Study of the Safety and Effectiveness of NXN-188 for the Treatment of Migraine Headache Without Aura

NCT00959751 | Completed Phase 2 Results

• 1 other identifier: NXN-188-204
• Study Type: interventional
• Target: 195
• Locations: 1 country
• Sites: 4

Brief Summary

This is a a multi-center, randomized, double-blind, parallel group, and placebo controlled, two-arm study of a single oral dose of NXN-188 for the treatment of acute migraine headache without aura. Up to 120 migraineurs will be enrolled. Approximately 60 subjects having a headache history of migraine without aura will complete each of the two treatment arms to evaluate NXN-188 600 mg or placebo.

Conditions

Migraine Without Aura

Keywords

migraine

Outcome Measures

Primary Outcomes (2)

• Headache Relief (Modified LOCF - Efficacy Evaluable Analysis Set)

  Headache relief at 2 hours post administration defined as reduction from Baseline moderate or severe score to mild or none.

  2 hours

• Headache Recurrence (Modified LOCF - Efficacy Evaluable Analysis Set)

  Headache recurrence is defined as any subject that experiences headache relief at the given time point (i.e., 2 hours or 4 hours), who did not use rescue medication and who experienced a worsening of their headache to moderate or severe within 24 hours following study drug administration. The denominator is the number of subjects who experienced headache relief at 2 hours/4 hours.

  4 hours

Secondary Outcomes (5)

• Headache Relief Based on a 2-Point Reduction From Baseline (Modified LOCF - Efficacy Evaluable Analysis Set)

  72 hours

• Headache Relief Based on a 1-Point Reduction From Baseline (Modified LOCF - Efficacy Evaluable Analysis Set)

  72 hours

• Complete Headache Relief (Efficacy Evaluable Analysis Set)

  72 hours

• Time (Hours) to First Use of Rescue Medication (Full Analysis Set)

  24 Hours

• Overall Evaluation of Study Medication at 24 Hours Post Administration (Full Analysis Set)

  24 hours

Study Arms (2)

NXN-188 600 mg

EXPERIMENTAL

3 x 200 mg capsules, PRN

Drug: NXN-188

Placebo

PLACEBO COMPARATOR

3 x 0 mg capsules, PRN

Drug: Placebo

Interventions

NXN-188 DRUG

200 mg capsules, 600 mg, PRN

Also known as: NXN-188 dihydrochloride

NXN-188 600 mg

Placebo DRUG

200 mg capsules with no active ingredient designed to match the NXN-188 capsules

Placebo

Eligibility Criteria

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

You may qualify if:

• Meets the following criteria for migraine headache without aura: Previously diagnosed with a history of migraine headaches; Headache has at least two (2) of the following characteristics: Unilateral location; Pulsating quality; Moderate or severe pain intensity; Aggravation by routine physical activity such as walking or climbing stairs; During headache, has at least one of the following characteristics: Nausea and/or vomiting; Photophobia and/or phonophobia;Not attributable to another disorder
• Headache frequency of at least 2 migraine attacks per month for the past 3 months but not more than 8 migraines in any 30 day period. 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
• BMI within the range of 18 to 35
• Good general health as determined by the medical history, physical exam, clinical laboratory tests, vital signs and electrocardiogram. ALT cannot be above 1.5x upper limit of normal; creatinine and urea must be within normal limits
• Speak, read, and understand English or French, sufficiently to understand the nature of the study, to provide written informed consent, and complete all study assessments.
• Willing and able to comply with all testing requirements defined in the protocol
• Females will avoid pregnancy at least 10 days before randomization, during the study and up until 3 months after treatment

You may not qualify if:

• Presence of any risk factors that would preclude the use of triptans: Uncontrolled hypertension; Ischemic heart disease; Prinzmetal angina; Cardiac arrhythmias; Multiple risk factors for ischemic atherosclerotic vascular disease; Primary vasculopathies; Basilar and hemiplegic migraine
• 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
• Pregnant or lactating
• History of significant neurological, hepatic, renal, endocrine, cardiovascular, gastrointestinal, pulmonary, rheumatologic, autoimmune, or metabolic disease
• Any use (within 30 days of randomization) of migraine prevention medication including: Valproate (Depakote), topiramate (Topamax), cyproheptadine (Periactin), montelukast (Singulair), or botulinum toxin, type A (Botox); Cardiovascular drugs (acceptable if reason for use is for treatment of cardiovascular disease and the subject has been on a stable dose; MAOIs 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 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 (4)

Comprehensive Neuroscience, Inc.

St. Petersburg, Florida, 33716, United States

Location

Comprehensive NeuroScience, Inc. Atlanta

Atlanta, Georgia, 30328, United States

Location

Elkind Headache Center

Mount Vernon, New York, 10550, United States

Location

Lifetree Clinical Research

Salt Lake City, Utah, 84106, United States

Location

MeSH Terms

Conditions

Migraine without Aura; Migraine Disorders

Condition Hierarchy (Ancestors)

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

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: August 14, 2009
• First Posted: August 17, 2009
• Study Start: July 1, 2009
• Primary Completion: February 1, 2010
• Study Completion: March 1, 2010
• Last Updated: July 23, 2014
• Results First Posted: July 11, 2014

Record last verified: 2014-07

Locations

US (4)