A Phase 4 interventional study of Maxalt and placebo pill in Episodic Migraine, sponsored by Beth Israel Deaconess Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2015-04-09.
Sponsored by Beth Israel Deaconess Medical Center · Phase 4, Interventional, and Basic science
Evidence-based medicine depends on distinguishing between pharmacological effects and placebo effects in randomized controlled trials (RCT). This proposal seeks to rigorously investigate fundamental questions concerning pharmacological effects, placebo effects and their interactions. Relief of symptoms of acute migraine will be the test condition for this scientific experiment because of migraine's evident clinical significance and the possibility of using participants as their own control during sequential acute migraine attacks. Our overall goal is to elucidate how the pharmacological effects of 100 mg rizatriptan (an FDA-proven effective medication for acute migraine) and the effects of placebo treatment can be modified by varied knowledge and/or expectation ("contextual") conditions. Such knowledge has the possibility to suggest potentially more efficient methodologies to test new medications that can be used to augment and enhance the apparatus of the RCT.
General Aim: To elucidate and clarify what is a pharmacological effect and what is a placebo effect, how such effects vary in different knowledge/expectations contexts, and mutually constitute one another and interact.
General Hypothesis: The measured pharmacological effect of an effective medication (rizatriptan) and the measured effect of placebo treatment are determined significantly by different knowledge/expectations contexts.
1,528 studies on the registry are indexed under Migraine Disorders; 299 are open to participants now.
This study's enrollment of 76 is close to the median of 80 across 1,175 interventional studies indexed under Migraine Disorders.
Browse Migraine Disorders studies →Beth Israel Deaconess Medical Center is the lead sponsor of 560 studies on the registry; 80 are open to participants now.
Of its 75 completed or terminated interventional studies of FDA-regulated products, 61 (81%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Maxalt administration at onset of migraine
Drug: Maxalt
Drug: placebo pill
Drug: Maxalt
Drug: placebo pills
Drug: Maxalt
Drug: placebo pills
anti-migraine drug
Also known as: rizatriptan
placebo pills
placebo pills
Change in Headache Intensity
The primary outcome measure was the change in headache between the baseline pain score recorded 30 min after the onset of headache and the pain score recorded 2 hours later as measured on a visual analog scale ranging from 0 (no pain) to 10 (worst pain imaginable).
Time frame: 2 hours after treatment
Pain Free at 2 Hours After Treatment
A secondary measure of attack outcome was based on categorical classification of the pain freedom (pain score = 0) 2.5 hours after onset of headache.
Time frame: 2 hours after treatment
Of 98 persons pre-screened for eligibility between December 2008 and March 2010, 19 were excluded and 3 declined to participate. The remaining 76 persons signed the consent form, but 10 of them dropped out of the study for various reasons. Participants were recruited from Beth Israel Deaconess Medical Center outpatient clinics.
| Milestone | All Participants |
|---|---|
| Started | 76 |
| Completed | 66 |
| Not completed | 10 |
The primary outcome measure was the change in headache between the baseline pain score recorded 30 min after the onset of headache and the pain score recorded 2 hours later as measured on a visual analog scale ranging from 0 (no pain) to 10 (worst pain imaginable).
| percent change | All Participants |
|---|---|
| percent change with Maxalt | -47.6 (-53.0 to -41.5) |
| percent change with placebo | -20.7 (-26.7 to -14.3) |
A secondary measure of attack outcome was based on categorical classification of the pain freedom (pain score = 0) 2.5 hours after onset of headache.
| percent of patients pain free | All Participants |
|---|---|
| pain free with maxalt | 25.5 (17.2 to 36.2) |
| pain free with placebo | 6.6 (3.4 to 12.2) |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Maxalt | — | 0/66 (0%) | 11/66 (16.7%) |
| Placebo | — | 0/66 (0%) | 11/66 (16.7%) |
| Event | Maxalt | Placebo |
|---|---|---|
| DrowsinessNervous system disorders | 9/66 | 1/66 |
| GastrointestinalNervous system disorders | 8/66 | 3/66 |
| Throat tightnessNervous system disorders | 7/66 | 4/66 |
| Chest tightnessNervous system disorders | 6/66 | 5/66 |
| Heart palpitationNervous system disorders | 4/66 | 6/66 |
| Skin sensitivityNervous system disorders | 6/66 | 3/66 |
| Age, Continuous(years) | All Participants |
|---|---|
| Mean | 40.6 ± 12.7 |
| Sex: Female, Male(Participants) | All Participants |
|---|---|
| Female | 65 |
| Male | 11 |
| Region of Enrollment(participants) | All Participants |
|---|---|
| United States | 76 |
| Headache intensity(units on a scale) | All Participants |
|---|---|
| Mean | 4.6 ± 1.8 |
This study is completed, as verified in Apr 2015. You cannot join it, but the record below documents what was studied.
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Beth Israel Deaconess Medical Center