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CTRI Number  CTRI/2023/01/048905 [Registered on: 11/01/2023] Trial Registered Prospectively
Last Modified On: 10/01/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   A clinical study to assess the Efficacy and Safety of Lasmiditan Tablets compared to Placebo in Acute Treatment of Migraine with or Without Aura in Adult Patients. 
Scientific Title of Study   A Phase III, Multi-centre, Randomised, Double-Blind, Parallel-Group, Placebo-controlled Trial to evaluate the Efficacy, Safety and Tolerability of Lasmiditan Tablets 50 mg/100 mg compared to Placebo in Adult Patients for the Acute Treatment of Migraine with or Without Aura. 
Trial Acronym  None 
Secondary IDs if Any  
Secondary ID  Identifier 
BRPL/CT/LASMI/09/22; Version 2.0; Date: 01.11.2022  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Aditi Datta 
Designation  Managing Director 
Affiliation  Biosite Research Private Limited 
Address  81-84, 2nd & 3rd Floor, Chandru Complex, 18th Main, RBI Layout, JP Nagar Phase 7, Bangalore, KARNATAKA-560078, India.

Bangalore
KARNATAKA
560078
India 
Phone  91-80-35104561  
Fax    
Email  aditi.datta@biositeindia.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Aditi Datta 
Designation  Managing Director 
Affiliation  Biosite Research Private Limited 
Address  81-84, 2nd & 3rd Floor, Chandru Complex, 18th Main, RBI Layout, JP Nagar Phase 7, Bangalore, KARNATAKA-560078, India.

Bangalore
KARNATAKA
560078
India 
Phone  91-80-35104561  
Fax    
Email  aditi.datta@biositeindia.com  
 
Details of Contact Person
Public Query  
Name  Dr Aditi Datta 
Designation  Managing Director 
Affiliation  Biosite Research Private Limited 
Address  81-84, 2nd & 3rd Floor, Chandru Complex, 18th Main, RBI Layout, JP Nagar Phase 7, Bangalore, KARNATAKA-560078, India.

Bangalore
KARNATAKA
560078
India 
Phone  91-80-35104561  
Fax    
Email  aditi.datta@biositeindia.com  
 
Source of Monetary or Material Support  
Pure And Cure Healthcare Private Limited 
 
Primary Sponsor  
Name  Pure And Cure Healthcare Private Limited 
Address  Plot No. 131 to 133, Block –C, Mangolpuri Industrial Area, Phase –I, New Delhi -110083. 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 12  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Menka Jha  All India Institute of Medical Sciences  Department of Neurology, Sijua, Patrapada, Bhubaneswar, Odisha - 751019
Khordha
ORISSA 		 8917312820

drmenkajha@yahoo.com 
Dr Karthikeya Parmar  B. J. Medical College and Civil Hospital  Department of neurology, Haripura, Asawa, Ahmedabad, Gujarat - 380016
Ahmadabad
GUJARAT 		 9924643799

drkarthik@gmail.com 
Dr Abu Zafar Ansari  City Neurology Centre  Department of Neurology, Behind Gautam Upvan, Maqbool Aalam Road, Khajuri, Varanasi-221002, Uttar Pradesh, India.
Varanasi
UTTAR PRADESH 		 7753936002

drzafar4@gmail.com 
Dr S S V V Narasinga Roa  Govt. Medical college & Govt General Hospital(Old RIMSGGH)  Deportment of neurology, Clinical Research, Research Wing, 2nd Floor, Beside FM Ward, Srikakulam -532001
Srikakulam
ANDHRA PRADESH 		 9908611119

drnarasingaraossvv@yahoo.com 
Dr Lalit Kumar  GSVM Medical College  Department of neurology , Swaroop Nagar, Kanpur-208002
Kanpur Nagar
UTTAR PRADESH 		 9889264230

lalit85gsvm@gmail.com 
Dr Sudhir Sharma  Indira Gandhi Medical College & Hospital  Department of Neurology, Sanjoli Ridge Road, Lakar Bazar, Shimla , Himachal Pradesh - 171001
Shimla
HIMACHAL PRADESH 		 9418523202

sharmasudhir21@gmail.com 
Dr K Vidya Sagar  Kurnool Medical College/ Govt. General Hospital.  Deportment of neurology, Budhawar Pet, Kurnool -518002, Andhra Pradesh.
Kurnool
ANDHRA PRADESH 		 9440403270

