Study of NXN 188 for the Treatment of Migraine With Aura

Condition(s) targeted: Migraine With Aura

Intervention: NXN-188 (Drug); placebo (Drug); sumatriptan succinate (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: NeurAxon Inc.

Official(s) and/or principal investigator(s):
Guy Boudreau, MD, Principal Investigator, Affiliation: Hopital Notre-Dame Du Chum, Montreal

Overall contact:
Robert A Medve, MD, Email: rmedve@neuraxon.com

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 history of aura.

Official title: A Phase 2 Study of the Safety and Effectiveness of a Single Oral Dose of NXN 188 for the Treatment of Moderate to Severe Migraine Headache With Aura

Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study

Primary outcome: The primary efficacy assessment will be the time to rescue medication usage.

Secondary outcome:

Headache severity score

Photophobia and Phonophobia

Nausea

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

1. Male or female migraineurs between 18 and 65 years old.

2. 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

3. Migraine pain following aura in at least 75% of occurrences

4. 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.

5. 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)

6. Body mass index (BMI) range of 18 to 35

7. 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

8. 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

9. The subject is willing and able to comply with all testing requirements defined in the protocol

10. All females will avoid pregnancy at least 10 days before randomization, and up until 3 months after dosing.

11. All subjects/partners must use a double-barrier method of birth control during the study and for 3 months after dosing.

Exclusion Criteria:

1. A diagnosis of headaches that is not consistent with migraine with aura.

2. Presence of any risk factors that would preclude the use of triptans:

3. Known allergy or hypersensitivity to triptans or history of any serious side effect with a triptan which would preclude further dosing with a triptan

4. Presence of any clinically significant condition that would preclude study participation, as evaluated by the investigator

5. Pregnancy or lactation

6. History of significant neurological, hepatic, renal, endocrine, cardiovascular, gastrointestinal, pulmonary, rheumatologic, autoimmune, or metabolic disease

7. 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.

8. Use of monoamine oxidase inhibitors within 30 days of randomization

9. 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)

10. 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

11. Participation in another drug or biologic study within 30 days of randomization into this study or during participation in this study

12. 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

Robert A Medve, MD, Email: rmedve@neuraxon.com

C. Philip O'Carrroll, MD, Inc., Newport Beach, California 92660, United States; Recruiting
Erin O'Carroll-Godinez, Phone: 949-759-8001, Ext: 203, Email: erin@nbneuro.com
Phillip O'Carroll, MD, Principal Investigator

San Francisco Headache Clinic, San Francisco, California 94109, United States; Recruiting
Jerome Goldstein, MD, Phone: 415-673-4600, Email: sfhaclin@aol.com
Jennifer Wong, Phone: 415-673-4600, Email: sfhaclin@aol.com
Jerome Goldstein, MD, Principal Investigator

California Medical Clinic for Headache, Santa Monica, California 90404, United States; Recruiting
Tatyana Neyman, Phone: 310-315-1456, Email: tneyman@drkudrow.com
David Kudrow, MD, Principal Investigator

The Research Center of Southern California, LLC, Oceanside, California 92056, United States; Recruiting
Guadalupe Sanchez, Phone: 760-732-0557, Ext: 147, Email: lsanchez@neurocenter.com
Andrew Blumenfeld, MD, Principal Investigator

Comprehensive Neuroscience, Inc., St. Petersburg, Florida 33702, United States; Recruiting
Judith Shea, MD, Phone: 727-576-8474, Email: jshea@cnsmail.com
Susan Montgomery, Phone: 727-576-8474, Email: smontgomery@cnsmail.com
Margarita Nunez, MD, Principal Investigator

Vince and Associates Clinical Research, Overland Park, Kansas 66212, United States; Recruiting
Martin K Kankam, MD

Michigan Head-Pain and Neurological Institute, Ann Arbor, Michigan 48104, United States; Recruiting
Kelly Kotecki, Phone: 734-677-6000, Ext: option 4, Email: research@mhni.com
James Weintraub, DO, Principal Investigator

Mercy Health Research, St. Louis, Missouri 63141, United States; Recruiting
Timothy R Smith, MD, Phone: 314-251-8893
Timothy R Smith, MD, Principal Investigator

Headache Care Center/Clinvest, Springfield, Missouri 65807, United States; Recruiting
Rhonda Cadle, RN, CCRP, Phone: 417-883-7889, Email: rcadle@clinvest.com
Roger Cady, MD, Principal Investigator

Meridian Clinical Research, LLC, Omaha, Nebraska 68134, United States; Recruiting
Jan Mitchell, CRC, Phone: 402-933-6500, Email: jmitchell@mcrmed.com
Brandon Essink, MD, Principal Investigator

Rochester Clinical Research, Inc, Rochester, New York 14609, United States; Recruiting
Jane VanDe Sande, Email: jvandesande@rcrclinical.com
Deb Lovett, Email: dlovett@rcrclinical.com
Matthew Davis, MD, Principal Investigator

Elkind Headache Center, Mount Vernon, New York 10550, United States; Recruiting
Barbara Parrilli, Phone: 914-667-2230, Email: arthur.elkind@verizon.net
Arthur Elkind, MD, Principal Investigator

Regional Clinical Research, Inc., Endwell, New York 13760, United States; Recruiting
Beth, Phone: 607-754-6247, Email: info@rcresearchinc.com
Duncan Sze-Tu, MD, Principal Investigator

Headache Wellness Center, Greensboro, North Carolina 27405, United States; Recruiting
Kathryn Poynter, RN, Phone: 336-574-8000, Ext: 130, Email: kp_hwc@yahoo.com
Marshall Freeman, MD, Principal Investigator

Coastal Carolina Research Center, Inc, Mt. PLeasant, South Carolina 29464, United States; Recruiting
Cynthia B Strout, MD

Advanced Clinical Research, Inc., West Jordan, Utah 84088, United States; Recruiting
Judith L Kirstein, MD

Starting date: June 2009
Ending date: March 2010
Last updated: July 28, 2009