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NCT01329562 · ClinicalTrials.gov registry record · Phase 4

CGRP, Estrogen, Cortisol, VIP, α-Amylase, PGE2, PGI2 and ß-Endorphin Levels in Menstrual Migraine Before and After Treximet

A Phase 4 study of Menstrual Migraine, sponsored by Cady, Roger, M.D..

Completed
Registry status
Phase 4
Development phase
41
Enrollment target
2
Study locations

NCT01329562 is a Phase 4 study of Menstrual Migraine that has completed, run by Cady, Roger, M.D.. The registered enrollment target is 41 participants, below the 269-participant average among 3 other Menstrual Migraine trials with a reported enrollment target (85% lower). The trial reports 2 study locations across 2 states.

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The verdict

NCT01329562, a Phase 4 study of Menstrual Migraine, has completed, sponsored by Cady, Roger, M.D..

COMPLETED
Registry status
Phase 4
Development phase
41 participants
Enrollment target
2
Study locations

Study Summary

The purpose of this study is to (1) evaluate pain-free efficacy of Treximet™ following treatment of menstrual migraine, (2) investigate levels of Calcitonin gene-related peptide (CGRP), estrogen, cortisol, vasoactive intestinal peptide (VIP), alpha (a)-amylase, Prostaglandin E2 (PGE2), Prostaglandin I2 (PGI2) and beta (ß)-endorphin in saliva before and after Treximet™, (3) evaluate efficacy of Treximet™ to return to baseline levels following treatment, and (4) correlate estrogen in saliva vs. urinary estradiol at mid-luteal, onset of menstrually-related migraine, and after successful treatment with Treximet™.

Conditions Studied

Menstrual Migraine

Interventions

  • DRUG Placebo
  • DRUG Treximet

Study Locations (2)

Missouri

  • Clinvest - Springfield

Ohio

  • University Internal Medicine Associates, Inc. - Cincinnati

Trial Details

FieldValue
Enrollment Target 41 participants
Start Date 2011-05
Est. Completion 2012-06
Phase Phase 4

Sponsor

Cady, Roger, M.D.

12 total trials

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What the Registry Record Tells You About NCT01329562

The ClinicalTrials.gov registry entry for NCT01329562 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 41 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 269-participant average among 3 other Menstrual Migraine trials with a reported enrollment target (85% lower). The listed sponsor is Cady, Roger, M.D., which has 12 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Menstrual Migraine appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT01329562 reports 2 study locations spanning 2 distinct geographic areas - top geographies include Missouri, Ohio.

Frequently Asked Questions

What is clinical trial NCT01329562 about?

NCT01329562 is a clinical study titled "CGRP, Estrogen, Cortisol, VIP, α-Amylase, PGE2, PGI2 and ß-Endorphin Levels in Menstrual Migraine Before and After Treximet". The purpose of this study is to (1) evaluate pain-free efficacy of Treximet™ following treatment of menstrual migraine, (2) investigate levels of Calcitonin gene-related peptide (CGRP), estrogen, cortisol, vasoactive intestinal peptide (VIP), alpha (a)-amylase, Prostaglandin E2 (PGE2), Prostaglandin...

What is the current status of trial NCT01329562?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 41 participants. The study started on 2011-05. Estimated completion is 2012-06.

What conditions does trial NCT01329562 study?

This clinical trial studies the following conditions: Menstrual Migraine.

What interventions are being tested in trial NCT01329562?

The interventions under investigation include: Placebo (DRUG), Treximet (DRUG).

Who is sponsoring clinical trial NCT01329562?

This trial is sponsored by Cady, Roger, M.D., which has 12 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01329562 being conducted?

This trial has 2 study locations across Missouri, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.