A study the safety and effects of ARA 290 administered subcutaneously on pain relief in patients with chronic pain from complex regional pain syndrome type 1.
- Conditions
- Complex regional pain syndromeTherapeutic area: Body processes [G] - Biological Phenomena [G16]
- Registration Number
- EUCTR2012-003688-24-NL
- Lead Sponsor
- eiden University Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
(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;
d. Motor/trophic: evidence of decreased motor ranges and/or motor dysfunction (weakness, tremor, dystonia) and/or trophic changes (hair, nail, skin);
(4) There is no other diagnosis that better explains the signs and symptoms.
(5) Pharmacotherapy for CRPS symptoms (e.g., analgesics, antidepressants, and/or anticonvulsants ) has been stable for at least 4 weeks
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
• 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;
• Subject has undergone major surgery within three months prior to screening;
• Inability or unwillingness to self-administer ARA 290 via subcutaneous injections
• Any other condition that in the opinion of the investigator would complicate or compromise the study, or the well being of the subject
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method