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

NCT01315899 | Terminated Phase 2 DMC

• 1 other identifier: 3098009
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Raynaud's Phenomenon

Keywords

Raynaud's phenomenon; Systemic sclerosis

Outcome Measures

Primary Outcomes (1)

• Finger temperature measurements and laser doppler imaging of the hands

  Finger temperature measurements and laser doppler imaging of the hands will be continually monitored from 0 minutes through to 90 minutes.

  0-90minutes continuous measurement

Study Arms (3)

ORM-12471 30mg

EXPERIMENTAL

Drug: ORM-12471 30mg

placebo

PLACEBO COMPARATOR

Drug: placebo

ORM-12471 100mg

EXPERIMENTAL

Drug: ORM-12471

Interventions

ORM-12471 30mg DRUG

Given as a single dose once during the crossover study as per Williams design

ORM-12471 30mg

ORM-12471 DRUG

Given as a single dose once during the study as per Williams crossover design

ORM-12471 100mg

placebo DRUG

Given once as a single dose during the study as per Williams crossover design

placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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, hepatic, renal, neurological, psychiatric or malignant disorder or any other major concurrent illness that in the opinion of the investigator would interfere with the interpretation of the study results or constitute a health risk for the subject if he/she takes part in the study
• Supine Heart rate (HR) \>100 beats per minute (bpm) after a 10 minute rest at screening
• Supine systolic BP (SBP)\>160 or diastolic BP (DBP)\>100 mmmHg after a 10 minute rest at screening visit
• Any other abnormal value of laboratory, vital signs or ECG which may in the opinion of the investigator interfere with the interpretation of the study results or cause a health risk for the subject if he/she takes part into the study.
• Pregnant or breast feeding or considering pregnancy in the next 4 months
• Female subjects of child bearing potential (i.e. menstruating or less than 2 years post menopausal) if they are not using proper contraception (hormonal contraception,intrauterine device \[IUD\] or surgical sterilisation, spermicidal foam in conjunction with condom on male partner)
• Subjects with pre-planned elective surgery during the estimated study period

Sponsors & Collaborators

• Orion Corporation, Orion Pharma: lead

Study Sites (1)

Salford Royal NHS foundation Trust

Salford, Greater Manchester, M6 8HD, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 24489014 RESULT

MeSH Terms

Conditions

Raynaud Disease; Scleroderma, Systemic

Condition Hierarchy (Ancestors)

Livedoid Vasculopathy; Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Connective Tissue Diseases

Study Officials

• Ariane L Herrick, MB,ChB, MD

  Northern Care Alliance NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2011
• First Posted: March 15, 2011
• Study Start: March 1, 2011
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: June 27, 2014

Record last verified: 2014-06

Locations

GB (1)