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RCVS: The Rational Approach to Diagnosis and Treatment

NCT03150524 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2019-09-18

No results posted yet for this study

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).

Conditions

  • Reversible Cerebral Vasoconstriction Syndrome

Interventions

DIAGNOSTIC_TEST

TCD- cerebral blood flow velocities

Participants will undergo daily TCD for monitoring of cerebral blood flow.

BEHAVIORAL

Headache pain score

Participants will be evaluated by nurses for headache frequency and severity every shift.

OTHER

Neurological examination

Patients will be examined routinely for evidence of neurological improvement/decline and/or evidence of a complication such as stroke or hemorrhage.

DIAGNOSTIC_TEST

Repeat Neuroimaging

All patients will also be seen at 90 days (+/- 30 days) and administered a headache diary, repeat neuroimaging, and neurological examination.

DRUG

Nimodipine

Participants will be administered nimodipine every 4 hours.

DRUG

Verapamil ER

Participants will be administered long acting verapamil every 12 hours.

Sponsors & Collaborators

Principal Investigators

  • Elisabeth B Marsh, MD · Johns Hopkins University

  • Rafael H Llinas, MD · Johns Hopkins University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-01
Primary Completion
2019-05-31
Completion
2019-05-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03150524 on ClinicalTrials.gov