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History of Changes for Study: NCT00724815
The Efficacy and Tolerability of NP101 Patch in the Treatment of Acute Migraine (NP101-007)
Latest version (submitted February 2, 2016) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 July 29, 2008 None (earliest Version on record)
2 August 1, 2008 Study Status and Contacts/Locations
3 November 5, 2008 Recruitment Status, Study Status, Study Design, Contacts/Locations, Eligibility, Outcome Measures, Arms and Interventions and Sponsor/Collaborators
4 December 19, 2008 Study Status and Contacts/Locations
5 January 6, 2009 Recruitment Status, Study Status and Contacts/Locations
6 January 16, 2009 Contacts/Locations and Study Status
7 January 29, 2009 Contacts/Locations and Study Status
8 March 10, 2009 Contacts/Locations and Study Status
9 April 29, 2009 Contacts/Locations and Study Status
10 May 29, 2009 Recruitment Status, Study Status and Contacts/Locations
11 July 30, 2009 Recruitment Status, Study Status, Outcome Measures and Study Design
12 April 25, 2012 Sponsor/Collaborators and Study Status
13 February 6, 2013 Study Status and Contacts/Locations
14 March 26, 2013 Outcome Measures, Arms and Interventions, Study Status, More Information, Study Description, Adverse Events, Baseline Characteristics and Participant Flow
15 February 2, 2016 Study Status, Study Identification and Baseline Characteristics
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Study NCT00724815
Submitted Date:  July 29, 2008 (v1)

Open or close this module Study Identification
Unique Protocol ID: PROT-15-NP101-007
Brief Title: The Efficacy and Tolerability of NP101 Patch in the Treatment of Acute Migraine (NP101-007)
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
Secondary IDs:
Open or close this module Study Status
Record Verification: July 2008
Overall Status: Not yet recruiting
Study Start: July 2008
Primary Completion: December 2008 [Anticipated]
Study Completion: December 2008 [Anticipated]
First Submitted: July 28, 2008
First Submitted that
Met QC Criteria:
July 29, 2008
First Posted: July 30, 2008 [Estimate]
Last Update Submitted that
Met QC Criteria:
July 29, 2008
Last Update Posted: July 30, 2008 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: NuPathe Inc.
Responsible Party:
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: No
Open or close this module Study Description
Brief Summary: 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.
Detailed Description:
Open or close this module Conditions
Conditions: Migraine Disorders
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 3
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: Triple (Participant, Care Provider, Investigator)
Allocation: Randomized
Enrollment: 530 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Active Comparator: 1
NP101 - sumatriptan iontophoretic transdermal patch
Drug: NP101
NP101 sumatriptan iontophoretic transdermal patch
Placebo Comparator: 2
Placebo iontophoretic transdermal patch
Drug: NP101 placebo
Placebo iontophoretic transdermal patch
Open or close this module Outcome Measures
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 65 Years
Sex: All
Gender Based:
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.

Exclusion Criteria:

  • Subject has started, stopped, changed treatment, or dose with prophylactic anti-migraine treatment within three months of the study randomization date. Subject must agree not to start, stop, change treatment, or change dose through Final Visit.
  • Subject has started, stopped or changed treatment or dose of any of the following within 3 months prior to randomization: anxiolytics, lithium and other mood stabilizers, hypnotics or antipsychotics. Subject must agree not to start, stop, change treatment or change dose through the Final Visit.
  • 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).
Open or close this module Contacts/Locations
Central Contact Person: Donna Kolbush Jackson, RN
Telephone: 484-567-0130 Ext. 1121
Email: dkjackson@nupathe.com
Study Officials: Mark Pierce, MD, PhD
Study Director
NuPathe Inc.
Locations:
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links:
Available IPD/Information:

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