MigraineNCT06162819
Efficacy of Flunarizine Vs Amitriptyline in Prophylaxis of Migraine Prophylaxis
A study testing Amitriptyline and Flunarizine 5mg in people with Migraine and Prophylaxis, run by Shalamar Institute of Health Sciences at 1 site in Pakistan.
Trial summary
To compare the frequency of acute attack and mean pain score ( assessed by visual analog scale) among subjects using either flunarizine or amitriptyline among patients with migraine coming to tertiary care Hospital in Lahore, Pakistan. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Migraine, Prophylaxis
- What is being tested?
- Amitriptyline and Flunarizine 5mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jan 2024to 30 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 18- 60 years 2. Both genders 3. 3 or more migraine attacks per month 4. normal systemic and neurological examination 5. not having taken any prophylactic medication for the last 4 months
Who cannot join
- Un controlled hypertension 2. Ischemic heart disease, chronic liver failure and chronic liver disease 3. Pregnant patient 4. Known allergies to drug being used in study 5. Major pathology or surgery at the neck or the head 6. Recent injury or road traffic injury at the head or the cervical spine 7. Cancer pain 8. Rheumatological or immune related diseases 9. Implantable metallic or electrical devices in the head 10. Patients using opioids or user of illicit drugs or has had recent history of alcohol or drug abuse.
Trial locations and contacts
1 site in 1 country.
About this study
To compare the frequency of acute attack and mean pain score ( assessed by visual analog scale) among subjects using either flunarizine or amitriptyline among patients with migraine coming to tertiary care Hospital in Lahore, Pakistan.
In this study 84 patients with migraine Age ranged between 18- 60 years, Both genders having 3 or more migraine attacks per month, normal systemic and neurological examination and not having taken any prophylactic medication for the last 4 months will randomly divided into two equal group of 42 subjects each.
Read the detailed description
Introduction:
Migraine is a genetically influenced complex disorder characterized by episodes of moderate-to-severe headache, most often unilateral and generally associated with nausea and increased sensitivity to light and sound. Migraine is a common cause of disability and loss of work. Migraine attacks are complex brain events that unfold over hours to days in a recurrent matter. Migraine can be classified into subtypes according to the headache classification committee of the International Headache Society these subtypes include migraine without aura, migraine with aura and chronic migraine. Etiology of migraine in related to genetic, dietary and environmental factors. Acute migraine attack is characterized in to four phases of prodrome, aura headache and postdrome. Migraine has an approximate prevalence of 14.7% globally, making it the third most common disease in the world. It occurs three times more commonly in women as compared to men, which is most probably due to hormonal differences. The migraine attacks were most frequently triggered by sleep disturbance (70.5%), stress (66.7%), fatigue (64.4%), excess screen time (61.1%), loud noise (58.8%), dehydration (49.9%), and missed meals or dieting (49.1%). Other common triggering factors were traveling (39.9%), bright sunshine (39.2%), and certain smells or perfume (30.8%). The migraine attacks were triggered by smoking in only 8.1% of the migraineurs and by exercise in only 10.4% of the migraineurs.4 The global prevalence of migraine has increased substantially over the last three decades. According to the Global Burden of Disease (GBD) 2019 study, the estimated global prevalence of migraine increased from 721.9 million in 1990 to 1.1 billion in 2019. Treatment of migraine is divided into abortive measures for an acute attack and prophylactic measures to decrease frequency, severity and duration of attacks. Acute treatment aims to stop the progression of a headache quickly and therapy consists of stratified options of pharmacological and non-pharmacological measures, these include non-steroidal anti-inflammatory drugs, triptans, ergot derivate, dexamethasonse, Transcutaneous electrical nerve stimulation (TENS) therapy and occipital nerve block.
