Onabotulinum Dose Comparison in Chronic Migraine Superior to 100 Units?

NCT04349176 | Terminated Phase 3 FDA Drug

• 1 other identifier: NMCSD.2016.0039
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Migraine, Headache

Outcome Measures

Primary Outcomes (1)

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

  24 weeks

Secondary Outcomes (4)

• frequency of migraine days

  24 weeks

• proportion of patients with severe (>=60) HIT-6 score

  24 weeks

• acute headache pain medication intakes

  24 weeks

• mean change in total HIT-6

  24 weeks

Study Arms (4)

Group A 100U

EXPERIMENTAL

Drug: Dose

Group A 155U

EXPERIMENTAL

Drug: Dose

Group B 100U

EXPERIMENTAL

Drug: Dose

Group B 155

EXPERIMENTAL

Drug: Dose

Interventions

Dose DRUG

Randomized to either 100U or 155U

Group A 100U; Group A 155U; Group B 100U; Group B 155

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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. -

You may not qualify if:

• 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

Sponsors & Collaborators

• United States Naval Medical Center, San Diego: lead

Study Sites (1)

Naval Medical Center San Diego

San Diego, California, 92134, United States

Location

MeSH Terms

Conditions

Headache

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: April 14, 2020
• First Posted: April 16, 2020
• Study Start: May 12, 2017
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2022
• Last Updated: February 5, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)