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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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04355117
Recruitment Status : Completed
First Posted : April 21, 2020
Results First Posted : October 28, 2021
Last Update Posted : October 28, 2021
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)
Actual Enrollment : 71 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
Actual Study Start Date : June 17, 2020
Actual Primary Completion Date : November 11, 2020
Actual Study Completion Date : November 11, 2020

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Migraine
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. Number of Subjects With at Least One Treatment-emergent Adverse Event (TEAE) [ Time Frame: [1] Baseline (Day 1) to Day 28, [2] Visit 3 (Day 29) up to end of treatment (Day 57) ]
    • TEAEs were defined as AEs that started after the start of investigational medicinal product (IMP) treatment; or if the event was continuous from baseline and was worsening after the start of IMP treatment.
    • The number of subjects with TEAEs were provided by self-administration at the trial site and by self-administration at home.

      1. For TEAEs following self-administration at the trial site, TEAEs that occurred after self-administration at the trial site (Baseline) but before self-administration at home (Visit 3) were tabulated.
      2. For TEAEs following self-administration at home, TEAEs that occurred after self-administration at home but before the end of the trial were tabulated.


Secondary Outcome Measures :
  1. Execution Status of Self-administration - Amount of Drug Solution Remaining in the AI [ Time Frame: Baseline (Day 1) and Visit 3 (Day 29) ]

    Following self-administration at the trial site and at home, the AI was checked to see whether or not all of the drug solution had been injected and the appropriate description of the amount of drug solution remaining in the AI was recorded based on th following 5-point scale (0 to 4) measure.

    • 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. Execution Status of Self-administration - Leakage of Drug Solution on the Skin [ Time Frame: Baseline (Day 1) and Visit 3 (Day 29) ]

    Following self-administration at the trial site and at home, the injection site was observed for any leakage of drug solution on the skin was recorded based on the following 5-point scale (0 to 4) measure. Criteria 0, 1, and 2 on the 5-point scale measure were deemed to represent a successful self-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: Baseline (Day 1) and Visit 3 (Day 29) ]

    Subject compliance with the self-administration procedure was evaluated based on information recorded on a checklist.

    Compliance with each of the procedures during IMP preparation, injection administration, and after injection was verified by checking the "Yes" or "No" responses marked for each item on the checklist. Based on this checklist, the investigator judged adherence to self-administration procedure.


  4. Number of Deficiencies With the AI Device [ Time Frame: Baseline (Day 1) and Visit 3 (Day 29) ]
    A deficiency with the AI device (AI device deficiency) is defined as any defect in the quality, safety, or performance of the device, such as mechanical breakage and malfunction, no matter whether it is caused by design, manufacture, dispensing, storage,or use.



Information from the National Library of Medicine

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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


Locations
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Japan
Sendai Zutsu No-Shinkei Clinic
Sendai, Japan
Sponsors and Collaborators
Otsuka Pharmaceutical Co., Ltd.
Investigators
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Study Director: Takehisa Matsumaru Otsuka Pharmaceutical Co., Ltd.
  Study Documents (Full-Text)

Documents provided by Otsuka Pharmaceutical Co., Ltd.:
Study Protocol  [PDF] March 16, 2020
Statistical Analysis Plan  [PDF] December 15, 2020

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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
Results First Posted: October 28, 2021
Last Update Posted: October 28, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Anonymized Individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: Data will be available after marketing approval in global markets, or beginning 1-3 years following article Publication. There is no end date to the availability of the data.
Access Criteria: Otsuka will share data on an Otsuka-owned remotely accessible data sharing platform with Python and R analytical software. Research requests should be directed to clinicaltransparency@Otsuka-us.com.

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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