NCT03150524

RCVS: The Rational Approach to Diagnosis and Treatment

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Johns Hopkins University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed description

Patients greater than 18 years of age presenting with clinical signs and symptoms consistent with RCVS (see inclusion criteria) will be enrolled. Neuroimaging (CT, Magnetic Resonance (MR), or 4 vessel angiogram) will be obtained along with a baseline transcranial doppler ultrasound (TCD). They will subsequently be randomized to receive nimodipine (every 4 hours) or extended release verapamil (twice daily). Mean cerebral blood flow velocities will be followed for reduction or normalization on daily TCD and medication dosing adjusted appropriately. Patients will be followed 90 days post-discharge at which time they will undergo repeat neuroimaging to confirm resolution of vascular abnormalities and repeat evaluation. To determine effectiveness, the investigators will evaluate both short-term (surrogate) in-hospital outcomes and long-term outcomes. Reduction of TCD velocities and headache severity will serve as our short-term surrogate outcomes; however, need for additional medications, blood pressure, new/recurrent stroke/Intracranial Hemorrhage (ICH) will also be evaluated along with modified Rankin score (mRS) on discharge, length of stay, and discharge disposition. At 90 days, the investigators will also assess headache control along with mRS.. Adverse events and their relation to the treatment arms will be assessed, and adherence to the medications will be evaluated.

Conditions

• Reversible Cerebral Vasoconstriction Syndrome

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2017-07-01
• Primary completion: 2019-05-31
• Completion: 2019-05-31
• First posted: 2017-05-12
• Last updated: 2019-09-18

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study