None listed
Conditions
Brief summary
Vestibular migraine is a syndrome characterised by recurrent episodes of vertigo or other dizziness-related symptoms causing imbalance, nausea, and disruption to daily functioning, There is currently no standard treatment to prevent these episodes. Doctors commonly prescribe medications based on treatments for other types of migraine which have not been specifically studied in people with vestibular migraine, including amitriptyline (often used for migraine and chronic pain) and cyproheptadine (used in children for allergic conditions and sometimes for migraine). Early research suggests both may be helpful, but no direct comparisons exist, This study aims to compare these two medications versus a placebo medication (folic acid) in a randomised controlled trial to better understand which is more effective and better tolerated for reducing the number and severity of vestibular migraine episodes. It is hypothesised that cyproheptadine will have better treatment outcomes and less side effects than amitriptyline for vestibular migraine.
Interventions
Intervention arm 1: Cyproheptadine orally 2mg nocte for 2 nights, then 4mg orally nocte ongoing for 11 weeks and 5 days
Intervention arm 2: Amitriptyline 5mg orally nocte for 2 nights, 10mg orally nocte ongoing for 11 weeks and 5 days
Participants will only be asked to take one drug.
Adherence to study medication will be assessed using multiple measures, with a medication diary as the primary tool. Participants will be provided with a diary to record daily medication use, including doses taken,
Intervention arm 1: Cyproheptadine orally 2mg nocte for 2 nights, then 4mg orally nocte ongoing for 11 weeks and 5 days Intervention arm 2: Amitriptyline 5mg orally nocte for 2 nights, 10mg orally nocte ongoing for 11 weeks and 5 days Participants will only be asked to take one drug. Adherence to study medication will be assessed using multiple measures, with a medication diary as the primary tool. Participants will be provided with a diary to record daily medication use, including doses taken, missed doses, and any treatment interruptions. Participants will be instructed to return all medication packaging, including unused tablets, at each study visit. Tablet counts will be performed and compared with diary entries to estimate adherence as the proportion of prescribed doses taken. At each follow-up visit, participants will be asked about adherence, including missed doses and reasons for non-adherence, and this will be recorded in the case report form. The clinical trials pharmacy will maintain investigational product accountability logs documenting dispensing, return, and reconciliation of study medication, which will be cross-checked against diary records and tablet counts. Any treatment interruptions, discontinuation, or adherence concerns will be documented and considered in the analysis.
Sponsors
Lauren Byrnes - Darling Downs Health
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients who are diagnosed in vestibular clinic with vestibular migraine per the Bárány Society diagnostic criteria for vestibular migraine AND including the following: a. Patients who have had an audiogram that excludes Meniere’s Disease b. In the case of unilateral hearing loss confirmed on audiogram, patients who have had an MRI to exclude a central cause for symptoms or retrocochlear pathology c. Patients who have had an Oculomotor exam by the vestibular physiotherapist d. Patients who have had a Video Head Impulse Test (VHIT) by the vestibular physiotherapist 2. Diagnosis over the course of the clinical trial 3. Age 18 years old and above 4. All genders
Exclusion criteria
1. Patients who are currently receiving treatment for vestibular migraine 2. Patients who are pregnant 3. Patients with cognitive impairment or who are legally not able to provide consent 4. Patients with substance abuse, especially alcohol due to the risk of central nervous system depressant effects with the medications 5. Patients on selective serotonin reuptake inhibitors (SSRIs) due to drug interaction with amitriptyline
Outcome results
None listed