeted: Migraine Disorders

Intervention: NP101 (Drug); NP101 placebo (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: NuPathe Inc.

Official(s) and/or principal investigator(s):
Angel S Angelov, MD, Study Director, Affiliation: NuPathe Inc.

Overall contact:
Donna Kolbush-Jackson, RN, BS, Phone: 866-876-2220, Email: dkjackson@nupathe.com

This study will use a randomized, parallel group, double-blind, placebo controlled design to compare the efficacy and tolerability of NP101 to a placebo iontophoretic transdermal patch. Adult subjects who meet the enrollment criteria will be randomized in a 1: 1 ratio and

stratified by race into one of two treatment groups: NP101 - sumatriptan iontophoretic

transdermal patch or placebo iontophoretic transdermal patch.

Official title: The Efficacy and Tolerability of NP101, a Sumatriptan Iontophoretic Transdermal Patch, in the Treatment of Acute Migraine: A Randomized, Double-Blind, Placebo-Controlled Study

Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Efficacy Study

Primary outcome: The primary objective of this study is to assess four individual endpoints which are to include the proportion of subjects who are headache pain free, nausea free, photophobia free and phonophobia free at two hours after patch activation.

Secondary outcome: To assess the proportion of subjects who are free from headache pain, nausea, photophobia, phonophobia, migraine, sustained headache, pain free response and do not use rescue medication at different time points.

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Subject is an adult male or female, age range 18 years to 65 years.

- Subject has a diagnosis of migraine headache, with or without aura, as defined in the

ICDH-II and the diagnosis was made before the age of 50.

- Subject typically experiences moderate to severe headaches during a migraine attack.

- Subject has at least a one year history of migraine.

- Subject will be judged to be in good health, based on results of a medical history,

physical examination, vital signs, ECG and laboratory profile.

- Female subject of childbearing potential must have a negative pregnancy test at

screening and prior to randomization.

- Subject must have a negative drug screen.

- Subject must be capable of reading and understanding either English or Spanish subject

information materials. Be able to successfully apply a practice patch, carry-out all subject procedures, and be able to voluntarily sign and date an IRB approved IC agreement.

- Subject has an acceptable patch application site (upper arm) that is relatively hair

free and has no scars, tattoos, scratches, or bruises.

Exclusion Criteria:

- Subject has or plans to start, stop, or change treatment or dose with prophylactic

anti-migraine treatment within 3 months prior to the subjects' study randomization date and through the final visit.

- Subject has or plans to start, stop, or change treatment or dose of any of the

following within 3 months prior to the subjects' study randomization date through final visit: anxiolytics, lithium and other mood stabilizers, hypnotics or antipsychotics.

- Subject had less than one migraine per month or more than six migraines per month, or

more than 15 headache days per month for any of the three months prior to randomization.

- Subject has suspected or confirmed cardiovascular disease that contraindicates study

participation.

- Subject has a history of epilepsy or conditions associated with a lowered seizure

threshold.

- Subject has Raynaud's disease.

- Subject has a history of basilar or hemiplegic migraines.

- Subject has a current diagnosis of a major depressive disorder per the DSM IV R.

- Subject has a history (within 1 year) or current evidence of drug or alcohol abuse or

dependence.

- Subject is unwilling to discontinue use of serotonin agonists (triptans), except for

the study patch, through the Final Visit.

- Subject has taken SSRI's, SNRI's, TCA's, MAOI's 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.

- Subject is unwilling to discontinue use of a PD-5 inhibitors through the Final Visit.

- Subject has taken ergot medications within 7 days prior to Randomization and/or is

unwilling to discontinue use through the Final Visit.

- Subject has a history of a significant allergy or hypersensitivity to any component of

the study patch.

- Subject has any generalized skin irritation or disease including eczema, psoriasis,

melanoma, or contact dermatitis.

- Subject has clinically significant abnormal laboratory parameters, vital signs or ECG

parameters.

- Subject is known to be hepatitis B, hepatitis C or HIV positive.

- Subject has hepatic dysfunction based on laboratory results or if in the opinion of

the Investigator the subject's history, physical examination or other laboratory tests suggest hepatic dysfunction.

- Female subject who is pregnant, breast feeding, or if of childbearing potential, is

not using or is unwilling to use an effective form of contraception during the study and for a period of 30 days following dosing.

- Subject has known history of failure to respond to sumatriptan.

- Subject has participated in a clinical study within 30 days of screening or is

planning to participate in another clinical study.

- Subject has been previously enrolled in NP101-007

- Subject is electrically sensitive or who have electrically sensitive support systems

(e. g., pacemaker).

Donna Kolbush-Jackson, RN, BS, Phone: 866-876-2220, Email: dkjackson@nupathe.com

Phoenix, Arizona, United States; Recruiting

Little Rock, Arkansas, United States; Recruiting

San Francisco, California, United States; Recruiting

Santa Monica, California, United States; Recruiting

Newport Beach, California, United States; Recruiting

Fairfield, Connecticut, United States; Recruiting

Sunrise, Florida, United States; Recruiting

Palm Beach Gardens, Florida, United States; Recruiting

Atlanta, Georgia, United States; Recruiting

Decatur, Georgia, United States; Recruiting

Savannah, Georgia, United States; Recruiting

Columbus, Georgia, United States; Recruiting

Chicago, Illinois, United States; Recruiting

Worcester, Massachusetts, United States; Recruiting

Kalamazoo, Michigan, United States; Recruiting

Ann Arbor, Michigan, United States; Recruiting

Springfield, Missouri, United States; Recruiting

St. Louis, Missouri, United States; Recruiting

Mount Vernon, New York, United States; Recruiting

Plainview, New York, United States; Recruiting

Greensboro, North Carolina, United States; Recruiting

West Chester, Ohio, United States; Recruiting

Oklahoma City, Oklahoma, United States; Not yet recruiting

Pittsburgh, Pennsylvania, United States; Not yet recruiting

Pittsburgh, Pennsylvania, United States; Recruiting

Wynnewood, Pennsylvania, United States; Recruiting

Philadelphia, Pennsylvania, United States; Recruiting

Nashville, Tennessee, United States; Recruiting

Memphis, Tennessee, United States; Recruiting

Dallas, Texas, United States; Recruiting

Houston, Texas, United States; Recruiting

San Antonio, Texas, United States; Recruiting

Alexandria, Virginia, United States; Recruiting

Virginia Beach, Virginia, United States; Recruiting

Seattle, Washington, United States; Recruiting

Starting date: July 2008
Ending date: August 2009
Last updated: January 29, 2009