Treatment of Complex Regional Pain Syndrome type 1: A randomized placebo controlled double-blind study with ARA 290 - CRPSARA

eiden University Medical Center0 sitesSeptember 18, 2012

Overview

No summary available.

Registry

who.int

Start Date

September 18, 2012

End Date

TBD

Last Updated

13 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

eiden University Medical Center

•(1\) Continuing pain, which is disproportionate to any inciting event;
•(2\) Must report at least one symptom in three of the four following categories:
•a. Sensory: reports of hyperesthesia and/or allodynia;
•b. Vasomotor: reports of temperature asymmetry and/or skin color changes and/or color asymmetry;
•c. Sudomotor/edema: reports of edema and/or sweating changes and sweating asymmetry;
•d. Motor/trophic: reports of decreased motor ranges and/or motor dysfunction (weakness, tremor, dystonia) and/or trophic changes (hair, nail, skin);
•(3\) Must display at least one sign at time of evaluation in two or more of the following categories:
•a. Sensory: hyperalgesia (to pinprick) and/or allodynia (to light touch and/or deep somatic pressure and/or joint movement);
•b. Vasomotor: evidence of temperature asymmetry and/or skin color changes and/or color asymmetry;
•c. Sudomotor/edema: evidence of edema and/or sweating changes and sweating asymmetry;

•Inability to give informed consent;
•Patients suffering from other pain syndromes;
•Clinically relevant abnormal history of physical and mental health, as determined by medical history taking and physical examinations obtained during the screening visit and/or prior to the administration of the initial dose of the study drug (as judged by the investigator);
•A semi recumbent systolic blood pressure of \>160 mmHg and/or diastolic blood pressure of \> 95 mmHg at screening;
•History of alcoholism or substance abuse within three years prior to screening;
•Positive pregnancy test or lactation
•Male subjects habitually using more than 21 units of alcohol per week and female subjects using more than 14 units of alcohol per week;
•Subject has a history of severe allergies, or has had an anaphylactic reaction or significant intolerability to prescription or non\-prescription drugs or food;
•Subjects that received a vaccination or immunization within the last month;
•Participation in an investigational drug trial in the 3 months prior to administration of the initial dose of study drug or more than 4 times per year;