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



Status:Completed
Conditions:Migraine Headaches
Therapuetic Areas:Neurology
Healthy:No
Age Range:18 - 70
Updated:2/21/2019
Start Date:March 24, 2016
End Date:December 7, 2018

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A Multicenter, Randomized, Double-Blind, Parallel-Group Study Evaluating the Long-Term Safety, Tolerability, and Efficacy of Subcutaneous Administration of TEV-48125 for the Preventive Treatment of Migraine

A study to evaluate the long-term safety, tolerability, and efficacy of subcutaneous
administration of TEV-48125 in adult patients with chronic migraine or episodic migraine


Inclusion Criteria:

Patients Rolling Over from the Pivotal Efficacy Studies may be included in this study only
if they meet all of the following criteria:

- Patient signs and dates the informed consent document.

- Patient must have completed the pivotal efficacy study without major protocol
violations.

- Additional criteria apply, please contact the investigator for more information

Patients Not Rolling Over from the Pivotal Efficacy Studies may be included in this study
only if they meet all of the following criteria:

- Males or females aged 18 to 70 years, inclusive, with migraine onset at ≤50 years of
age

- Patient signs and dates the informed consent document.

- Patient has history of migraine or clinical judgment suggests a migraine diagnosis

- Patient fulfills the criteria for episodic migraine (EM) or chronic migraine (CM)

- Total body weight between 99 and 265 lbs., inclusive

- All patients must be of nonchildbearing potential

- Patients must simultaneously use 2 forms of highly effective contraception
methods

- Patients will remain abstinent throughout the study

- Patients have sexual preference that precludes the possibility of pregnancy.

- Female patients of childbearing potential must have a negative serum beta-human
chorionic gonadotropin (β-HCG) pregnancy test prior to randomization (confirmed by
urine dipstick at baseline).

- The patient must be willing and able to comply with study restrictions, to remain at
the clinic for the required duration during the study period, and to return to the
clinic for the follow-up evaluation as specified in this protocol.

- Additional criteria apply, please contact the investigator for more information

Exclusion Criteria:

Patients Rolling Over from the Pivotal Efficacy Studies will be excluded from participating
in this study if they meet any of the following criteria:

- Pregnant or nursing females

- Compliance with daily diary entry lower than 75% at the last month of the double-blind
treatment period of the pivotal efficacy study

Patients Not Rolling Over from the Pivotal Efficacy Studies will be excluded from
participating in this study if they meet any of the following criteria:

- Clinically significant findings at the discretion of the investigator

- Evidence or medical history of clinically significant psychiatric issues, including
any suicide attempt in the past, or suicidal ideation with a specific plan in the past
2 years

- History of clinically significant cardiovascular disease or vascular ischemia

- Known infection or history of human immunodeficiency virus, tuberculosis, or chronic
hepatitis B or C infection

- Past or current history of cancer in the past 5 years, except for appropriately
treated nonmelanoma skin carcinoma

- Pregnant or nursing females

- History of hypersensitivity reactions to injected proteins, including monoclonal
antibodies h. Participation in a clinical study of a new chemical entity or a
prescription medicine within 2 months before study drug administration or 5
half-lives, whichever is longer

- Any finding considered clinically significant in the judgment of the investigator

- History of alcohol or drug abuse during the past 2 years, or alcohol or drug
dependence during the past 5 years

- The patient cannot participate or successfully complete the study, in the opinion of
their healthcare provider or the investigator, for any of the following reasons:

- mentally or legally incapacitated or unable to give consent for any reason

- in custody due to an administrative or a legal decision, under tutelage, or being
admitted to a sanitarium or social institution

- unable to be contacted in case of emergency

- has any other condition, which, in the opinion of the investigator, makes the
patient inappropriate for inclusion in the study

- Patient is a study center or sponsor employee who is directly involved in the study or
the relative of such an employee.

- Additional criteria apply, please contact the investigator for more information
We found this trial at
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Lebanon, New Hampshire
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