MigrainePhase 4NCT00335777
A Research Study Examining Migranal and Skin Sensitivity in Subjects With Migraine
A Phase 4 study testing Migranal nasal spray at 1 hour and Migranal nasal spray at 4 hour in people with Migraine, run by Thomas Jefferson University at 1 site in United States.
Trial summary
This is a research study looking at Migranal (study drug) in the treatment of two migraine attacks in patients who have a history of cutaneous allodynia (pronounced q-tay-nee-us al-o-din-ee-a). Cutaneous allodynia is an increased skin sensitivity experienced during a headache. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Migraine
- What is being tested?
- Migranal nasal spray at 1 hour and Migranal nasal spray at 4 hour
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2006to Apr 2009
- Phase
- Phase 4
- 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 and female subjects between the ages of 18 and 65, inclusive
- Subjects diagnosed with episodic migraine, with or without aura according to IHS (International Headache Society) criteria (Appendix B) for at least one-year prior to screening
- Subjects who experience between 3-10 migraine attacks (inclusive) per month (during the previous 6 months) with no more than 15 days of headache per month.
- Subjects who report their migraine pain quality as pulsating/ throbbing.
- Subject experiences episodic migraine associated with cutaneous allodynia, as determined by the Cutaneous Allodynia screening tool and investigator.
- Subject is using or agrees to use for the duration of participation a medically acceptable form of contraception (as determined by investigator), if female of child-bearing potential
- Subjects who are able to understand and comply with all study procedures.
- Subject provides written informed consent prior to any screening procedures being conducted
Who cannot join
- Pregnant and/or lactating women
- Subjects who, in the investigators opinion, have a history or have evidence of a medical or psychiatric condition that would expose them to an increased risk of a significant adverse event or would interfere with the assessments of efficacy and tolerability during this trial
- Subjects with an abnormal ECG that, in the investigators opinion, would expose them to increased risk of adverse events or interfere with study drug and/or analysis of efficacy/tolerability
- Subjects currently using, or expecting to use during the trial, CYP 3A4(CYP3A4 enzyme) inhibitors (such as protease inhibitors and macrolide antibiotics)
- Subjects with severely impaired hepatic or renal function, as determined by the investigator
- Subjects who have participated in an investigational drug trial in the 30 days prior to the screening visit
Show all 12Show fewer
- Subjects who currently have or have a history of basilar or hemiplegic migraine
- Subjects who have previously shown hypersensitivity to ergot alkaloids
- Subjects who have a history of non-response to DHE-45 (dihydroergotamine) or Migranal®, as determined by investigator
- Subjects with uncontrolled hypertension
- Subjects who currently have or who have a history of ischemia and/or vasospastic coronary artery disease
- Subjects who, in the investigators opinion, have significant risk factors of coronary artery disease
Trial locations and contacts
1 site in 1 country.
United States1 site
Jefferson Headache Center
Philadelphia, Pennsylvania, 19107
About this study
Official title: An Open-Label Pilot Trial To Collect And Evaluate Data On The Use Of Migranal® In The Treatment Of Two Acute Migraine Attacks Associated With Cutaneous Allodynia
This is a research study looking at Migranal (study drug) in the treatment of two migraine attacks in patients who have a history of cutaneous allodynia (pronounced q-tay-nee-us al-o-din-ee-a). Cutaneous allodynia is an increased skin sensitivity experienced during a headache. It has been noted in several studies that in patients with migraine, seventy nine percent of the patients experienced allodynia on the facial skin on the same side as the headache. Understanding more about allodynia may help us understand how the pain system works in migraine.
This study will compare the differences, if any, in attacks treated early with study drug (at 1-hour from onset) and attacks treated later (at 4-hours). You will be asked to treat one attack early and one attack late for this study. If the first attack you treat is early (at 1 hour following onset of throbbing pain) then the second attack you treat should be late (at 4 hours following onset of throbbing pain).
It is hoped that this study will provide information on the use of Migranal in subjects who have cutaneous allodynia. The results from this study may be used in the development of larger clinical trials. The study drug is a medication that is taken in the form of nasal spray.
Read the detailed description
This is a three visit trial consisting of a screening visit, one follow-up visit and a termination visit. Subjects will be screened using the Cutaneous Allodynia Screening Tool (Appendix A) and the investigator will determine whether or not the subject experiences episodic migraine headaches associated with cutaneous allodynia. Those subjects who test positive for the afore-stated will then proceed with the treatment phase of the project.
Migranal® will be taken by the subject at home at 1-hour following the onset of throbbing pain for one of the two qualifying migraine attacks and at 4-hours following onset of throbbing pain for the second qualifying migraine attack. Migranal® 4 mg. will be self administered by each subject in the following manner: one spray in each nostril, wait 15 minutes then follow with one spray in each nostril. This will deliver the desired 4 mg. dose. Cutaneous allodynia assessments will be made periodically prior to and after administration of study drug. Subjects will be asked to return to the center within 1 week of treating each attack. Subjects will be instructed to treat their 1st qualifying attack within 6 weeks of the screening visit and their 2nd qualifying attack within 6 weeks of their follow-up visit 1.
