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Study of NXN 188 for the Treatment of Migraine With Aura

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
NeurAxon Inc.
ClinicalTrials.gov Identifier:
NCT00920686
First received: June 12, 2009
Last updated: July 20, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Migraine With Aura
Drug: NXN-188
Drug: placebo
Drug: sumatriptan succinate
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: 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

Resource links provided by NLM:


Further study details as provided by NeurAxon Inc.:

Primary Outcome Measures:
  • Time (Hours) to First Use of Rescue Medication [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Headache Relief and Recurrence (Observed Cases) [ Time Frame: 2, 4 and up to 24 hours ] [ Designated as safety issue: No ]

    Headache relief is defined as a ≥ 1-point reduction from baseline in Headache Severity Score. The Headache Severity Score is a four-point scale: 0=no pain; 1 = mild pain; 2 = moderate pain; and 3 = severe pain.

    Headache recurrence is defined as any subject that experiences headache relief within 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.


  • 2 Hours Post Administration - Incidence of Complete Headache Relief, Photophobia, Phonophobia and Nausea [ Time Frame: 2 hours ] [ Designated as safety issue: No ]

    Complete headache relief is defined as reduction of headache severity from moderate or severe to absent.

    Presence of Photophobia and Phonophobia measured on a 2-point scale: 0 = absent; 1 = present

    Nausea was measured on a 4-point scale: 0 = no nausea; 1 = mild nausea; 2 = moderate nausea; 3 = severe nausea


  • 4 Hours Post Administration - Incidence of Complete Headache Relief, Photophobia, Phonophobia and Nausea [ Time Frame: 4 hours ] [ Designated as safety issue: No ]

    Complete headache relief is defined as reduction of headache severity from moderate or severe to absent.

    Presence of Photophobia and Phonophobia measured on a 2-point scale: 0 = absent; 1 = present

    Nausea was measured on a 4-point scale: 0 = no nausea; 1 = mild nausea; 2 = moderate nausea; 3 = severe nausea


  • 24 Hours Post Administration - Incidence of Complete Headache Relief, Photophobia, Phonophobia and Nausea [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

    Complete headache relief is defined as reduction of headache severity from moderate or severe to absent.

    Presence of Photophobia and Phonophobia measured on a 2-point scale: 0 = absent; 1 = present

    Nausea was measured on a 4-point scale: 0 = no nausea; 1 = mild nausea; 2 = moderate nausea; 3 = severe nausea



Enrollment: 239
Study Start Date: June 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
NXN-188, 600 mg, PRN
Drug: NXN-188
NXN-188 hard gelatin capsules, 600 mg administered as three 200 mg capsules
Other Name: NXN-188 dihydrochloride
Active Comparator: sumatriptan succinate 100 mg
Sumatriptan, 100 mg, PRN
Drug: sumatriptan succinate
administered in a hard gelatin capsule with 2 capsules of placebo
Placebo Comparator: placebo
matching, PRN
Drug: placebo
administered as 3 placebo hard gelatin capsules
Other Name: placebo capsules

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00920686

Locations
United States, California
C. Philip O'Carrroll, MD, Inc.
Newport Beach, California, United States, 92660
The Research Center of Southern California, LLC
Oceanside, California, United States, 92056
San Francisco Headache Clinic
San Francisco, California, United States, 94109
California Medical Clinic for Headache
Santa Monica, California, United States, 90404
United States, Florida
Comprehensive Neuroscience, Inc.
St. Petersburg, Florida, United States, 33702
United States, Kansas
Vince and Associates Clinical Research
Overland Park, Kansas, United States, 66212
United States, Michigan
Michigan Head-Pain and Neurological Institute
Ann Arbor, Michigan, United States, 48104
United States, Missouri
Headache Care Center/Clinvest
Springfield, Missouri, United States, 65807
Mercy Health Research
St. Louis, Missouri, United States, 63141
United States, Nebraska
Meridian Clinical Research, LLC
Omaha, Nebraska, United States, 68134
United States, New York
Regional Clinical Research, Inc.
Endwell, New York, United States, 13760
Elkind Headache Center
Mount Vernon, New York, United States, 10550
Rochester Clinical Research, Inc
Rochester, New York, United States, 14609
United States, North Carolina
Headache Wellness Center
Greensboro, North Carolina, United States, 27405
United States, South Carolina
Coastal Carolina Research Center, Inc
Mt. PLeasant, South Carolina, United States, 29464
United States, Utah
Advanced Clinical Research, Inc.
West Jordan, Utah, United States, 84088
Sponsors and Collaborators
NeurAxon Inc.
Investigators
Principal Investigator: Guy Boudreau, MD Hopital Notre-Dame Du Chum, Montreal
  More Information

No publications provided

Responsible Party: NeurAxon Inc.
ClinicalTrials.gov Identifier: NCT00920686     History of Changes
Other Study ID Numbers: NXN-188-203
Study First Received: June 12, 2009
Results First Received: May 8, 2013
Last Updated: July 20, 2014
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Keywords provided by NeurAxon Inc.:
Migraine
aura

Additional relevant MeSH terms:
Migraine Disorders
Migraine with Aura
Brain Diseases
Central Nervous System Diseases
Headache Disorders
Headache Disorders, Primary
Nervous System Diseases
Sumatriptan
Cardiovascular Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Serotonin 5-HT1 Receptor Agonists
Serotonin Agents
Serotonin Receptor Agonists
Therapeutic Uses
Vasoconstrictor Agents

ClinicalTrials.gov processed this record on November 24, 2014