Het effect van ARA290 op de regeneratie van zenuwvezels bij patienten met sarcoidose en dunne vezelneuropathie.
Recruiting
- Conditions
- sarcoidosissmall fiber neuropathypaineye examsskin biopsy
- Registration Number
- NL-OMON22194
- Lead Sponsor
- eiden University Medical Center
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 40
Inclusion Criteria
1. Age of 18 to 65 years (inclusive);
2. Body Mass Index (BMI) between 18 and 30 kg/m2 (inclusive) and body weight between 50 kg and 90 kg (inclusive);
Exclusion Criteria
1. 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);
2. A semi recumbent systolic blood pressure of >150 mmHg and/or diastolic blood pressure of > 90 mmHg at screening;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Change in epidermal nerve fiber density;<br /><br>2. Change in cutaneous sensitivity;<br /><br>3. Change in visual test, OCT, oximap and/or CCM (eye department).
- Secondary Outcome Measures
Name Time Method 1. Change in the small fiber neuropathy score;<br /><br>2. Change in Brief Pain Inventory;<br /><br>3. Change in 6 minut walking test.