| CTRI Number |
CTRI/2015/05/005829 [Registered on: 29/05/2015] Trial Registered Prospectively |
| Last Modified On: |
04/05/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
A clinical trial to study the effect of Timolol eyedrops in patients with acute migraine |
|
Scientific Title of Study
|
Topical betablockers(Timolol ophthalmic solution 0.5 %) in acute migraine-a prospective randomised crossover trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Protocol No: CEHRI/IEC/15/03-06;Amendment 1 |
Protocol Number |
| U1111-1167-6439, Protocol No: CEHRI/IEC/15/03-06;Version 1 |
UTN |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Abraham Kurian |
| Designation |
Senior Consultant |
| Affiliation |
Chaithanya Eye Hospital and Research Institute |
| Address |
Kesavadasapuram
Thiruvananthapuram
KERALA
695004
India |
| Phone |
91-9847094478 |
| Fax |
0471-2443985 |
| Email |
abrahamkurian55@yahoo.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Iodine Reghunadhan |
| Designation |
Consultant |
| Affiliation |
Chaithanya Eye Hospital and Research Institute |
| Address |
Kesavadasapuram
Thiruvananthapuram
KERALA
695004
India |
| Phone |
919847104830 |
| Fax |
0471-2443985 |
| Email |
iodine_b@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pratibha Thilak |
| Designation |
DNB trainee |
| Affiliation |
Chaithanya Eye Hospital and Research Institute |
| Address |
Kesavadasapuram
Thiruvananthapuram
KERALA
695004
India |
| Phone |
91-8111921884 |
| Fax |
0471-2443985 |
| Email |
pratibhathilak@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Chaithanya Eye Hospital and Research Institute, Kesavadasapuram,
Thiruvananthapuram |
|
|
Primary Sponsor
|
| Name |
Dr Abraham Kurian |
| Address |
Chaithanya Eye Hospital and Research Institute, Kesavadasapuram, Thiruvananthapuram |
| Type of Sponsor |
Other [Principal Investigator] |
|
|
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 Abraham Kurian |
Chaithanya Eye Hospital and Research Institute |
Kesavadasapuram
Thiruvananthapuram
KERALA |
91-9847094478
0471-2443985
abrahamkurian55@yahoo.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee-Chaithanya Eye Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Migraine, (1) ICD-10 Condition: G439||Migraine, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
SODIUM CARBOXY METHYL CELLULOSE EYEDROPS 0.5% |
SODIUM CARBOXY METHYL CELLULOSE EYEDROPS 0.5% as placebo - 1 drop in each eye at the onset of migraine headache/ aura. If there is no relief after 10 minutes,1 more drp is instilled at 10 minutes and if still no relief after further 10 minutes, patient is free to use any of the existing prescribed oral antimigraine medications for pain relief.The total duration of the study will be for 7 months during which the patient will be using the intervention eyedrops for 3months and the comparator eyedrops for another 3 months with a medication free period of 3 month in between |
| Intervention |
TIMOLOL OPHTHALMIC SOLUTION 0.5% |
TIMOLOL OPHTHALMIC SOLUTION 0.5% 1 drop in each eye at the onset of migraine headache/aura. If there is no relief after 10 minutes,1 more drp is instilled at 10 minutes and if still no relief after further 10 minutes, patient is free to use any of the existing prescribed oral antimigraine medications for pain relief.The total duration of the study will be for 7 months during which the patient will be using the intervention eyedrops for 3months and the comparator eyedrops for another 3 months with a medication free period of 3 month in between. |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Male of female patients at least 12 years of age.
2. Female of childbearing potential should use a reliable form of contraception throughout the study period.
3. A negative urine pregnancy test result at Enrolment on Day 1 for women of childbearing potential.
4. Written informed consent to be obtained.
5. Clinical diagnosis of migraine -Migraine with aura(1.1), Migraine without aura(1.2), Probable Migraine without aura(1.5.1) or Probable Migraine with aura(1.5.2) according to the ICHD III diagnostic criteria.
6. Not be on any antimigraine medications for atleast 1 month.
7. Ability to understand and follow the study instructions you receive and willingness for 7 months followup.
|
|
| ExclusionCriteria |
| Details |
1. Known Allergy or hypersensitivity to the study medications.
2. Female patients who are pregnant, Breastfeeding, or planning to become pregnant during the study.
3. Females in childbearing age who are not using a reliable means of contraception
4. Patients with Bronchial Asthma, Bradyarrhythmias and cardiac dysfunction
5. Patients with coexistent Glaucoma, in whom use of topical Betablockers is anticipated.
6. Patients not amenable to a minimum followup of 7 months
7. Patients on medications for migraine, who were not willing to stop existing treatment for atleast 1 month.
8. Obstruction of lacrimal drainage system detected on baseline evaluation.
9. Current enrolment in another investigational study or participation in such a study within 30 days of entry into this study.
10. Patient has a condition or situation which in the investigators opinion, may put the patient at a significant risk, may confound the study results, or interfere with the participation in the study
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Treatment Success with Timolol eyedrops assessed by the alleviation of pain as assessed by a decrease in pain score by the numerical pain rating scale for each attack |
On study completion (at 7 months) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assessment of Safety indices like BCVA, IOP, Slit Lamp Biomicroscopy, General and Systemic examination |
At each visit after baseline Day15, Month1, Month2, Month3, Month4, Month5, Month6, Month7 |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="50" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
01/06/2015 |
| Date of Study Completion (India) |
28/10/2017 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is a prospective, randomised, double blind, single centre, placebo controlled crossover trial comparing the efficacy and safety of topical timolol 0.5% eyedrops in patients with acute migraine. Primary outcome measures will be treatment success defined as a decrease in pain score on a numerical pain scale by the patient before and after treatment for the acute attack. The secondary outcomes will be the assessment for safety indices at each visit. |