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Dronabinol MDI

Phase 2

Migraine With Aura | Small molecule | Neurology |Nektar Therapeutics|Trials Updated: Jan 16, 2015

Dronabinol MDI development status

Highest phase Phase 2
Registered trials 1 across 1 sponsor since Jul 2001

Dronabinol MDI target and mechanism

Molecular targetCNR1
Target classAgonist
ModalitySmall molecule
ChEMBLCHEMBL465

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment -

FDA Designations

No designations recorded

Dronabinol MDI clinical trials

Dronabinol MDI · 1 trial · 2 indications

Phase 2 1
NCT00123201Study to Evaluate the Efficacy and Safety of Dronabinol Metered Dose Inhaler (MDI) in Acute Treatment of Migraine HeadacheMigraine With Aura
COMPLETED- Analytics
PHASE2COMPLETED
Study to Evaluate the Efficacy and Safety of Dronabinol Metered Dose Inhaler (MDI) in Acute Treatment of Migraine Headache
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Interventions

NameTypeDescription
Dronabinol MDIDRUG -
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites29

Inclusion Criteria: * Male or female subjects 18 to 65 years, inclusive, with clinically diagnosed migraine with or without aura based on International Headache Society criteria Exclusion Criteria: * Subjects who experience migraine with prolonged aura; familiar hemiplegic migraine; migrainous in...

Countries:United States
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Competitive Landscape -Migraine 43 trials (matched to "Migraine With Aura")

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Frequently asked questions about Dronabinol MDI

What is Dronabinol MDI?

Dronabinol MDI is an investigational metered dose inhaler formulation of dronabinol being developed by Nektar Therapeutics. It is a small molecule therapy in Phase 2 clinical development for the acute treatment of migraine with aura. The inhaler delivers a controlled dose of dronabinol directly to the lungs.

What is Dronabinol MDI used for in migraine with aura?

Dronabinol MDI is being studied for the acute treatment of migraine headache in patients with migraine with aura. It is intended to provide rapid relief during a migraine attack. The drug is investigational and has not been approved for any indication.

What does Dronabinol MDI target?

Dronabinol MDI targets the cannabinoid receptor 1, also known as CNR1. It acts as an agonist at this receptor. CNR1 is a G protein-coupled receptor found primarily in the central nervous system and is involved in modulating pain and other neurological processes.

Who is developing Dronabinol MDI?

Dronabinol MDI is being developed by Nektar Therapeutics, which trades on the Nasdaq under the ticker symbol NKTR. Nektar is a biopharmaceutical company focused on developing therapeutics in areas including neurology.

What phase is Dronabinol MDI in?

Dronabinol MDI is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA for any indication. The Phase 2 program is focused on evaluating the drug in patients with migraine with aura.

What clinical trials is Dronabinol MDI in?

Dronabinol MDI has been evaluated in a completed Phase 2 trial, NCT00123201, titled Study to Evaluate the Efficacy and Safety of Dronabinol Metered Dose Inhaler (MDI) in Acute Treatment of Migraine Headache. The trial enrolled adults aged 18 years and older in the United States and included patients with migraine with aura and migraine without aura.