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

This study has been completed.
Sponsor:
Information provided by:
NeurAxon Inc.
ClinicalTrials.gov Identifier:
NCT00959751
First received: August 14, 2009
Last updated: June 28, 2010
Last verified: June 2010
  Purpose

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.


Condition Intervention Phase
Migraine Without Aura
Drug: NXN-188
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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 Without Aura

Resource links provided by NLM:


Further study details as provided by NeurAxon Inc.:

Primary Outcome Measures:
  • change (from baseline) in headache severity at 2 hours as recorded in the study diary [ Time Frame: 2 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Headache severity score, Photophobia and Phonophobia (absent or present), Nausea, Overall Evaluation of the study medication at 24 hours,Use of any rescue medication [ Time Frame: up to 72 hours ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: August 2009
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NXN-188 Drug: NXN-188
capsules, 600 mg, PRN
Placebo Comparator: Placebo Drug: Placebo
capsules, PRN

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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
  2. 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.
  3. 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
  4. BMI within the range of 18 to 35
  5. 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
  6. 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.
  7. Willing and able to comply with all testing requirements defined in the protocol
  8. Females will avoid pregnancy at least 10 days before randomization, during the study and up until 3 months after treatment
  9. All subjects/partners must use a double-barrier method of birth control during the study and for 3 months after dosing (female subjects who have had a tubal ligation > 1 year or who are post menopausal or post hysterectomy > 1 year and male subjects who are surgically sterile are exempted from this inclusion criteria.

Exclusion Criteria:

A diagnosis of headaches that is not consistent with migraine without aura as defined in the inclusion criteria. Subjects with a history of migraine with aura are excluded.

  1. 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
  2. Known allergy or hypersensitivity to triptans or history of any serious side effect with a triptan which would preclude further dosing with a triptan
  3. Presence of any clinically significant condition that would preclude study participation, as evaluated by the investigator
  4. Pregnant or lactating
  5. History of significant neurological, hepatic, renal, endocrine, cardiovascular, gastrointestinal, pulmonary, rheumatologic, autoimmune, or metabolic disease
  6. 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
  7. 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)
  8. 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
  9. Participation in another drug or biologic study within 30 days of randomization into this study or during participation in this study
  10. Subjects unable or unwilling, in the opinion of the Investigator, to comply with all study procedures and cooperate fully with study center staff
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00959751

Locations
United States, Florida
Comprehensive Neuroscience, Inc.
St. Petersburg, Florida, United States, 33716
United States, Georgia
Comprehensive NeuroScience, Inc. Atlanta
Atlanta, Georgia, United States, 30328
United States, New York
Elkind Headache Center
Mount Vernon, New York, United States, 10550
United States, Utah
Lifetree Clinical Research
Salt Lake City, Utah, United States, 84106
Sponsors and Collaborators
NeurAxon Inc.
Investigators
Principal Investigator: Guy Boudreau, MD Hopital Notre-Dame Du Chum, Montreal
  More Information

No publications provided

Responsible Party: Robert A. Medve, M.D., NeurAxon, Inc
ClinicalTrials.gov Identifier: NCT00959751     History of Changes
Other Study ID Numbers: NXN-188-204
Study First Received: August 14, 2009
Last Updated: June 28, 2010
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Keywords provided by NeurAxon Inc.:
migraine

Additional relevant MeSH terms:
Migraine Disorders
Migraine without Aura
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on April 17, 2014