The Efficacy and Tolerability of NP101 Patch in the Treatment of Acute Migraine (NP101-007)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
NuPathe Inc.
ClinicalTrials.gov Identifier:
NCT00724815
First received: July 28, 2008
Last updated: March 26, 2013
Last verified: November 2012
  Purpose

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.

Condition Intervention Phase
Migraine Disorders
Drug: NP101 - Sumatriptan iontophoretic transdermal patch
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by NuPathe Inc.:

Primary Outcome Measures:
  • Pain Free at Two Hours [ Time Frame: 2 hours post patch activation ] [ Designated as safety issue: No ]
    Subjects whose headache severity score equaled zero (0) two hours post patch activation and who had not received any rescue medication before their two-hour assessment.


Secondary Outcome Measures:
  • Photophobia Free at Two Hours [ Time Frame: 2 hours post patch activation ] [ Designated as safety issue: No ]
    Subjects who were photophobia free and who had not received any rescue medication before their two-hour assessment.

  • Phonophobia Free at Two Hours [ Time Frame: 2 hours post patch activation ] [ Designated as safety issue: No ]
    Subjects who were phonophobia free and who had not received any rescue medication before their two-hour assessment.

  • Nausea Free at Two Hours [ Time Frame: 2 hours post patch activation ] [ Designated as safety issue: No ]
    Number of subjects who were nausea free and who had not received any rescue medication before their two-hour assessment.


Enrollment: 530
Study Start Date: January 2009
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sumatriptan
NP101 - sumatriptan iontophoretic transdermal patch
Drug: NP101 - Sumatriptan iontophoretic transdermal patch
Sumatriptan iontophoretic transdermal patch
Other Name: Sumatriptan
Placebo Comparator: Placebo
Placebo iontophoretic transdermal patch
Drug: Placebo
NP101 Placebo iontophoretic transdermal patch
Other Name: NP101 Placebo

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00724815

  Show 34 Study Locations
Sponsors and Collaborators
NuPathe Inc.
Investigators
Study Director: Mark Pierce, MD NuPathe Inc.
  More Information

No publications provided by NuPathe Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: NuPathe Inc.
ClinicalTrials.gov Identifier: NCT00724815     History of Changes
Other Study ID Numbers: PROT-15-NP101-007
Study First Received: July 28, 2008
Results First Received: February 15, 2013
Last Updated: March 26, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Sumatriptan
Vasoconstrictor Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 14, 2014