| CTRI Number |
CTRI/2026/03/105199 [Registered on: 02/03/2026] Trial Registered Prospectively |
| Last Modified On: |
23/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Comparative Study of
OnabotulinumtoxinA Injection Methods - Follow-the-suture vs PREEMPT in patients of Chronic Migraine. |
|
Scientific Title of Study
|
Follow-the-Suture vs PREEMPT: A Comparative Study of
OnabotulinumtoxinA Injection Methods for Chronic Migraine |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Aktar Hussain Barbhuiya |
| Designation |
SENIOR RESIDENT |
| Affiliation |
Atal Bihari Vajpayee Institute of Medical Sciences and Dr. RML Hospital |
| Address |
Department of Neurology, ABVIMS and Dr. Rml Hospital, Baba Kharak Singh Marg, Cannaught Place, New Delhi
New Delhi
DELHI
110001
India |
| Phone |
8133878991 |
| Fax |
|
| Email |
hussain.aktar11@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ashish Kumar Duggal |
| Designation |
Professor |
| Affiliation |
Atal Bihari Vajpayee Institute of Medical Sciences and Dr. RML Hospital |
| Address |
Room No. 607, Administrative Building, ABVIMS and Dr. RML Hospital, Baba Kharak Singh Marg, Cannaught Place, New Delhi.
New Delhi
DELHI
110001
India |
| Phone |
981052332 |
| Fax |
|
| Email |
ashishduggal2005@rediffmai.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ashish Kumar Duggal |
| Designation |
Professor |
| Affiliation |
Atal Bihari Vajpayee Institute of Medical Sciences and Dr. RML Hospital |
| Address |
Room NO. 607, Administrative Building, ABVIMS and Dr. RML Hospital, Baba Kharak Singh Marg, Cannaught Place, New Delhi.
DELHI
110001
India |
| Phone |
981052332 |
| Fax |
|
| Email |
ashishduggal2005@rediffmai.com |
|
|
Source of Monetary or Material Support
|
| ABVIMS and Dr. RML Hospital, Baba Kharak Singh Marg, Cannaught Place, New Delhi. PIN 110001 |
|
|
Primary Sponsor
|
| Name |
ABVIMS AND Dr RML HOSPITAL |
| Address |
ABVIMS and Dr RML Hospital, Baba Kharak Singh Marg, Cannaught Place, NEW DELHI PIN 110001 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Aktar Hussain Barbhuiya |
ABVIMS AND Dr RML Hospital |
ROOM NO. NH16, Department of Neurology, ABVIMS and Dr.RML Hospital, Cannaught Place, NEW DELHI- PIN 110001
New Delhi
DELHI |
8133878991
hussain.aktar11@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, ABVIMS, Dr. RML Hospital, New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G437||Chronic migraine without aura, (2) ICD-10 Condition: G431||Migraine with aura, (3) ICD-10 Condition: G430||Migraine without aura, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
OnabotulinumtoxinA administered using Follow-the-Suture protocol in patients of chronic migraine. |
OnabotulinumtoxinA is administered as per follow-the-suture protocol in patients of chronic migraine and outcome assessment is done. About 100 units of Onabotulinum toxin shall be given across 18 predefined sites along the cranial suture lines, each site will receive approximately about 5 units using a 30 gauze needle. To be given at week 0 after a baseline assessment period of 4 weeks and outcome to measured at week 4,8 and 12. |
| Comparator Agent |
OnabotulinumtoxinA administered using the PREEMPT protocol in patients of chronic migraine. |
OnabotulinumtoxinA is administered using the PREEMPT protocol in patients of chronic migraine and outcome assessment is done. In this method about 155 units of OnabotulinuntoxinA shall be administered along 31 fixed sites across 7 specific muscle groups of head and neck, each injection shall receive 5 units. Injection to be given after a baseline assesment of 4 weeks at week 0 and outcome to be measured at wekk 4,8 and 12 and compared with baseline. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
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.
|
|
| ExclusionCriteria |
| Details |
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. |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 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. |
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 Outcome
|
| Outcome |
TimePoints |
| Difference in the mean change of monthly headache days from baseline to week 12 between the FTS group & the PREEMPT protocol group. |
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. |
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. |
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. |
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. |
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. |
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. |
Assessment done at Week 0, Week 4, Week 8 & Week 12. |
|
|
Target Sample Size
|
Total Sample Size="44"
Sample Size from India="44"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
30/03/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [hussain.aktar11@gmail.com].
- For how long will this data be available start date provided 01-01-2028 and end date provided 01-01-2033?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
OnabotulinumtoxinA is currently one of the therapies specifically approved for the prevention of chronic migraine. Its efficacy was firmly established in the pivotal Phase III PREEMPT (Phase 3 Research Evaluating Migraine Prophylaxis Therapy) trials, which demonstrated significant reductions in headache frequency and disability, alongside improvements in quality of life compared with placebo. There is a paucity of data comparing alternative techniques like Follow-the-suture method with PREEMPT protocol for administration of OnabotulinumtoxinA in patients with chronic migraine. Recent anatomical and experimental insights suggest that cranial sutures represent critical sites for nociceptive innervation, as meningeal collaterals traverse the skull through these junctions. Based on this rationale, an alternative injection approach termed the Follow-the-Sutures method has been proposed, wherein it is administered along cranial suture lines rather than muscle groups. This strategy may offer similar or improved efficacy. Herein we aim to compare, Follow-the-suture technique for administering OnabotulinumtoxinA to the PREEMPT method in patients of Chronic Migraine. |