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Almotriptan

Phase 3

Migraine | Small molecule | Neurology |Johnson & Johnson|Last Updated: Feb 21, 2014

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials2
Total Enrollment1,313

FDA Designations

No designations recorded

Clinical trial landscape

Almotriptan · 2 trials · 1 indication

Phase 3 2
NCT00257010A 1-year Study in Adolescents to Assess the Long-term Safety of Almotriptan Malate When Treating Their Migraine HeadachesMigraine
COMPLETED447 Analytics
NCT00210483A Study of 3 Dosage Strengths of Almotriptan Malate (AXERT®) in the Treatment of Acute Migraine in AdolescentsMigraine
COMPLETED866 Analytics
PHASE3COMPLETED
A 1-year Study in Adolescents to Assess the Long-term Safety of Almotriptan Malate When Treating Their Migraine Headaches
MigraineUnlock trial analytics
PHASE3COMPLETED
A Study of 3 Dosage Strengths of Almotriptan Malate (AXERT®) in the Treatment of Acute Migraine in Adolescents
MigraineUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of Pain Free Headaches at 2 and 24 Hours Post-Dose
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.

Efficacy determined by patient 2 hours after dosing by rating of headache intensity as a decrease from moderate or severe to mild or no pain

Secondary Endpoints

Number of Headaches Achieving Pain Relief at 2 and 24 Hours Post-Dose
2 hours and 24 hours post-dose
Number of Headaches With Photophobia
Baseline (after onset of migraine headache pain and before treatment), 2 hours and 24 hours post-dose
Number of Headaches With Phonophobia
Baseline (after onset of migraine headache pain and before treatment), 2 hours and 24 hours post-dose
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

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

Interventions

NameTypeDescription
Almotriptan MalateDRUGPatients will take one 12.5 mg almotriptan malate tablet by mouth after the onset of migraine headache pain
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Eligibility Criteria

Age Range12 Years to 17 Years
SexALL
Healthy VolunteersNo
Study Sites49

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...

Countries:United States
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Competitive Landscape -Migraine 30 trials

Frequently asked questions about Almotriptan

What is Almotriptan used for?

Almotriptan is used for the treatment of migraine. It is a small molecule being developed by Johnson & Johnson (JNJ) for the neurology therapeutic area. The drug is currently in Phase 3 clinical development and is being studied in adolescent patients aged 12 years and older.

Who makes Almotriptan?

Almotriptan is being developed by Johnson & Johnson, which trades under the ticker JNJ. The company is conducting clinical trials to evaluate the drug for the treatment of migraine in adolescent patients.

What phase is Almotriptan in?

Almotriptan is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Two Phase 3 trials have been completed, with a total enrollment of 1,313 participants.

What clinical trials is Almotriptan in?

Almotriptan has been studied in two completed Phase 3 trials. NCT00210483 evaluated three dosage strengths of Almotriptan Malate (AXERT) in 866 adolescents with acute migraine. NCT00257010 assessed the long-term safety of the drug in 447 adolescents over one year.

Is Almotriptan the same as AXERT?

Yes, Almotriptan is the same as AXERT. The clinical trial NCT00210483 refers to Almotriptan Malate as AXERT, indicating that AXERT is a brand name for the drug. Both names refer to the same medication used for migraine treatment.