TerminatedPhase 2

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

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

United Kingdom15 participantsStarted 2011-03

Plain-language 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.

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Written informed consent obtained * Age of 10-75 years (inclusive) * Body mass index (BMI) between 10-30 kg/m2 (inclusive) * Male or female patients with a diagnosis of active Raynaud's phenomenon (RP) secondary to systemic sclerosis. Active RP will be defined as a history of cold sensitivity associated with colour changes of cyanosis or pallor, as well as of at least 6 attacks weekly during the winter months. Diagnosis of systemic sclerosis will be defined by the European League Against Rheumatism (EULAR) criteria. * Stable symptoms for RP and medication requirements within 2 months prior to screening * Negative pregnancy test for females of childbearing potential Exclusion Criteria: * Treatment with nitrates * Treatment with calcium channel blockers (CCBs)for indications other than the relief of RP symptoms * Treatment with calcium channel blockers (CCBs) for the relief of RP symptoms that in the opinion of the investigator cannot be stopped from the screening visit until end of the last experimental session * Changes in dosing of other vasoactive medications within 1 month prior to screening or during the study * Smoking or smoking cessation using nicotine products within 3 months prior to screening * Current active ischemic digital ulcer and/or tissue gangrene * History of sympathectomy * Upper extremity deep vein thrombosis or lymphoedema within 3 months prior to screening. * Clinically significant cardiovascular, pulmonary, gastrointestinal, hep…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Finger temperature measurements and laser doppler imaging of the hands

Timeframe: 0-90minutes continuous measurement

Trial details

NCT IDNCT01315899

SponsorOrion Corporation, Orion Pharma

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2011-12

View on ClinicalTrials.gov More Raynaud's Phenomenon trials