Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Study to Assess Satisfaction With Modafinil Treatment in Children and Adolescents With ADHD

8. maj 2014 opdateret af: Cephalon

An 8 Week, Open-Label Study to Characterize the Response to Modafinil (85 mg Film Coated Tablet) Treatment at Dosages Up to 425 mg/Day in Children and Adolescents With Attention Deficit/Hyperactivity Disorder (ADHD) (With an Open Ended Extension Period)

An 8-week, Open-Label Study to Characterize the Response to Modafinil (85mg Film-Coated Tablet) Treatment at Dosages up to 425mg/Day in Children and Adolescents with Attention-Deficit/Hyperactivity Disorder (ADHD) (With an Open-Ended Extension Period)

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Arizona
      • Scottsdale, Arizona, Forenede Stater, 85254
        • Melmed Center
    • California
      • Irvine, California, Forenede Stater, 92612
        • UCI Child Development Center
      • Northridge, California, Forenede Stater, 91324
        • Pharmacology Research Institut
      • San Diego, California, Forenede Stater, 92121
        • Pacific Sleep Medicine Service
    • Florida
      • Gainesville, Florida, Forenede Stater, 32607
        • Sarkis Clinical Trials
      • Jacksonville, Florida, Forenede Stater, 32216
        • Clinical Neuroscience Solution
      • Orlando, Florida, Forenede Stater, 32806
        • Clinical Neurosciences
      • West Palm Beach, Florida, Forenede Stater, 33407
        • Laszlo J. Mate, MD, PA
    • Georgia
      • Marietta, Georgia, Forenede Stater, 30060
        • Northwest Behavioral Research
      • Woodstock, Georgia, Forenede Stater, 30189
        • Pediatrics and Adolescent
    • Illinois
      • Maywood, Illinois, Forenede Stater, 60153
        • Loyola University Medical Center Department of Psychiatry
      • Northbrook, Illinois, Forenede Stater, 60062
        • HALP Clinic and ADHD Research
    • Kansas
      • Wichita, Kansas, Forenede Stater, 67207
        • Cientifica, Inc.
    • Kentucky
      • Lexington, Kentucky, Forenede Stater, 40509
        • Michael J. Rieser, MD
      • Owensboro, Kentucky, Forenede Stater, 42301
        • Pedia Research, LLC
    • Louisiana
      • New Orleans, Louisiana, Forenede Stater, 70114
        • Louisiana Research Associates
      • Shreveport, Louisiana, Forenede Stater, 71103
        • Psycopharmacology Research - LSU Health Science Center
    • Massachusetts
      • Cambridge, Massachusetts, Forenede Stater, 02138
        • Massachusetts General Hospital
    • Michigan
      • Dearborn, Michigan, Forenede Stater, 48126
        • Odyssey Research
      • Flint, Michigan, Forenede Stater, 48503
        • Hurley Medical Center
      • Kalamazoo, Michigan, Forenede Stater, 49008
        • ProMed HealthCare
    • Minnesota
      • St. Paul, Minnesota, Forenede Stater, 55101
        • Regions Hospital
    • Nebraska
      • McCook, Nebraska, Forenede Stater, 69001
        • Odyssey Research
      • Omaha, Nebraska, Forenede Stater, 68198-7630
        • University of Nebraska
    • New Jersey
      • Cherry Hill, New Jersey, Forenede Stater, 08034
        • Bancroft Clinical Research
      • Flemington, New Jersey, Forenede Stater, 08822
        • Hunterdon Pediatric Associates
    • North Dakota
      • Bismarck, North Dakota, Forenede Stater, 58501
        • Odyssey Research
      • Fargo, North Dakota, Forenede Stater, 58104
        • Prairie at Saint John's
      • Minot, North Dakota, Forenede Stater, 58701
        • Odyssey Research
    • Ohio
      • Cincinnati, Ohio, Forenede Stater, 45229
        • Cincinnati Children's Hospital
    • Oregon
      • Salem, Oregon, Forenede Stater, 97301
        • OCCI, Inc Salem
    • South Carolina
      • Charleston, South Carolina, Forenede Stater, 29425
        • Medical University of SC
    • Tennessee
      • Memphis, Tennessee, Forenede Stater, 38105
        • UT Medical Group
      • Memphis, Tennessee, Forenede Stater, 38119
        • Clinical Neuroscience Solution
    • Texas
      • Bellaire, Texas, Forenede Stater, 77401
        • Claghorn-Lesem Research
    • Vermont
      • Burlington, Vermont, Forenede Stater, 05401
        • The Clinical Study Ceneter
    • Virginia
      • Midlothian, Virginia, Forenede Stater, 23112
        • Dominion Clinical Research
      • Vienna, Virginia, Forenede Stater, 22180
        • Advanced Pediatrics
    • Washington
      • Kirkland, Washington, Forenede Stater, 98033
        • Eastside Therapeutic Resource

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

6 år til 17 år (Barn)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

Patients are included in the study if all of the following criteria are met:

  • Written informed consent/assent is obtained.
  • The patient is a boy or girl 6 through 17 years of age (inclusive) at the screening visit, and both the patient and parent/legal guardian are English-speaking.
  • The patient has a previous diagnosis of ADHD and is currently receiving medication for the treatment of ADHD.
  • The patient, or the patient's parent/legal guardian, is dissatified (VAS score <50) with current ADHD medication (medication and reason for dissatisfaction documented).
  • The patient is in good health as determined by a medical or psychiatric history, screening physical examination, and clinical laboratory evaluations.
  • Girls who are postmenarche or sexually active, must have a negative urine pregnancy test prior to the baseline visit, must be using a medically acceptable method of birth control, and must agree to continue use of this method for the duration of the study (and for 30 days after participation in the study). Acceptable methods of birth control include the following: barrier method with spermicide; steroidal contraceptive (eg, oral, transdermal, implant, or injected) in conjunction with a barrier method; intrauterine device (IUD); and abstinence.
  • The patient's parent/legal guardian must be willing and able to comply with study procedures and restrictions.

Exclusion Criteria:

Patients are excluded from participating in this study if 1 or more of the following criteria are met:

  • The patient has any current psychiatric comorbidity, including but not limited to depression or other mood disorder, or pervasive mental disorder, that requires pharmacotherapy.
  • The patient is satisfied with current ADHD medication and has no side effects.
  • The patient is using other prescription medications for ADHD with psychoactive properties (eg, amphetamine, dextroamphetamine, methylphenidate, pemoline, atomoxetine) after the baseline visit.
  • The patient has used monoamine oxidase (MAO) inhibitors within 1 week before the baseline visit.
  • The patient has used an investigational drug within 1 month before the screening visit.
  • The patient has a known clinically significant drug sensitivity to modafinil or any of its inactive ingredients.
  • The patient is pregnant or lactating. (Any patients becoming pregnant during the study will be withdrawn from study).

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Ikke-randomiseret
  • Interventionel model: Faktoriel opgave
  • Maskning: Ingen (Åben etiket)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Cephalon

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. september 2005

Studieafslutning (Faktiske)

1. september 2006

Datoer for studieregistrering

Først indsendt

27. september 2005

Først indsendt, der opfyldte QC-kriterier

27. september 2005

Først opslået (Skøn)

29. september 2005

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

9. maj 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

8. maj 2014

Sidst verificeret

1. maj 2014

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • C1538/3044/AD/US

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med ADHD

Kliniske forsøg med Modafinil

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Armenia

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

3
Abonner