Migraine pain and associated symptoms assessments will be measured by the subjects for 24-hours from the administration of study drug for each attack.
- Conditions
- Migraine
- Being tested
- Migranal nasal spray at 1 hour, Migranal nasal spray at 4 hour
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Migranal nasal spray at 1 hourDrug
Also called Dihydroergotamine (DHE)
Migranal® 4 mg. will be self administered by each subject in the following manner: one spray in each nostril, wait 15 minutes then follow with one spray in each nostril. This will deliver the desired 4 mg. dose.
Migranal nasal spray at 4 hourDrug
Also called Dihydroergotamine (DHE)
Migranal® 4 mg. will be self administered by each subject in the following manner: one spray in each nostril, wait 15 minutes then follow with one spray in each nostril. This will deliver the desired 4 mg. dose.
| Study group | Role | What they receive |
|---|---|---|
| Migranal treatment first treatment phase | Experimental | All subjects were asked to treat one headache at 1 hour (early) and one headache at 4 hours after onset of throbbing (late). Dose of nasal spray constant for both time points. The subject could determine the order in which they could treat the headaches (early (first treatment phase) then late (second treatment phase), or late (first treatment phase) then early (second treatment phase). Receives: Drug: Migranal nasal spray at 1 hour |
| Migranal second treatment phase | Experimental | All subjects were asked to treat one headache at 1 hour (early) and one headache at 4 hours after onset of throbbing (late). Dose of nasal spray constant for both time points. The subject could determine the order in which they could treat the headaches (early (first treatment phase) then late (second treatment phase), or late (first treatment phase) then early (second treatment phase). Receives: Drug: Migranal nasal spray at 4 hour |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects Who Were Pain Free at 2 Hours Post Treatment With Study Drug.
Number of subjects who were pain free at 2 hours after treatment with study medication when they treated a migraine early (defined as treatment within 1 hour of onset of throbbing pain) compared to the number of subjects who were pain free at 2 hours after treatment with study medication when they treated late (defined as 4 hours after onset of throbbing pain). "Pain free" is defined as a subject rating of zero on a 4 point pain scale; (0=None, 1=mild, 2= moderate, 3=severe).
Measured: 2 hours post treatment with study medication
Secondary outcomes (1)
Number of Subjects Who Had Pain Relief at 2 Hours Post Treatment With Study Drug.
Number of subjects who had pain relief at 2 hours after treatment with study medication when they treated a migraine early (defined as treatment within 1 hour of onset of throbbing pain) compared to the number of subjects who were pain relief at 2 hours after treatment with study medication when they treated late (defined as 4 hours after onset of throbbing pain). "Pain reduction" is defined as a subject with a 1 or more point decrease on a 4 point pain scale; (0=None, 1=mild, 2= moderate, 3=severe).
Measured: 2 hours post treatment with study medication
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2006 (estimated)
- Study startAug 2006
- Primary completionDec 2008
- Study completionApr 2009
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 MigraineStudies of the same condition, open and under way.
- More trials run by Thomas Jefferson UniversityThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stephen D. Silberstein, M.D., Principal investigator, Jefferson Headache Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00335777
- Sponsor's protocol ID
- SDS/MIG-CA/ 01
- Status last verified
- Feb 2022
- First submitted
- 9 Jun 2006
- Last updated
- 11 Mar 2022
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Pilot Trial To Collect And Evaluate Data On The Use Of Migranal® In The Treatment Of Two Acute Migraine Attacks Associated With Cutaneous Allodynia
- ClinicalTrials.gov ID
- NCT00335777
- Acronym / sponsor ID
- SDS/MIG-CA/ 01
- Conditions
- Migraine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Thomas Jefferson UniversityUniversity, hospital or other
- Study start
- Aug 2006
- Primary completion
- Dec 2008 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 12 Jun 2006 (estimated)
- Results
- Posted 14 Oct 2011
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 research study looking at Migranal (study drug) in the treatment of two migraine attacks in patients who have a history of cutaneous allodynia (pronounced q-tay-nee-us al-o-din-ee-a). Cutaneous allodynia is an increased skin sensitivity experienced during a headache. It has been noted in several studies that in patients with migraine, seventy nine percent of the patients experienced allodynia on the facial skin on the same side as the headache. Understanding more about allodynia may help us understand how the pain system works in migraine.
This study will compare the differences, if any, in attacks treated early with study drug (at 1-hour from onset) and attacks treated later (at 4-hours). You will be asked to treat one attack early and one attack late for this study. If the first attack you treat is early (at 1 hour following onset of throbbing pain) then the second attack you treat should be late (at 4 hours following onset of throbbing pain).
It is hoped that this study will provide information on the use of Migranal in subjects who have cutaneous allodynia. The results from this study may be used in the development of larger clinical trials. The study drug is a medication that is taken in the form of nasal spray.
