- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00566449
A Safety and Effectiveness Study of JNJ-31001074 in Adults With Attention-Deficit/Hyperactivity Disorder.
24. april 2014 opdateret af: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
A Multi-Center, Double-Blind, Placebo-Controlled, Randomized, Parallel-Group Study to Investigate the Safety and Efficacy of JNJ-31001074 in Adults With Attention-Deficit/Hyperactivity Disorder
The purpose of this study is to evaluate the safety and effectiveness of JNJ-31001074 compared to placebo in adults with Attention Deficit Hyperactivity Disorder (ADHD).
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
This study is being done to assess safety and tolerability and to explore the effectiveness of a new, experimental drug in the treatment of attention deficit hyperactivity disorder in adults.
Approximately 144 adult patients with ADHD will be recruited for the study.
Patients who meet study criteria will need to stop taking any ADHD medications they are currently using.
They will be randomly assigned to one of 3 treatment arms; each patient has an equal chance of receiving 10 mg JNJ-31001017, 30 mg JNJ-31001074, or placebo.
Placebo has no active drug.
This is a blinded study, i.e. the patient, the study doctor and the study sponsor will not know what treatment the patient receives until all patients complete the study.
Patients will be dispensed a bottle containing study drug for the upcoming week at 4 of the study visits.
The study doctor and the sponsor will monitor the study for the occurrence of possible side effects.
In addition to a screening visit, patients will return weekly for 6 additional study visits including an end of study visit and a follow-up visit.
Patients will take study drug for a total of 4 weeks.
After completing the study, patients may resume other ADHD medications.
Medical and ADHD history, physical examination, blood pressure, heart rate, temperature, weight and ECGs will be checked periodically throughout the study.
Blood samples will be taken for standard safety laboratory tests as well as for the measurement of the drug blood level.
Questionnaires relating to ADHD and cognitive testing will be administered throughout the study.
Each day for four weeks, patients will take orally, at least one hour before eating in the morning, 1 tablet containing either 10 mg JNJ-31001074, 30 mg JNJ-31001074 or placebo.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
32
Fase
- Fase 2
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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California
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Irvine, California, Forenede Stater
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Lafayette, California, Forenede Stater
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San Francisco, California, Forenede Stater
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Florida
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Bradenton, Florida, Forenede Stater
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Fort Myers, Florida, Forenede Stater
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Orlando, Florida, Forenede Stater
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South Miami, Florida, Forenede Stater
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Idaho
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Eagle, Idaho, Forenede Stater
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Illinois
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Libertyville, Illinois, Forenede Stater
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Kansas
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Overland Park, Kansas, Forenede Stater
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Massachusetts
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Boston, Massachusetts, Forenede Stater
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Michigan
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Farmington, Michigan, Forenede Stater
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North Carolina
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Chapel Hll, North Carolina, Forenede Stater
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Raleigh, North Carolina, Forenede Stater
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Ohio
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Dayton, Ohio, Forenede Stater
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Oregon
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Portland, Oregon, Forenede Stater
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Pennsylvania
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Media, Pennsylvania, Forenede Stater
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Texas
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Austin, Texas, Forenede Stater
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Houston, Texas, Forenede Stater
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Virginia
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Herndon, Virginia, Forenede Stater
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Washington
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Seattle, Washington, Forenede Stater
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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
18 år til 64 år (Voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Han
Beskrivelse
Inclusion Criteria:
- Diagnosis of attention deficit hyperactivity disorder with symptoms from age 7
- In good general health
- Willing to not take any other ADHD medication or start any behaviorial modification programs during the study
- Willing to use approved birth control throughout the study and for 3 months afterwards
Exclusion Criteria:
- Any psychiatric condition including acute mood disorder, bipolar disorder, acute obsessive-compulsive disorder (OCD), anti-social personality disorder or borderline personality disorder
- Autism, asperger's syndrome, mental retardation
- Presence of motor tics, history of Tourette's syndrome or family history of Tourette's syndrome
- History of substance use/abuse disorder or eating disorder
- History of myocardial infarction, stroke, glaucoma, seizures, hypertension, heart rhythm abnormalities or color blindness
- Use of prescription medication or herbal supplements
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: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Tredobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: 001
JNJ-31001074 10 mg daily for 4 weeks
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10 mg daily for 4 weeks
30 mg daily for 4 weeks
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Placebo komparator: 003
Placebo one dose daily for 4 weeks
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one dose daily for 4 weeks
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Eksperimentel: 002
JNJ-31001074 30 mg daily for 4 weeks
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10 mg daily for 4 weeks
30 mg daily for 4 weeks
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
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The primary study objective is to evaluate the safety and effectiveness of JNJ- 31001074 in adult patients with ADHD.
