Efficacy and Safety of Subcutaneous Administration of TEV-48125 for the Preventive Treatment of Chronic Migraine

Otsuka

Status and phase: Completed; Phase 3; Phase 2

Conditions: Migraine

Treatments: Drug: Placebo; Drug: TEV-48125 or placebo; Drug: TEV-48125

Study type: Interventional

Funder types: Industry

Identifiers

NCT03303079

JapicCTI-173723 (Other Identifier)

406-102-00001

Details and patient eligibility

About

To evaluate the efficacy and safety of subcutaneous (SC) administration of TEV-48125 [monthly TEV-48125 225 mg (loading dose only: 675 mg) and TEV-48125 675 mg once over a period of 3 months] compared with placebo for preventive treatment in Chronic Migraine patients

Enrollment: 571 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient has a history of migraine (according to The International Classification of Headache Disorders, third edition [beta version] criteria) or clinical judgment suggests a migraine diagnosis
• Patient fulfills the criteria for Chronic migraine in baseline information collected during the 28 day screening period
• Not using preventive migraine medications for migraine or other medical conditions or using no more than 1 preventive migraine medication for migraine or other medical conditions if the dose and regimen have been stable for at least 2 months prior to giving informed consent.
• Patient demonstrates compliance with the electronic headache diary during the screening period by entry of headache data on a minimum of 24 of 28 days and the entered data is judged appropriate by the investigator.

Exclusion criteria

• Patients who have previously failed (lack of efficacy) 2 or more of the clusters of the medications for treatment of migraine after use for at least 3 months at accepted migraine therapeutic doses
• Patient suffers from unremitting headaches, defined as having headaches for more than 80% of the time that he/she is awake, and less than 4 days without headache per month. Daily headache is acceptable if the patient has headaches 80% or less of the time they are awake on most days.
• Hematological, cardiac, renal, endocrine, pulmonary, gastrointestinal, genitourinary, neurologic, hepatic, or ocular disease considered clinically significant in the judgment of the investigator

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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571 participants in 3 patient groups, including a placebo group

TEV-48125 (675/225/225 mg) group

Experimental group

Description:

TEV-48125 will be subcutaneously administered once monthly for 3 months (675/225/225 mg).

Treatment:

Drug: TEV-48125

TEV-48125 (675 mg/placebo/placebo) group

Experimental group

Description:

TEV-48125 or placebo will be subcutaneously administered once monthly for 3 months (675 mg/ placebo/placebo).

Treatment:

Drug: TEV-48125 or placebo

Placebo group

Placebo Comparator group

Description:

Placebo will be subcutaneously administered once monthly for 3 months (placebo/placebo/placebo).

Treatment:

Drug: Placebo