NL-OMON37009
Withdrawn
Phase 2
Treatment of Complex Regional Pain Syndrome type 1: A randomized placebo controlled double-blind study with ARA 290, The CRPSARA Study - Treatment of CRPS with ARA290
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- nerve pain
- Sponsor
- eids Universitair Medisch Centrum
- Enrollment
- 40
- Status
- Withdrawn
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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;
Exclusion Criteria
- •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;
Outcomes
Primary Outcomes
Not specified
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