Status:
COMPLETED
Study of NXN 188 for the Treatment of Migraine With Aura
Lead Sponsor:
NeurAxon Inc.
Conditions:
Migraine With Aura
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
NXN-188 Dihydrochloride is being developed as an immediate release oral product for the treatment of acute migraine. This study is being conducted to evaluate NXN-188 in subjects with a migraine histo...
Detailed Description
This was a multicenter, double-blind, parallel group, active and placebo-controlled, three arm study of a single oral dose of NXN-188 for the treatment of acute migraine headache with aura. After stu...
Eligibility Criteria
Inclusion
- Male or female migraineurs between 18 and 65 years old.
- Subjects must have a headache history of migraine with aura as defined by:
- Aura consisting of at least one of the following, but no muscle weakness or paralysis:
- Fully reversible visual symptoms
- Fully reversible sensory symptoms
- Fully reversible dysphasia
- Aura has at least two of the following characteristics:
- Visual symptoms affecting only one side of the field of vision and/or sensory symptoms affecting only one side of the body
- At least one aura symptom that develops gradually over more than 5 minutes and/or different aura symptoms occur in succession over more than 5 minutes
- Each symptom lasts from 5-60 minutes
- Headache begins during the aura or follows aura within 60 minutes
- Headache not attributable to another disorder
- Migraine pain following aura in at least 75% of occurrences
- Headache frequency of at least 1 migraine attack (with or without aura) per month for the past 3 months but not more than 8 migraines in any 30 day period. Subjects must have at least 1 migraine headache with aura per month
- • Each migraine attack should last at least 4 hours (without treatment) and not longer than 72 hours.
- At the time of the study migraine, prior to dosing with study medication, the headache severity, as judged and documented by the subject, is either moderate or severe (on a 4-point categorical scale)
- Body mass index (BMI) range of 18 to 35
- The subject is in general good health.
- • ALT cannot be above 1.5x upper limit of normal; creatinine and urea must be within normal limits
- Speak, read, and understand English, French, or Spanish sufficiently to understand the nature of the study, to provide written informed consent, and complete all study assessments
- The subject is willing and able to comply with all testing requirements defined in the protocol
- All females will avoid pregnancy at least 10 days before randomization, and up until 3 months after dosing.
- All subjects/partners must use a double-barrier method of birth control during the study and for 3 months after dosing.
Exclusion
- A diagnosis of headaches that is not consistent with migraine with aura.
- Presence of any risk factors that would preclude the use of triptans:
- Known allergy or hypersensitivity to triptans or history of any serious side effect with a triptan which would preclude further dosing with a triptan
- Presence of any clinically significant condition that would preclude study participation, as evaluated by the investigator
- Pregnancy or lactation
- History of significant neurological, hepatic, renal, endocrine, cardiovascular, gastrointestinal, pulmonary, rheumatologic, autoimmune, or metabolic disease
- Use of the following if taken for migraine prevention:
- Cardiovascular drugs (acceptable if reason for use is for treatment of cardiovascular disease and the subject has been on a stable dose for 3 months)
- Valproate, topiramate, cyproheptadine, montelukast, or botulinum toxin.
- Use of monoamine oxidase inhibitors within 30 days of randomization
- Initiation of therapy with SSRIs or SNRIs for depression or other approved indication within 90 days of randomization (subjects on stable dose for \>3 months for treatment of depression or other approved indication may be included)
- Are known to or suspected to be currently abusing alcohol or drugs, or have a history (within the past 12 months) of active alcohol or drug abuse
- Participation in another drug or biologic study within 30 days of randomization into this study or during participation in this study
- Subjects who are unable or unwilling, in the opinion of the Investigator, to comply with all study procedures and cooperate fully with study center staff
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
239 Patients enrolled
Trial Details
Trial ID
NCT00920686
Start Date
June 1 2009
End Date
March 1 2010
Last Update
August 11 2014
Active Locations (16)
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1
C. Philip O'Carrroll, MD, Inc.
Newport Beach, California, United States, 92660
2
The Research Center of Southern California, LLC
Oceanside, California, United States, 92056
3
San Francisco Headache Clinic
San Francisco, California, United States, 94109
4
California Medical Clinic for Headache
Santa Monica, California, United States, 90404