Treatment of Complex Regional Pain Syndrome type 1: A randomized placebo controlled double-blind study with ARA 290, The CRPSARA Study
- Conditions
- nerve painneuropathic pain10034606
- Registration Number
- NL-OMON37009
- Lead Sponsor
- eids Universitair Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- Not specified
- Target Recruitment
- 40
Inclusion criteria will be the *Budapest Criteria* for CRPS1. These criteria have a high specificity and sensitivity for the diagnosis of the disease [1]. The criteria are:
(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
Exclusion criteria are:
* 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
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The main study end-point is:<br /><br>* Change in Numerical Rating Score of *pain now* as reported at the end of<br /><br>each treatment week and at the end of each week in the 4 weeks following<br /><br>treatment.<br /><br>* Global Health self-assessment</p><br>
- Secondary Outcome Measures
Name Time Method <p>Additional endpoints are:<br /><br>* Change in Brief Pain Inventory<br /><br>* Change in Short Form-36 questionnaire<br /><br>* Change in Radboud Skills Questionnaire<br /><br>* Change in the Walking Ability questionnaire<br /><br>* Change in Hospital Anxiety and Depression Scale<br /><br>* Change in Pain Coping Inventory<br /><br>* Change in analgesic/antidepressant use</p><br>