RCVS: The Rational Approach to Diagnosis and Treatment

• Status: Withdrawn
• Trial end date: 2019-05-31
• Target enrollment: 0
• Participant gender: All

Summary

This is a randomized clinical trial of short-acting nimodipine versus twice daily extended release verapamil to treat patients presenting with Reversible Cerebral Vasoconstriction Syndrome (RCVS).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johns Hopkins University
• Treatments: Nimodipine; Verapamil

Criteria

Patients 18 years of age or greater meeting the following inclusion criteria adapted from Singhal and colleagues 2 will be included:

1. presentation consistent with RCVS :

• acute thunderclap/severe headache and

**supporting clinical features should prompt increased clinical suspicion (eg., potential medication trigger, recent pregnancy, migraine history)**

• evidence of beading/elevated velocities on imaging (Transcranial Doppler (TCD), angiogram, Computer Tomography Angiogram (CTA), MRA) and

• reversibility (by 90 days)-will not be required for inclusion but will be retrospectively adjudicated

Participants will be excluded from the study if they are:

• unable to consent AND no family present to consent, or

• have presence of aneurysmal, traumatic, or mesencephalic Subarachnoid Hemorrhage (SAH), or

• have presence of other supported diagnosis (eg., vasculitis- inflammatory lumbar puncture) or

• are currently pregnant or

• the use of nimodipine or verapamil is contraindicated for any reason (eg., allergy, breast feeding) or

• have limited TCD sonographic window

• stroke or ICH/SAH on presentation will not be a contraindication to inclusion in the trial **