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

NCT ID: NCT00724815

Last Updated: 2016-02-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 530 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2009-07-31

Brief Summary

This study was a randomized, parallel group, double-blind, placebo controlled design to compare the efficacy and tolerability of NP101 to a placebo iontophoretic transdermal patch. The primary objective of this study was to assess the proportion of subjects who were headache pain free at two hours after patch activation.

Key secondary objectives included:

1. The proportion of subjects who were nausea free at two hours after patch activation.

2. The proportion of subjects who were photophobia free at two hours after patch activation.

3. The proportion of subjects who were phonophobia free at two hours after patch activation.

Detailed Description

Subjects stayed in the study until they had treated one migraine headache with a study patch or two months after randomization, whichever occurred first. During a migraine headache, subjects rated their baseline headache pain severity in a Migraine Study Diary using a 4-point scale (0 = none, 1 = mild, 2 = moderate, 3 = severe) and applied the study patch only if their score was 2 or 3 (i.e., qualifying migraine headache). In addition to headache pain severity, subjects also recorded the presence or absence of aura, nausea, phonophobia, and photophobia, as well as the location of their headache (unilateral or bilateral) and whether their headache increased with movement.

Conditions

Migraine Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Sumatriptan

NP101 - sumatriptan iontophoretic transdermal patch

Group Type: EXPERIMENTAL

NP101 - Sumatriptan iontophoretic transdermal patch

Intervention Type: DRUG

Sumatriptan iontophoretic transdermal patch

Placebo

Placebo iontophoretic transdermal patch

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

NP101 Placebo iontophoretic transdermal patch

Interventions

NP101 - Sumatriptan iontophoretic transdermal patch

Sumatriptan iontophoretic transdermal patch

Intervention Type: DRUG

Placebo

NP101 Placebo iontophoretic transdermal patch

Intervention Type: DRUG

Other Intervention Names

Sumatriptan; NP101 Placebo

Eligibility 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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NuPathe Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mark Pierce, MD

Role: STUDY_DIRECTOR

NuPathe Inc.

Locations

Phoenix, Arizona, United States

Little Rock, Arkansas, United States

Newport Beach, California, United States

San Francisco, California, United States

Santa Monica, California, United States

Fairfield, Connecticut, United States

Ocala, Florida, United States

Palm Beach Gardens, Florida, United States

Sunrise, Florida, United States

Atlanta, Georgia, United States

Columbus, Georgia, United States

Decatur, Georgia, United States

Savannah, Georgia, United States

Chicago, Illinois, United States

Ann Arbor, Michigan, United States

Kalamazoo, Michigan, United States

Springfield, Missouri, United States

St Louis, Missouri, United States

Mount Vernon, New York, United States

Plainview, New York, United States

Greensboro, North Carolina, United States

West Chester, Ohio, United States

Oklahoma City, Oklahoma, United States

Philadelphia, Pennsylvania, United States

Pittsburgh, Pennsylvania, United States

Wynnewood, Pennsylvania, United States

Memphis, Tennessee, United States

Nashville, Tennessee, United States

Dallas, Texas, United States

Houston, Texas, United States

San Antonio, Texas, United States

Alexandria, Virginia, United States

Virginia Beach, Virginia, United States

Seattle, Washington, United States

Countries

United States

References

Goldstein J, Smith TR, Pugach N, Griesser J, Sebree T, Pierce M. A sumatriptan iontophoretic transdermal system for the acute treatment of migraine. Headache. 2012 Oct;52(9):1402-10. doi: 10.1111/j.1526-4610.2012.02198.x. Epub 2012 Jun 13.

Reference Type: DERIVED

PMID: 22694484 (View on PubMed)

Other Identifiers

PROT-15-NP101-007

Identifier Type: -

Identifier Source: org_study_id