4-Aminopyridine, Atenolol, or Placebo in Patients With Vestibular Migraine

Mass Eye and Ear

Status and phase: Withdrawn; Phase 2

Conditions: Vestibular Migraine; Migraine Disorders; Vestibular Diseases

Treatments: Drug: Atenolol; Drug: 4-aminopyridine; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT03578354

Pending

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Severe vestibular migraine (VM)

Exclusion criteria

• 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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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0 participants in 3 patient groups, including a placebo group

4-AP

Experimental group

Description:

15 mg 4-aminopyridine twice daily

Treatment:

Drug: 4-aminopyridine

Atenolol

Experimental group

Description:

25 mg atenolol twice daily

Treatment:

Drug: Atenolol

Placebo

Placebo Comparator group

Description:

Masked placebo twice daily

Treatment:

Other: Placebo