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

Migraine Disorders Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03193359
• Other study ID #: 1313-302-008
• Status: Withdrawn
• Phase: Phase 3
• First received: June 19, 2017
• Last updated: July 12, 2017
• Start date: January 15, 2018
• Est. completion date: September 9, 2021

Study information

• Verified date: July 2017
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 9, 2021
• Est. primary completion date: September 9, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Headache
• Migraine Disorders

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with Adverse Events (AEs)	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.	24 Weeks
Primary	Percentage of Participants with AEs Leading to Discontinuation		24 Weeks
Primary	Change from Baseline in Vital Signs	Vital signs include blood pressure and pulse.	Baseline, Week 24
Primary	Change from Baseline in 12-Lead Electrocardiograms (ECGs) Parameters	A standard 12-lead ECG will be performed at Baseline and Week 24.	Baseline, Week 24
Primary	Change from Baseline in Clinical Laboratory Parameters	Blood samples will be collected at Baseline and Week 24 for standard clinical laboratory testing including hematology, chemistry, urinalysis an immunogenicity parameters.	Baseline, Week 24
Secondary	Change from Baseline in the Frequency of Headache Days during 28-Day Period Ending with 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.	Baseline, Weeks 12 and 24
Secondary	Change from Baseline in Total Cumulative Hours of Headache Days during 28-Day period	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.	Baseline, Weeks 12 and 24

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