NCT02712788

Milrinone in Addition to Hyperdynamic Therapy in the Treatment of Vasospasm Following Aneurysmal Subarachnoid Hemorrhage

Terminated Phase 2 Results posted Last updated 2 July 2019

What this trial tests

Phase 2 trial testing Milrinone in Cerebral Vasospasm in 4 participants. Terminated before completion.

Timeline

18 April 2016

Primary endpoint
24 October 2017

3 May 2018

Quick facts

Lead sponsor	Indiana University
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	4
Start date	18 April 2016
Primary completion	24 October 2017
Estimated completion	3 May 2018
Sites	1 location across United States

Drugs / interventions tested

• Milrinone (MILRINONE) — full drug profile →
• Placebo

Conditions studied

• Cerebral Vasospasm — all drugs for Cerebral Vasospasm →

Sponsor

Indiana University

Who can join

18 and older, any sex, with Cerebral Vasospasm. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Modified Rankin Scale (mRS) at 6 Months Primary · 6 months

Reported as number for each subject and then will look statistically to see if there is a difference between the active arm and the placebo arm. The Modified Rankin scale is Scored as follows: 0 = No symptoms, 1 = No significant disability. Able to carry out all usual activities, despite some symptoms, 2 = Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities, 3 = Moderate disability. Requires some help, but able to walk unassisted, 4 = Moderately severe disability. Unable to attend to own bodily needs without assistance, and unab

Group	Value	95% CI
Placebo	1.5	0 – 3

mRS at 12 Months Secondary · 12 months

Reported as number for each subject and then will look statistically to see if there is a difference between the active arm and the placebo arm. THe Modified Rankin Scale is Scored as follows: 0 = No symptoms, 1 = No significant disability. Able to carry out all usual activities, despite some symptoms, 2 = Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities, 3 = Moderate disability. Requires some help, but able to walk unassisted, 4 = Moderately severe disability. Unable to attend to own bodily needs without assistance, and unab

Group	Value	95% CI
Placebo	2	1 – 3

Adverse events — posted to ClinicalTrials.gov

Time frame: 30 days following discontinuation of study drug. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Milrinone

Serious: 1/2 (50%)

Deaths: 0/2

Placebo

Serious: 1/2 (50%)

Deaths: 0/2

Serious adverse events (3 terms)

Reaction	System	Milrinone	Placebo
Hypotension	Cardiac disorders	—	—
Gastroduodenal Artery Bleed	Vascular disorders	—	—
Thalamic and basal ganglia infarcts	Vascular disorders	—	—

Other adverse events (7 terms — click to expand)

Reaction	System	Milrinone	Placebo
Urinary Tract Infection	Renal and urinary disorders	—	—
Fever (neurogenic)	Nervous system disorders	—	—
epistaxis	Vascular disorders	—	—
Hyponatremia	Metabolism and nutrition disorders	—	—
Acute Deep Venous Thrombosis	Vascular disorders	—	—
Hematochezia	Gastrointestinal disorders	—	—
Incontinence associated dermatitis	Skin and subcutaneous tissue disorders	—	—

Most-reported serious reactions: Hypotension, Gastroduodenal Artery Bleed, Thalamic and basal ganglia infarcts.

Data from ClinicalTrials.gov NCT02712788 adverse events section.

Sponsor's own description

The purpose of this study is to evaluate the usefulness of adding Milrinone to the current standard treatment for cerebral vasospasm.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Phosphodiesterase Inhibitors as a Therapeutic Approach to Neuroprotection and Repair.
   Knott EP, Assi M, Rao SN, Ghosh M, et al · · 2017 · cited 55× · PMID 28338622 · DOI 10.3390/ijms18040696
2. Efficacy and safety of milrinone in the treatment of cerebral vasospasm after subarachnoid hemorrhage: a systematic review.
   Santos-Teles AG, Ramalho C, Ramos JGR, Passos RDH, et al · · 2020 · cited 11× · PMID 33470361 · DOI 10.5935/0103-507x.20200097