Phase 2 Study of Montelukast for the Treatment of Sickle Cell Anemia

NCT01960413 ↗

Phase 2 Completed 46 enrolled Vanderbilt University Medical Center Medical College of Wisconsin · collab Versiti Blood Health · collab

RandomizedParallel-groupTriple-blindTreatment

Summary

In this feasibility trial, the investigators will compare participants treated with montelukast and hydroxyurea to those treated with placebo and hydroxyurea for a total of 8 weeks.

Timeline

Start: 2013-11
Primary completion: 2018-03
Completion: 2018-03

Outcome

Missed primary endpoint

paper We found no difference between the montelukast and placebo groups with regard to the levels of sVCAM PMID 32208487 ↗

Publications

Field JJ, Kassim A, Brandow A, Embury SH, Matsui N, Wilkerson K, Bryant V, Zhang L, Simpson P, DeBaun MR. Phase 2 trial of montelukast for prevention of pain in sickle cell disease. Blood Adv. 2020 Mar 24;4(6):1159-1165. doi: 10.1182/bloodadvances.2019001165.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Montelukast	Other / unclassified	—	Oral
Comparator	Hydroxyurea	Other / unclassified	—	—