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

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: NCT00724815
Recruitment Status : Completed
First Posted : July 30, 2008
Results First Posted : May 7, 2013
Last Update Posted : February 4, 2016
Sponsor:
Information provided by (Responsible Party):
Teva Branded Pharmaceutical Products R&D, Inc. ( NuPathe Inc. )

Tracking Information
First Submitted Date  ICMJE July 28, 2008
First Posted Date  ICMJE July 30, 2008
Results First Submitted Date  ICMJE February 15, 2013
Results First Posted Date  ICMJE May 7, 2013
Last Update Posted Date February 4, 2016
Study Start Date  ICMJE January 2009
Actual Primary Completion Date July 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 26, 2013)
Pain Free at Two Hours [ Time Frame: 2 hours post patch activation ]
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.
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 26, 2013)
  • Photophobia Free at Two Hours [ Time Frame: 2 hours post patch activation ]
    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 ]
    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 ]
    Number of subjects who were nausea free and who had not received any rescue medication before their two-hour assessment.
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 The Efficacy and Tolerability of NP101 Patch in the Treatment of Acute Migraine
Official Title  ICMJE The Efficacy and Tolerability of NP101, a Sumatriptan Iontophoretic Transdermal Patch, in the Treatment of Acute Migraine: A Randomized, Double-Blind, Placebo-Controlled Study
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Migraine Disorders
Intervention  ICMJE
  • Drug: NP101 - Sumatriptan iontophoretic transdermal patch
    Sumatriptan iontophoretic transdermal patch
    Other Name: Sumatriptan
  • Drug: Placebo
    NP101 Placebo iontophoretic transdermal patch
    Other Name: NP101 Placebo
Study Arms  ICMJE
  • Experimental: Sumatriptan
    NP101 - sumatriptan iontophoretic transdermal patch
    Intervention: Drug: NP101 - Sumatriptan iontophoretic transdermal patch
  • Placebo Comparator: Placebo
    Placebo iontophoretic transdermal patch
    Intervention: Drug: Placebo
Publications * 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.

*   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: July 29, 2008)
530
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2009
Actual Primary Completion Date July 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00724815
Other Study ID Numbers  ICMJE PROT-15-NP101-007
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Teva Branded Pharmaceutical Products R&D, Inc. ( NuPathe Inc. )
Original Responsible Party Mark Pierce, MD, PhD, Chief Scientific Officer, NuPathe Inc.
Current Study Sponsor  ICMJE NuPathe Inc.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Mark Pierce, MD NuPathe Inc.
PRS Account Teva Branded Pharmaceutical Products R&D, Inc.
Verification Date February 2016

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