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NCT01053507 · ClinicalTrials.gov registry record · Phase 4

Treximet for Prevention of Post Traumatic Headache Associated With Cognitive Dysfunction

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

Terminated
Registry status
Phase 4
Development phase
23
Enrollment target

NCT01053507 is a Phase 4 study that was terminated before completion, run by Cady, Roger, M.D.. The registered enrollment target is 23 participants.

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The verdict

NCT01053507, a Phase 4 study, was terminated before completion, sponsored by Cady, Roger, M.D..

TERMINATED
Registry status
Phase 4
Development phase
23 participants
Enrollment target

Study Summary

This study will evaluate the effectiveness of Treximet when taken for post traumatic headache by measuring any change in the number of headache days or any change in a subject's ability to think following treatment with study medication. Eligible subjects will complete 3 visits. Following Visit 1, subjects will treat with their usual medication and document headache symptoms and therapy in a Headache Diary. After 30 days, subjects will return for Visit 2 and be randomized (like the flip of a coin) to receive Treximet or matching placebo to treat at the same time each day. Treximet will be provided to treat any headache that occurs. Subjects will complete a daily Diary. After 30 days, subjects will exit the study at Visit 3.

Interventions

  • DRUG Placebo
  • DRUG sumatriptan/naproxen sodium

Trial Details

FieldValue
Enrollment Target 23 participants
Start Date 2010-05
Est. Completion 2012-11
Phase Phase 4

Sponsor

Cady, Roger, M.D.

12 total trials

What the Registry Record Tells You About NCT01053507

The ClinicalTrials.gov registry entry for NCT01053507 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 23 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Cady, Roger, M.D., which has 12 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT01053507 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01053507 about?

NCT01053507 is a clinical study titled "Treximet for Prevention of Post Traumatic Headache Associated With Cognitive Dysfunction". This study will evaluate the effectiveness of Treximet when taken for post traumatic headache by measuring any change in the number of headache days or any change in a subject's ability to think following treatment with study medication. Eligible subjects will complete 3 visits. Following Visit 1, s...

What is the current status of trial NCT01053507?

This trial is currently terminated. It is a Phase 4 study. The enrollment target is 23 participants. The study started on 2010-05. Estimated completion is 2012-11.

What interventions are being tested in trial NCT01053507?

The interventions under investigation include: Placebo (DRUG), sumatriptan/naproxen sodium (DRUG).

Who is sponsoring clinical trial NCT01053507?

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

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.