Open Label Study of BOTOX® (Botulinum Toxin Type A) as Headache Prophylaxis in Chinese Patients With Chronic Migraine

NCT ID: NCT03193359

Last Updated: 2017-07-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-15

Study Completion Date

2021-09-09

Brief Summary

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This study is an open-label extension study to evaluate the safety, tolerability and efficacy of BOTOX® as headache prophylaxis in Chinese patients with chronic migraine who have successfully completed the double-blind study: 1313-301-008.

Detailed Description

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Conditions

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Migraine Disorders

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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BOTOX®

BOTOX® (botulinum toxin Type A) 155U to 195U intramuscular (IM) injections to head/neck areas at Day 0 and Week 12.

Group Type EXPERIMENTAL

botulinum toxin Type A

Intervention Type BIOLOGICAL

Botulinum toxin Type A (BOTOX®) IM 155U to 195U injections in head/neck areas.

Interventions

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botulinum toxin Type A

Botulinum toxin Type A (BOTOX®) IM 155U to 195U injections in head/neck areas.

Intervention Type BIOLOGICAL

Other Intervention Names

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BOTOX® onabotulinumtoxinA

Eligibility Criteria

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Inclusion Criteria

-Has successfully completed the double-blind study (1313-301-008).

Exclusion Criteria

* Has met any of the withdrawal criteria in the double-blind study or has clinical significant abnormal laboratory or electrocardiogram (ECG) findings
* Headache attributable to another disorder (eg, cervical dystonia, craniotomy, head/neck trauma)
* Any medical condition that may put the patient at increased risk with exposure to Botulinum Toxin Type A, including diagnosed myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or any other significant disease that might interfere with neuromuscular function.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Allergan

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Arlene Lum

Role: STUDY_DIRECTOR

Allergan

Related Links

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Other Identifiers

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1313-302-008

Identifier Type: -

Identifier Source: org_study_id

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