- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT00406458
Clinical Trial of SB-509 in Subjects With Diabetic Neuropathy
A Phase 2 Repeat Dosing Clinical Trial of SB-509 in Subjects With Diabetic Neuropathy
Panoramica dello studio
Stato
Intervento / Trattamento
Descrizione dettagliata
SB-509 contains the gene (DNA-a kind of biological "blueprint") for a protein. When a researcher injects SB-509 into your legs, the drug enters the muscle and nerve cells around the injection site and causes these cells to make a protein. This protein causes your cells to increase production of another protein called vascular endothelial growth factor (VEGF), which may improve the structure and function of nerves. In addition, there are changes in the levels of 28 additional proteins in your cells. These proteins function to promote the growth of cells, are structures in cells, help synthesize products, and affect immune cells, and some have unknown functions. This increase in your own VEGF proteins may protect and repair the damaged nerves caused by diabetic neuropathy.
The study doctor will test SB-509 (60 mg) and placebo. Everyone in this study will receive intramuscular (IM-directly into the muscle) injections into both legs. This will happen 3 times over about 4 months. Two out of every 3 participants will receive SB-509 and 1 out of every 3 will receive placebo. You will not know, and the study doctor will not know, whether you will receive SB-509 or whether you will receive placebo.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Fase 2
Contatti e Sedi
Luoghi di studio
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Col. Roma
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Mexico City, Col. Roma, Messico, 06700
- Instituto Mexicano de Investigación Clinica
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California
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La Jolla, California, Stati Uniti, 92037
- Coordinated Clinical Research
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Lakewood, California, Stati Uniti, 90712
- Advanced Medical Research, LLC
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San Francisco, California, Stati Uniti, 94109
- SF Clinical Research Center
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Walnut Creek, California, Stati Uniti, 94598
- Diablo Clinical Research
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Florida
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Bradenton, Florida, Stati Uniti, 34205
- Bradenton Research Center
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Miami, Florida, Stati Uniti, 33136
- University of Miami, Diabetes Research Institute
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Sunrise, Florida, Stati Uniti, 33351
- Neurology Clinical Research
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Kansas
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Kansas City, Kansas, Stati Uniti, 66160
- University of Kansas Medical Center
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Nebraska
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Omaha, Nebraska, Stati Uniti, 68131
- Creighton Diabetes Center
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New York
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Albany, New York, Stati Uniti, 12205
- Upstate Clinical Research
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New York, New York, Stati Uniti, 10022
- Peripheral Neuropathy Center, Weill Medical College of Cornell University
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Pennsylvania
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Duncansville, Pennsylvania, Stati Uniti, 16635
- Altoona Center for Clinical Research
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Texas
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Houston, Texas, Stati Uniti, 77030
- Nerve and Muscle Center of Texas
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San Antonio, Texas, Stati Uniti, 78229
- DGD Research
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Key Inclusion Criteria:
- Have a clinical diagnosis of diabetes mellitus type I or II for at least 12 months prior to the study.
- Have received a diagnosis of mild to moderate sensorimotor diabetic neuropathy from a neurologist (a doctor who specializes in disorders of the nervous system) or endocrinologist (a doctor who specializes in diabetes). This type of neuropathy is a loss of sensation and muscle function that occurs in the legs and hands in a stocking and glove distribution. Subjects with diabetic neuropathy that results in loss of sensation or muscle function in only one nerve and results in loss of nerve function of the blood vessels and causes low blood pressure, will not be eligible.
- If female and of childbearing potential, agree to use a medically acceptable physical barrier method during the study.
- Have blood pressure < 140/90 mm Hg
- Body mass index (BMI) < 38 kg/m2
Key Exclusion Criteria:
Subjects with the following are NOT eligible to participate in this study:
- Have moderate to severe ischemic heart disease, any history of congestive heart failure, or have had a myocardial infarction (heart attack) within the previous 6 months.
- Have chronic foot or leg ulcers for >1 month, gangrene in the legs, or any previous amputation of the lower extremity.
- Have symptoms of intermittent claudication (or leg pain during exercise associated with peripheral artery disease) and/or an ankle brachial index (or a calculation of the difference between arm and leg blood pressures) of less than (<) 0.75.
- Have a history of cancer within the past 5 years (except for curable non-melanoma cancer of the skin, superficial bladder cancer in complete remission, or any other cancer that has been in complete remission for at least 5 years).
- Have colon polyps. If patients have a history of benign colonic polyps that have been removed, they must have evidence of a normal colonoscopy within the last 12 months.
- Require any drug that depresses patients' immune systems (such as methotrexate, cyclophosphamide, or cyclosporine) when they receive the study drug and for 30 days afterwards.
- Have a known disorder that affects patients' immune systems (such as HIV/AIDS, hepatitis B virus [HBV], hepatitis C virus [HCV], sarcoidosis, tuberculosis, rheumatoid arthritis, or autoimmune disorders).
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Doppio
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Sperimentale: SB-509
60 mg SB-509 injected IM into lower limbs every 2 months
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60 mg dose
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Comparatore placebo: Normal Saline
Normal saline injected IM into lower limbs every 2 months
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
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Visual analog scale for pain intensity (VASPI), Nerve Conduction Velocity (NCV), Total Neuropathy Score (TNS), Epidermal Nerve Fiber Density (ENFD) & Epidermal Nerve Fiber Density Regeneration (ENFDR)
Lasso di tempo: One year
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One year
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Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
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Sicurezza
Lasso di tempo: Un anno
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Un anno
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Collaboratori e investigatori
Sponsor
Collaboratori
Pubblicazioni e link utili
Collegamenti utili
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Disturbi del metabolismo del glucosio
- Malattie metaboliche
- Malattie del sistema nervoso
- Malattie del sistema immunitario
- Malattie autoimmuni
- Malattie del sistema endocrino
- Complicanze del diabete
- Malattie neuromuscolari
- Malattie del sistema nervoso periferico
- Diabete mellito
- Diabete mellito, tipo 2
- Diabete mellito, tipo 1
- Polineuropatie
- Neuropatie diabetiche
Altri numeri di identificazione dello studio
- SB-509-0601
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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