Study of NXN 188 for the Treatment of Migraine With Aura

NCT ID: NCT00920686

Last Updated: 2014-08-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 239 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-06-30
• Study Completion Date: 2010-03-31

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.

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 study eligibility was confirmed, subjects were randomized to NXN-188 600 mg, sumatriptan 100 mg, or placebo in a 1:1:1 ratio. Subjects left the clinic to self-administer the treatment at home at the onset of moderate to severe headache in a suitable dosing environment.

Treatment was not to exceed 42 days from Randomization. If the subject did not have a headache within 42 days of randomization (s)he did not take the study medication and returned it to the site. If the subject experienced a qualifying headache (s)he recorded the symptoms in a diary, dosed with the study drug, and called the IVRS to record assessments all adverse events and to report dosing. If the study drug provided insufficient relief 2 hours post dosing (s)he was permitted to use non-triptan rescue medication recommended by the investigator.

Conditions

Migraine With Aura

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

NXN-188

NXN-188, 600 mg, PRN

Group Type: EXPERIMENTAL

NXN-188

Intervention Type: DRUG

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

sumatriptan succinate 100 mg

Sumatriptan, 100 mg, PRN

Group Type: ACTIVE_COMPARATOR

sumatriptan succinate

Intervention Type: DRUG

administered in a hard gelatin capsule with 2 capsules of placebo

placebo

matching, PRN

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

administered as 3 placebo hard gelatin capsules

Interventions

NXN-188

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

Intervention Type: DRUG

placebo

administered as 3 placebo hard gelatin capsules

Intervention Type: DRUG

sumatriptan succinate

administered in a hard gelatin capsule with 2 capsules of placebo

Intervention Type: DRUG

Other Intervention Names

NXN-188 dihydrochloride; placebo capsules

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NeurAxon Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Guy Boudreau, MD

Role: PRINCIPAL_INVESTIGATOR

Hopital Notre-Dame Du Chum, Montreal

Locations

C. Philip O'Carrroll, MD, Inc.

Newport Beach, California, United States

The Research Center of Southern California, LLC

Oceanside, California, United States

San Francisco Headache Clinic

San Francisco, California, United States

California Medical Clinic for Headache

Santa Monica, California, United States

Comprehensive Neuroscience, Inc.

St. Petersburg, Florida, United States

Vince and Associates Clinical Research

Overland Park, Kansas, United States

Michigan Head-Pain and Neurological Institute

Ann Arbor, Michigan, United States

Headache Care Center/Clinvest

Springfield, Missouri, United States

Mercy Health Research

St Louis, Missouri, United States

Meridian Clinical Research, LLC

Omaha, Nebraska, United States

Regional Clinical Research, Inc.

Endwell, New York, United States

Elkind Headache Center

Mount Vernon, New York, United States

Rochester Clinical Research, Inc

Rochester, New York, United States

Headache Wellness Center

Greensboro, North Carolina, United States

Coastal Carolina Research Center, Inc

Mt. Pleasant, South Carolina, United States

Advanced Clinical Research, Inc.

West Jordan, Utah, United States

Countries

United States

Other Identifiers

NXN-188-203

Identifier Type: -

Identifier Source: org_study_id