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MigrainePhase 3NCT00257010

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

A Phase 3 study testing Almotriptan Malate in people with Migraine, run by Janssen-Ortho LLC at 49 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 12 to 17 years
Conditions the study is for
Migraine
What is being tested?
Almotriptan Malate
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
447 participants
Where
49 sitesUnited States
Study dates
Dec 2005to Dec 2007
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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)

Who cannot join

  • 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

Trial locations and contacts

49 sites in 1 country.

49 sites in 1 country

United States49 sites

  • Study site

    Alcoa, Tennessee

  • Study site

    Ann Arbor, Michigan

  • Study site

    Atlanta, Georgia

  • Study site

    Bristol, Tennessee

  • Study site

    Centennial, Colorado

  • Study site

    Chicago, Illinois

  • Study site

    Cincinnati, Ohio

  • Study site

    Columbia, Missouri

  • Study site

    Columbus, Ohio

  • Study site

    Dallas, Texas

  • Study site

    Denver, Colorado

  • Study site

    Des Moines, Iowa

  • Study site

    Endwell, New York

  • Study site

    Fort Worth, Texas

  • Study site

    Germantown, Tennessee

  • Study site

    Houston, Texas

  • Study site

    Idaho Falls, Idaho

  • Study site

    Jonesboro, Arkansas

  • Study site

    Little Rock, Arkansas

  • Study site

    Louisville, Kentucky

  • Study site

    Loxahatchee Groves, Florida

  • Study site

    Madison, Wisconsin

  • Study site

    Mesa, Arizona

  • Study site

    Miami, Florida

  • Study site

    Mineola, New York

  • Study site

    Mobile, Alabama

  • Study site

    Montgomery, Alabama

  • Study site

    Morristown, Tennessee

  • Study site

    Mount Vernon, New York

  • Study site

    Nashville, Tennessee

  • Study site

    Oklahoma City, Oklahoma

  • Study site

    Orlando, Florida

  • Study site

    Oxford, Alabama

  • Study site

    Philadelphia, Pennsylvania

  • Study site

    Phoenix, Arizona

  • Study site

    Pittsburgh, Pennsylvania

  • Study site

    Plainview, New York

  • Study site

    Raleigh, North Carolina

  • Study site

    Salt Lake City, Utah

  • Study site

    San Antonio, Texas

  • Study site

    San Marcos, Texas

  • Study site

    Santa Monica, California

  • Study site

    Snellville, Georgia

  • Study site

    Springfield, Missouri

  • Study site

    St Louis, Missouri

  • Study site

    Tampa, Florida

  • Study site

    Topeka, Kansas

  • Study site

    West Palm Beach, Florida

  • Study site

    Witchita, Kansas

Other trials in United States

About this study

Official title: 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.

Read the 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.

Conditions
Migraine
Being tested
Almotriptan Malate
Keywords
Migraine, Almotriptan Malate, Headache, Triptan
Medical subject headings
Migraine Disorders, Headache

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Almotriptan MalateDrug

    Patients will take one 12.5 mg almotriptan malate tablet by mouth after the onset of migraine headache pain

Study groups in NCT00257010
Study groupRoleWhat they receive
Almotriptan MalateExperimentalPatients will take one 12.5 mg almotriptan malate tablet by mouth after the onset of migraine headache pain
Receives: Drug: Almotriptan Malate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Pain Free Headaches at 2 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.

    Measured: 2 hours and 24 hours post-dose

Secondary outcomes (5)

  1. Number of Headaches Achieving Pain Relief at 2 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.

    Measured: 2 hours and 24 hours post-dose

  2. Number of Headaches With Photophobia

    Occurrence and intensity of photophobia post-dose of study medication. Photophobia is an abnormal sensitivity to or intolerance of light, especially by the eyes.

    Measured: Baseline (after onset of migraine headache pain and before treatment), 2 hours and 24 hours post-dose

  3. Number of Headaches With Phonophobia

    Occurrence and intensity of phonophobia post-dose of study medication. Phonophobia is an abnormal sensitivity to or intolerance of noise.

    Measured: Baseline (after onset of migraine headache pain and before treatment), 2 hours and 24 hours post-dose

  4. Number of Headaches With Nausea

    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.

    Measured: Baseline (after onset of migraine headache pain and before treatment), 2 hours and 24 hours post-dose

  5. Number of Headaches With Vomiting

    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.

    Measured: Baseline (after onset of migraine headache pain and before treatment), 2 hours and 24 hours post-dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Nov 2005 (estimated)
  2. Study startDec 2005
  3. Primary completionDec 2007
  4. Study completionDec 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
447 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00257010
Sponsor's protocol ID
CR002827
Other IDs
CAPSS-368
Status last verified
Jan 2014
First submitted
18 Nov 2005
Last updated
21 Feb 2014
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Almotriptan Malate in people with Migraine, run by Janssen-Ortho LLC at 49 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 49 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Dec 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Pain Free Headaches at 2 and 24 Hours Post-Dose (time frame: 2 hours and 24 hours post-dose). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00257010.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2014.

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