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Migraine DisordersPhase 3NP101-007NCT00724815

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

A Phase 3 study testing NP101 - Sumatriptan iontophoretic transdermal patch in people with Migraine Disorders, run by NuPathe Inc. at 34 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Migraine Disorders
What is being tested?
NP101 - Sumatriptan iontophoretic transdermal patch
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
530 participants
Where
34 sitesUnited States
Study dates
Jan 2009to Jul 2009
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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).

Trial locations and contacts

34 sites in 1 country.

34 sites in 1 country

United States34 sites

  • Study site

    Alexandria, Virginia

  • Study site

    Ann Arbor, Michigan

  • Study site

    Atlanta, Georgia

  • Study site

    Chicago, Illinois

  • Study site

    Columbus, Georgia

  • Study site

    Dallas, Texas

  • Study site

    Decatur, Georgia

  • Study site

    Fairfield, Connecticut

  • Study site

    Greensboro, North Carolina

  • Study site

    Houston, Texas

  • Study site

    Kalamazoo, Michigan

  • Study site

    Little Rock, Arkansas

  • Study site

    Memphis, Tennessee

  • Study site

    Mount Vernon, New York

  • Study site

    Nashville, Tennessee

  • Study site

    Newport Beach, California

  • Study site

    Ocala, Florida

  • Study site

    Oklahoma City, Oklahoma

  • Study site

    Palm Beach Gardens, Florida

  • Study site

    Philadelphia, Pennsylvania

  • Study site

    Phoenix, Arizona

  • Study site

    Pittsburgh, Pennsylvania

  • Study site

    Plainview, New York

  • Study site

    San Antonio, Texas

  • Study site

    San Francisco, California

  • Study site

    Santa Monica, California

  • Study site

    Savannah, Georgia

  • Study site

    Seattle, Washington

  • Study site

    Springfield, Missouri

  • Study site

    St Louis, Missouri

  • Study site

    Sunrise, Florida

  • Study site

    Virginia Beach, Virginia

  • Study site

    West Chester, Ohio

  • Study site

    Wynnewood, Pennsylvania

Other trials in United States

About this study

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

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.
Read the 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.

Being tested
NP101 - Sumatriptan iontophoretic transdermal patch, Placebo
Medical subject headings
Migraine Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NP101 - Sumatriptan iontophoretic transdermal patchDrug

    Also called Sumatriptan

    Sumatriptan iontophoretic transdermal patch

  • PlaceboDrug

    Also called NP101 Placebo

    NP101 Placebo iontophoretic transdermal patch

Study groups in NCT00724815
Study groupRoleWhat they receive
SumatriptanExperimentalNP101 - sumatriptan iontophoretic transdermal patch
Receives: Drug: NP101 - Sumatriptan iontophoretic transdermal patch
PlaceboPlacebo comparatorPlacebo iontophoretic transdermal patch
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pain Free at Two Hours

    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.

    Measured: 2 hours post patch activation

Secondary outcomes (3)

  1. Photophobia Free at Two Hours

    Subjects who were photophobia free and who had not received any rescue medication before their two-hour assessment.

    Measured: 2 hours post patch activation

  2. Phonophobia Free at Two Hours

    Subjects who were phonophobia free and who had not received any rescue medication before their two-hour assessment.

    Measured: 2 hours post patch activation

  3. Nausea Free at Two Hours

    Number of subjects who were nausea free and who had not received any rescue medication before their two-hour assessment.

    Measured: 2 hours post patch activation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jul 2008 (estimated)
  2. Study startJan 2009
  3. Primary completionJul 2009
  4. Study completionJul 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
530 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00724815
Sponsor's protocol ID
PROT-15-NP101-007
Acronym
NP101-007
Status last verified
Feb 2016
First submitted
28 Jul 2008
Last updated
4 Feb 2016
Data monitoring committee
No

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.

    PubMed 22694484

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing NP101 - Sumatriptan iontophoretic transdermal patch in people with Migraine Disorders, run by NuPathe Inc. at 34 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 34 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 May 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain Free at Two Hours (time frame: 2 hours post patch activation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00724815, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2016.

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