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Onabotulinum Dose Comparison in Chronic Migraine Superior to 100 Units?

Primary Purpose

Chronic Migraine, Headache

Status
Unknown status
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Dose
Sponsored by
United States Naval Medical Center, San Diego
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Migraine, Headache

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Chronic migraine headache - Diagnostic criteria:

A. Headache (tension-type-like and/or migraine-like) on 15 days per month for >3 months2 and fulfilling criteria B and C B. Occurring in a patient who has had at least five attacks fulfilling criteria B-D for 1.1 Migraine without aura and/or criteria B and C for 1.2 Migraine with aura

C. On 8 days per month for >3 months, fulfilling any of the following 3 :

  1. criteria C and D for 1.1 Migraine without aura
  2. criteria B and C for 1.2 Migraine with aura
  3. believed by the patient to be migraine at onset and relieved by a triptan or ergot derivative D. Not better accounted for by another ICHD-3 diagnosis. -

Exclusion Criteria:

Previous exposure at any time to any botulinum toxin serotype Pregnancy, breastfeeding or plans to become pregnant within 6 months Age <18 years Failure to complete at least 20 days of headache diary in the 28 day baseline period

Sites / Locations

  • Naval Medical Center San DiegoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Group A 100U

Group A 155U

Group B 100U

Group B 155

Arm Description

Outcomes

Primary Outcome Measures

mean change in frequency of headache days for the baseline period compared to the 28-day period ending with week 24

Secondary Outcome Measures

frequency of migraine days
proportion of patients with severe (>=60) HIT-6 score
acute headache pain medication intakes
mean change in total HIT-6

Full Information

First Posted
April 14, 2020
Last Updated
April 14, 2020
Sponsor
United States Naval Medical Center, San Diego
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1. Study Identification

Unique Protocol Identification Number
NCT04349176
Brief Title
Onabotulinum Dose Comparison in Chronic Migraine Superior to 100 Units?
Official Title
OnabotulinumtoxinA for Chronic Headaches: Is 155 Units Superior to 100 Units?
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Unknown status
Study Start Date
May 12, 2017 (Actual)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
June 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
United States Naval Medical Center, San Diego

4. Oversight

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

5. Study Description

Brief Summary
The study will enroll patients through the Neurology Department at Naval Medical Center San Diego (NMCSD). Eligible participants will meet criteria for chronic migraine, but will not be excluded based on the presence of significant comorbidities. Participants with comorbidities and medication regimens commonly exhibited within real-world DOD medical settings will not be excluded, such as pain disorders, psychiatric illness, medication overuse, and those who have used prophylactic medication during the baseline period. This will comprise "Group A". A carefully screened group will comprise "Group B" and meet exclusion criteria designed to approximate that of the PREEMPT2 trial. Within each group, half of the patients (155U Arm) will be randomly selected to receive the standard 155U over 31 fixed sites every 12 weeks while the other half (100U Arm) will receive 100U over 19 fixed sites every 12 weeks. Minimum sample size for the entire cohort is 132 participants (maximum n = 180), with a minimum of 66 participants per comparison.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Migraine, Headache

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group A 100U
Arm Type
Experimental
Arm Title
Group A 155U
Arm Type
Experimental
Arm Title
Group B 100U
Arm Type
Experimental
Arm Title
Group B 155
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Dose
Intervention Description
Randomized to either 100U or 155U
Primary Outcome Measure Information:
Title
mean change in frequency of headache days for the baseline period compared to the 28-day period ending with week 24
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
frequency of migraine days
Time Frame
24 weeks
Title
proportion of patients with severe (>=60) HIT-6 score
Time Frame
24 weeks
Title
acute headache pain medication intakes
Time Frame
24 weeks
Title
mean change in total HIT-6
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Chronic migraine headache - Diagnostic criteria: A. Headache (tension-type-like and/or migraine-like) on 15 days per month for >3 months2 and fulfilling criteria B and C B. Occurring in a patient who has had at least five attacks fulfilling criteria B-D for 1.1 Migraine without aura and/or criteria B and C for 1.2 Migraine with aura C. On 8 days per month for >3 months, fulfilling any of the following 3 : criteria C and D for 1.1 Migraine without aura criteria B and C for 1.2 Migraine with aura believed by the patient to be migraine at onset and relieved by a triptan or ergot derivative D. Not better accounted for by another ICHD-3 diagnosis. - Exclusion Criteria: Previous exposure at any time to any botulinum toxin serotype Pregnancy, breastfeeding or plans to become pregnant within 6 months Age <18 years Failure to complete at least 20 days of headache diary in the 28 day baseline period
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sarah Hodges, DO
Phone
6195327472
Facility Information:
Facility Name
Naval Medical Center San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92134
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sarah Hodges, DO

12. IPD Sharing Statement

Plan to Share IPD
No

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Onabotulinum Dose Comparison in Chronic Migraine Superior to 100 Units?

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