An Open-Label Study to Evaluate the Safety of NP101 in the Treatment of Acute Migraine Over 12 Months



Status:Completed
Conditions:Migraine Headaches
Therapuetic Areas:Neurology
Healthy:No
Age Range:18 - 65
Updated:4/21/2016
Start Date:January 2009
End Date:September 2010

Use our guide to learn which trials are right for you!

An Open-Label Study to Evaluate the Safety of NP101, a Sumatriptan Iontophoretic Transdermal Patch, in the Treatment of Acute Migraine Over 12 Months

The primary objective is to evaluate the safety of long-term treatment with NP101 as
assessed by:

- Subject self-examination skin irritation scores

- Adverse events

- Changes in vital signs and ECG parameters

The secondary objective is to evaluate the long term efficacy of NP101 as assessed by:

- Headache pain free at two hours after patch activation for all initial acute migraine
attacks treated with NP101

- Headache pain relief at two hours after patch activation for all initial acute migraine
attacks treated with NP101

- Nausea free at two hours after patch activation for all initial acute migraine attacks
treated with NP101

- Phonophobia free at two hours after patch activation for all initial acute migraine
attacks treated with NP101

- Photophobia free at two hours after patch activation for all initial acute migraine
attacks treated with NP101

- Migraine free at two hours after patch activation for all initial acute migraine
attacks treated with NP101

This study will use an open-label design to assess the long term safety of NP101
(sumatriptan iontophoretic transdermal patch).

Subjects who continue to be in good health (use of a triptan or use of an NP101 patch is not
contraindicated) and received treatment (patch activation) with the study patch for a
qualifying migraine under study NP101-007 will be considered eligible for enrollment into
the open-label study. Subjects will be expected to remain in the study for up to 12 months.


Inclusion Criteria:

- Subject was previously enrolled in study NP101-007 and treated (patch activation) a
qualifying migraine.

- Subject will be judged to be in good health, based upon the results of a medical
history, physical examination, vital signs, and ECG. Subjects will not have any
clinically significant abnormal vital signs or ECG parameters in order to qualify for
enrollment. ECG must be done at enrollment for NP101-008 unless ECG for the Final
Visit of study NP101-007 was conducted within 30 days.

- Female subjects of childbearing potential (not surgically sterile or 2 years post
menopausal) must have a negative pregnancy test at enrollment.

Exclusion Criteria:

- Subject has less than two potential skin application sites.

- Subject has clinically significant abnormal vital signs or ECG parameters or had an
adverse event while participating in NP101-007 that would preclude the continued
treatment with the NP101 patch.

- Subject has had changes in their medical history or medication use that would
preclude their use of sumatriptan as per the approved Imitrex® product Prescribing
Information (PI) or their safe use of NP101 as per the NP101 Investigator's Brochure.

- Subject has or plans to start, stop, change treatment or dose of any of the following
within 3 months prior to the subject's study Enrollment date and through the Final
Visit: anxiolytics, lithium and other mood stabilizers such as valproate,
carbamazepine or lamotrigine, hypnotics or antipsychotics.

- Subject has taken non-triptan serotonergic drugs including selective serotonin
reuptake inhibitor (SSRI), serotonin and norepinephrine reuptake inhibitor (SNRI),
tricyclic antidepressants (TCAs), monoamine oxidase inhibitor (MAOI) or preparations
containing St. John's Wort within 1 month prior to enrollment and/or is planning to
start any of these medications during the study (through Final Visit).

- Female subjects who are pregnant, breast feeding, or of childbearing potential, and
are not using or are unwilling to use an effective form of contraception during the
study and for a period of 30 days following Final Visit. Acceptable methods of
contraception include barrier method with spermicide, intrauterine device (IUD),
steroidal contraceptive (oral, transdermal, implanted or injected) or abstinence. If
the exclusive male partner is surgically sterile, this will be acceptable.

- Subject has participated in a clinical study within 30 days of enrollment (excluding
NP101-007) or is planning to participate in another clinical study for the duration
of NP101-008.
We found this trial at
34
sites
Greensboro, North Carolina 27401
?
mi
from
Greensboro, NC
Click here to add this to my saved trials
?
mi
from
Alexandria, VA
Click here to add this to my saved trials
?
mi
from
Ann Arbor, MI
Click here to add this to my saved trials
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
?
mi
from
Chicago, IL
Click here to add this to my saved trials
?
mi
from
Columbus, GA
Click here to add this to my saved trials
?
mi
from
Dallas, TX
Click here to add this to my saved trials
?
mi
from
Decatur, GA
Click here to add this to my saved trials
?
mi
from
Fairfield, CT
Click here to add this to my saved trials
?
mi
from
Houston, TX
Click here to add this to my saved trials
?
mi
from
Kalamazoo, MI
Click here to add this to my saved trials
?
mi
from
Little Rock, AR
Click here to add this to my saved trials
?
mi
from
Memphis, TN
Click here to add this to my saved trials
?
mi
from
Mount Vernon, NY
Click here to add this to my saved trials
?
mi
from
Nashville, TN
Click here to add this to my saved trials
Newport Beach, California 92660
?
mi
from
Newport Beach, CA
Click here to add this to my saved trials
?
mi
from
Ocala, FL
Click here to add this to my saved trials
?
mi
from
Oklahoma City, OK
Click here to add this to my saved trials
Palm Beach Gardens, Florida 33410
?
mi
from
Palm Beach Gardens, FL
Click here to add this to my saved trials
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
?
mi
from
Phoenix, AZ
Click here to add this to my saved trials
?
mi
from
Pittsburgh, PA
Click here to add this to my saved trials
?
mi
from
Plainview, NY
Click here to add this to my saved trials
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
?
mi
from
San Francisco, CA
Click here to add this to my saved trials
?
mi
from
Santa Monica, CA
Click here to add this to my saved trials
?
mi
from
Savannah, GA
Click here to add this to my saved trials
?
mi
from
Seattle, WA
Click here to add this to my saved trials
?
mi
from
Springfield, MO
Click here to add this to my saved trials
?
mi
from
St. Louis, MO
Click here to add this to my saved trials
?
mi
from
Sunrise, FL
Click here to add this to my saved trials
?
mi
from
Virginia Beach, VA
Click here to add this to my saved trials
?
mi
from
West Chester, OH
Click here to add this to my saved trials
?
mi
from
Wynnewood, PA
Click here to add this to my saved trials