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Een dubbelblind, placebo-gecontroleerd fase 2 onderzoek naar de effecten van ARA 290 op neuropathische symptomen in patiŽnten met type 2 diabetes.


- candidate number14386
- NTR NumberNTR3858
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR14-feb-2013
- Secondary IDsP12.293 METC LUMC
- Public TitleEen dubbelblind, placebo-gecontroleerd fase 2 onderzoek naar de effecten van ARA 290 op neuropathische symptomen in patiŽnten met type 2 diabetes.
- Scientific TitleA double blind, placebo controlled Phase 2 study comparing the effects of ARA 290 on neuropathic symptoms of patients with type 2 diabetes.
- ACRONYMARAND
- hypothesisARA 290 improves neuropathic symptoms in patients with type 2 diabetes.
- Healt Condition(s) or Problem(s) studiedDiabetes Mellitus type 2 (DM type II), Small fiber neuropathy, Pain, Eye exams, Skin biopsy
- Inclusion criteria1. Established diagnosis of diabetes mellitus type 2;
2. Screening HbA1c between 7.5 % and 10 % inclusive;
3. Spontaneous discomfort level of 6 or greater on Pain Now (Pain Detect; 0 (least discomfort)-10 (worst discomfort)), OR;
4. Small fiber neuropathy screening list score (SFNSL) > 22, AND;
5. Quantitative sensory testing shows allodynia and altered temperature thresholds, OR;
6. Discomfort defined as distal pain/discomfort plus one of the following:
A. Paresthesia;
B. Burning/painful feet worsening at night;
C. Intolerance of sheets or clothes touching the legs or feet.
7. Be able to read and understand the written consent form, complete studyrelated procedures, and communicate with the study staff;
8. Be willing to comply with study restrictions;
9. Be willing to check in with the study center via the telephone;
10. Between 18 and 70 years of age (inclusive);
11. Body Mass Index (BMI) < 40 kg/m2 (inclusive);
12. If female of childbearing potential, a negative urine pregnancy test at screening and acceptable contraception will be maintained during the screening and dosing period and 1 month beyond. Acceptable contraception consists of hormonal methods such as oral, implantable, injectable, or transdermal contraceptives for a minimum of 1 full cycle (based on the patientís usual menstrual cycle period) before study entry, intrauterine device (IUD), or double-barrier method (condoms, sponge, diaphragm, or vaginalring with spermicidal jellies or cream);
13. Able to complete self-administered questionnaires (RAND-36, SFNSL, Pain Detect);
14. Refrigerator at home for storage of study medication.
- Exclusion criteria1. Clinically relevant abnormal history of physical and mental health other than conditions related to diabetes, as determined by medical history taking (as judged by the investigator);
2. Clinically relevant abnormal laboratory results, vital signs, or physical findings other than conditions related to diabetes (as judged by the investigator);
3. Known clinically relevant abnormalities in ECG (as judged by the investigator);
4. Episodes of significant hypoglycemia (as judged by the investigator);
5. Illicit drug abuse or excessive alcohol consumption (as judged by the investigator);
6. History of serious malignancy (as judged by the investigator);
7. History of fainting (as judged by the investigator);
8. History of severe allergies, or has had an anaphylactic reaction or significant intolerability to prescription or non-prescription drugs or food (as judged by the investigator);
9. Subjects that received a vaccination or immunization within the month prior to screening;
10. Anti-TNF therapy or other biological anti-inflammatory agents administered within the 6 months prior to screening;
11. Use of erythropoiesis stimulating agents within the two months prior to screening or during the trial;
12. 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;
13. Inadequate venous accessibility as judged by clinicians (physician or nurse);
14. Inability or unwillingness to self-administer ARA 290 via subcutaneous injections (or not have access to home health care for assistance in administration);
15. If female, pregnant or breast-feeding;
16. Any other condition that in the opinion of the investigator would complicate or compromise the study, or the well being of the patient.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-mrt-2013
- planned closingdate1-mrt-2014
- Target number of participants50
- InterventionsARA 290 subcutaneous during 28 days or placebo.
- Primary outcome1. Collection of adverse events, serious adverse events, and laboratory parameters;
2. Change in hemoglobin A1c at day 28 and 56 compared to baseline;
3. Change in the scores of the Small Fiber Neuropathy Screening List, Pain Detect, and RAND-36 (pain and physical function components) at days 28, 56, 84, and 112 compared to screening.
- Secondary outcome1. Change in quantitative sensory testing at day 28 and day 112 versus baseline;
2. Change in intra epidermal nerve fiber density at day 28 and day 112 versus baseline;
3. Change in the 6 minute walk test at day 28 versus baseline;
4. Change in visual acuity at day 28 versus baseline;
5. Change in heart rate variability (R-R and QT intervals) at day 28 versus baseline;
6. Change in retinal thickness at day 28 versus baseline as determined by optical coherence tomography;
7. Change in cornea fiber density or length at day 28 and day 112 versus baseline as determined by cornea confocal microscopy;
8. Additionally, the effect of ARA 290 on glucose control, C reactive protein, and microalbuminuria in patients with diabetes will be assessed.
- TimepointsWeekly questionnaires and follow-up for 12 weeks.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIES M. Velzen, van
- CONTACT for SCIENTIFIC QUERIES M. Velzen, van
- Sponsor/Initiator Leiden University Medical Center (LUMC)
- Funding
(Source(s) of Monetary or Material Support)
Araim Pharmaceuticals, New York, US
- PublicationsN/A
- Brief summaryARA 290 has been demonstrated to be a neuroprotective and neurotrophic agent in a variety of preclinical in vitro and in vivo models. We will determine the effect of ARA 290 on neuropathic symptoms in patients with type 2 diabetes. Patient will be enrolled in one single center.
- Main changes (audit trail)
- RECORD14-feb-2013 - 10-mrt-2013


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