Migraine Clinical Trial
Official title:
Comparison of Efficacy Between Combination of Amitriptyline-propranolol and Pizotifen for Migraine Prophylaxis: A Single-blind Randomized Controlled Trial
Verified date | November 2023 |
Source | Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The goal of this clinical trial is to compare efficacy and observe common adverse effects of a combination of amitriptyline-propranolol and pizotifen as prophylactic treatments for migraine. The main question it aims to answer is: • Does pizotifen more effective than the combination of amitriptyline-propranolol in migraine prophylaxis? Participants will be asked to : - Maintain the provided headache diary accordingly - Take supplied drugs as described during clinical visits - Contact principle investigator if there is any issues regarding drug use and/or their adverse effects
Status | Active, not recruiting |
Enrollment | 140 |
Est. completion date | January 15, 2024 |
Est. primary completion date | November 25, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 50 Years |
Eligibility | Inclusion Criteria: 1. Patient of migraine (with typical aura or without aura) according to ICHD-3 (International Classification of Headache Disorder, 3rd edition) criteria. 2. Age at entry: 18 to 50 years (to minimize the risks related to adverse effects of study drugs such as drowsiness, weight gain, A-V conduction block, postural hypotension) 3. Patients not on any prophylactic medications. 4. Patients willing to take part in the study. 5. Patients being able to fill a headache diary successfully & reliably. Exclusion Criteria: 1. Age <18 years or >50 years 2. Patients having headache other than migraine, complicated migraine, ophthalmoplegic migraine, catamenial migraine, basilar migraine. 3. Patients on prophylactic medication. 4. Co-morbidities such as heart failure, hepatic or renal impairment, diabetes, bronchial asthma, malignancy, intracranial vascular aneurysm, pregnancy & breastfeeding etc. 5. Patients having known hypersensitivity to amitriptyline, propranolol or pizotifen |
Country | Name | City | State |
---|---|---|---|
Bangladesh | Bangabandhu Sheikh Mujib Medical University | Dhaka |
Lead Sponsor | Collaborator |
---|---|
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh |
Bangladesh,
Chitsaz, A., Najafi, M.R., Zangeneh, F.A., Norouzi, R. and Salari, M., 2012. Pizotifen in migraine prevention: A comparison with sodium valproate. Neurology Asia, 17(4), pp.319-324.
Islam MA, Shaikh AK, AlamSkM, Sultana D, Islam MS, Rashid MM. Safety and Efficacy of Propranolol and amitriptyline combination therapy in migraine prophylaxis: A Randomized Control Trial. J NatlInstNeurosci Bangladesh, 2018;4(1): 3-7
Israil A, Ahmed S, Rahman KM, Uddin MJ, Dey SK, Battacharjee M, Mondal G, Ali MA, Alam MN, Miah AH, Uddin MS. Efficacy of amitriptyline, pizotifen and propranolol in the prevention of migraine. Mymensingh Med J. 2013 Jan;22(1):93-100. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Frequency of headache per month | Comparison of reduction of frequency of headache attack in immediate last month with initial baseline one month without any medication. These values will be compared between two study groups | 12 weeks | |
Primary | Duration of headache per month | Comparison of reduction of total duration of headache attack in immediate last month with initial baseline one month without any medication. These values will be compared between two study groups | 12 weeks | |
Primary | Severity of headache | Comparison of reduction of severity of headache attack in immediate last month with initial baseline one month without any medication using visual analogue scale. The visual analogue scale is numbered from 0 to 10. 0 stands for no pain, 1-3 for mild pain, 4-6 for moderate pain and 7-9 for severe pain and 10 for very severe unbearable pain. These values will be compared between two study groups | 12 weeks | |
Secondary | Adverse effects of drugs | Adverse effects (e.g., somnolence, dizziness, dry mouth, weight gain, constipation, bradycardia) of study drugs will be observed | 12 weeks |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05525611 -
Cabergoline as a Preventive Treatment for Chronic Migraine
|
N/A | |
Completed |
NCT06192173 -
Patent Foramen Ovale Closure in Migraine
|
||
Recruiting |
NCT03832998 -
Efficacy and Safety of Erenumab in Pediatric Subjects With Chronic Migraine
|
Phase 3 | |
Enrolling by invitation |
NCT04196933 -
Analysis of Vestibular Compensation Following Clinical Intervention for Vestibular Schwannoma
|
N/A | |
Not yet recruiting |
NCT06428838 -
Eptinezumab as an Adjunct to Standard of Care for Migraine in an Acute Emergency Context
|
Phase 3 | |
Completed |
NCT06304675 -
Manageable Environmental Factors in Migraine
|
||
Completed |
NCT04084314 -
Assessment of Prolonged Safety and tOLerability of in Migraine Patients in a Long-term OpeN-label Study
|
Phase 4 | |
Recruiting |
NCT05517200 -
Pilot Study for a Machine Learning Test for Migraine
|
||
Completed |
NCT04179474 -
Safety, Tolerability and Drug- Drug Interaction Study of Ubrogepant With Erenumab or Galcanezumab in Participants With Migraine
|
Phase 1 | |
Recruiting |
NCT04603976 -
Registry for Migraine - Clinical Core
|
Phase 4 | |
Completed |
NCT03597529 -
CHOCOlate MeLatonin for AdolescenT MigrainE
|
Phase 2 | |
Completed |
NCT04197349 -
Safety, Tolerability and Pharmacokinetics of ALD1910 in Healthy Men and Woman
|
Phase 1 | |
Recruiting |
NCT05891808 -
miR-155 Expression in Episodic and Chronic Migraine
|
||
Active, not recruiting |
NCT05064371 -
Long-Term Extension Study With Eptinezumab as Preventive Treatment in Participants With Migraine in Japan
|
Phase 3 | |
Suspended |
NCT04069572 -
Vibratory Stimulation for the Treatment of Chronic Pain
|
N/A | |
Not yet recruiting |
NCT04859374 -
Chronic Pain and Conditioned Pain Modulation After on Line-behavioral Approach
|
N/A | |
Not yet recruiting |
NCT03083860 -
Evaluation of Migraine Management Mobile App Combined With Electrophysiological Measurements for Identification of Migraine Attack Risk and Beneficial Preventive Actions.
|
N/A | |
Completed |
NCT02905227 -
A Study of the Pulmonary Safety and Pharmacokinetics of Zolmitriptan Inhalation Powder
|
Phase 1 | |
Enrolling by invitation |
NCT02532023 -
The Combined Effects of omega3 Fatty Acids and Curcumin Supplementation on Inflammatory and Endothelial Factors in Migraine Patients
|
Phase 4 | |
Completed |
NCT02108678 -
One-Day Intervention for Depression and Impairment in Migraine Patients
|
N/A |