Status:
COMPLETED
A Research Study Examining Migranal and Skin Sensitivity in Subjects With Migraine
Lead Sponsor:
Thomas Jefferson University
Conditions:
Migraine
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief 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). Cutane...
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 in...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2009
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT00335777
Start Date
August 1 2006
End Date
April 1 2009
Last Update
March 11 2022
Active Locations (1)
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1
Jefferson Headache Center
Philadelphia, Pennsylvania, United States, 19107