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NCT00719134 · ClinicalTrials.gov registry record · Phase 4
The Effects of Expectation and Knowledge on Rizatriptan and Placebo Treatment of Acute Migraine Headache
A Phase 4 study of Episodic Migraine, sponsored by Beth Israel Deaconess Medical Center.
- Completed
- Registry status
- Phase 4
- Development phase
- 76
- Enrollment target
- 1
- Study location
NCT00719134: Completed Phase 4 study of Episodic Migraine, sponsored by Beth Israel Deaconess Medical Center.
NCT00719134 is a Phase 4 study of Episodic Migraine that has completed, run by Beth Israel Deaconess Medical Center. The registered enrollment target is 76 participants, below the 491-participant average among 13 other Episodic Migraine trials with a reported enrollment target (85% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00719134, a Phase 4 study of Episodic Migraine, has completed, sponsored by Beth Israel Deaconess Medical Center.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 76 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Primary Outcome
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).
Conditions Studied
Interventions
- DRUG placebo pill
- DRUG Maxalt
- DRUG placebo pills
Study Locations (1)
Massachusetts
- Pain Clinic at Beth Israel Deaconess Medical Center - Brookline
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 76 participants |
| Start Date | 2008-09 |
| Est. Completion | 2013-12 |
| Phase | Phase 4 |
What the finished NCT00719134 record still lists
NCT00719134 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 76 participants, a relatively small participant target, below the 491-participant average among 13 other Episodic Migraine trials with a reported enrollment target (85% lower).
The record links to 1 condition, with Episodic Migraine appearing as the primary indexed condition, and to 3 interventions - of which placebo pill is the first listed.
NCT00719134 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT00719134 about?
NCT00719134 is a clinical study titled "The Effects of Expectation and Knowledge on Rizatriptan and Placebo Treatment of Acute Migraine Headache". 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 sympt...
What is the current status of trial NCT00719134?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 76 participants. The study started on 2008-09. Estimated completion is 2013-12.
What conditions does trial NCT00719134 study?
This clinical trial studies the following conditions: Episodic Migraine.
What interventions are being tested in trial NCT00719134?
The interventions under investigation include: placebo pill (DRUG), Maxalt (DRUG), placebo pills (DRUG).
Who is sponsoring clinical trial NCT00719134?
This trial is sponsored by Beth Israel Deaconess Medical Center, which has 488 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00719134 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Episodic Migraine
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00719134's enrollment target sits among peer trials
76 12th of 13 higher than 2 of 13 other Episodic Migraine trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Episodic Migraine trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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