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

Primary Purpose

Migraine Without Aura

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

NXN-188

Placebo

About this trial

This is an interventional treatment trial for Migraine Without Aura focused on measuring migraine

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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
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.

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

Sites / Locations

Comprehensive Neuroscience, Inc.
Comprehensive NeuroScience, Inc. Atlanta
Elkind Headache Center
Lifetree Clinical Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

NXN-188 600 mg

Placebo

Arm Description

3 x 200 mg capsules, PRN

3 x 0 mg capsules, PRN

Outcomes

Primary Outcome Measures

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.

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.

Secondary Outcome Measures

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

The Headache Severity Score (HSS) assessment was recorded in the diary by the subject and used the following categories: 0 = no pain; 1 = mild pain; 2 = moderate pain; and, 3 = severe pain

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

The Headache Severity Score (HSS) assessment was recorded in the diary by the subject and used the following categories: 0 = no pain; 1 = mild pain; 2 = moderate pain; and, 3 = severe pain

Complete Headache Relief (Efficacy Evaluable Analysis Set)

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

Subjects who do not require rescue medication are censored at the time of their last diary assessment completed up to 24 hours following study drug administration.

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

Overall evaluation of the study drug was measured with a 4-point scale at 24 hours and used the following categories: 1 = Poor; 2 = Moderate; 3 = Good; and,4 = Excellent

Full Information

NCT ID

NCT00959751

First Posted

August 14, 2009

Last Updated

July 12, 2014

Sponsor

NeurAxon Inc.

1. Study Identification

Unique Protocol Identification Number

NCT00959751

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2014

Overall Recruitment Status

Completed

Study Start Date

July 2009 (undefined)

Primary Completion Date

February 2010 (Actual)

Study Completion Date

March 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

NeurAxon Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

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.

Detailed Description

After study eligibility was confirmed and all screening procedures completed, subjects were randomized at Visit 1 to receive either NXN-188 600 mg or placebo in a 1:1 ratio. Study drug and diaries were dispensed, and subjects were instructed regarding when to dose with study drug. Subjects were also trained regarding the Interactive Voice Response System (IVRS), and made familiar with the study diary and the completion of study diary assessments. Subjects left the clinic to self-administer treatment as an outpatient at the onset of a moderate to severe migraine headache without aura (as rated on a 4-point categorical scale). Dosing with study drug was to take place within 42 days from Randomization (Visit 1). The subject contacted the investigatorI or designee at 14 and 28 days after Randomization if they had not yet treated a migraine headache without aura in order to receive verbal permission from the site personnel to continue in the study as appropriate. If the subject had not treated a migraine headache within 42 days of Visit 1, the subject did not take study drug and returned all materials, including the unused study drug, to the study site. If the subject experienced a qualifying migraine without aura during the treatment period, (s)he recorded headache symptoms in the study diary when first noticed (and menstrual cycle status [female subjects only]). If the subject met dosing requirements as outlined in the protocol, they dosed with the study drug, called the IVRS to report dosing, recorded all assessments and adverse events (AEs) and contacted the study center to schedule a post treatment visit (Visit 2) within 6 days (± 2 days) of treatment. If study drug resulted in insufficient relief at 2 hours p.a., subjects were permitted to use the non-triptan rescue medication recommended by the PI at Visit 1. Within 6 days (± 2 days) of treatment, the subject returned to the study center for Visit 2. The subject had a brief physical examination, a 12-lead electrocardiogram (ECG), and had samples taken for clinical laboratory tests, including a serum pregnancy test for all females. Concomitant medications taken and adverse events (AEs) experienced from time of dosing to Visit 2 were reported to site personnel and recorded. Study diaries were reviewed and information recorded. Discontinuing subjects returned unused study drug and study material. One safety follow-up telephone contact was made within 15 days (± 2 days) post treatment. For those subjects not meeting the Treatment/Enrollment criteria by Day 42 (i.e., not experiencing a qualifying headache) and for other subjects discontinuing the study protocol post Randomization (Visit 1), a second visit, Visit 2, was required and subjects underwent a brief physical examination, had vital signs and ECGs performed, samples collected for clinical labs, concomitant medications and AEs reviewed, and returned all study drug and study materials.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Migraine Without Aura

Keywords

migraine

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

195 (Actual)

8. Arms, Groups, and Interventions

Arm Title

NXN-188 600 mg

Arm Type

Experimental

Arm Description

3 x 200 mg capsules, PRN

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

3 x 0 mg capsules, PRN

Intervention Type

Drug

Intervention Name(s)

NXN-188

Other Intervention Name(s)

NXN-188 dihydrochloride

Intervention Description

200 mg capsules, 600 mg, PRN

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

Headache Relief (Modified LOCF - Efficacy Evaluable Analysis Set)

Description

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

Time Frame

2 hours

Title

Headache Recurrence (Modified LOCF - Efficacy Evaluable Analysis Set)

Description

Time Frame

4 hours

Secondary Outcome Measure Information:

Title

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

Description

The Headache Severity Score (HSS) assessment was recorded in the diary by the subject and used the following categories: 0 = no pain; 1 = mild pain; 2 = moderate pain; and, 3 = severe pain

Time Frame

72 hours

Title

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

Description

The Headache Severity Score (HSS) assessment was recorded in the diary by the subject and used the following categories: 0 = no pain; 1 = mild pain; 2 = moderate pain; and, 3 = severe pain

Time Frame

72 hours

Title

Complete Headache Relief (Efficacy Evaluable Analysis Set)

Time Frame

72 hours

Title

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

Description

Subjects who do not require rescue medication are censored at the time of their last diary assessment completed up to 24 hours following study drug administration.

Time Frame

24 Hours

Title

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

Description

Overall evaluation of the study drug was measured with a 4-point scale at 24 hours and used the following categories: 1 = Poor; 2 = Moderate; 3 = Good; and,4 = Excellent

Time Frame

24 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 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. 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Guy Boudreau, MD

Organizational Affiliation

Hopital Notre-Dame Du Chum, Montreal

Official's Role

Principal Investigator

Facility Information:

Facility Name

Comprehensive Neuroscience, Inc.

City

St. Petersburg

State/Province

Florida

ZIP/Postal Code

33716

Country

United States

Facility Name

Comprehensive NeuroScience, Inc. Atlanta

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30328

Country

United States

Facility Name

Elkind Headache Center

City

Mount Vernon

State/Province

New York

ZIP/Postal Code

10550

Country

United States

Facility Name

Lifetree Clinical Research

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84106

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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