Efficacy of ORM-12741 for Prevention of Raynaud's Phenomenon

Summary

Raynaud's phenomenon (RP) is a disorder of the digital blood vessels resulting in episodic impairment of blood flow. During an attack of RP which commonly affects the hands and feet these arteries contract briefly which limits the blood flow (this is called a vasospasm) and deprived of blood the skin turns white then blue. The aim of this study is to prove the concept that ORM-12741 can prevent these blood vessel spasms.

Timeline

Start

2011-03

Primary completion

2011-12

Completion

2011-12

Outcome

Missed primary endpoint

Stopped: “Recommendation by study DSMC to the sponsor following interim analysis of 8 subjects.”

paper The area under the rewarming curve (LDI) of the right index finger (arbitrary flux units × time) was lower for both 30 mg (P = 0.043) and 100 mg (P = 0.025) of ORM-12741 compared with placebo, indicating delayed reperfusion. PMID 24489014 ↗

paper CONCLUSION: ORM-12741 did not expedite recovery from a cold challenge in the fingers of patients with SSc. PMID 24489014 ↗

Publications

• Results Herrick AL, Murray AK, Ruck A, Rouru J, Moore TL, Whiteside J, Hakulinen P, Wigley F, Snapir A. A double-blind, randomized, placebo-controlled crossover trial of the alpha2C-adrenoceptor antagonist ORM-12741 for prevention of cold-induced vasospasm in patients with systemic sclerosis. Rheumatology (Oxford). 2014 May;53(5):948-52. doi: 10.1093/rheumatology/ket421. Epub 2014 Jan 31.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	ORM-12471	Unknown	30 mg	Oral
Subject	ORM-12471	Unknown	100 mg	Oral

Indications