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

• Register: ClinicalTrials.gov
• Last refreshed on: 11 February 2013
• Main ID: NCT00724815
• Date of registration: 28/07/2008
• Primary sponsor: NuPathe Inc.
• Public title: The Efficacy and Tolerability of NP101 Patch in the Treatment of Acute Migraine NP101-007
• Scientific 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
• Date of first enrolment: July 2008
• Target sample size: 530
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00724815
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: Mark Pierce, MD
• Affiliation: NuPathe Inc.

Key inclusion & exclusion 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).



Age minimum: 18 Years
Age maximum: 65 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Migraine Disorders

Intervention(s)

Drug: NP101

Drug: NP101 placebo

Primary Outcome(s)

The primary objective of this study is to assess the proportion of subjects who are headache pain free at two hours after patch activation. [Time Frame: 2 hours after patch activation]

Secondary Outcome(s)

To assess the proportion of subjects who are free from nausea, photophobia, phonophobia at two hours after patch activation. [Time Frame: 2 hours after patch activation]

Secondary ID(s)

PROT-15-NP101-007

Source(s) of Monetary Support

Please refer to primary and secondary sponsors