Recent studies have emphasized the role of prophylactic treatment of migraine because once an acute attack occurs, it often incapacitating its sufferers, reduce quality of life and cause significant disability. Preventive treatment aims to reduce attack frequency, improve responsiveness to acute attacks severity and duration, and reduce disability. Indications for preventive treatment include but not limited to frequent or long-lasting headaches, failure of acute therapy, and migraine with complications. Preventive treatment agents include beta blockers e.g. metoprolol and propranolol - especially in hypertensive and non-smoker patients, anti-depressants, amitriptyline and venlafaxine - especially in patients with depression or anxiety disorders and insomnia, Anticonvulsants: valproate acid and topiramate - especially in epileptic patients and Calcitonin gene-related peptide antagonists: erenumab, fremanezumab, and galcanezumab. Along with pharmacological measures life style changes must be a commitment from patient and these include regular exercise, avoidance of dietary triggers and cognitive-behavioural therapy
- Conditions
- Migraine, Prophylaxis
- Being tested
- Amitriptyline, Flunarizine 5mg
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmitriptylineDrug
Also called Amyline
Amitriptyline will be used for prophylaxis of migraine, also used as antidepressant
Flunarizine 5mgDrug
Also called Sibelium
Flunarizine will be used for prophylaxis of migraine,
| Study group | Role | What they receive |
|---|---|---|
| GroupA | Experimental | Amitriptyline group will be assessed at baseline and will be followed up at 6th week after treatment and at 12th week after treatment Receives: Drug: Amitriptyline |
| Group B | Experimental | Flunarizine group will be assessed at baseline and will be followed up at 6th week after treatment and at 12th week after treatment Receives: Drug: Flunarizine 5mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity of headache
pain severity will be assessed using Visual Analogue Scale (VAS)
Measured: It will be asses at baseline, at 6th week, and at 12th week
No. of Attacks per month
reduction in number of attacks
Measured: It will be asses at baseline, at 6th week, and at 12th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2023
- Study start1 Jan 2024 (estimated)
- Primary completion30 Jun 2024 (estimated)
- Study completion30 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for MigraineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single blind, Randomized Parallel study design, All the consented participants will be randomized into two equal groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shalamar Institute of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mujeeb-ur-Rehman Abid Butt, FCPS, Study director, Shalamar Institute of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06162819
- Sponsor's protocol ID
- R&ID003
- Status last verified
- Dec 2023
- First submitted
- 30 Nov 2023
- Last updated
- 29 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Over all results will be presented in the form of publication.
Publications
Gorur K, Gur H, Ismi O, Ozcan C, Vayisoglu Y. The effectiveness of propranolol, flunarizine, amitriptyline and botulinum toxin in vestibular migraine complaints and prophylaxis: a non-randomized controlled study. Braz J Otorhinolaryngol. 2022 Nov-Dec;88(6):975-981. doi: 10.1016/j.bjorl.2021.02.005. Epub 2021 Mar 7.
PubMed 33722518Athar F, Zahid A, Farooq M, Ayyan M, Ashraf M, Farooq M, Naeem F, Badar A, Ehsan M, Hussain A, Ilyas MA. Frequency of migraine according to the ICHD-3 criteria and its association with sociodemographic and triggering factors in Pakistan: A cross-sectional study. Ann Med Surg (Lond). 2022 Sep 17;82:104589. doi: 10.1016/j.amsu.2022.104589. eCollection 2022 Oct.
PubMed 36268304Amiri P, Kazeminasab S, Nejadghaderi SA, Mohammadinasab R, Pourfathi H, Araj-Khodaei M, Sullman MJM, Kolahi AA, Safiri S. Migraine: A Review on Its History, Global Epidemiology, Risk Factors, and Comorbidities. Front Neurol. 2022 Feb 23;12:800605. doi: 10.3389/fneur.2021.800605. eCollection 2021.
PubMed 35281991Bendtsen L, Sacco S, Ashina M, Mitsikostas D, Ahmed F, Pozo-Rosich P, Martelletti P. Guideline on the use of onabotulinumtoxinA in chronic migraine: a consensus statement from the European Headache Federation. J Headache Pain. 2018 Sep 26;19(1):91. doi: 10.1186/s10194-018-0921-8.
PubMed 30259200
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Flunarizine Vs Amitriptyline in Prophylaxis of Migraine Prophylaxis
- ClinicalTrials.gov ID
- NCT06162819
- Acronym / sponsor ID
- R&ID003
- Conditions
- Migraine, Prophylaxis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Shalamar Institute of Health SciencesUniversity, hospital or other
- Study start
- 1 Jan 2024 (estimated)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 8 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To compare the frequency of acute attack and mean pain score ( assessed by visual analog scale) among subjects using either flunarizine or amitriptyline among patients with migraine coming to tertiary care Hospital in Lahore, Pakistan.
In this study 84 patients with migraine Age ranged between 18- 60 years, Both genders having 3 or more migraine attacks per month, normal systemic and neurological examination and not having taken any prophylactic medication for the last 4 months will randomly divided into two equal group of 42 subjects each.
Detailed description
Introduction:
Migraine is a genetically influenced complex disorder characterized by episodes of moderate-to-severe headache, most often unilateral and generally associated with nausea and increased sensitivity to light and sound. Migraine is a common cause of disability and loss of work. Migraine attacks are complex brain events that unfold over hours to days in a recurrent matter. Migraine can be classified into subtypes according to the headache classification committee of the International Headache Society these subtypes include migraine without aura, migraine with aura and chronic migraine. Etiology of migraine in related to genetic, dietary and environmental factors. Acute migraine attack is characterized in to four phases of prodrome, aura headache and postdrome. Migraine has an approximate prevalence of 14.7% globally, making it the third most common disease in the world. It occurs three times more commonly in women as compared to men, which is most probably due to hormonal differences. The migraine attacks were most frequently triggered by sleep disturbance (70.5%), stress (66.7%), fatigue (64.4%), excess screen time (61.1%), loud noise (58.8%), dehydration (49.9%), and missed meals or dieting (49.1%). Other common triggering factors were traveling (39.9%), bright sunshine (39.2%), and certain smells or perfume (30.8%). The migraine attacks were triggered by smoking in only 8.1% of the migraineurs and by exercise in only 10.4% of the migraineurs.4 The global prevalence of migraine has increased substantially over the last three decades. According to the Global Burden of Disease (GBD) 2019 study, the estimated global prevalence of migraine increased from 721.9 million in 1990 to 1.1 billion in 2019. Treatment of migraine is divided into abortive measures for an acute attack and prophylactic measures to decrease frequency, severity and duration of attacks. Acute treatment aims to stop the progression of a headache quickly and therapy consists of stratified options of pharmacological and non-pharmacological measures, these include non-steroidal anti-inflammatory drugs, triptans, ergot derivate, dexamethasonse, Transcutaneous electrical nerve stimulation (TENS) therapy and occipital nerve block.
Recent studies have emphasized the role of prophylactic treatment of migraine because once an acute attack occurs, it often incapacitating its sufferers, reduce quality of life and cause significant disability. Preventive treatment aims to reduce attack frequency, improve responsiveness to acute attacks severity and duration, and reduce disability. Indications for preventive treatment include but not limited to frequent or long-lasting headaches, failure of acute therapy, and migraine with complications. Preventive treatment agents include beta blockers e.g. metoprolol and propranolol - especially in hypertensive and non-smoker patients, anti-depressants, amitriptyline and venlafaxine - especially in patients with depression or anxiety disorders and insomnia, Anticonvulsants: valproate acid and topiramate - especially in epileptic patients and Calcitonin gene-related peptide antagonists: erenumab, fremanezumab, and galcanezumab. Along with pharmacological measures life style changes must be a commitment from patient and these include regular exercise, avoidance of dietary triggers and cognitive-behavioural therapy
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Single blind, Randomized Parallel study design, All the consented participants will be randomized into two equal groups
| Arm | Type | Receives |
|---|---|---|
| GroupA | Experimental | Drug: AmitriptylineAmitriptyline group will be assessed at baseline and will be followed up at 6th week after treatment and at 12th week after treatment |
| Group B | Experimental | Drug: Flunarizine 5mgFlunarizine group will be assessed at baseline and will be followed up at 6th week after treatment and at 12th week after treatment |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Age 18- 60 years 2. Both genders 3. 3 or more migraine attacks per month 4. normal systemic and neurological examination 5. not having taken any prophylactic medication for the last 4 months
Key exclusion criteria (1 listed)
- Un controlled hypertension 2. Ischemic heart disease, chronic liver failure and chronic liver disease 3. Pregnant patient 4. Known allergies to drug being used in study 5. Major pathology or surgery at the neck or the head 6. Recent injury or road traffic injury at the head or the cervical spine 7. Cancer pain 8. Rheumatological or immune related diseases 9. Implantable metallic or electrical devices in the head 10. Patients using opioids or user of illicit drugs or has had recent history of alcohol or drug abuse.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AmitriptylineAlso: AmylineAmitriptyline will be used for prophylaxis of migraine, also used as antidepressant | Drug | GroupA |
| Flunarizine 5mgAlso: SibeliumFlunarizine will be used for prophylaxis of migraine, | Drug | Group B |
Primary outcome
Severity of headache
Time frame: It will be asses at baseline, at 6th week, and at 12th week
pain severity will be assessed using Visual Analogue Scale (VAS)
No. of Attacks per month
Time frame: It will be asses at baseline, at 6th week, and at 12th week
reduction in number of attacks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2023.
- Background: PubMed 33722518Gorur K, Gur H, Ismi O, Ozcan C, Vayisoglu Y. The effectiveness of propranolol, flunarizine, amitriptyline and botulinum toxin in vestibular migraine complaints and prophylaxis: a non-randomized controlled study. Braz J Otorhinolaryngol. 2022 Nov-Dec;88(6):975-981. doi: 10.1016/j.bjorl.2021.02.005. Epub 2021 Mar 7.
- Results publication: PubMed 36268304Athar F, Zahid A, Farooq M, Ayyan M, Ashraf M, Farooq M, Naeem F, Badar A, Ehsan M, Hussain A, Ilyas MA. Frequency of migraine according to the ICHD-3 criteria and its association with sociodemographic and triggering factors in Pakistan: A cross-sectional study. Ann Med Surg (Lond). 2022 Sep 17;82:104589. doi: 10.1016/j.amsu.2022.104589. eCollection 2022 Oct.
- Results publication: PubMed 35281991Amiri P, Kazeminasab S, Nejadghaderi SA, Mohammadinasab R, Pourfathi H, Araj-Khodaei M, Sullman MJM, Kolahi AA, Safiri S. Migraine: A Review on Its History, Global Epidemiology, Risk Factors, and Comorbidities. Front Neurol. 2022 Feb 23;12:800605. doi: 10.3389/fneur.2021.800605. eCollection 2021.
- Results publication: PubMed 30259200Bendtsen L, Sacco S, Ashina M, Mitsikostas D, Ahmed F, Pozo-Rosich P, Martelletti P. Guideline on the use of onabotulinumtoxinA in chronic migraine: a consensus statement from the European Headache Federation. J Headache Pain. 2018 Sep 26;19(1):91. doi: 10.1186/s10194-018-0921-8.
- Individual participant dataSharing planned: No. Over all results will be presented in the form of publication.
Related trials for Migraine
RecruitingObservational study
Study of the Glymphatic System in Migraine
Migraine
Active, not recruiting
Clinical and Neurophysiological Effects of tDCS to Visual and Motor Cortex in Migraine
Migraine
Active, not recruiting
App-Based Migraine Treatment: The Health enSuite Study
Migraine, Migraine With Aura
Not yet recruiting
A Prospective Study of Rimegepant for Short-term Preventive Treatment of Night-shift-related Migraine in Healthcare Professionals
Migraine Disorders
Recruiting
Marine Lipids Ease Painful TMD
Temporomandibular Disorder (TMD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mujeeb-ur-Rehman Abid Butt, FCPS study director
Shalamar Institute of Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Amitriptyline and Flunarizine 5mg in people with Migraine and Prophylaxis, run by Shalamar Institute of Health Sciences at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mahpara Nawazish, MBBS (+923060657757, mahpararajpoot123@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severity of headache (time frame: It will be asses at baseline, at 6th week, and at 12th week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06162819, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2023.