A 1-year Study in Adolescents to Assess the Long-term Safety of Almotriptan Malate When Treating Their Migraine Headaches

January 23, 2014 updated by: Janssen-Ortho LLC

Long-Term, Open-Label Safety Study of Oral Almotriptan Malate 12.5 mg in the Treatment of Migraine in Adolescents

The purpose of this study is to evaluate the long-term safety of almotriptan malate (a migraine headache medication) in the treatment of migraine headaches in adolescents for up to one year.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Almotriptan malate, and several other treatments for migraine headaches, known as triptans, are approved for the treatment of migraine headaches in adults. To date, none of these have been approved by the Food and Drug Administration (FDA) for use in adolescents. This is an open-label, multi-center study that will enroll approximately 450 patients aged 12 - 17 years old with a history of one to 14 migraines per month for the 6 months prior to entering the study. The total study duration will be up to one year. There is a screening phase to determine if the patient is eligible for study entry, followed by an open-label treatment phase that can last up to one year. Almotriptan malate 12.5 mg tablets will be used to treat all migraine headaches during the study, as needed. The primary outcome of the study is an assessment of the long-term safety of almotriptan malate in adolescent migraine sufferers. The study hypothesis is that the almotriptan malate will be safe and well tolerated in the treatment of adolescent migraine headaches. Safety measurements will be performed at set time points during the study and will include laboratory tests, physical and neurological exams, electrocardiograms (ECGs) and the incidence of adverse events. A diary will be completed by the patient for each migraine headache for which they take almotriptan malate. Migraine pain information and almotriptan malate use will be recorded in the headache diary. An equal number of patients in the 12 - 14 year old range as the 15 - 17 year old range will be enrolled. Patients will take one 12.5 mg almotriptan malate tablet by mouth after the onset of migraine headache pain. The dose may be repeated once if the pain continues 2 hours after the first dose, but no more than 2 doses can be taken within a 24-hour period. Study medication will be taken for up to one year.

Study Type

Interventional

Enrollment (Actual)

447

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Mobile, Alabama, United States
      • Montgomery, Alabama, United States
      • Oxford, Alabama, United States
    • Arizona
      • Mesa, Arizona, United States
      • Phoenix, Arizona, United States
    • Arkansas
      • Jonesboro, Arkansas, United States
      • Little Rock, Arkansas, United States
    • California
      • Santa Monica, California, United States
    • Colorado
      • Centennial, Colorado, United States
      • Denver, Colorado, United States
    • Florida
      • Loxahatchee, Florida, United States
      • Miami, Florida, United States
      • Orlando, Florida, United States
      • Tampa, Florida, United States
      • West Palm Beach, Florida, United States
    • Georgia
      • Atlanta, Georgia, United States
      • Snellville, Georgia, United States
    • Idaho
      • Idaho Falls, Idaho, United States
    • Illinois
      • Chicago, Illinois, United States
    • Iowa
      • Des Moines, Iowa, United States
    • Kansas
      • Topeka, Kansas, United States
      • Witchita, Kansas, United States
    • Kentucky
      • Louisville, Kentucky, United States
    • Michigan
      • Ann Arbor, Michigan, United States
    • Missouri
      • Columbia, Missouri, United States
      • Saint Louis, Missouri, United States
      • Springfield, Missouri, United States
    • New York
      • Endwell, New York, United States
      • Mineola, New York, United States
      • Mount Vernon, New York, United States
      • Plainview, New York, United States
    • North Carolina
      • Raleigh, North Carolina, United States
    • Ohio
      • Cincinnati, Ohio, United States
      • Columbus, Ohio, United States
    • Oklahoma
      • Oklahoma City, Oklahoma, United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States
      • Pittsburgh, Pennsylvania, United States
    • Tennessee
      • Alcoa, Tennessee, United States
      • Bristol, Tennessee, United States
      • Germantown, Tennessee, United States
      • Morristown, Tennessee, United States
      • Nashville, Tennessee, United States
    • Texas
      • Dallas, Texas, United States
      • Fort Worth, Texas, United States
      • Houston, Texas, United States
      • San Antonio, Texas, United States
      • San Marcos, Texas, United States
    • Utah
      • Salt Lake City, Utah, United States
    • Wisconsin
      • Madison, Wisconsin, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Have a history of migraine for at least one year
  • Have an average of 1 - 14 migraines per month for the 6 months prior to study entry
  • Able to swallow oral medication
  • Able to complete a headache diary
  • Only taking one migraine preventive medication and on the same dose of that medication for at least 30 days before entering the study)

