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

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ClinicalTrials.gov Identifier: NCT03193359
Recruitment Status : Withdrawn (Corporate Decision)
First Posted : June 20, 2017
Last Update Posted : July 14, 2017
Sponsor:
Information provided by (Responsible Party):
Allergan

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Migraine Disorders Biological: botulinum toxin Type A Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Multicenter, Open-label, Safety, Tolerability and Efficacy Study of BOTOX® (Botulinum Toxin Type A) as Headache Prophylaxis in Chinese Patients With Chronic Migraine
Estimated Study Start Date : January 15, 2018
Estimated Primary Completion Date : September 9, 2021
Estimated Study Completion Date : September 9, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: BOTOX®
BOTOX® (botulinum toxin Type A) 155U to 195U intramuscular (IM) injections to head/neck areas at Day 0 and Week 12.
Biological: botulinum toxin Type A
Botulinum toxin Type A (BOTOX®) IM 155U to 195U injections in head/neck areas.
Other Names:
  • BOTOX®
  • onabotulinumtoxinA




Primary Outcome Measures :
  1. Number of Participants with Adverse Events (AEs) [ Time Frame: 24 Weeks ]
    An AE is any untoward medical occurrence in a patient or a participant using an investigational drug, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product.

  2. Percentage of Participants with AEs Leading to Discontinuation [ Time Frame: 24 Weeks ]
  3. Change from Baseline in Vital Signs [ Time Frame: Baseline, Week 24 ]
    Vital signs include blood pressure and pulse.

  4. Change from Baseline in 12-Lead Electrocardiograms (ECGs) Parameters [ Time Frame: Baseline, Week 24 ]
    A standard 12-lead ECG will be performed at Baseline and Week 24.

  5. Change from Baseline in Clinical Laboratory Parameters [ Time Frame: Baseline, Week 24 ]
    Blood samples will be collected at Baseline and Week 24 for standard clinical laboratory testing including hematology, chemistry, urinalysis an immunogenicity parameters.


Secondary Outcome Measures :
  1. Change from Baseline in the Frequency of Headache Days during 28-Day Period Ending with Weeks 12 and 24 [ Time Frame: Baseline, Weeks 12 and 24 ]
    Mean change from Baseline (28-days prior to first treatment) in frequency (number) of headache days during the 28-day period ending with Weeks 12 and 24. A headache day was defined as a calendar day [00:00 to 23:59] for which the participant reported ≥ 4 continuous hours of headache per patient diary.

  2. Change from Baseline in Total Cumulative Hours of Headache Days during 28-Day period [ Time Frame: Baseline, Weeks 12 and 24 ]
    Mean change from Baseline (28-days prior to first treatment) in the total cumulative hours of headache days during the 28-day period ending with Weeks 12 and 24. A headache day is defined as a day (00:00 to 23:59) with 4 or more continuous hours of headache per patient diary.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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): NCT03193359


Sponsors and Collaborators
Allergan
Investigators
Study Director: Arlene Lum Allergan

Additional Information:
Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT03193359     History of Changes
Other Study ID Numbers: 1313-302-008
First Posted: June 20, 2017    Key Record Dates
Last Update Posted: July 14, 2017
Last Verified: July 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Migraine Disorders
Headache
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Botulinum Toxins
onabotulinumtoxinA
Botulinum Toxins, Type A
abobotulinumtoxinA
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents