Migraine With AuraPhase 2NCT00920686
Study of NXN 188 for the Treatment of Migraine With Aura
A Phase 2 study testing NXN-188 and sumatriptan succinate in people with Migraine With Aura, run by NeurAxon Inc. at 16 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Migraine With Aura
- What is being tested?
- NXN-188 and sumatriptan succinate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 239 participants
- Where
- 16 sitesUnited States
- Study dates
- Jun 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
- Male or female migraineurs between 18 and 65 years old.
- 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
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- 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
- Migraine pain following aura in at least 75% of occurrences
- 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.
- 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)
- Body mass index (BMI) range of 18 to 35
- 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
- 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
- The subject is willing and able to comply with all testing requirements defined in the protocol
- All females will avoid pregnancy at least 10 days before randomization, and up until 3 months after dosing.
- All subjects/partners must use a double-barrier method of birth control during the study and for 3 months after dosing.
Who cannot join
- A diagnosis of headaches that is not consistent with migraine with aura.
- Presence of any risk factors that would preclude the use of triptans:
- 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
- Pregnancy or lactation
- History of significant neurological, hepatic, renal, endocrine, cardiovascular, gastrointestinal, pulmonary, rheumatologic, autoimmune, or metabolic disease
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- 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.
- Use of monoamine oxidase inhibitors 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 who are 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
16 sites in 1 country.
16 sites in 1 country
United States16 sites
Michigan Head-Pain and Neurological Institute
Ann Arbor, Michigan, 48104
Regional Clinical Research, Inc.
Endwell, New York, 13760
Headache Wellness Center
Greensboro, North Carolina, 27405
Elkind Headache Center
Mount Vernon, New York, 10550
Coastal Carolina Research Center, Inc
Mt. Pleasant, South Carolina, 29464
C. Philip O'Carrroll, MD, Inc.
Newport Beach, California, 92660
The Research Center of Southern California, LLC
Oceanside, California, 92056
Meridian Clinical Research, LLC
Omaha, Nebraska, 68134
Vince and Associates Clinical Research
Overland Park, Kansas, 66212
Rochester Clinical Research, Inc
Rochester, New York, 14609
San Francisco Headache Clinic
San Francisco, California, 94109
California Medical Clinic for Headache
Santa Monica, California, 90404
Headache Care Center/Clinvest
Springfield, Missouri, 65807
Mercy Health Research
St Louis, Missouri, 63141
Comprehensive Neuroscience, Inc.
St. Petersburg, Florida, 33702
Advanced Clinical Research, Inc.
West Jordan, Utah, 84088
About this study
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
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.
Read the 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.
- Conditions
- Migraine With Aura
- Being tested
- NXN-188, placebo, sumatriptan succinate
- Keywords
- Migraine, aura
- Medical subject headings
- Migraine with Aura, Migraine Disorders, Epilepsy
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
NXN-188 hard gelatin capsules, 600 mg administered as three 200 mg capsules
placeboDrug
Also called placebo capsules
administered as 3 placebo hard gelatin capsules
sumatriptan succinateDrug
administered in a hard gelatin capsule with 2 capsules of placebo
| Study group | Role | What they receive |
|---|---|---|
| NXN-188 | Experimental | NXN-188, 600 mg, PRN Receives: Drug: NXN-188 |
| sumatriptan succinate 100 mg | Active comparator | Sumatriptan, 100 mg, PRN Receives: Drug: sumatriptan succinate |
| placebo | Placebo comparator | matching, PRN Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time (Hours) to First Use of Rescue Medication
Measured: 24 hours
Secondary outcomes (4)
Headache Relief and Recurrence (Observed Cases)
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.
Measured: 2, 4 and up to 24 hours
2 Hours Post Administration - Incidence of Complete Headache Relief, Photophobia, Phonophobia and Nausea
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
Measured: 2 hours
4 Hours Post Administration - Incidence of Complete Headache Relief, Photophobia, Phonophobia and Nausea
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
Measured: 4 hours
24 Hours Post Administration - Incidence of Complete Headache Relief, Photophobia, Phonophobia and Nausea
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
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 posted15 Jun 2009 (estimated)
- Study startJun 2009
- Primary completionMar 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 With 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
- 239 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
- NCT00920686
- Sponsor's protocol ID
- NXN-188-203
- Status last verified
- Jul 2014
- First submitted
- 12 Jun 2009
- Last updated
- 11 Aug 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 11 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00920686
- Acronym / sponsor ID
- NXN-188-203
- Conditions
- Migraine With Aura
- Keywords
- Migraine, aura
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 239 participants (actual)
- Lead sponsor
- NeurAxon Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2009
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 15 Jun 2009 (estimated)
- Results
- Posted 11 Aug 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| NXN-188 | Experimental | Drug: NXN-188NXN-188, 600 mg, PRN |
| sumatriptan succinate 100 mg | Active comparator | Drug: sumatriptan succinateSumatriptan, 100 mg, PRN |
| placebo | Placebo comparator | Drug: placebomatching, PRN |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- Male or female migraineurs between 18 and 65 years old.
- Subjects must have a headache history of migraine with aura as defined by:
- Migraine pain following aura in at least 75% of occurrences
- 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
- 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)
Key exclusion criteria (14 listed)
- A diagnosis of headaches that is not consistent with migraine with aura.
- Presence of any risk factors that would preclude the use of triptans:
- 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
- Pregnancy or lactation
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 dihydrochlorideNXN-188 hard gelatin capsules, 600 mg administered as three 200 mg capsules | Drug | NXN-188 |
| placeboAlso: placebo capsulesadministered as 3 placebo hard gelatin capsules | Drug | placebo |
| sumatriptan succinateadministered in a hard gelatin capsule with 2 capsules of placebo | Drug | sumatriptan succinate 100 mg |
Primary outcome
Time (Hours) to First Use of Rescue Medication
Time frame: 24 hours
4 secondary outcomes
Headache Relief and Recurrence (Observed Cases)
Time frame: 2, 4 and up to 24 hours
2 Hours Post Administration - Incidence of Complete Headache Relief, Photophobia, Phonophobia and Nausea
Time frame: 2 hours
4 Hours Post Administration - Incidence of Complete Headache Relief, Photophobia, Phonophobia and Nausea
Time frame: 4 hours
24 Hours Post Administration - Incidence of Complete Headache Relief, Photophobia, Phonophobia and Nausea
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 11 Aug 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
16 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 and sumatriptan succinate in people with Migraine With Aura, run by NeurAxon Inc. at 16 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 23 inclusion and 14 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 11 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 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 Aug 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?
Time (Hours) to First Use of Rescue Medication (time frame: 24 hours). 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 11 Aug 2014.