Study of the Safety and Effectiveness of NXN-188 for the Treatment of Migraine Headache Without Aura
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.
|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|
- Headache Relief (Modified LOCF - Efficacy Evaluable Analysis Set) [ Time Frame: 2 hours ] [ Designated as safety issue: No ]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) [ Time Frame: 4 hours ] [ Designated as safety issue: No ]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.
- Headache Relief Based on a 2-Point Reduction From Baseline (Modified LOCF - Efficacy Evaluable Analysis Set) [ Time Frame: 72 hours ] [ Designated as safety issue: No ]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) [ Time Frame: 72 hours ] [ Designated as safety issue: No ]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 Frame: 72 hours ] [ Designated as safety issue: No ]
- Time (Hours) to First Use of Rescue Medication (Full Analysis Set) [ Time Frame: 24 Hours ] [ Designated as safety issue: No ]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) [ Time Frame: 24 hours ] [ Designated as safety issue: No ]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
|Study Start Date:||July 2009|
|Study Completion Date:||March 2010|
|Primary Completion Date:||February 2010 (Final data collection date for primary outcome measure)|
Experimental: NXN-188 600 mg
3 x 200 mg capsules, PRN
200 mg capsules, 600 mg, PRN
Other Name: NXN-188 dihydrochloride
Placebo Comparator: Placebo
3 x 0 mg capsules, PRN
200 mg capsules with no active ingredient designed to match the NXN-188 capsules
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00959751
|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|
|Principal Investigator:||Guy Boudreau, MD||Hopital Notre-Dame Du Chum, Montreal|