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Almotriptan

Phase 3FDA approved

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

Almotriptan development status

FDA approval on record May 7, 2001 as Axert
Approval holderJanssen Pharms
ApplicationNDA021001
Highest phase Phase 3

Almotriptan target and mechanism

Molecular targetHTR1B, HTR1D, HTR1F
Target classAgonist
ModalitySmall molecule

Also known as Almotriptan Malate

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

Almotriptan clinical trials

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 43 trials

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Frequently asked questions about Almotriptan

What is almotriptan used for?

Almotriptan is used to treat migraine headaches. It belongs to the triptan class of medicines and is taken to relieve acute migraine attacks. The clinical program described here focused on treating migraine in adolescents aged 12 years and older, studied across two completed Phase 3 trials.

What does almotriptan target?

Almotriptan targets the serotonin receptors HTR1B, HTR1D, and HTR1F, where it acts as an agonist. By activating these receptors, the small molecule is designed to produce its effects in the treatment of acute migraine. These receptor targets define its pharmacology within the triptan class.

Who makes almotriptan?

Almotriptan is developed by Johnson & Johnson, which trades under the ticker JNJ. The company sponsored the clinical development program for the drug in migraine, including the Phase 3 studies conducted in adolescents. Almotriptan is a small molecule developed within Johnson & Johnson's neurology portfolio.

What phase is almotriptan in?

Almotriptan has been studied in Phase 3 clinical development for migraine. Two Phase 3 trials have been completed, and no trials are currently active. The program enrolled a total of 1,313 participants across those completed studies, which were randomized and double blind.

What clinical trials is almotriptan in?

Almotriptan has been evaluated in two completed Phase 3 trials. NCT00257010 was a one-year study in adolescents assessing long-term safety of almotriptan malate for migraine headaches, enrolling 447 participants in the United States. NCT00210483 studied three dosage strengths of almotriptan malate in acute migraine in adolescents, enrolling 866 participants.

Is almotriptan the same as almotriptan malate?

Yes, almotriptan malate is the same drug as almotriptan. Almotriptan malate is the salt form used in the clinical trials and in the studied product, including the Phase 3 adolescent migraine studies. The two names refer to the same active agent rather than to different medicines.