- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT02006160
Effects of Dalfampridine on Cognition in Multiple Sclerosis
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
3a. Patient Sample and Recruitment
Subjects will be consecutively selected from the Western New York (NY) region where the Baird MS Center and the Jacobs Neurological Institute are located. Patients will be interviewed and their records reviewed to assess for inclusion/exclusion. Patients will then be approached in the clinic or contacted by telephone and invited to participate in this clinical trial. The attached flier will also be used to directly advertise the study to patients. Patients who initiate contact with the researcher will be interviewed to assess eligibility.
Inclusion Criteria. Patients will be eligible for the study if they fulfill all the inclusion criteria specified below
- Males/Females who are ≥ 18 years old and < 65 years old and are capable of understanding and complying with the protocol, including speaking and writing fluent English and having at least a 9th grade education.
- Have a diagnosis of MS, as per revised McDonald's Criteria.
- Have not received steroids in last thirty (30) days or a relapse in the last ninety (90) days, and whose MS is considered stable.
- Impression of cognitive impairment as indicated by one of the following: (a) positive NP testing following diagnosis of MS as determined by board certified neuropsychologist or with z scores <-1.5 below expectation in at least one cognitive domain, or (b) informant Multiple Sclerosis Neuropsychological Questionnaire (MSNQ) >28.
- An Expanded Disability Status Scale (EDSS) of ≤ 6.5.
- Have given written informed consent prior to any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to his/her future medical care.
- Are capable of performing the requirements of a NP test battery including at least 20/70 near visual acuity by near vision chart, with correction allowed.
- If female, must neither be pregnant nor breast-feeding and must either (a) be > 12 months post-menopausal or surgically sterilized, or (b) agree to use an acceptable method of birth control for the duration of the study. Abstinence will not be considered an acceptable method of birth control.
Exclusion Criteria. Patients will be excluded from the study if they meet any one or more of the exclusion criteria specified below:
- Have cognitive deficits caused by concomitant medication usage or other significant neurological/psychological disease e.g. Alzheimer's disease, Parkinson's disease, stroke, transient ischemic attack, Vascular Dementia, Huntington's disease, traumatic brain injury or chronic central nervous system (CNS) infection
- Have evidence of other medical cause(s) of cognitive impairment
- Evidence of major mental illness predating the onset of MS
- Have evidence of major depression as determined by a positive Beck Depression Index-Fast Screen (BDIFS) and clinician interview
- Have report of uncontrolled or labile hypertension, tachycardia, cardiovascular or cerebrovascular disease
- History of seizure disorder.
- Optic neuritis within 6 months of enrollment.
- Trigeminal neuralgia.
- Prior exposure to aminopyridines.
Additional Exclusion Criteria for optional speech module. Patients will not be eligible for enrollment in the optional speech module is they meet one or more of the exclusion criteria below:
- Have any language/dialect other than Standard American English as their first language.
- Make use of a mechanical hearing aid.
3b. Outcome Measures
Cognition Endpoints. Psychometric testing will incorporate gold standard tests from validated test batteries by Benedict et al and Rao et al [7-9, 47-49]. The test order is described below:
Table 2. Cognitive Battery Test Domain Time in min California Verbal Learning Test 2 (CVLT2) Learning Trials Auditory/Verbal Memory 15 Brief Visuospatial Memory Test Revised (BVMTR) Learning Trials Visual/Spatial Memory 05 Paced Auditory Serial Addition Test (PASAT) 3 sec Auditory Processing Speed 05 Symbol Digit Modalities Test (SDMT) Visual Processing speed 05 Delis Kaplan Executive Function System (DKEFS) Sorting Test Executive Function 12 California Verbal Learning Test 2 (CVLT2) Delayed Recall Auditory/Verbal Memory 05 Brief Visuospatial Memory Test Revised (BVMTR) Delayed Recall Visual/Spatial Memory 03 Total Time 50 min
Typ studie
Zápis (Aktuální)
Fáze
- Fáze 2
- Fáze 3
Kontakty a umístění
Studijní místa
-
-
New York
-
Buffalo, New York, Spojené státy, 14203
- Buffalo General Hospital
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
Patients will be eligible for the study if they fulfill all the inclusion criteria specified below:
- Males/Females who are ≥ 18 years old and < 65 years old and are capable of understanding and complying with the protocol, including speaking and writing fluent English and having at least a 9th grade education.
- Have a diagnosis of MS, as per revised McDonald's Criteria.
- Have not received steroids in last thirty (30) days or a relapse in the last ninety (90) days, and whose MS is considered stable.
- Impression of cognitive impairment as indicated by one of the following: (a) positive NP testing following diagnosis of MS as determined by board certified neuropsychologist or with z scores <-1.5 below expectation in at least one cognitive domain, or (b) informant MSNQ >28.
- An Expanded Disability Status Scale (EDSS) of ≤ 6.5.
- Have given written informed consent prior to any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to his/her future medical care.
- Are capable of performing the requirements of a NP test battery including at least 20/70 near visual acuity by near vision chart, with correction allowed.
- If female, must neither be pregnant nor breast-feeding and must either (a) be > 12 months post-menopausal or surgically sterilized, or (b) agree to use an acceptable method of birth control for the duration of the study. Abstinence will not be considered an acceptable method of birth control.
Exclusion Criteria:
- Have cognitive deficits caused by concomitant medication usage or other significant neurological/psychological disease e.g. Alzheimer's disease, Parkinson's disease, stroke, transient ischemic attack, Vascular Dementia, Huntington's disease, traumatic brain injury or chronic CNS infection
- Have evidence of other medical cause(s) of cognitive impairment
- Evidence of major mental illness predating the onset of MS
- Have evidence of major depression as determined by a positive BDIFS and clinician interview
- Have report of uncontrolled or labile hypertension, tachycardia, cardiovascular or cerebrovascular disease
- History of seizure disorder.
- Optic neuritis within 6 months of enrollment.
- Trigeminal neuralgia.
- Prior exposure to aminopyridines within the last six months.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Čtyřnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
---|---|
Komparátor placeba: řízení
placebo
|
10 mg bid
|
Aktivní komparátor: treatment
dalfampridine
|
10 mg bid
Ostatní jména:
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Symbol Digit Modalities Test
Časové okno: Week 0, Week 12
|
The Symbol Digit Modalities Test is a measure of cognitive processing speed.
The outcome is the total number of correct digit substitutions in 90 seconds, with a possible total range of 0-120.
Higher values reflect a better score/outcome than lower scores.
|
Week 0, Week 12
|
Spolupracovníci a vyšetřovatelé
Vyšetřovatelé
- Vrchní vyšetřovatel: Ralph Benedict, PhD, University at Buffalo
- Vrchní vyšetřovatel: Bianca Weinstock-Guttman, MD, University at Buffalo
Publikace a užitečné odkazy
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
- Patologické procesy
- Nemoci nervového systému
- Onemocnění imunitního systému
- Demyelinizační autoimunitní onemocnění, CNS
- Autoimunitní onemocnění nervového systému
- Demyelinizační onemocnění
- Autoimunitní onemocnění
- Roztroušená skleróza
- Skleróza
- Molekulární mechanismy farmakologického působení
- Membránové transportní modulátory
- Blokátory draslíkových kanálů
- 4-Aminopyridin
Další identifikační čísla studie
- NEU3270511E
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