Tidsramme: ADHD assessments, vital signs, laboratory tests and ECGs will be collected 7 times during the study; at screening, baseline and 5 weekly visit. Adverse events will be collected throughout the study.
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ADHD assessments, vital signs, laboratory tests and ECGs will be collected 7 times during the study; at screening, baseline and 5 weekly visit. Adverse events will be collected throughout the study.
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Sekundære resultatmål
Resultatmål |
Tidsramme |
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The secondary study objective is to assess drug levels in adults with ADHD after taking JNJ-31001074.
Tidsramme: Samples to measure drug levels in the blood will be collected three times at baseline and termination visits and once at visits done at Weeks 1, 2, and 3.
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Samples to measure drug levels in the blood will be collected three times at baseline and termination visits and once at visits done at Weeks 1, 2, and 3.
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
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. december 2007
Primær færdiggørelse (Faktiske)
1. juli 2008
Studieafslutning (Faktiske)
1. juli 2008
Datoer for studieregistrering
Først indsendt
29. november 2007
Først indsendt, der opfyldte QC-kriterier
29. november 2007
Først opslået (Skøn)
3. december 2007
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
13. maj 2014
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
24. april 2014
Sidst verificeret
1. april 2014
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- CR014608
- C-2007-008
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 Attention Deficit Hyperactivity Disorder
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Children's National Research InstituteRekrutteringADHD | Attention Deficit Hyperactivity Disorder | Attention-Deficit Hyperactivity Disorder | Attention Deficit Disorder | TILFØJE | ADHD Overvejende uopmærksom type | ADHD - kombineret type | ADHD, overvejende hyperaktiv - impulsiv | Attention-Deficit Disorder i ungdomsårene | Attention-Deficit Hyperactivity...Forenede Stater
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Ornit CohenUkendtAttention Deficit Hyperactivity Disorder | Attention Deficit Disorder med hyperaktivitet | Attention Deficit Disorder | Attention Deficit Disorders med hyperaktivitet | Attention Deficit Hyperactivity DisordersIsrael
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Purdue Pharma LPAfsluttetAttention Deficit/Hyperactivity DisorderForenede Stater
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The Hospital for Sick ChildrenEhave; Ontario Brain InstituteAfsluttetAttention-deficit Hyperactivity DisorderCanada
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National Taiwan University HospitalAfsluttetAttention-deficit/Hyperactivity Disorder
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National Taiwan University HospitalNational Science Council, TaiwanUkendtAttention Deficit/Hyperactivity DisorderTaiwan
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National Taiwan University HospitalAfsluttetAttention-deficit/Hyperactivity DisorderTaiwan
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University of California, Los AngelesNational Institute of Mental Health (NIMH)RekrutteringAttention-Deficit Hyperactivity DisorderForenede Stater
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Ironshore Pharmaceuticals and Development, IncAfsluttetAttention-Deficit Hyperactivity DisorderForenede Stater
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Florida International UniversityAfsluttetAttention-deficit/Hyperactivity DisorderForenede Stater
Kliniske forsøg med JNJ-31001074
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Johnson & Johnson Pharmaceutical Research & Development...AfsluttetAttention Deficit Hyperactivity Disorder | Attention Deficit Disorders med hyperaktivitet
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Johnson & Johnson Pharmaceutical Research & Development...AfsluttetAttention Deficit Hyperactivity Disorder | Attention Deficit Disorders med hyperaktivitet
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Johnson & Johnson Pharmaceutical Research & Development...Trukket tilbageSund og rask | Farmakokinetik | Lægemiddelinteraktioner
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Johnson & Johnson Pharmaceutical Research & Development...AfsluttetSund og rask | Farmakokinetik
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Johnson & Johnson Pharmaceutical Research & Development...AfsluttetAttention Deficit Hyperactivity DisorderForenede Stater
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AttenuonProstate Cancer Clinical Trials ConsortiumUkendt
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Shenzhen Kangzhe Pharmaceutical Co., Ltd.LanZhou University; Beijing Friendship Hospital; The Third Affiliated Hospital... og andre samarbejdspartnereRekruttering
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AttenuonUkendt
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Janssen Research & Development, LLCRekrutteringLymfom, Non-HodgkinDanmark, Israel, Spanien, Australien
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Janssen Research & Development, LLCAfsluttet