Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsors and Collaborators: |
IRCCS San Raffaele Merck Sharp & Dohme |
---|---|
Information provided by: | IRCCS San Raffaele |
ClinicalTrials.gov Identifier: | NCT00753311 |
Triptans are first choice drugs in the acute treatment of migraine and cluster headache. However, while in cluster headache the response rate to subcutaneous sumatriptan is 96%, around 30% of patients fail to respond to a particular triptan4. Nonresponse is likely to be due to a variety of factors, including low and inconsistent absorption, inadequate dosing, and variability in individual response5. Timing of administration is also a crucial issue. In fact, an early treatment of the attack, when the pain is still mild, may increase the responders rate by circumventing the development of cutaneous allodynia (expression of central sensitization of pain pathway) during the course of the attack6,7. Several studies have been performed in an attempt to genetically, psychologically and clinically characterize the triptan responders but failed to provide conclusive results8-10. Nevertheless, we suggested that the presence of UAs during the migraine attack might predict a good response to triptans1,11. UAs are common in migraine patients. They have been reported in almost one out of two migraineurs (45.8%) attending a tertiary headache centre and in more than one out of four (26.9%) in a population-based study1,3. In an open study with sumatriptan 50 mg performed on 72 migraine patients with UAs, we described pain relief in 65.3% of the patients at 1 h and in 81.9% at 2 h, while pain-free in 30.6% at 1 h and in 61.1% at 2 h11. We hypothesized a large-scale recruitment of peripheral neurovascular 5-HT1B/1D receptors consequent to the activation of the trigeminal-autonomic reflex in such patients. Our hypothesis has received further confirmation by the demonstration of higher levels of calcitonin gene-related peptide, neurokinin A and vasoactive intestinal peptide (the hallmark of the activation of the trigeminal autonomic reflex) in external jugular blood in rizatriptan responders than in non-responders 12. The investigators therefore postulate that migraineurs with UAs may respond better to rizatriptan than "general" migraine population.
Objectives:
To evaluate the efficacy of rizatriptan 10 mg lyophilized wafer (MLT) compared to placebo in the treatment of acute migraine in patients with unilateral autonomic symptoms (UAs: unilateral lacrimation, eye redness, eyelid oedema, nasal congestion or rhinorrhoea, miosis or ptosis, forehead or facial sweating) during the attack
Condition | Intervention | Phase |
---|---|---|
Migraine |
Drug: Rizatriptan |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | A Randomized, Double Blind, Controlled Versus Placebo in Parallel Groups, Study to Evaluate the Efficacy of 10 mg Lyophilized Oral Rizatriptan in the Acute Treatment of Migraine in Patients With Unilateral Trigeminal Autonomic Symptoms. |
Estimated Enrollment: | 80 |
Arms | Assigned Interventions |
---|---|
A: Experimental
Treatment Plan Patients who meet all the study entry criteria will be enrolled and randomly provided with study drug (rizatriptan 10 mg MLT or placebo, ratio 1:1) to be taken on an outpatient basis as soon as they experience a moderate-to-severe (Grade 2 or 3) migraine headache. As soon as patient experiences a moderate or severe (Grade 2/3) migraine headache, patients will administer their treatment if the headache has not started to resolve spontaneously. Patients should be encouraged to treat their migraine headache within 4 hours of migraine onset.
|
Drug: Rizatriptan
Treatment Plan Patients who meet all the study entry criteria will be enrolled and randomly provided with study drug (rizatriptan 10 mg MLT or placebo, ratio 1:1) to be taken on an outpatient basis as soon as they experience a moderate-to-severe (Grade 2 or 3) migraine headache. As soon as patient experiences a moderate or severe (Grade 2/3) migraine headache, patients will administer their treatment if the headache has not started to resolve spontaneously. Patients should be encouraged to treat their migraine headache within 4 hours of migraine onset.
|
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | IRCCS San Raffaele ( Piero Barbanti, MD ) |
Study ID Numbers: | 50/07ssr-msd01-3407 |
Study First Received: | September 15, 2008 |
Last Updated: | September 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00753311 History of Changes |
Health Authority: | Italy: The Italian Medicines Agency |
migraine aura rizatriptan unilateral trigeminal autonomic symptoms Migraine with or without aura with unilateral trigeminal autonomic symptoms |
Serotonin Agonists Neurotransmitter Agents Migraine Disorders Headache Central Nervous System Diseases |
Headache Disorders, Primary Rizatriptan Brain Diseases Serotonin Headache Disorders |
Serotonin Agonists Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Nervous System Diseases Physiological Effects of Drugs Central Nervous System Diseases Headache Disorders, Primary |
Rizatriptan Brain Diseases Pharmacologic Actions Headache Disorders Serotonin Agents Migraine Disorders |