Vestibular MigrainePhase 2NCT03578354
4-Aminopyridine, Atenolol, or Placebo in Patients With Vestibular Migraine
A Phase 2 study testing 4-aminopyridine and Atenolol in people with Vestibular Migraine and Migraine Disorders, run by Massachusetts Eye and Ear Infirmary at 1 site in United States.
Trial summary
This phase 2 randomized study will be used to test the efficacy of 4-aminopyridine (4AP) or atenolol to reduce severity and frequency of vestibular and headache symptoms of vestibular migriane sufferers. Blinded study drug will be taken by mouth twice a day for 14 weeks on study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vestibular Migraine, Migraine Disorders, Vestibular Diseases
- What is being tested?
- 4-aminopyridine and Atenolol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2019to Aug 2024
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Severe vestibular migraine (VM)
Who cannot join
- Neurologic or otologic disease other than VM
- Psychiatric illness requiring medication
- Medical illness including cancer, coronary artery or cerebrovascular disease
- Known allergy to one of the test medications
- Contraindication to use of one of the test medications - asthma, symptomatic hypotension, history of seizures
- Taking migraine prophylactic medication or vestibular suppressants.
- Pregnant or breast feeding women
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts Eye and Ear Infirmary
Boston, Massachusetts, 02114
About this study
Official title: Prospective, Randomized, Placebo-controlled, Phase 2 Study of 4-aminopyridine, Atenolol, or Placebo in the Treatment of Patients With Vestibular Migraine
This phase 2 randomized study will be used to test the efficacy of 4-aminopyridine (4AP) or atenolol to reduce severity and frequency of vestibular and headache symptoms of vestibular migriane sufferers. Blinded study drug will be taken by mouth twice a day for 14 weeks on study.
- Conditions
- Vestibular Migraine, Migraine Disorders, Vestibular Diseases
- Being tested
- 4-aminopyridine, Atenolol, Placebo
- Medical subject headings
- Migraine Disorders, Vestibular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
4-aminopyridineDrug
an oral drug to be swallowed
AtenololDrug
an oral drug to be swallowed
PlaceboOther
a masked placebo to be swallowed
| Study group | Role | What they receive |
|---|---|---|
| 4-AP | Experimental | 15 mg 4-aminopyridine twice daily Receives: Drug: 4-aminopyridine |
| Atenolol | Experimental | 25 mg atenolol twice daily Receives: Drug: Atenolol |
| Placebo | Placebo comparator | Masked placebo twice daily Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Dizziness Handicap Score
Dizziness Handicap Inventory (DHI) will be compared pre- and post- study drug treatment
Measured: 14 weeks
Secondary outcomes (7)
Change in number of dizziness episodes
Incidence of dizziness episodes will be compared pre- and post- study drug treatment
Measured: 14 weeks
Change in motion sickness susceptibility
Motion sickness susceptibility questionnaire (MSSQ) will be compared pre- and post- study drug treatment. MSSQ is reported as a scale (0 - 100) with 0 being no or very little experience of motion sickness, and 100 being very frequent experience of motion sickness.
Measured: 14 weeks
Change in roll tilt perceptual threshold
Rolt tilt perceptual thresholds will be compared pre- and post- study drug treatment
Measured: 14 weeks
Change in vestibulo-ocular reflex (VOR) time constant
Standard low-frequency rotational testing to measure VOR will be compared pre- and post- study drug treatment
Measured: 14 weeks
Change in number of migraine episodes
Incidence of migraine episodes will be compared pre- and post- study drug treatment
Measured: 14 weeks
Change in Headache Impact Test (HIT) score
Headache Impact Test (HIT) will be compared pre- and post- study drug treatment
Measured: 14 weeks
Change in quality of life score
Quality of life will be measured using 36-Item Short Form Health Survey (SF-36) questionnaires and compared pre- and post- study drug treatment. The SF-36 consists of 8 sub-scores. Each score is reported as a scale (0 - 100) with 0 being maximally disabled and 100 having no disability.
Measured: 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2018
- Study startJan 2019 (estimated)
- Primary completionJan 2023 (estimated)
- Study completionAug 2024 (estimated)
Why it stopped: Funding not acquired
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vestibular 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts Eye and Ear Infirmary
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Richard Lewis, Massachusetts Eye and Ear Infirmary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03578354
- Sponsor's protocol ID
- Pending
- Status last verified
- Jun 2024
- First submitted
- 31 May 2018
- Last updated
- 1 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomized, Placebo-controlled, Phase 2 Study of 4-aminopyridine, Atenolol, or Placebo in the Treatment of Patients With Vestibular Migraine
- ClinicalTrials.gov ID
- NCT03578354
- Acronym / sponsor ID
- Pending
- Conditions
- Vestibular Migraine, Migraine Disorders, Vestibular Diseases
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Funding not acquired
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Massachusetts Eye and Ear InfirmaryUniversity, hospital or other
- Study start
- Jan 2019 (estimated)
- Primary completion
- Jan 2023 (estimated)
- Study completion
- Aug 2024 (estimated)
- First posted
- 6 Jul 2018 (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.
This phase 2 randomized study will be used to test the efficacy of 4-aminopyridine (4AP) or atenolol to reduce severity and frequency of vestibular and headache symptoms of vestibular migriane sufferers. Blinded study drug will be taken by mouth twice a day for 14 weeks on study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 4-AP | Experimental | Drug: 4-aminopyridine15 mg 4-aminopyridine twice daily |
| Atenolol | Experimental | Drug: Atenolol25 mg atenolol twice daily |
| Placebo | Placebo comparator | Other: PlaceboMasked placebo twice daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Severe vestibular migraine (VM)
Key exclusion criteria (7 listed)
- Neurologic or otologic disease other than VM
- Psychiatric illness requiring medication
- Medical illness including cancer, coronary artery or cerebrovascular disease
- Known allergy to one of the test medications
- Contraindication to use of one of the test medications - asthma, symptomatic hypotension, history of seizures
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 |
|---|---|---|
| 4-aminopyridinean oral drug to be swallowed | Drug | 4-AP |
| Atenololan oral drug to be swallowed | Drug | Atenolol |
| Placeboa masked placebo to be swallowed | Other | Placebo |
Primary outcome
Change in Dizziness Handicap Score
Time frame: 14 weeks
Dizziness Handicap Inventory (DHI) will be compared pre- and post- study drug treatment
7 secondary outcomes
Change in number of dizziness episodes
Time frame: 14 weeks
Change in motion sickness susceptibility
Time frame: 14 weeks
Change in roll tilt perceptual threshold
Time frame: 14 weeks
Change in vestibulo-ocular reflex (VOR) time constant
Time frame: 14 weeks
Change in number of migraine episodes
Time frame: 14 weeks
Change in Headache Impact Test (HIT) score
Time frame: 14 weeks
Change in quality of life score
Time frame: 14 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 4-aminopyridine and Atenolol in people with Vestibular Migraine and Migraine Disorders, run by Massachusetts Eye and Ear Infirmary at 1 site in United States.
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 7 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: withdrawn, as of the sponsor's last update on 1 Jul 2024. 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 United States. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was withdrawn before enrolling participants, so there are no results.
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?
Change in Dizziness Handicap Score (time frame: 14 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Jul 2024.