Recruiting

Nimodipine

Sponsor:

University of Alberta

Code:

NCT07065903

Conditions

Subarachnoid Aneurysm Hemorrhage

Subarachnoid Hemorrhage, Aneurysmal

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

Aneurysmal subarachnoid hemorrhage (SAH) is a life-threatening neurological illness: it is bleeding in the brain after a bulging blood vessel (a brain aneurysm) ruptures. Although SAH accounts for only 5% of all strokes, it often happens in middle age and it puts a significant burden on many patients during their most productive years. Complications following SAH are common, and they can cause major long-term disability. Only one medication - nimodipine - has been proven to benefit the health and wellbeing of these patients. All SAH patients should receive nimodipine for 21 days at a fixed dose. However, our early work suggested that all patients are not getting equal amounts of nimodipine into their blood. In addition, the two different forms (structural mirror images) of nimodipine might have different effects. Reduced amounts of nimodipine in the blood may lessen its benefit and contribute to worsening health and wellbeing of SAH patients.

The overall goal of this research is to see what happens with different nimodipine doses and to confirm whether the two forms of nimodipine have different effects. The investigators will conduct a multi-centre study in adult patients admitted for SAH in Canada and the USA. The investigators will collect blood samples to determine the amount of each type of nimodipine in each participant's body, and then will check to see how each participant is doing at 90 days following SAH. They will also check other factors affecting nimodipine levels, so that they can in the future suggest dose recommendations that are actually tailored to each patient.

Conditions

Subarachnoid Aneurysm Hemorrhage

Subarachnoid Hemorrhage, Aneurysmal

Study ID

NCT07065903

Start date

May 13, 2024

Status verified date

Feb, 2026

Completion date

Sep, 2029

Anticipated

Primary completion date

Sep, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Age 18-85 years
  • Diagnosis of aneurysmal SAH
  • Provision of informed consent
  • Treated with nimodipine
  • Presence of intravascular catheter at the time of sampling

Exclusion Criteria:

  • Anticipated hospital length of stay <48 hours
  • Non-aneurysmal SAH
  • Not treated with nimodipine
  • Incarceration
  • Delayed presentation to the hospital (>96 h from SAH onset)

Study Design

Enrollment

500 participants

Anticipated

Interventions and Outcome Measures

Arms

Aneurysmal subarachnoid hemorrhage (SAH) Patients

Adult patients admitted for aneurysmal SAH to any of the participating centres, who consent to participate in the study and meet the inclusion and exclusion criteria.

Primary outcome measure

  • modified Rankin Scale (mRS) score [ Time Frame: 90 days from hospital admission ]

Central Contacts and Locations

Central contacts

Sherif H Mahmoud, BSc (Pharm), MSc, PhD, FNCS

780.492.5364smahmoud@ualberta.ca

Locations

VCU Medical Center

Recruiting

Richmond, Virginia, United States, 23219

Contacts

Gretchen M Brophy, PharmD, BCPS, FCCP, FNCS, MCCM

804-828-1201gbrophy@vcu.edu

University of Alberta Hospital

Recruiting

Edmonton, Alberta, Canada, T6G 2X8

Contacts

Sherif H Mahmoud, BSc (Pharm), MSc, PhD, FNCS

780-492-5364smahmoud@ualberta.ca

Principal Investigator:

Sherif H Mahmoud, BSc (Pharm), MSc, PhD, FNCS

University Health Network - Toronto Western Hospital

Recruiting

Toronto, Ontario, Canada, M5T 2S8

Contacts

Victoria McCredie, MBChB PhD FRCP(C) FRCP(UK)

416-302-1959Victoria.McCredie@uhn.ca

More Information

Sponsor

University of Alberta

Last update posted

Feb 9, 2026

Last verified

Feb, 2026

Keywords

  • nimodipine
  • subarachnoid hemorrhage
  • pharmacokinetics

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Alberta on 2026-02-09.