- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT00001669
A 48-Week (24-Week Baseline Followed by a 24-Week Treatment) Phase II Pilot Study of the Tolerability and Effect/Efficacy of Subcutaneously Administered Insulin-Like Growth Factor-1 (rhIGF) (CEP-151) in Multiple Sclerosis (MS) Patients
Panoramica dello studio
Descrizione dettagliata
Tipo di studio
Iscrizione
Fase
- Fase 2
Contatti e Sedi
Luoghi di studio
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Maryland
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Bethesda, Maryland, Stati Uniti, 20892
- National Institute of Neurological Disorders and Stroke (NINDS)
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Bambino
- Adulto
- Adulto più anziano
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Patients must be between 18-55 years old; meet the diagnostic criteria for clinical definite or laboratory supported definite MS with either a relapsing remitting or secondary progressive course;
Stage I - known by history to have a mean enhancing lesion frequency of 0.3 per month or greater;
Stage II - known by history to have a mean enhancing lesion frequency of 0.5 per month or greater;
Ability to comply with protocol requirements;
Provide written informed consent;
If a female patient, not of child bearing potential (surgically sterilized or post-menopausal) or if of child bearing potential, documented to be nonpregnant by urine pregnancy test and not lactating with adequate contraception and counseling.
Male patients should also receive adequate counseling and exercise adequate contraception.
No clinically significant abnormalities on the prestudy laboratory evaluations, physical examination, electrocardiogram (ECG), chest x-ray, mammogram or ophthalmologic exam.
No connective tissue or rheumatic disorder (systemic lupus erythematosus [SLE] ; rheumatoid arthritis [RA]; progressive systemic sclerosis [PSS]; Sjogren's syndrome [SS]).
Patient may not be HIV (human immunodeficiency virus), HTLV-1 (human T cell leukemia virus), or HB/C Ag (hepatitis B or C surface antigen) positive.
No history of insulin-producing tumors or reactive hypoglycemia.
No clinically significant medical condition (e.g., within 6 months of screen had myocardial infarction, angina pectoris, untreated hypertension, and/or congestive heart failure [CHF] that, in the opinion of the investigator would compromise the safety of the patient.
Ability to tolerate MRI examinations due to claustrophobia, or have contraindications to MRI scanning, such as pacemakers, aneurysm clips, or shrapnel fragments. Welders and metal workers must have radiographic evidence to document lack of foreign bodies in the eyes or they will be excluded, due to the risk of eye injury while in the MRI machine.
No history of substance use disorder (DSM-IV criteria) within the past two years.
No Type I or Type II diabetes treated with hypoglycemic agents (diet-controlled Type II diabetes may be included.)
No history of cancer (with the exception of localized skin cancers with no evidence of metastasis, significant invasion, or recurrence) within three years of screening.
No first or second degree relatives with breast cancer.
Have not used an investigational drug within 30 days of the screen visit.
Have previously received interferon-alpha, interferon-beta, copolymer 1, cyclophosphamide, intravenous immunoglobulin, oral myelin, or other immunosuppressive drugs within 6 months of screen.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
Collaboratori e investigatori
Pubblicazioni e link utili
Pubblicazioni generali
- Liu X, Linnington C, Webster HD, Lassmann S, Yao DL, Hudson LD, Wekerle H, Kreutzberg GW. Insulin-like growth factor-I treatment reduces immune cell responses in acute non-demyelinative experimental autoimmune encephalomyelitis. J Neurosci Res. 1997 Mar 1;47(5):531-8. doi: 10.1002/(sici)1097-4547(19970301)47:53.0.co;2-i.
- Miller DH, Albert PS, Barkhof F, Francis G, Frank JA, Hodgkinson S, Lublin FD, Paty DW, Reingold SC, Simon J. Guidelines for the use of magnetic resonance techniques in monitoring the treatment of multiple sclerosis. US National MS Society Task Force. Ann Neurol. 1996 Jan;39(1):6-16. doi: 10.1002/ana.410390104.
- Stone LA, Frank JA, Albert PS, Bash C, Smith ME, Maloni H, McFarland HF. The effect of interferon-beta on blood-brain barrier disruptions demonstrated by contrast-enhanced magnetic resonance imaging in relapsing-remitting multiple sclerosis. Ann Neurol. 1995 May;37(5):611-9. doi: 10.1002/ana.410370511.
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Studia le date principali
Inizio studio
Completamento dello studio
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
- Processi patologici
- Malattie del sistema nervoso
- Malattie del sistema immunitario
- Malattie autoimmuni demielinizzanti, SNC
- Malattie autoimmuni del sistema nervoso
- Malattie demielinizzanti
- Malattie autoimmuni
- Sclerosi multipla
- Sclerosi
- Effetti fisiologici delle droghe
- Sostanze per la crescita
- Mecasermina
Altri numeri di identificazione dello studio
- 970148
- 97-N-0148
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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