vidyasagarkekathi37@gmail.com 
Dr Janardhan D C  Rajalakshmi Hospital & Research Centre  Deportment of neurology,#21/1 Lakshmipura Main Road,Vidyarnyapura post, Bangalore-560097
Bangalore
KARNATAKA 		 08023254855

drjanardhandc@gmail.com 
Dr Priyank Shah  Shakti Research Centre  Department of Neurology, A108, Krishna Complex, B/H Shahwadi Bus Stop, N/ H 08, Narol, Ahmedabad- 382105
Ahmadabad
GUJARAT 		 9978815568

dr.priyankshah1385@gmail.com 
Dr Anuj Nehete  Signus Hospital  Department of Neurology, 5th Floor, Atlanta Shoppers, Pathardi Road, Pathardi Phata, Nashik - 422010
Nashik
MAHARASHTRA 		 08105672524

anujneheten@gmail.com 
Dr Zubair Sarkar  Tulsi Hospital India Ltd  Department of Neurology, 14/116,-A, Civil Lines, Kanpur - 208001
Kanpur Nagar
UTTAR PRADESH 		 9760253536

drzubairsarkar@gmail.com 
Dr Keyur Machhavada  Unity Hospital  Department of Neurology,51 Shripal Nagar, Soc. Opp Pebble bay Flats, Nr. Ankini School, Chanadkheda, Ahmedabad, Gujarat-382424
Ahmadabad
GUJARAT 		 8691833327

machhavadakeyur@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 12  
Name of Committee  Approval Status 
Ethics Committee GSVM Medical college  Submittted/Under Review 
INDEPENDENT EC NAMASTE INTEGRATED SERVICES  Submittted/Under Review 
Institutional Ethics Committee Rajalakshmi Hospital  Approved 
Institutional ethics Committee, All India Institute of Medical Sciences  Submittted/Under Review 
Institutional Ethics Committee, B. J. Medical College and Civil Hospital  Submittted/Under Review 
Institutional Ethics Committee, Govt. Medical college & Govt General Hospital(Old RIMSGGH)  Approved 
Institutional Ethics Committee, Indira Gandhi Medical College & Hospital  Submittted/Under Review 
INSTITUTIONAL ETHICS COMMITTEE, Kurnool Medical College/Government General Hospital  Submittted/Under Review 
Muktai Hospital Institutional Ethics Committee  Submittted/Under Review 
Sangini Hospital Ethics Committee  Approved 
Tulsi Hospital Ethics Committee  Approved 
Vrajesh Hospital Institutional Ethics Committee  Submittted/Under Review 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G438||Other migraine,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Lasmiditan Tablets 50 mg  Orally Once onset of migraine attack (within 4 hrs of attack)for the duration of Within 1 week (7 days) after treating 4 attacks; or at the end of 09 weeks (Irrespective of number of attacks) whichever earlier . 
Intervention  Lasmiditan Tablets 100 mg  Orally Once onset of migraine attack( within 4 hrs of attack)for the duration of Within 1 week (7 days) after treating 4 attacks; or at the end of 09 weeks (Irrespective of number of attacks) whichever earlier 
Comparator Agent  Placebo  Orally Once onset of migraine attack( within 4 hrs of attack)for the duration of Within 1 week (7 days) after treating 4 attacks; or at the end of 09 weeks (Irrespective of number of attacks) whichever earlier 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  1. Patients who are able and willing to give written informed consent and are at least
18 years of age at time of screening visit with migraine with or without aura
fulfilling the IHS diagnostic criteria 1.1 (migraine without aura) or 1.2.1
(migraine with aura).
2. History of disabling migraine for at least 1 year.
3. Migraine onset before the age of 50 years.
4. History of 3 – 8 migraine attacks per month (< 15 headache days per month)
during the past 3 months.
5. MIDAS score ≥11.
6. Patients who are able and willing to complete subject dairy to record the details
of each migraine attack treated with study drug.
7. Females of child-bearing potential must agree to use a highly effective method of
contraception (that is, one with less than 1% failure rate) such as combined oral
contraceptives, implanted/injected contraceptives, intrauterine devices (IUD) or
sterile partner until 30 days after the last dose of study medication. 
 
