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Trial record 2 of 2 for:    LAT8881

A Proof of Concept Study of the Efficacy and Safety of Oral LAT8881 in Acute Migraine

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04153409
Recruitment Status : Recruiting
First Posted : November 6, 2019
Last Update Posted : November 6, 2019
Sponsor:
Information provided by (Responsible Party):
Lateral Pharma Pty Ltd

Brief Summary:
This is a randomised, placebo controlled, double blind, crossover proof of concept study to investigate the efficacy and safety of oral LAT8881 in acute migraine, with or without aura.

Condition or disease Intervention/treatment Phase
Acute Migraine Drug: LAT8881 Drug: Placebo Phase 2

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Randomised assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache Migraine

Arm Intervention/treatment
Experimental: Active
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.
Drug: LAT8881
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.
Drug: Placebo
Two capsules of placebo




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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)

  2. 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)

  3. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Males or females aged 18 to 75 years at the time of consent
  2. Diagnosis of episodic migraine headache at least 12 months ago with or without aura as defined in International Classification of Headache-3
  3. Onset of migraine headache before age 50
  4. Medical history of 2 - 8 migraine headache attacks per month for the previous 12 months; ≥ 75% of attacks progress to moderate or severe pain within 2 hours (ie, rapidly-escalating)
  5. Minimum 48 hours on average between migraine headache attacks
  6. Acute headache medication on ≤ 14 days/month in the 3 months prior to screening
  7. Willing and able to comply with all study procedures including completion of a headache diary and a migraine diary on the day of a migraine headache
  8. Female subjects must be:

    1. of non-child-bearing potential [surgically sterilised or postmenopausal (12 months with no menses without alternative medical cause)] OR
    2. not pregnant, breast feeding or planning to become pregnant AND willing to comply with the medically acceptable contraceptive requirements of the study from screening to at least 28 days after the last IMP administration
  9. Male subjects with female partners of childbearing potential must use adequate and highly effective methods of contraception, from screening until 28 days after their last IMP administration.
  10. Subjects must be sufficiently competent in English to understand the purposes and risks of the study and to provide written informed consent -

Exclusion Criteria:

  1. Unable to distinguish migraine from other primary headache conditions
  2. Average of 15 or more headache (migraine or nonmigraine) days per month or history of more than 25% of headaches occurring at time of wakening (wake up headaches)
  3. History of aura lasting more than 60 minutes
  4. History of vomiting within 2 hours of onset of a migraine headache in more than 25% of migraine headaches
  5. Medication overuse headache, defined as:

    1. use of opioids, triptans or ergot alkaloids or any combination of these medications for treatment of headaches 10 or more days per month during the 90 days prior to screening OR
    2. Non-steroidal anti-inflammatory drugs (NSAIDs) or simple analgesics for treatment of headaches on more than 14 days per month during the 90 days prior to screening
  6. Recent (3 years) history of frequent or chronic hemiplegic/ basilar migraine, tension headache, retinal migraine, ophthalmoplegic migraine as per ICHD classification, or treatment resistant atypical migraine
  7. Hospital admission for status intractable migraine or medication overuse headache within 6 months of screening
  8. Current clinically significant systemic disease or neurological or psychiatric condition which in the opinion of the investigator or sponsor could jeopardise the safety of the subject or the validity of the study results
  9. Cerebrovascular disease, including but not limited to a history of stroke or recent (3 years) transient ischaemic attack (TIA)
  10. Major surgery within 6 weeks of screening or planned during the study period
  11. Clinically significant abnormality as assessed by the investigator or sponsor's medical monitor on haematology, biochemistry, vital signs, physical examination or 12-lead electrocardiogram (ECG)
  12. Malignancy within 5 years of screening, with the exception of carcinoma in situ, non-melanoma skin cancers and prostate cancer not requiring treatment or on stable (> 6 months) treatment with hormone therapy
  13. History of alcohol abuse, illicit or illegal drug use in the last 2 years
  14. Use of prohibited medications or treatments within the specified time period before Screening or planned during the study
  15. Participation in another clinical trial or administration of any investigational product or experimental product within 60 days or 5 half-lives (whichever is longer) prior to screening
  16. History of significant hypersensitivity to LAT8881 (formerly known as AOD9604), excipients in the drug product formulation or drugs of a similar chemical or pharmacological class.
  17. Surgical or medical conditions which could significantly alter drug absorption, distribution, metabolism or excretion
  18. An employee of the sponsor or research site personnel directly affiliated with this study, whether biological or legally adopted, or their immediate family members, defined as a spouse, parent, sibling, or child

Information from the National Library of Medicine

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


Contacts
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Contact: Louise Murdoch, MBBS +6195096166 info@emeritusresearch.com

Locations
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Australia, New South Wales
Paratus Clinical Research, Central Coast Recruiting
Kanwal, New South Wales, Australia, 2259
Contact    +61 2 4393 3852    info@paratusclinical.com   
Principal Investigator: Joshua Kim, MD         
Australia, NNSW
Paratus Clinical Research, Blacktown Recruiting
Sydney, NNSW, Australia, 2148
Contact    +61 1300 742 326    info@paratusclinical.com   
Principal Investigator: Chris Argent, MD         
Sponsors and Collaborators
Lateral Pharma Pty Ltd
Investigators
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Principal Investigator: Louise Murdoch, MBBS Emeritus Research

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Responsible Party: Lateral Pharma Pty Ltd
ClinicalTrials.gov Identifier: NCT04153409    
Other Study ID Numbers: LAT-MIG-001
First Posted: November 6, 2019    Key Record Dates
Last Update Posted: November 6, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases