MigraineNCT00203268
A Study Examining the Use of a Migraine Medicine in the Treatment of Two Migraine Attacks in Patients Who Have Increased Skin Sensitivity
A study testing dihydroergotamine mesylate in people with Migraine, run by Thomas Jefferson University at 1 site in United States.
Trial summary
This is a research study examining a migraine medicine dihydroergotamine mesylate (DHE-45).It will be used to treat two migraine attacks in subjects who have a history of skin sensitivity associated with their headaches.This skin sensitivity is called cutaneous allodynia (pronounced q-tay-nee-us… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Migraine
- What is being tested?
- dihydroergotamine mesylate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2003to Mar 2005
- Phase
- Interventional
- 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 International Headache Criteria (IHS) (Appendix B) for at least one-year prior to screening
- Subjects who experience between 3-10 migraine attacks 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 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 come for 2-hour in-clinic treatment of two separate migraine attacks
- 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, Cytochrome P450 3A4 (CYP3A4 enzymes) 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, 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 Dihydroergotamine Mesylate in the Treatment of Two Migraine Attacks Associated With Cutaneous Allodynia
This is a research study examining a migraine medicine dihydroergotamine mesylate (DHE-45).It will be used to treat two migraine attacks in subjects who have a history of skin sensitivity associated with their headaches.This skin sensitivity is called cutaneous allodynia (pronounced q-tay-nee-us al-o-din-ee-uh).Cutaneous allodynia is a sensation of pain when a non-noxious stimulus is applied to normal skin. It has been noted in several studies that in subjects with migraine, seventy nine percent of the subjects experienced allodynia on the facial skin on the same side as the headache. It has also been shown that that once allodynia develops, other migraine medicines that would normally be very effective for migraine pain, become much less effective or ineffective. This study will compare the differences,if any, in attacks treated early with this study drug and treated later with the same study drug. It is hoped that that this trial will provide information on the use of DHE-45 in subjects who have cutaneous allodynia. Understanding more about allodynia may help us understand how the pain system works in migraine.
- Conditions
- Migraine
- Being tested
- dihydroergotamine mesylate
- Keywords
- migraine, cutaneous allodynia
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dihydroergotamine mesylateDrug
Also called DHE-45
1.0 mg. intramuscularly
| Study group | Role | What they receive |
|---|---|---|
| Treatment with dihydroergotamine mesylate (DHE-45) | Experimental | Subjects who treated a moderate to severe migraine 2 and 4 hours after the onset of throbbing headache pain Receives: Drug: dihydroergotamine mesylate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects Reporting Headache Relief at the 2 Hour Post Treatment Assessment. Relief Was Measured as a 2-point Change on a 4-point Scale (0=None, 1=Mild, 2=Moderate, 3=Severe)in Both the Early Treatment and Late Treatment Groups.
Data was collected at 2 hours post treatment to assess pain level. This assessment was done when subjects treated a migraine early (defined as treatment at 2 hours after onset of throbbing pain)and then late (defined as treatment at 4 hours after onset of throbbing pain). The proportion of subjects reporting headache relief at the 2 hour post treatment assessment was determined for each group and then compared.
Measured: 2 hours post treatment and 4 hours post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startDec 2003
- Primary completionMar 2005
- Study completionMar 2005
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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Collaborators
- Bausch Health Americas, Inc.
- Responsible party
- Sponsor
- Investigators
- Stephen D Silberstein, MD, Principal investigator, Thomas Jefferson University, Jefferson Headache Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00203268
- Sponsor's protocol ID
- SDS/DHE/01
- Status last verified
- May 2014
- First submitted
- 13 Sep 2005
- Last updated
- 9 Jun 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 9 Jun 2014. 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 Dihydroergotamine Mesylate in the Treatment of Two Migraine Attacks Associated With Cutaneous Allodynia
- ClinicalTrials.gov ID
- NCT00203268
- Acronym / sponsor ID
- SDS/DHE/01
- Conditions
- Migraine
- Keywords
- migraine, cutaneous allodynia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Thomas Jefferson UniversityUniversity, hospital or other
- Collaborators
- Bausch Health Americas, Inc.
- Study start
- Dec 2003
- Primary completion
- Mar 2005 (actual)
- Study completion
- Mar 2005 (actual)
- First posted
- 20 Sep 2005 (estimated)
- Results
- Posted 9 Jun 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 research study examining a migraine medicine dihydroergotamine mesylate (DHE-45).It will be used to treat two migraine attacks in subjects who have a history of skin sensitivity associated with their headaches.This skin sensitivity is called cutaneous allodynia (pronounced q-tay-nee-us al-o-din-ee-uh).Cutaneous allodynia is a sensation of pain when a non-noxious stimulus is applied to normal skin. It has been noted in several studies that in subjects with migraine, seventy nine percent of the subjects experienced allodynia on the facial skin on the same side as the headache. It has also been shown that that once allodynia develops, other migraine medicines that would normally be very effective for migraine pain, become much less effective or ineffective. This study will compare the differences,if any, in attacks treated early with this study drug and treated later with the same study drug. It is hoped that that this trial will provide information on the use of DHE-45 in subjects who have cutaneous allodynia. Understanding more about allodynia may help us understand how the pain system works in migraine.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment with dihydroergotamine mesylate (DHE-45) | Experimental | Drug: dihydroergotamine mesylateSubjects who treated a moderate to severe migraine 2 and 4 hours after the onset of throbbing headache pain |
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 International Headache Criteria (IHS) (Appendix B) for at least one-year prior to screening
- Subjects who experience between 3-10 migraine attacks 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 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
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, Cytochrome P450 3A4 (CYP3A4 enzymes) 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 |
|---|---|---|
| dihydroergotamine mesylateAlso: DHE-451.0 mg. intramuscularly | Drug | Treatment with dihydroergotamine mesylate (DHE-45) |
Primary outcome
Number of Subjects Reporting Headache Relief at the 2 Hour Post Treatment Assessment. Relief Was Measured as a 2-point Change on a 4-point Scale (0=None, 1=Mild, 2=Moderate, 3=Severe)in Both the Early Treatment and Late Treatment Groups.
Time frame: 2 hours post treatment and 4 hours post treatment
Data was collected at 2 hours post treatment to assess pain level. This assessment was done when subjects treated a migraine early (defined as treatment at 2 hours after onset of throbbing pain)and then late (defined as treatment at 4 hours after onset of throbbing pain). The proportion of subjects reporting headache relief at the 2 hour post treatment assessment was determined for each group and then compared.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 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.
Stephen D Silberstein, MD principal investigator
Thomas Jefferson University, 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 study testing dihydroergotamine mesylate 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 9 Jun 2014. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Jun 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?
Number of Subjects Reporting Headache Relief at the 2 Hour Post Treatment Assessment. Relief Was Measured as a 2-point Change on a 4-point Scale (0=None, 1=Mild, 2=Moderate, 3=Severe)in Both the Early Treatment and Late Treatment Groups. (time frame: 2 hours post treatment and 4 hours post treatment). 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 9 Jun 2014.