Exclusion Criteria:

  • Have an allergy to almotriptan malate or have stopped taking almotriptan malate due to side effects
  • Have 15 or more days within a month in which you have a headache
  • Usually experience migraine aura (most common symptoms being visual disturbances or tingling sensations before migraine pain begins) without a headache
  • Experience more than 6 non-migraine headaches per month

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Almotriptan Malate
Patients will take one 12.5 mg almotriptan malate tablet by mouth after the onset of migraine headache pain
Drug: Almotriptan Malate
Patients will take one 12.5 mg almotriptan malate tablet by mouth after the onset of migraine headache pain

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Pain Free Headaches at 2 and 24 Hours Post-Dose
Time Frame: 2 hours and 24 hours post-dose
Headache pain free is defined as a decrease in baseline pain intensity from severe, moderate or mild to no pain, without the use of supplemental pain medication and/or anti-emetic medication (including a second dose of study medication) within 2 (or 24) hours of first dose of study medication. Sustained pain free is defined as pain free at 2 and 24 hours without the use of supplemental pain medication and/or anti-emetic medication (including a second dose of study medication) within 24 hours.
2 hours and 24 hours post-dose

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Headaches Achieving Pain Relief at 2 and 24 Hours Post-Dose
Time Frame: 2 hours and 24 hours post-dose
Headache pain relief is defined as a decrease in baseline pain intensity from either severe or moderate intensity to mild or no pain, without the use of supplemental pain medication and/or anti-emetic medication (including a second dose of study medication) within 2 (or 24) hours of first dose of study medication. Sustained pain relief is defined as pain relief at 2 and 24 hours without the use of supplemental pain medication and/or anti-emetic medication (including a second dose of study medication) within 24 hours.
2 hours and 24 hours post-dose
Number of Headaches With Photophobia
Time Frame: Baseline (after onset of migraine headache pain and before treatment), 2 hours and 24 hours post-dose
Occurrence and intensity of photophobia post-dose of study medication. Photophobia is an abnormal sensitivity to or intolerance of light, especially by the eyes.
Baseline (after onset of migraine headache pain and before treatment), 2 hours and 24 hours post-dose
Number of Headaches With Phonophobia
Time Frame: Baseline (after onset of migraine headache pain and before treatment), 2 hours and 24 hours post-dose
Occurrence and intensity of phonophobia post-dose of study medication. Phonophobia is an abnormal sensitivity to or intolerance of noise.
Baseline (after onset of migraine headache pain and before treatment), 2 hours and 24 hours post-dose
Number of Headaches With Nausea
Time Frame: Baseline (after onset of migraine headache pain and before treatment), 2 hours and 24 hours post-dose
Occurrence and intensity of nausea post-dose of study medication. Nausea is a feeling of sickness characterized by gastrointestinal distress and an urge to vomit.
Baseline (after onset of migraine headache pain and before treatment), 2 hours and 24 hours post-dose
Number of Headaches With Vomiting
Time Frame: Baseline (after onset of migraine headache pain and before treatment), 2 hours and 24 hours post-dose
Occurrence and intensity of vomiting post-dose of study medication. Vomiting is an act or instance of disgorging the contents of the stomach through the mouth also called emesis.
Baseline (after onset of migraine headache pain and before treatment), 2 hours and 24 hours post-dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Janssen-Ortho LLC

Collaborators

Ortho-McNeil Neurologics, Inc.

Investigators

  • Study Director: Janssen Ortho LLC Clinical Trial, Janssen-Ortho LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2005

Primary Completion (Actual)

December 1, 2007

Study Completion (Actual)

December 1, 2007

Study Registration Dates

First Submitted

November 18, 2005

First Submitted That Met QC Criteria

November 18, 2005

First Posted (Estimate)

November 22, 2005

Study Record Updates

Last Update Posted (Estimate)

February 21, 2014

Last Update Submitted That Met QC Criteria

January 23, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR002827
  • CAPSS-368 (Other Identifier: Janssen-Ortho LLC)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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