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A Safety Evaluation Trial of TEV-48125 Self-administered in Migraine Patients

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: NCT04355117
Recruitment Status : Recruiting
First Posted : April 21, 2020
Last Update Posted : April 21, 2020
Sponsor:
Information provided by (Responsible Party):
Otsuka Pharmaceutical Co., Ltd.

Brief Summary:
This trial assesses the safety of TEV-48125 when subcutaneously self-administered in Japanese migraine patients using an autoinjector (AI) at home. Each subject will subcutaneously self-administer TEV 48125 at 225 mg/1.5 mL (150 mg/mL) once monthly for a total of 2 doses. The first dose will be self-administered at the trial site under the supervision of the investigator and the second dose will be self-administered at home.

Condition or disease Intervention/treatment Phase
Migraine Drug: Each subject will subcutaneously self-administer TEV 48125 at 225 mg/1.5 mL (150 mg/mL) once monthly for a total of 2 doses. Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter, Open-label Trial to Evaluate the Safety of TEV-48125 When Subcutaneously Self-administered in Migraine Patients at the Trial Site and at Home
Estimated Study Start Date : May 2020
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : November 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Migraine

Arm Intervention/treatment
Experimental: Treatment: TEV-48125 Drug: Each subject will subcutaneously self-administer TEV 48125 at 225 mg/1.5 mL (150 mg/mL) once monthly for a total of 2 doses.
Each subject will subcutaneously self-administer TEV 48125 at 225 mg/1.5 mL (150 mg/mL) once monthly for a total of 2 doses.




Primary Outcome Measures :
  1. Occurrence of adverse events (AEs) [ Time Frame: Baseline (Day 0) up to follow-up treatment(Day57) ]
    The primary objective is to assess the safety of TEV-48125 when subcutaneously self-administered in Japanese migraine patients using an autoinjector (AI) at home.


Secondary Outcome Measures :
  1. The execution status of self-administration at home.Amount of drug solution remaining in the AI. [ Time Frame: Visit 3((Day 29) ]

    Amount of drug solution remaining in the AI are recorded based on the checklist as the execution status.

    [Amount of drug solution remaining in the AI]

    0 :All drug solution has been injected

    1. : Approximately 1/4 of the drug solution remaining
    2. : Approximately 1/2 of the drug solution remaining
    3. : Approximately 3/4 of the drug solution remaining
    4. : Almost all of the drug solution remaining

  2. The execution status of self-administration at home. Leakage of drug solution on the skin. [ Time Frame: Visit 3(Day 29) ]

    Leakage of drug solution on the skin are recorded based on the checklist as the execution status.

    [Leakage of drug solution on the skin after subcutaneous injection]

    0 :No sign of drug solution on the skin

    1. : Slight wetness on the skin (mist)
    2. : Approx. 1/5 (0.3 mL) of the drug solution observed on the skin (most of the drug solution subcutaneously administered)
    3. : Approx. 1/2 (0.75 mL) of the drug solution observed on the skin (ie, approx. 1/2 of drug solution subcutaneously administered)
    4. : Almost all of the drug solution observed on the skin (ie, little or no drug solution subcutaneously administered)

  3. Subject compliance with the self-administration procedure . [ Time Frame: Visit 3(Day 29) ]
    Subject compliance with the self-administration procedure will be evaluated based on information recorded on a checklist.And frequency distributions will be summerized .Compliance with each of the procedures during IMP preparation, injection administration, and after injection will be verified by checking the "Yes" or "No" responses marked for each item on the checklist. Based on this checklist, the investigator will judge adherence to self-adminstration procedure.

  4. Any deficiencies with the auto injector device [ Time Frame: Baseline(Day 0) up to Visit 3(Day 29) ]
    Whether there are any problems with AI device are reported.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient has a history of migraine (according to the ICHD-3 criteria) diagnosis for ≥12 months prior to giving informed consent.
  • Patient fulfills any of the migraine criteria(according to the ICHD-3 criteria) on ≥4 days in baseline information collected during the 28-day screening period

Exclusion Criteria:

  • History of hypersensitivity reactions to injected proteins, including monoclonal antibodies
  • Prior exposure to a monoclonal antibody targeting (CGRP) pathway meeting the following conditions:

    • Less than 5 months has passed since the final administration of AMG334, ALD304, or LY2951742.
    • Less than 1 year has passed since the final administration of TEV-48125

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): NCT04355117


Contacts
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Contact: Drug Information Center +81-3-6361-7314

Locations
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Japan
Sendai Zutsu No-Shinkei Clinic Recruiting
Sendai, Japan
Sponsors and Collaborators
Otsuka Pharmaceutical Co., Ltd.
Investigators
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Study Director: Takehisa Matsumaru Otsuka Pharmaceutical Co., Ltd.

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Responsible Party: Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT04355117    
Other Study ID Numbers: 406-102-00005
First Posted: April 21, 2020    Key Record Dates
Last Update Posted: April 21, 2020
Last Verified: April 2020

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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