Chronic Migraine Clinical Trial
— ARWMOfficial title:
Aspirin Resistance in Women With Migraine
Verified date | May 2013 |
Source | Swedish Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
The purpose of this study is to compare the rates of aspirin resistance (high residual
platelet reactivity) between women with episodic and chronic migraine and women without
migraine.
Emerging evidence suggests that migraineurs, especially women < 45 years who have aura, have
an increased risk of stroke and myocardial infarction (MI, or heart attack). The mechanism
linking migraine, stroke and MI is unclear although increased platelet activation and
aggregation observed during and between migraine attacks may be a plausible theory.
Aspirin is an inexpensive, relatively safe antiplatelet drug that reduces the risk of stroke
and MI. Preliminary data suggest that aspirin's (325mg) therapeutic effect on platelet
inhibition may be reduced in migraineurs (i.e., aspirin resistance), thus limiting aspirin's
effectiveness at preventing stroke and MI risks in persons with migraine. Additional
research is warranted to confirm these findings in migraineurs because daily, low-dose
aspirin 81 mg is the recommended first line therapy for primary and secondary prevention of
stroke and MI
The researchers hypothesize that resistance to aspirin 81mg may occur more frequently in
women with episodic and chronic migraine than in women without migraine. The findings may
have important implications for women who have migraine and use aspirin to prevent migraine
symptoms or comorbidities associated with migraine including stroke and MI.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | August 2012 |
Est. primary completion date | October 2011 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 50 Years |
Eligibility |
Inclusion Criteria: - Women 18-50 years of age, of childbearing potential - Able to read, speak, and understand English -- except if patient is blind, in which case only the ability to understand English is required. Episodic Migraine Group: - Documented diagnosis of episodic migraine for a 2-year period preceding enrollment, using the International Headache Society (IHS) criteria. - Frequency of 2-14 migraine days in the three months prior to enrollment. - Equal numbers (n=20 each) will have a documented diagnosis of migraine with aura (MA) and migraine without aura (MO). - For women who have a diagnosis of MA, focal neurologic symptoms must precede or accompany the headache (aura) for at least one headache in the 12 months prior to enrollment. Chronic Migraine Group: - Frequency of = 15 headache days per month for = 3 months. - On at least 8 days per month for = 3 months headache has fulfilled criteria for pain and associated symptoms of MO. Control group: - No diagnosis of migraine, confirmed by the Migraine Assessment Tool. Exclusion Criteria: - Pregnancy or lactation - Post-menopausal, either natural or surgical (bilateral oophorectomy) - Current prescribed daily medication regimen includes any of the following: warfarin, glycoprotein IIb/IIIa inhibitors (abciximab, tirofiban), antiplatelet agents (clopidogrel, ticlopidine, dipyridamole), or non-steroidal anti-inflammatory drugs (e.g., ibuprofen, naproxen, celecoxib), Vitamin E in doses > 800 IU per day, Omega-3 fatty acids in doses > 3 g/day, willow bark (any amount), aspirin or aspirin-containing medications. - Aspirin intolerance or allergy, or peptic ulcer disease. - Platelet count <150,000/µl or >450,000/µl. - Hemoglobin <10 g/dL. - History or current diagnosis of myocardial infarction, stroke, coronary artery disease, peripheral arterial disease, diabetes mellitus, or renal disease. - Unable to tolerate washout of protocol-restricted medications and/or supplements (see #3). - Family (first-degree relative) or patient history of bleeding or hemorrhagic disorders including von Willebrand Factor Deficiency, Glanzmann Thrombasthenia, Bernard-Soulier Syndrome or myeloproliferative syndromes. - Major surgical procedure, trauma, blood donation, or major blood loss (>300 cc) within 30 days prior to enrollment. |
Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Screening
Country | Name | City | State |
---|---|---|---|
United States | The University of Washington | Seattle | Washington |
Lead Sponsor | Collaborator |
---|---|
Swedish Medical Center | Accumetrics, Inc., National Headache Foundation, University of Washington, Wadsworth Foundation |
United States,
Jesurum, J.T., Fuller, C.J., Lucas, S.M., Murinova, N., Hales, L.E., McGee, E.A. The association between migraine frequency and platelet activation in episodic migraine: a pilot study. Cephalalgia 2009; 29 (Suppl. 1); 2009.
