Health Condition 1: G437- Chronic migraine without aura Health Condition 2: G431- Migraine with aura Health Condition 3: G430- Migraine without aura
Conditions
Interventions
Intervention1: OnabotulinumtoxinA administered using Follow-the-Suture protocol in patients of chronic migraine.: OnabotulinumtoxinA is administered as per follow-the-suture protocol in patients of ch
Sponsors
ABVIMS AND Dr RML HOSPITAL
Eligibility
Inclusion criteria
Inclusion criteria: 1. Fulfilling diagnostic criteria for chronic migraine as per ICHD-3. 2. Patients who have been on at least one preventive medication for a minimum duration of 3 months, with no dose changes in the preceding month. 3. Patients willing to provide informed written consent.
Exclusion criteria
Exclusion criteria: 1. Prior neurological diseases such as brain tumors, dementia, seizures, encephalitis, meningitis, or stroke. 2. Patients failing to complete the headache diary for more than six non-consecutive days during the 28-day baseline period. 3. Patients unable to maintain a headache diary due to illiteracy or lack of caregiver support. 4. Patients with contraindications to OnabotulinumtoxinA injections (e.g., prior allergy, infection at injection site, neuromuscular disorders). 5. Pregnancy or lactation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Difference in the percentage of patients achieving at least a 50% reduction in monthly mod-severe headache days at Week 12 between the FTS and PREEMPT groups.Timepoint: Difference in the percentage of patients achieving at least a 50% reduction in monthly mod-severe headache days at Week 12 between the FTS and PREEMPT groups. | — |
Secondary
| Measure | Time frame |
|---|---|
| Difference in the mean change of monthly headache days from baseline to week 12 between the FTS group & the PREEMPT protocol group.Timepoint: Assessment done at Week 0, Week 4, Week 8 & Week 12.;Difference in the mean change of monthly migraine days from baseline to week 12 between the FTS group & the PREEMPT protocol group.Timepoint: Assessment done at Week 0, Week 4, Week 8 & Week 12.;Difference in the mean change of PHQ-9 scores from baseline to week 12 between the FTS group & the PREEMPT protocol group.Timepoint: Assessment done at Week 0, Week 4, Week 8 & Week 12.;Difference in the mean change of MIDAS scores from baseline to week 12 between the FTS group & the PREEMPT protocol group.Timepoint: Assessment done at Week 0, Week 4, Week 8 & Week 12.;Difference in the mean change of HIT-6 scores from baseline to week 12 between the FTS group & the PREEMPT protocol group.Timepoint: Assessment done at Week 0, Week 4, Week 8 & Week 12.;Difference in the mean change of MSQL scores from baseline to week 12 between the FTS group & the PREEMPT protocol group.Timepoint: Assessment done at Week 0, Week 4, Week 8 & Week 12.;Incidence & nature of treatment-emergent adverse events (TEAEs) reported by participants following administration of Onabotulinum toxin using the Follow the suture technique compared to the PREEMPT protocol.Timepoint: Assessment done at Week 0, Week 4, Week 8 & Week 12. | — |
Countries
India
Contacts
Public ContactDr Ashish Kumar Duggal
Atal Bihari Vajpayee Institute of Medical Sciences and Dr. RML Hospital
Outcome results
None listed