Study of NXN 188 for the Treatment of Migraine With Aura

NCT00920686 | Completed Phase 2 Results

• 1 other identifier: NXN-188-203
• Study Type: interventional
• Target: 239
• Locations: 1 country
• Sites: 16

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 history of aura.

Conditions

Migraine With Aura

Keywords

Migraine; aura

Outcome Measures

Primary Outcomes (1)

• Time (Hours) to First Use of Rescue Medication

  24 hours

Secondary Outcomes (4)

• Headache Relief and Recurrence (Observed Cases)

  2, 4 and up to 24 hours

• 2 Hours Post Administration - Incidence of Complete Headache Relief, Photophobia, Phonophobia and Nausea

  2 hours

• 4 Hours Post Administration - Incidence of Complete Headache Relief, Photophobia, Phonophobia and Nausea

  4 hours

• 24 Hours Post Administration - Incidence of Complete Headache Relief, Photophobia, Phonophobia and Nausea

  24 hours

Study Arms (3)

NXN-188

EXPERIMENTAL

NXN-188, 600 mg, PRN

Drug: NXN-188

sumatriptan succinate 100 mg

ACTIVE COMPARATOR

Sumatriptan, 100 mg, PRN

Drug: sumatriptan succinate

placebo

PLACEBO COMPARATOR

matching, PRN

Drug: placebo

Interventions

NXN-188 DRUG

NXN-188 hard gelatin capsules, 600 mg administered as three 200 mg capsules

Also known as: NXN-188 dihydrochloride

NXN-188

placebo DRUG

administered as 3 placebo hard gelatin capsules

Also known as: placebo capsules

placebo

sumatriptan succinate DRUG

administered in a hard gelatin capsule with 2 capsules of placebo

sumatriptan succinate 100 mg

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• NeurAxon Inc.: lead

Study Sites (16)

C. Philip O'Carrroll, MD, Inc.

Newport Beach, California, 92660, United States

Location

The Research Center of Southern California, LLC

Oceanside, California, 92056, United States

Location

San Francisco Headache Clinic

San Francisco, California, 94109, United States

Location

California Medical Clinic for Headache

Santa Monica, California, 90404, United States

Location

Comprehensive Neuroscience, Inc.

St. Petersburg, Florida, 33702, United States

Location

Vince and Associates Clinical Research

Overland Park, Kansas, 66212, United States

Location

Michigan Head-Pain and Neurological Institute

Ann Arbor, Michigan, 48104, United States

Location

Headache Care Center/Clinvest

Springfield, Missouri, 65807, United States

Location

Mercy Health Research

St Louis, Missouri, 63141, United States

Location

Meridian Clinical Research, LLC

Omaha, Nebraska, 68134, United States

Location

Regional Clinical Research, Inc.

Endwell, New York, 13760, United States

Location

Elkind Headache Center

Mount Vernon, New York, 10550, United States

Location

Rochester Clinical Research, Inc

Rochester, New York, 14609, United States

Location

Headache Wellness Center

Greensboro, North Carolina, 27405, United States

Location

Coastal Carolina Research Center, Inc

Mt. Pleasant, South Carolina, 29464, United States

Location

Advanced Clinical Research, Inc.

West Jordan, Utah, 84088, United States

Location

MeSH Terms

Conditions

Migraine with Aura; Migraine Disorders; Epilepsy

Interventions

Sumatriptan

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Thomas Lategan, PhD
• Organization: NeurAxon, Inc

tlategan@neuraxon.com

417 673 6697

Study Officials

• Guy Boudreau, MD

  Hopital Notre-Dame Du Chum, Montreal

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2009
• First Posted: June 15, 2009
• Study Start: June 1, 2009
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: August 11, 2014
• Results First Posted: August 11, 2014

Record last verified: 2014-07

Locations

US (16)