Jesurum, J.T., Fuller, C.J., Lucas, S.M., Murinova, N., Truva, C.M., McGee, E.A., Reisman, M. High prevalence of aspirin resistance in migraineurs. Cephalalgia 2009; 29 (Suppl. 1): 138.
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Aspirin Reaction Units (ARU) | Measurement of ARU, indicative of platelet inhibition, using the VerifyNow Aspirin Assay (Accumetrics, San Diego, CA) | 10-14 days | No |
Secondary | Serum thromboxane B2 | Aspirin acts by inhibiting production of thromboxane A2 by platelets. Thromboxane B2 is the stable product of thromboxane A2. | 10-14 days | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05720819 -
Biofeedback-VR for Treatment of Chronic Migraine
|
N/A | |
Not yet recruiting |
NCT06428838 -
Eptinezumab as an Adjunct to Standard of Care for Migraine in an Acute Emergency Context
|
Phase 3 | |
Recruiting |
NCT05517200 -
Pilot Study for a Machine Learning Test for Migraine
|
||
Recruiting |
NCT05891808 -
miR-155 Expression in Episodic and Chronic Migraine
|
||
Completed |
NCT02514148 -
Biobehavioral Physical Therapy Strategies Based on Therapeutic Exercise Applied to Chronic Migraine Patients
|
N/A | |
Enrolling by invitation |
NCT02291380 -
A Study to Evaluate Botulinum Toxin Type A for Injection(HengLi®)for Prophylactic Treatment of Chronic Migraine
|
Phase 3 | |
Withdrawn |
NCT02122744 -
RCT Versus Placebo of rTMSQP Over Visual Cortex for the Prevention of Chronic Migraine
|
N/A | |
Completed |
NCT02122237 -
Cathodal tDCS in Chronic Migraine: Neurophysiological Study and Pilot Therapeutic Trial
|
Phase 3 | |
Recruiting |
NCT02202486 -
Investigation of the Blood-brain and Blood-dura Barrier Durin Migraine Attacks Using MRI
|
N/A | |
Completed |
NCT01709708 -
Use of the Tx360 Nasal Applicator in the Treatment of Chronic Migraine
|
Phase 4 | |
Completed |
NCT01741246 -
Neuroimaging Studies of Chronic Primary Headaches Using Positron Emission Tomography and Magnetic Resonance Imaging
|
N/A | |
Completed |
NCT01090050 -
Treximet in the Treatment of Chronic Migraine
|
Phase 4 | |
Recruiting |
NCT03507400 -
Introvision for Migraine and Headaches
|
N/A | |
Completed |
NCT04161807 -
Efficacy and Safety of Nerivio™ for Acute Treatment of Migraine in People With Chronic Migraine
|
N/A | |
Completed |
NCT03175263 -
OnabotulinumtoxinA Injections in Chronic Migraine, Targeted to Sites of Pericranial Myofascial Pain
|
N/A | |
Withdrawn |
NCT04353505 -
Intra-arterial Sphenopalatine Ganglion Block for Patients With Refractory Headache
|
Phase 1 | |
Completed |
NCT01667250 -
Non-Invasive Neurostimulation for the Prevention of Chronic Migraine
|
N/A | |
Completed |
NCT01700387 -
A Study to Evaluate the Tolerability of Botox and Topiramate or Botox and Placebo and Effect on Cognitive Efficiency
|
Phase 4 | |
Not yet recruiting |
NCT01135784 -
Study of MIGRA-ZEN RELIEF PLUS In the Treatment of Chronic Migraine Headache
|
Phase 2 | |
Completed |
NCT00772031 -
NINDS CRC Chronic Migraine Treatment Trial
|
Phase 3 |