- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT02006160
Effects of Dalfampridine on Cognition in Multiple Sclerosis
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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prior to any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to his/her future medical care.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
Studientyp
Einschreibung (Tatsächlich)
Phase
- Phase 2
- Phase 3
Kontakte und Standorte
Studienorte
-
-
New York
-
Buffalo, New York, Vereinigte Staaten, 14203
- Buffalo General Hospital
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Vervierfachen
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
---|---|
Placebo-Komparator: Kontrolle
Placebo
|
10 mg bid
|
Aktiver Komparator: treatment
dalfampridine
|
10 mg bid
Andere Namen:
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Symbol Digit Modalities Test
Zeitfenster: 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
|
Mitarbeiter und Ermittler
Ermittler
- Hauptermittler: Ralph Benedict, PhD, University at Buffalo
- Hauptermittler: Bianca Weinstock-Guttman, MD, University at Buffalo
Publikationen und hilfreiche Links
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
- Pathologische Prozesse
- Erkrankungen des Nervensystems
- Erkrankungen des Immunsystems
- Demyelinisierende Autoimmunerkrankungen, ZNS
- Autoimmunerkrankungen des Nervensystems
- Demyelinisierende Krankheiten
- Autoimmunerkrankungen
- Multiple Sklerose
- Sklerose
- Molekulare Mechanismen der pharmakologischen Wirkung
- Membrantransportmodulatoren
- Kaliumkanalblocker
- 4-Aminopyridin
Andere Studien-ID-Nummern
- NEU3270511E
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
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