ExclusionCriteria 
Details  1. Known hypersensitivity to lasmiditan, or to any excipient of Lasmiditan oral
tablets.
2. History or evidence of hemorrhagic stroke, epilepsy or any other condition
placing the patient at increased risk of seizures.
3. History of recurrent dizziness and/or vertigo including benign paroxysmal
positional vertigo (BPPV), Meniere’s disease, vestibular migraine, and other
vestibular disorders.
4. History of diabetes mellitus HbA1C > 8% with complications (diabetic
retinopathy, nephropathy, or neuropathy).
5. History of orthostatic hypotension with syncope.
6. Significant renal or hepatic impairment in the opinion of investigator.
7. History, within past 12 months of chronic migraine or other forms of primary or
secondary chronic headache disorders (eg, hemicranias continua, medication
overuse headache where headache frequency is ≥ 15 headache days per month).
8. Patients with use of more than 3 doses per month either opioids or barbiturates.
9. Initiation of or a change in concomitant medication to reduce the frequency of
migraine episodes within 3 months prior to screening visit.
10. Female patients who are pregnant or breast-feeding.
11. Women of childbearing potential who test positive for pregnancy based on
serum/urine pregnancy test collected at screening visit.
12. History of drug or alcohol abuse/dependence within 1 year prior to screening visit
(excessive or compulsive use as judged by the investigator), or currently using
drugs of potential abuse or any prescribed or over-the-counter medication in a
manner that the investigator considers indicative of abuse/dependence.
13. Have an acute, serious, or unstable medical condition, or a history or presence of
any other medical illness including but not limited to any autoimmune disease,
CV, hepatic, respiratory, hematological, endocrine, psychiatric, or neurological
disease, or any clinically significant laboratory abnormality, that, in the
judgement of the investigator, indicates a medical problem that would preclude
study participation. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Evaluate proportion of patients in each group that are headache free at 2 hours
post dose during the Migraine attacks. 		 Randomization/Baseline Visit (Day 1); End of Study Visit (Week 09/Day 63 ± 2 or whichever earlier) 
 
Secondary Outcome  
Outcome  TimePoints 
Evaluate proportion of patients in each group that are free of MBS associated
with migraine at 2 hours post dose during the Migraine attacks. 		 Randomization/Baseline Visit (Day 1); End of Study Visit (Week 09/Day 63 ± 2 or whichever earlier) 
Evaluate proportion of patients with pain relief in each group at 2 hours post
dose during the Migraine attacks.
[Pain relief is defined as moderate or severe headache pain becoming mild or
none and mild pain becoming none] 		 Randomization/Baseline Visit (Day 1); End of Study Visit (Week 09/Day 63 ± 2 or whichever earlier) 
Evaluate proportion of patients in each group with 24-hour sustained pain
freedom during the Migraine attacks.
[Sustained pain freedom during the first attack defined as pain-free at 2 and
24 hours with no rescue medication] 		 Randomization/Baseline Visit (Day 1); End of Study Visit (Week 09/Day 63 ± 2 or whichever earlier) 
Evaluate proportion of patients in each group requiring rescue medication for
migraine within 24 hours of treatment during the Migraine attacks. 		 Randomization/Baseline Visit (Day 1); End of Study Visit (Week 09/Day 63 ± 2 or whichever earlier) 
Evaluate proportion of patients in each group that are free of symptoms
associated with migraine at 2 hours post dose during the Migraine attacks.
Symptoms includes: Phonophobia, Photophobia, Nausea and Vomiting. 		 Randomization/Baseline Visit (Day 1); End of Study Visit (Week 09/Day 63 ± 2 or whichever earlier) 
 
Target Sample Size   Total Sample Size="246"
Sample Size from India="246" 
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   Phase 3 
Date of First Enrollment (India)   16/01/2023 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NA 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

After informed consent process, completion of all screening assessments and once all the inclusion/exclusion criteria are met, the eligible subjects shall be enrolled into the study. Demographics, Medical and surgical history shall be done during screening visit and baseline visit. Physical examination shall be done during each successive visit. MIDAS questionnaire assessments and BMI will be performed at screening visit.


Eligible subjects will be enrolled to receive treatment with investigational products orally once for the migraine attacks during the study period.

Subjects will be asked to treat their migraine attack within 4 hours of onset providing that the headache severity is at least moderate (moderate pain is applicable only for first attack) at that time and not improving.

Subjects will be asked not to use rescue medication until at least 2 hours after dosing with study drug and completing the 2-hour assessments. If the migraine does not respond at 2 hours (headache becomes pain free), patients will be allowed to take rescue medication. The efficacy and safety analysis will be conducted in Modified Intention to treat population.

 
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