WithdrawnPhase 4

RCVS: The Rational Approach to Diagnosis and Treatment

Stopped: Failure to recruit patients meeting inclusion criteria.

United States0Started 2017-07-01

Plain-language 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).

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 \*\*

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Peak TCD velocities

Timeframe: daily from admission to discharge (approx 5-7 days)

Duration of elevated TCD velocities

Timeframe: daily from admission to discharge (approx 5-7 days)

Normalization of TCD velocities

Timeframe: daily from admission to discharge (approx 5-7 days)

Trial details

NCT IDNCT03150524

SponsorJohns Hopkins University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-05-31

View on ClinicalTrials.gov More Reversible Cerebral Vasoconstriction Syndrome trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.