A Proof of Concept Study of the Efficacy and Safety of Oral LAT8881 in Acute Migraine
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|ClinicalTrials.gov Identifier: NCT04153409|
Recruitment Status : Recruiting
First Posted : November 6, 2019
Last Update Posted : November 6, 2019
|Condition or disease||Intervention/treatment||Phase|
|Acute Migraine||Drug: LAT8881 Drug: Placebo||Phase 2|
Subjects enrolled in the study will be randomised to receive investigational medicinal product (LAT8881 60 mg or placebo), to be taken at the onset (within one hour from the onset of pain) of a migraine headache of moderate to severe intensity [Numeric rating scale greater than 4]. Rescue medication should not be taken until at least 2 hours post dose. Subjects will be given a single dose of either active or placebo, to treat one migraine headache.
After treatment of one migraine headache (or a maximum 28 days) the subject will return to the clinic for re-evaluation and crossover to the second treatment. After treatment of one migraine headache in the second treatment period or a maximum of 28 days from commencement of the second treatment period, the subject will return to the clinic for re-evaluation. An End of study visit (telephone) will occur 7 days after the end of the second treatment period.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||26 participants|
|Intervention Model:||Crossover Assignment|
|Intervention Model Description:||Randomised assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Proof of Concept Study of the Efficacy and Safety of Oral LAT8881 in Acute Migraine|
|Actual Study Start Date :||September 24, 2019|
|Estimated Primary Completion Date :||January 31, 2020|
|Estimated Study Completion Date :||February 29, 2020|
Subjects will be given two 30 mg capsules of the investigational medicinal product (LAT8881), and instructed to take both capsules within the first hour of the onset of a migraine of moderate to severe intensity.
Two 30 mg capsules of LAT8881
Other Name: Placebo
Placebo Comparator: Placebo
Subjects will be given two capsules of placebo, and instructed to take both capsules within the first hour of the onset of a migraine of moderate to severe intensity.
Two capsules of placebo
- Change in migraine headache pain score [ Time Frame: 0 minutes, 30 minutes, 60 minutes, 90 minutes, 2 hours, 4 hours, 8 hours and 24 hours post dose ]Change in migraine headache pain score, using an 11-point numeric rating scale, (0 = none, 10 = worst imaginable), Pain is recorded in a subject diary and should reflect the subject's pain at the time of recording.
- Change in migraine-associated symptoms of nausea, photophobia and phonophobia [ Time Frame: 0 minutes, 30 minutes, 60 minutes, 90 minutes, 2 hours, 4 hours, 8 hours and 24 hours post dose ]Symptoms are assessed on an 11- point Likert scale (0 = no symptoms, 10 = severe symptoms)
- Change in each subject's most troublesome symptom [ Time Frame: 0 minutes, 30 minutes, 60 minutes, 90 minutes, 2 hours, 4 hours, 8 hours and 24 hours post dose ]Symptoms are assessed on an 11- point Likert scale (0 = no symptoms, 10 = severe symptoms)
- The percentage of subjects achieving "no headache pain" [ Time Frame: 30 minutes, 60 minutes, 90 minutes, 2 hours, 4 hours, 8 hours post-dose ]Defined as having no migraine headache pain
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04153409
|Contact: Louise Murdoch, MBBSfirstname.lastname@example.org|
|Australia, New South Wales|
|Paratus Clinical Research, Central Coast||Recruiting|
|Kanwal, New South Wales, Australia, 2259|
|Contact +61 2 4393 3852 email@example.com|
|Principal Investigator: Joshua Kim, MD|
|Paratus Clinical Research, Blacktown||Recruiting|
|Sydney, NNSW, Australia, 2148|
|Contact +61 1300 742 326 firstname.lastname@example.org|
|Principal Investigator: Chris Argent, MD|
|Principal Investigator:||Louise Murdoch, MBBS||Emeritus Research|