Detailed description
This is a three visit trial consisting of a screening visit, one follow-up visit and a termination visit. Subjects will be screened using the Cutaneous Allodynia Screening Tool (Appendix A) and the investigator will determine whether or not the subject experiences episodic migraine headaches associated with cutaneous allodynia. Those subjects who test positive for the afore-stated will then proceed with the treatment phase of the project.
Migranal® will be taken by the subject at home at 1-hour following the onset of throbbing pain for one of the two qualifying migraine attacks and at 4-hours following onset of throbbing pain for the second qualifying migraine attack. Migranal® 4 mg. will be self administered by each subject in the following manner: one spray in each nostril, wait 15 minutes then follow with one spray in each nostril. This will deliver the desired 4 mg. dose. Cutaneous allodynia assessments will be made periodically prior to and after administration of study drug. Subjects will be asked to return to the center within 1 week of treating each attack. Subjects will be instructed to treat their 1st qualifying attack within 6 weeks of the screening visit and their 2nd qualifying attack within 6 weeks of their follow-up visit 1.
Migraine pain and associated symptoms assessments will be measured by the subjects for 24-hours from the administration of study drug for each attack.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Migranal treatment first treatment phase | Experimental | Drug: Migranal nasal spray at 1 hourAll subjects were asked to treat one headache at 1 hour (early) and one headache at 4 hours after onset of throbbing (late). Dose of nasal spray constant for both time points. The subject could determine the order in which they could treat the headaches (early (first treatment phase) then late (second treatment phase), or late (first treatment phase) then early (second treatment phase). |
| Migranal second treatment phase | Experimental | Drug: Migranal nasal spray at 4 hourAll subjects were asked to treat one headache at 1 hour (early) and one headache at 4 hours after onset of throbbing (late). Dose of nasal spray constant for both time points. The subject could determine the order in which they could treat the headaches (early (first treatment phase) then late (second treatment phase), or late (first treatment phase) then early (second treatment phase). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male and female subjects between the ages of 18 and 65, inclusive
- Subjects diagnosed with episodic migraine, with or without aura according to IHS (International Headache Society) criteria (Appendix B) for at least one-year prior to screening
- Subjects who experience between 3-10 migraine attacks (inclusive) per month (during the previous 6 months) with no more than 15 days of headache per month.
- Subjects who report their migraine pain quality as pulsating/ throbbing.
- Subject experiences episodic migraine associated with cutaneous allodynia, as determined by the Cutaneous Allodynia screening tool and investigator.
Key exclusion criteria (12 listed)
- Pregnant and/or lactating women
- Subjects who, in the investigators opinion, have a history or have evidence of a medical or psychiatric condition that would expose them to an increased risk of a significant adverse event or would interfere with the assessments of efficacy and tolerability during this trial
- Subjects with an abnormal ECG that, in the investigators opinion, would expose them to increased risk of adverse events or interfere with study drug and/or analysis of efficacy/tolerability
- Subjects currently using, or expecting to use during the trial, CYP 3A4(CYP3A4 enzyme) inhibitors (such as protease inhibitors and macrolide antibiotics)
- Subjects with severely impaired hepatic or renal function, as determined by the investigator
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 |
|---|---|---|
| Migranal nasal spray at 1 hourAlso: Dihydroergotamine (DHE)Migranal® 4 mg. will be self administered by each subject in the following manner: one spray in each nostril, wait 15 minutes then follow with one spray in each nostril. This will deliver the desired 4 mg. dose. | Drug | Migranal treatment first treatment phase |
| Migranal nasal spray at 4 hourAlso: Dihydroergotamine (DHE)Migranal® 4 mg. will be self administered by each subject in the following manner: one spray in each nostril, wait 15 minutes then follow with one spray in each nostril. This will deliver the desired 4 mg. dose. | Drug | Migranal second treatment phase |
Primary outcome
Number of Subjects Who Were Pain Free at 2 Hours Post Treatment With Study Drug.
Time frame: 2 hours post treatment with study medication
Number of subjects who were pain free at 2 hours after treatment with study medication when they treated a migraine early (defined as treatment within 1 hour of onset of throbbing pain) compared to the number of subjects who were pain free at 2 hours after treatment with study medication when they treated late (defined as 4 hours after onset of throbbing pain). "Pain free" is defined as a subject rating of zero on a 4 point pain scale; (0=None, 1=mild, 2= moderate, 3=severe).
1 secondary outcome
Number of Subjects Who Had Pain Relief at 2 Hours Post Treatment With Study Drug.
Time frame: 2 hours post treatment with study medication
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2022.
- 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.
Stephen D. Silberstein, M.D. principal investigator
Jefferson Headache Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Migranal nasal spray at 1 hour and Migranal nasal spray at 4 hour in people with Migraine, run by Thomas Jefferson University at 1 site 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 8 inclusion and 12 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 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 14 Oct 2011). 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?
Number of Subjects Who Were Pain Free at 2 Hours Post Treatment With Study Drug. (time frame: 2 hours post treatment with study medication). 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 Mar 2022.