A Phase 2/3, Multicenter, Randomized, Double-Blind, Placebo Controlled, Parallel-Group Study To Evaluate The Efficacy, Safety, And Tolerability Of Multiple Dosing Regimens Of Oral AGN-241689 In Episodic Migraine Prevention

  • STATUS
    Recruiting
  • sponsor
    Allergan
Updated on 25 March 2021

Summary

A Phase 2/3, Multicenter, Randomized, Double-Blind, Placebo Controlled, Parallel-Group Study To Evaluate The Efficacy, Safety, And Tolerability Of Multiple Dosing Regimens Of Oral AGN-241689 In Episodic Migraine Prevention

Description

This study will evaluate safety and tolerability of the of the different doses of investigational medication for prevention of episodic migraine.

There 8 clinic visits required for this trial participation. For more information contact our qualified staff at 718-616-2400.

Details
Condition Migraine and Cluster Headaches
Clinical Study IdentifierTX145503
SponsorAllergan
Last Modified on25 March 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Has at least a 1-year history of migraine with or without aura
Age of the patient at the time of migraine onset < 50 years
History of 4 to 14 migraine/probable migraine headache days per month on average in the 3 months prior to Visit 1 in the Investigator's judgment
Demonstrated compliance with e-diary

Exclusion Criteria

Has a history of migraine accompanied by diplopia or decreased level of consciousness, hemiplegic migraine, and retinal migraine
Has a current diagnosis of chronic migraine, new persistent daily headache, trigeminal autonomic cephalgia (eg, cluster headache), or painful cranial neuropathy
Difficulty distinguishing migraine headache from other headaches
Has a history of malignancy in the prior 5 years, except for adequately treated basal cell or squamous cell skin cancer, or in situ cervical cancer
Has a history of gastric or small intestinal surgery, or has a disease that causes malabsorption
Has a history of hepatitis within previous 6 months
Usage of opioids or barbiturates > 2 days/month, triptans or ergots ≥ 10 days/month, or simple analgesics (eg, aspirin, non-steroidal anti-inflammatory drugs [NSAIDs], acetaminophen) ≥ 15 days/month in the 3 months prior to Visit 1
Pregnant or nursing females
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How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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