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- Sperimentazione clinica NCT00220506
Fatigue Treatment Using Provigil
Fatigue Treatment Using Provigil in Patients With Relapsing Remitting Multiple Sclerosis
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
Multiple sclerosis and fatigue Fatigue is one of the most common symptoms of multiple sclerosis (MS), occurring in 30%-80% of patients and for many of them fatigue is the most disabling symptom (1).
Definition of fatigue according to the MS Council for Clinical Practice Guidelines is as follows: "A subjective lack of physical and/or mental energy that is perceived by the individual or caregiver to interfere with usual and desired activities".
As fatigue is a subjective and non-specific symptom, and can easily be confused with either weakness or depressed mood, both common in MS, the following characteristics have been defined to better diagnose MS-associated fatigue:
- MS-related fatigue generally occurs on a daily basis.
- It tends to worsen as the day progresses.
- It tends to be aggravated by heat and humidity.
- It is not directly correlated with either depression or the degree of physical impairment.
- It may occur first thing in the morning even if the patient has had a restful full night's sleep.
The current medications used for the treatment of MS-associated fatigue such as amantadine hydrochloride and pemoline are useful to some, but not all patients. In a multicenter trial (2) it was found that 100 mg amantadine twice daily significantly improves fatigue. Pemoline in a placebo-controlled trial (3) failed to show significant effect on fatigue in MS patients and was poorly tolerated as side effects occurred in 25% of patients. A third trial (4) compared pemoline to amantadine and placebo, and showed only a positive trend for pemoline, while amantadine had a benefit over placebo in some fatigue measures. There was also a marked placebo effect in this trial, with approximately half of patients reporting improvement in fatigue no matter what treatment (pemoline, amantadine or placebo) they were taking.
In the current study proposal we intend to evaluate the effect of Provigil on MS-associated fatigue.
The possibility for add-on drug that will affect fatigue in MS is of importance, as fatigue has a significant impact on activities of daily living, interfering with work, family life and social activities.
1.2. The fatigue scale named "Fatigue Impact Scale" The awareness of the impact of fatigue on patient's quality of life (QOL) and the need to evaluate the effect of the different therapies on this parameter resulted in the development and validation of different questionnaires for the measurement of fatigue, i.e., the Fatigue Impact Scale (FIS), which has been shown to measure both, fatigue and treatment effect on fatigue (6-9).
The FIS is a reliable and validated 40-items questionnaire that is capable of selecting a treatment effect. It is a made up of 3 sub-scales: physical, cognitive and social. Each question is scored from 0-4, allowing a total score of 160. High scores indicate high impairment.
Tipo di studio
Iscrizione
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Tel Hashomer, Israele
- Reclutamento
- Multiple Sclerosis Center
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Contatto:
- Mark Dolev, MD
- Numero di telefono: 973-3-5303899
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Investigatore principale:
- Mark Dolev, MD
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- The patients should be diagnosed with clinically definite MS (Posner criteria).
- EDSS at screening: 0 to 5.5, inclusive.
- Positive Fatigue impact scale 40 points or more.
- Age 18-55 years.
- Co-operating patient, capable of complying with all of trial procedures (i.e. FIS, QOL, etc…).
- Patient who signed written informed consent.
- Women of childbearing potential must use effective birth control method during study.
Exclusion Criteria:
- Life threatening and/or unstable clinical condition which in the opinion of the investigator might compromise trial completion
- A relapse during the last 30 days prior to the study.
- Systemic steroid therapy within 30 days
- Known hypersensitivity or intolerance, to Provigil or related substances or to any component of the formulation.
- Sleep apnea
- Narcolepsy
- Participation in experimental drug trials during the last 30 days prior to the trial.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Non randomizzato
- Modello interventistico: Assegnazione incrociata
- Mascheramento: Nessuno (etichetta aperta)
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
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To determine fatigue impact scale
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Misure di risultato secondarie
Misura del risultato |
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to determine cognition measurements
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Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Mark Dolev, MD, Sheba Medical Center
Studiare le date dei record
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
- Fatica
- Effetti fisiologici delle droghe
- Meccanismi molecolari dell'azione farmacologica
- Induttori enzimatici del citocromo P-450
- Induttori del citocromo P-450 CYP3A
- Stimolanti del sistema nervoso centrale
- Agenti che promuovono la veglia
- Modafinil
Altri numeri di identificazione dello studio
- SHEBA-05-3769-MD-CTIL
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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