Migraine Without AuraPhase 2NCT00959751
Study of the Safety and Effectiveness of NXN-188 for the Treatment of Migraine Headache Without Aura
A Phase 2 study testing NXN-188 in people with Migraine Without Aura, run by NeurAxon Inc. at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Migraine Without Aura
- What is being tested?
- NXN-188
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 195 participants
- Where
- 4 sitesUnited States
- Study dates
- Jul 2009to Mar 2010
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Comprehensive NeuroScience, Inc. Atlanta
Atlanta, Georgia, 30328
Elkind Headache Center
Mount Vernon, New York, 10550
Lifetree Clinical Research
Salt Lake City, Utah, 84106
Comprehensive Neuroscience, Inc.
St. Petersburg, Florida, 33716
About this study
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
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.
Read the 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.
- Conditions
- Migraine Without Aura
- Being tested
- NXN-188, Placebo
- Keywords
- migraine
- Medical subject headings
- Migraine without Aura, Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NXN-188Drug
Also called NXN-188 dihydrochloride
200 mg capsules, 600 mg, PRN
PlaceboDrug
200 mg capsules with no active ingredient designed to match the NXN-188 capsules
| Study group | Role | What they receive |
|---|---|---|
| NXN-188 600 mg | Experimental | 3 x 200 mg capsules, PRN Receives: Drug: NXN-188 |
| Placebo | Placebo comparator | 3 x 0 mg capsules, PRN Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 hours
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.
Measured: 4 hours
Secondary outcomes (5)
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
Measured: 72 hours
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
Measured: 72 hours
Complete Headache Relief (Efficacy Evaluable Analysis Set)
Measured: 72 hours
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.
Measured: 24 Hours
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
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2009 (estimated)
- Study startJul 2009
- Primary completionFeb 2010
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Migraine Without AuraStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 195 participants (actual)
Sponsor and investigators
- Lead sponsor
- NeurAxon Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Guy Boudreau, MD, Principal investigator, Hopital Notre-Dame Du Chum, Montreal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00959751
- Sponsor's protocol ID
- NXN-188-204
- Status last verified
- Jul 2014
- First submitted
- 14 Aug 2009
- Last updated
- 23 Jul 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00959751
- Acronym / sponsor ID
- NXN-188-204
- Conditions
- Migraine Without Aura
- Keywords
- migraine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 195 participants (actual)
- Lead sponsor
- NeurAxon Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2009
- Primary completion
- Feb 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 17 Aug 2009 (estimated)
- Results
- Posted 11 Jul 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NXN-188 600 mg | Experimental | Drug: NXN-1883 x 200 mg capsules, PRN |
| Placebo | Placebo comparator | Drug: Placebo3 x 0 mg capsules, PRN |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NXN-188Also: NXN-188 dihydrochloride200 mg capsules, 600 mg, PRN | Drug | NXN-188 600 mg |
| Placebo200 mg capsules with no active ingredient designed to match the NXN-188 capsules | Drug | Placebo |
Primary outcome
Headache Relief (Modified LOCF - Efficacy Evaluable Analysis Set)
Time frame: 2 hours
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
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.
5 secondary outcomes
Headache Relief Based on a 2-Point Reduction From Baseline (Modified LOCF - Efficacy Evaluable Analysis Set)
Time frame: 72 hours
Headache Relief Based on a 1-Point Reduction From Baseline (Modified LOCF - Efficacy Evaluable Analysis Set)
Time frame: 72 hours
Complete Headache Relief (Efficacy Evaluable Analysis Set)
Time frame: 72 hours
Time (Hours) to First Use of Rescue Medication (Full Analysis Set)
Time frame: 24 Hours
Overall Evaluation of Study Medication at 24 Hours Post Administration (Full Analysis Set)
Time frame: 24 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guy Boudreau, MD principal investigator
Hopital Notre-Dame Du Chum, Montreal
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing NXN-188 in people with Migraine Without Aura, run by NeurAxon Inc. at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Jul 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Headache Relief (Modified LOCF - Efficacy Evaluable Analysis Set) (time frame: 2 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2014.