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Study of NXN 188 for the Treatment of Migraine With Aura

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ClinicalTrials.gov Identifier: NCT00920686
Recruitment Status : Completed
First Posted : June 15, 2009
Results First Posted : August 11, 2014
Last Update Posted : August 11, 2014
Sponsor:
Information provided by (Responsible Party):
NeurAxon Inc.

Tracking Information
First Submitted Date  ICMJE June 12, 2009
First Posted Date  ICMJE June 15, 2009
Results First Submitted Date  ICMJE May 8, 2013
Results First Posted Date  ICMJE August 11, 2014
Last Update Posted Date August 11, 2014
Study Start Date  ICMJE June 2009
Actual Primary Completion Date March 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 20, 2014)
Time (Hours) to First Use of Rescue Medication [ Time Frame: 24 hours ]
Original Primary Outcome Measures  ICMJE
 (submitted: June 12, 2009)
The primary efficacy assessment will be the time to rescue medication usage. [ Time Frame: 24 hours ]
Change History Complete list of historical versions of study NCT00920686 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 20, 2014)
  • Headache Relief and Recurrence (Observed Cases) [ Time Frame: 2, 4 and up to 24 hours ]
    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 ]
    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 ]
    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 ]
    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
Original Secondary Outcome Measures  ICMJE
 (submitted: June 12, 2009)
  • Headache severity score [ Time Frame: 72 hours ]
  • Photophobia and Phonophobia [ Time Frame: 72 hours ]
  • Nausea [ Time Frame: 72 hours ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of NXN 188 for the Treatment of Migraine With Aura
Official Title  ICMJE 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
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Migraine With Aura
Intervention  ICMJE
  • Drug: NXN-188
    NXN-188 hard gelatin capsules, 600 mg administered as three 200 mg capsules
    Other Name: NXN-188 dihydrochloride
  • Drug: placebo
    administered as 3 placebo hard gelatin capsules
    Other Name: placebo capsules
  • Drug: sumatriptan succinate
    administered in a hard gelatin capsule with 2 capsules of placebo
Study Arms  ICMJE
  • Experimental: NXN-188
    NXN-188, 600 mg, PRN
    Intervention: Drug: NXN-188
  • Active Comparator: sumatriptan succinate 100 mg
    Sumatriptan, 100 mg, PRN
    Intervention: Drug: sumatriptan succinate
  • Placebo Comparator: placebo
    matching, PRN
    Intervention: Drug: placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 20, 2014)
239
Original Estimated Enrollment  ICMJE
 (submitted: June 12, 2009)
300
Actual Study Completion Date  ICMJE March 2010
Actual Primary Completion Date March 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00920686
Other Study ID Numbers  ICMJE NXN-188-203
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party NeurAxon Inc.
Study Sponsor  ICMJE NeurAxon Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Guy Boudreau, MD Hopital Notre-Dame Du Chum, Montreal
PRS Account NeurAxon Inc.
Verification Date July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP