Adolescent MigrainePhase 4NCT04064814
Evaluation of Efficacy and Safety of add-on Alpha-lipoic Acid on Migraine Prophylaxis in Adolescent Population
A Phase 4 study testing Flunarizine 5mg and Alpha lipoic acid 300mg in people with Adolescent Migraine, run by All India Institute of Medical Sciences, Bhubaneswar at 1 site in India.
Trial summary
Migraine causes a substantial impact on the physical and mental health of a child and it is a major cause for time-off school leading to impaired academic performance. Therefore prophylactic treatment is suggested for adolescents with frequent or disabling migraine, aiming at improving the function, quality of life… Read more about this study
- Who is it for?
- Ages 10 to 19 years
- Conditions the study is for
- Adolescent Migraine
- What is being tested?
- Flunarizine 5mg and Alpha lipoic acid 300mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteIndia
- Study dates
- 14 Sep 2019to 30 Jun 2021
- Phase
- Phase 4
- 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 10 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients with "15 or more headache days per month with at least 8 days having migraine features for at least 3 months (according to the criteria of the International Classification of Headache Disorders, 3rd edition [beta version], or ICHD-3 beta)."
- Adolescent migraineurs aged 10 to 19 years of age of either sex.
- Patients who have not taken any prophylactic treatment within the last three months before their inclusion in the study.
- Patients and/or parents have given informed written consent/assent.
Who cannot join
- Patient with headache other than migraine.
- Patients who were on corticosteroids
- Treatment with any test drugs in the preceding three months from the start of the trial.
- If there is any history of interventions or devices used for the treatment of migraine, such as transcranial magnetic stimulation and nerve blocks during the 3 months before screening.
- Any other accompanying systemic illness; abnormalities revealed on neurologic examination.
- Psychiatric disturbances, history of epilepsy , learning disabilities, head trauma or use of other drugs acting on the central nervous system, including, smoking, alcohol consumption or any illicit drug abuse
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Efficacy and Safety of add-on Alpha-lipoic Acid on Migraine Prophylaxis in Adolescent Population: A Randomized Controlled Trial
Migraine causes a substantial impact on the physical and mental health of a child and it is a major cause for time-off school leading to impaired academic performance. Therefore prophylactic treatment is suggested for adolescents with frequent or disabling migraine, aiming at improving the function, quality of life and reducing disability.
The most commonly used non-pharmacological agents for the prophylactic management of migraine in adolescents are nutraceuticals. Amongst all nutraceuticals, most commonly used agents for prophylaxis are coenzyme Q10, magnesium, riboflavin, feverfew and butterbur .
Read more
Alpha-lipoic acid (ALA) or 6,8-thioctic acid, is an endogenous molecule which functions as an important co-factor for various enzyme complexes in mitochondria and plays an important role in energy metabolism.ALA is a nutraceutical agent which also has neuroprotective and anti-inflammatory effects. It has been proved that the thiol level remains low in migraine patients.
However, only one study has been done by Ali et al in the pediatric population where the combination of ALA and topiramate has shown promising results but the study result is not generalizable due to its inherent limitations.
So, the study has been planned with an aim to evaluate the efficacy and safety of ALA as add-on therapy with flunarizine in the adolescent age group
Read the detailed description
Migraine causes a substantial impact on the physical and mental health of a child and it is a major cause for time-off school leading to impaired academic performance. Therefore prophylactic treatment is suggested for adolescents with frequent or disabling migraine, aiming at improving the function, quality of life and reducing disability. Pharmacological agents commonly used for migraine prophylaxis in adolescents are topiramate, cyproheptadine, amitriptyline, valproate, propranolol and flunarizine. These preventive medications are effective first-line treatment but the associated adverse effects have limited their use amongst the adolescent population. In this clinical scenario nutraceuticals may be an alternative option.
The most commonly used non-pharmacological agents for the prophylactic management of migraine in adolescents are nutraceuticals. Amongst all nutraceuticals, most commonly used agents for prophylaxis are coenzyme Q10, magnesium, riboflavin, feverfew and butterbur . Despite being largely used for prophylaxis of adolescent migraine, sufficient evidences are lacking which support the safety and efficacy of these agents. The findings from the previous studies on riboflavin and coenzyme Q10 are conflicting and inconclusive. Thus there is a need for a clinically effective nutraceutical in migraine prophylaxis.
Alpha-lipoic acid (ALA) or 6,8-thioctic acid, is an endogenous molecule which functions as an important co-factor for various enzyme complexes in mitochondria and plays an important role in energy metabolism. ALA is a nutraceutical agent which also has neuroprotective and anti-inflammatory effects. It has been proved that the thiol level remains low in migraine patients. In some recent studies, ALA has been found to be beneficial in migraine prophylaxis in adults. However, only one study has been done by Ali et al in the pediatric population where the combination of ALA and topiramate has shown promising results but the study result is not generalizable due to its inherent limitations.
From the literature search, it is evident that there is a lack of data on the efficacy and safety of ALA as a prophylactic agent in migraine. So, the study has been planned with an aim to evaluate the efficacy and safety of ALA as add-on therapy with flunarizine in the adolescent age group. The choice of flunarizine as standard prophylactic therapy in the present study is supported by the fact that flunarizine is efficacious and safer in the adolescent population due to its fewer adverse effects in comparison to topiramate and propranolol.
- Conditions
- Adolescent Migraine
- Being tested
- Flunarizine 5mg, Alpha lipoic acid 300mg
- Keywords
- Adolescent Migraine, Flunarizine, Alpha Lipoic Acid, Thiol Level, Calcitonin gene regulated peptide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flunarizine 5mgDrug
Flunarizine 5mg once daily,orally for 12 weeks
Alpha lipoic acid 300mgDrug
Alpha lipoic acid 300mg ,once daily ,orally for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Flunarizine | Active comparator | flunarizine will be prescribed at a dose of 5mg once daily , orally for 12 weeks Receives: Drug: Flunarizine 5mg |
| Alpha Lipoic Acid | Experimental | Alpha Lipoic Acid will be prescribed at a dose of 300mg once daily,orally for 12 weeks Receives: Drug: Flunarizine 5mg; Drug: Alpha lipoic acid 300mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean monthly migraine attack rate
Change in the mean monthly migraine attack rate from baseline after treatment with Flunarizine vs Alpha Lipoic Acid
Measured: 12 weeks
Secondary outcomes (8)
Responder rate
percentage of patients having ≥50% reduction in migraine frequency from baseline after treatment with Flunarizine vs Alpha Lipoic Acid
Measured: 12 weeks
The number of days with migraine headache
The number of days with migraine headache from baseline after treatment with Flunarizine vs Alpha Lipoic Acid
Measured: 12 weeks
The mean severity of acute attacks
The mean severity of acute attacks will be considered as severity basis where 3 will be severe and 1 will be mild attack (on a 3-point scale: 3, severe; 2, moderate; 1, mild) from baseline after treatment with Flunarizine vs Alpha Lipoic Acid
Measured: 12 weeks
The number of days with nausea or vomiting
The number of days with nausea or vomiting from baseline after treatment with Flunarizine vs Alpha Lipoic Acid
Measured: 12 weeks
The headache disability will be assessed by pedMIDAS (pediatric migraine disability assessment score)
The headache disability will be assessed by pedMIDAS (pediatric migraine disability assessment score) scoring system (denotes 0 to 10 as little to no dyability and greater than 50 as severe disability) from baseline after treatment with Flunarizine vs Alpha Lipoic Acid
Measured: 12 weeks
The relapse rate among the responders after stoppage of prophylactic therapy .
The relapse rate among the responders after stoppage of prophylactic therapy over the next 12 weeks.
Measured: 12 weeks
Serum thiol levels
Serum thiol levels from baseline after treatment with Flunarizine vs Alpha Lipoic Acid
Measured: 12 weeks
Serum CGRP
Serum CGRPlevels from baseline after treatment with Flunarizine vs Alpha Lipoic Acid
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2019
- Study start14 Sep 2019
- Primary completion30 Apr 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Adolescent 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, open Label , active controlled study
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- All India Institute of Medical Sciences, Bhubaneswar
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Monalisa Jena, M.D., All India Institute of Medical Sciences, Bhubaneswar
- Investigators
- Rituparna Maiti, MD, Study director, Additional Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04064814
- Sponsor's protocol ID
- AIIMSBBSR/PGThesis/2019-20/15
- Status last verified
- Jul 2023
- First submitted
- 20 Aug 2019
- Last updated
- 25 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Karsan N, Prabhakar P, Goadsby PJ. Premonitory Symptoms of Migraine in Childhood and Adolescence. Curr Pain Headache Rep. 2017 Jul;21(7):34. doi: 10.1007/s11916-017-0631-y.
PubMed 28647791Eiland LS, Jenkins LS, Durham SH. Pediatric migraine: pharmacologic agents for prophylaxis. Ann Pharmacother. 2007 Jul;41(7):1181-90. doi: 10.1345/aph.1K049. Epub 2007 Jun 5.
PubMed 17550953O'Brien HL, Kabbouche MA, Hershey AD. Treating pediatric migraine: an expert opinion. Expert Opin Pharmacother. 2012 May;13(7):959-66. doi: 10.1517/14656566.2012.677434. Epub 2012 Apr 14.
PubMed 22500646D'Onofrio F, Raimo S, Spitaleri D, Casucci G, Bussone G. Usefulness of nutraceuticals in migraine prophylaxis. Neurol Sci. 2017 May;38(Suppl 1):117-120. doi: 10.1007/s10072-017-2901-1.
PubMed 28527067Wang J, Tang J, Zhou X, Xia Q. Physicochemical characterization, identification and improved photo-stability of alpha-lipoic acid-loaded nanostructured lipid carrier. Drug Dev Ind Pharm. 2014 Feb;40(2):201-10. doi: 10.3109/03639045.2012.753901. Epub 2013 Jan 22.
PubMed 23336811Magis D, Ambrosini A, Sandor P, Jacquy J, Laloux P, Schoenen J. A randomized double-blind placebo-controlled trial of thioctic acid in migraine prophylaxis. Headache. 2007 Jan;47(1):52-7. doi: 10.1111/j.1526-4610.2006.00626.x.
PubMed 17355494Sorge F, De Simone R, Marano E, Nolano M, Orefice G, Carrieri P. Flunarizine in prophylaxis of childhood migraine. A double-blind, placebo-controlled, crossover study. Cephalalgia. 1988 Mar;8(1):1-6. doi: 10.1046/j.1468-2982.1988.0801001.x.
PubMed 3282670Abu-Arafeh I, Hershey AD, Diener HC, Tassorelli C; Clinical Trials Standing Committee and the Child and Adolescent Standing Committee of the International Headache Society. Guidelines of the International Headache Society for controlled trials of preventive treatment of migraine in children and adolescents, 1st edition. Cephalalgia. 2019 Jun;39(7):803-816. doi: 10.1177/0333102419842188. Epub 2019 Apr 4.
PubMed 30947525Sorge F, Marano E. Flunarizine v. placebo in childhood migraine. A double-blind study. Cephalalgia. 1985 May;5 Suppl 2:145-8. doi: 10.1177/03331024850050S227.
PubMed 2861907Kenney D, Jenkins S, Youssef P, Kotagal S. Patient Use of Complementary and Alternative Medicines in an Outpatient Pediatric Neurology Clinic. Pediatr Neurol. 2016 May;58:48-52.e7. doi: 10.1016/j.pediatrneurol.2015.11.003. Epub 2016 Jan 11.
PubMed 26923752Puliappadamb HM, Satpathy AK, Mishra BR, Maiti R, Jena M. Evaluation of Safety and Efficacy of Add-on Alpha-Lipoic Acid on Migraine Prophylaxis in an Adolescent Population: A Randomized Controlled Trial. J Clin Pharmacol. 2023 Dec;63(12):1398-1407. doi: 10.1002/jcph.2331. Epub 2023 Aug 24.
PubMed 37563914
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Efficacy and Safety of add-on Alpha-lipoic Acid on Migraine Prophylaxis in Adolescent Population: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04064814
- Acronym / sponsor ID
- AIIMSBBSR/PGThesis/2019-20/15
- Conditions
- Adolescent Migraine
- Keywords
- Adolescent Migraine, Flunarizine, Alpha Lipoic Acid, Thiol Level, Calcitonin gene regulated peptide
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- All India Institute of Medical Sciences, BhubaneswarUniversity, hospital or other
- Study start
- 14 Sep 2019 (actual)
- Primary completion
- 30 Apr 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 22 Aug 2019 (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.
Migraine causes a substantial impact on the physical and mental health of a child and it is a major cause for time-off school leading to impaired academic performance. Therefore prophylactic treatment is suggested for adolescents with frequent or disabling migraine, aiming at improving the function, quality of life and reducing disability.
The most commonly used non-pharmacological agents for the prophylactic management of migraine in adolescents are nutraceuticals. Amongst all nutraceuticals, most commonly used agents for prophylaxis are coenzyme Q10, magnesium, riboflavin, feverfew and butterbur .
Alpha-lipoic acid (ALA) or 6,8-thioctic acid, is an endogenous molecule which functions as an important co-factor for various enzyme complexes in mitochondria and plays an important role in energy metabolism.ALA is a nutraceutical agent which also has neuroprotective and anti-inflammatory effects. It has been proved that the thiol level remains low in migraine patients.
However, only one study has been done by Ali et al in the pediatric population where the combination of ALA and topiramate has shown promising results but the study result is not generalizable due to its inherent limitations.
So, the study has been planned with an aim to evaluate the efficacy and safety of ALA as add-on therapy with flunarizine in the adolescent age group
Detailed description
Migraine causes a substantial impact on the physical and mental health of a child and it is a major cause for time-off school leading to impaired academic performance. Therefore prophylactic treatment is suggested for adolescents with frequent or disabling migraine, aiming at improving the function, quality of life and reducing disability. Pharmacological agents commonly used for migraine prophylaxis in adolescents are topiramate, cyproheptadine, amitriptyline, valproate, propranolol and flunarizine. These preventive medications are effective first-line treatment but the associated adverse effects have limited their use amongst the adolescent population. In this clinical scenario nutraceuticals may be an alternative option.
The most commonly used non-pharmacological agents for the prophylactic management of migraine in adolescents are nutraceuticals. Amongst all nutraceuticals, most commonly used agents for prophylaxis are coenzyme Q10, magnesium, riboflavin, feverfew and butterbur . Despite being largely used for prophylaxis of adolescent migraine, sufficient evidences are lacking which support the safety and efficacy of these agents. The findings from the previous studies on riboflavin and coenzyme Q10 are conflicting and inconclusive. Thus there is a need for a clinically effective nutraceutical in migraine prophylaxis.
Alpha-lipoic acid (ALA) or 6,8-thioctic acid, is an endogenous molecule which functions as an important co-factor for various enzyme complexes in mitochondria and plays an important role in energy metabolism. ALA is a nutraceutical agent which also has neuroprotective and anti-inflammatory effects. It has been proved that the thiol level remains low in migraine patients. In some recent studies, ALA has been found to be beneficial in migraine prophylaxis in adults. However, only one study has been done by Ali et al in the pediatric population where the combination of ALA and topiramate has shown promising results but the study result is not generalizable due to its inherent limitations.
From the literature search, it is evident that there is a lack of data on the efficacy and safety of ALA as a prophylactic agent in migraine. So, the study has been planned with an aim to evaluate the efficacy and safety of ALA as add-on therapy with flunarizine in the adolescent age group. The choice of flunarizine as standard prophylactic therapy in the present study is supported by the fact that flunarizine is efficacious and safer in the adolescent population due to its fewer adverse effects in comparison to topiramate and propranolol.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized, open Label , active controlled study
| Arm | Type | Receives |
|---|---|---|
| Flunarizine | Active comparator | Drug: Flunarizine 5mgflunarizine will be prescribed at a dose of 5mg once daily , orally for 12 weeks |
| Alpha Lipoic Acid | Experimental | Drug: Flunarizine 5mg, Drug: Alpha lipoic acid 300mgAlpha Lipoic Acid will be prescribed at a dose of 300mg once daily,orally for 12 weeks |
Who may qualify
- Ages
- 10 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Patients with "15 or more headache days per month with at least 8 days having migraine features for at least 3 months (according to the criteria of the International Classification of Headache Disorders, 3rd edition [beta version], or ICHD-3 beta)."
- Adolescent migraineurs aged 10 to 19 years of age of either sex.
- Patients who have not taken any prophylactic treatment within the last three months before their inclusion in the study.
- Patients and/or parents have given informed written consent/assent.
Key exclusion criteria (6 listed)
- Patient with headache other than migraine.
- Patients who were on corticosteroids
- Treatment with any test drugs in the preceding three months from the start of the trial.
- If there is any history of interventions or devices used for the treatment of migraine, such as transcranial magnetic stimulation and nerve blocks during the 3 months before screening.
- Any other accompanying systemic illness; abnormalities revealed on neurologic examination.
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 |
|---|---|---|
| Flunarizine 5mgFlunarizine 5mg once daily,orally for 12 weeks | Drug | Alpha Lipoic Acid, Flunarizine |
| Alpha lipoic acid 300mgAlpha lipoic acid 300mg ,once daily ,orally for 12 weeks | Drug | Alpha Lipoic Acid |
Primary outcome
Mean monthly migraine attack rate
Time frame: 12 weeks
Change in the mean monthly migraine attack rate from baseline after treatment with Flunarizine vs Alpha Lipoic Acid
8 secondary outcomes
Responder rate
Time frame: 12 weeks
The number of days with migraine headache
Time frame: 12 weeks
The mean severity of acute attacks
Time frame: 12 weeks
The number of days with nausea or vomiting
Time frame: 12 weeks
The headache disability will be assessed by pedMIDAS (pediatric migraine disability assessment score)
Time frame: 12 weeks
The relapse rate among the responders after stoppage of prophylactic therapy .
Time frame: 12 weeks
Serum thiol levels
Time frame: 12 weeks
Serum CGRP
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2023.
- Background: PubMed 28647791Karsan N, Prabhakar P, Goadsby PJ. Premonitory Symptoms of Migraine in Childhood and Adolescence. Curr Pain Headache Rep. 2017 Jul;21(7):34. doi: 10.1007/s11916-017-0631-y.
- Background: PubMed 17550953Eiland LS, Jenkins LS, Durham SH. Pediatric migraine: pharmacologic agents for prophylaxis. Ann Pharmacother. 2007 Jul;41(7):1181-90. doi: 10.1345/aph.1K049. Epub 2007 Jun 5.
- Background: PubMed 22500646O'Brien HL, Kabbouche MA, Hershey AD. Treating pediatric migraine: an expert opinion. Expert Opin Pharmacother. 2012 May;13(7):959-66. doi: 10.1517/14656566.2012.677434. Epub 2012 Apr 14.
- Background: PubMed 28527067D'Onofrio F, Raimo S, Spitaleri D, Casucci G, Bussone G. Usefulness of nutraceuticals in migraine prophylaxis. Neurol Sci. 2017 May;38(Suppl 1):117-120. doi: 10.1007/s10072-017-2901-1.
- Background: PubMed 23336811Wang J, Tang J, Zhou X, Xia Q. Physicochemical characterization, identification and improved photo-stability of alpha-lipoic acid-loaded nanostructured lipid carrier. Drug Dev Ind Pharm. 2014 Feb;40(2):201-10. doi: 10.3109/03639045.2012.753901. Epub 2013 Jan 22.
- Background: PubMed 17355494Magis D, Ambrosini A, Sandor P, Jacquy J, Laloux P, Schoenen J. A randomized double-blind placebo-controlled trial of thioctic acid in migraine prophylaxis. Headache. 2007 Jan;47(1):52-7. doi: 10.1111/j.1526-4610.2006.00626.x.
- Background: PubMed 3282670Sorge F, De Simone R, Marano E, Nolano M, Orefice G, Carrieri P. Flunarizine in prophylaxis of childhood migraine. A double-blind, placebo-controlled, crossover study. Cephalalgia. 1988 Mar;8(1):1-6. doi: 10.1046/j.1468-2982.1988.0801001.x.
- Background: PubMed 30947525Abu-Arafeh I, Hershey AD, Diener HC, Tassorelli C; Clinical Trials Standing Committee and the Child and Adolescent Standing Committee of the International Headache Society. Guidelines of the International Headache Society for controlled trials of preventive treatment of migraine in children and adolescents, 1st edition. Cephalalgia. 2019 Jun;39(7):803-816. doi: 10.1177/0333102419842188. Epub 2019 Apr 4.
- Background: PubMed 2861907Sorge F, Marano E. Flunarizine v. placebo in childhood migraine. A double-blind study. Cephalalgia. 1985 May;5 Suppl 2:145-8. doi: 10.1177/03331024850050S227.
- Background: PubMed 26923752Kenney D, Jenkins S, Youssef P, Kotagal S. Patient Use of Complementary and Alternative Medicines in an Outpatient Pediatric Neurology Clinic. Pediatr Neurol. 2016 May;58:48-52.e7. doi: 10.1016/j.pediatrneurol.2015.11.003. Epub 2016 Jan 11.
- Derived from this study: PubMed 37563914Puliappadamb HM, Satpathy AK, Mishra BR, Maiti R, Jena M. Evaluation of Safety and Efficacy of Add-on Alpha-Lipoic Acid on Migraine Prophylaxis in an Adolescent Population: A Randomized Controlled Trial. J Clin Pharmacol. 2023 Dec;63(12):1398-1407. doi: 10.1002/jcph.2331. Epub 2023 Aug 24.
- Individual participant dataSharing planned: No
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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.
Rituparna Maiti, MD study director
Additional Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Flunarizine 5mg and Alpha lipoic acid 300mg in people with Adolescent Migraine, run by All India Institute of Medical Sciences, Bhubaneswar at 1 site in India.
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 4 inclusion and 6 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: finished, as of the sponsor's last update on 25 Jul 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 India. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean monthly migraine attack rate (time frame: 12 weeks). 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 NCT04064814, which also lists 11 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 25 Jul 2023.