- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02581865
Safety and Efficacy Study of NBI-98854 in Adults With Tourette Syndrome
27. april 2020 oppdatert av: Neurocrine Biosciences
A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of NBI-98854 in Adult Subjects With Tourette Syndrome
Phase 2, double-blind, placebo-controlled study to assess the safety and efficacy of NBI-98854 administered once daily (qd) for a total of 8 weeks of treatment.
This study will enroll approximately 90 male and female subjects clinically diagnosed with Tourette Syndrome.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
124
Fase
- Fase 2
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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California
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Long Beach, California, Forente stater
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National City, California, Forente stater
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San Bernardino, California, Forente stater
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San Diego, California, Forente stater
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Upland, California, Forente stater
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Florida
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Gainesville, Florida, Forente stater
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Hialeah, Florida, Forente stater
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Saint Petersburg, Florida, Forente stater
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Tampa, Florida, Forente stater
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Georgia
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Atlanta, Georgia, Forente stater
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Illinois
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Chicago, Illinois, Forente stater
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Massachusetts
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Boston, Massachusetts, Forente stater
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Natick, Massachusetts, Forente stater
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Missouri
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Saint Louis, Missouri, Forente stater
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New Hampshire
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Nashua, New Hampshire, Forente stater
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New Jersey
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Summit, New Jersey, Forente stater
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New York
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Albany, New York, Forente stater
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Manhasset, New York, Forente stater
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New York, New York, Forente stater
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Staten Island, New York, Forente stater
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Ohio
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Cincinnati, Ohio, Forente stater
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Oklahoma
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Oklahoma City, Oklahoma, Forente stater
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Pennsylvania
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Norristown, Pennsylvania, Forente stater
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Tennessee
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Nashville, Tennessee, Forente stater
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Texas
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Dallas, Texas, Forente stater
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Irving, Texas, Forente stater
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Utah
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Orem, Utah, Forente stater
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Salt Lake City, Utah, Forente stater
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Washington
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Kirkland, Washington, Forente stater
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Spokane, Washington, Forente stater
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 64 år (Voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Have a clinical diagnosis of Tourette Syndrome (TS)
- Have at least moderate tic severity
- Have TS symptoms that impair school, occupational, and/or social function
- If using maintenance medication(s) for TS or TS spectrum diagnoses (e.g. obsessive-compulsive disorder [OCD], Attention-Deficit Hyperactivity Disorder [ADHD]), be on stable doses
- Be in good general health
- Have a negative urine drug screen for amphetamines, barbiturates, benzodiazepine, phencyclidine, cocaine, or opiates, and a negative alcohol screen
- Subjects of childbearing potential who do not practice total abstinence must agree to use hormonal or two forms of nonhormonal contraception (dual contraception) consistently during the screening, treatment and follow-up periods of the study
Exclusion Criteria:
- Have an active, clinically significant unstable medical condition within 1 month prior to screening
- Have a known history of long QT syndrome or cardiac tachy-arrhythmia
- Have a known history of neuroleptic malignant syndrome
- Have a cancer diagnosis within 3 years prior to screening (some exceptions allowed)
- Have an allergy, hypersensitivity, or intolerance to VMAT2 inhibitors
- Have a known history of substance dependence, substance (drug) or alcohol abuse
- Have a significant risk of suicidal or violent behavior
- Are currently pregnant or breastfeeding
- Have initiated Comprehensive Behavioral Intervention for Tics (CBIT) during the screening period or at baseline or plan to initiate CBIT during the study
- Have received an investigational drug within 30 days before screening or plan to use an investigational drug (other than NBI-98854) during the study
- Have a blood loss ≥550 mL or donated blood within 30 days prior to screening
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Firemannsrom
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Placebo komparator: Placebo
Placebo administered once daily for 8 weeks
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Eksperimentell: Dose Group 1
Fixed dose administered once daily for 8 weeks
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Eksperimentell: Dose Group 2
Fixed dose administered once daily for 8 weeks
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Change From Baseline to Week 8 in the YGTSS TTS
Tidsramme: Baseline, Week 8
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The YGTSS is designed to rate the overall severity of motor and phonic tic symptoms across a range of dimensions: number, frequency, intensity, complexity, and interference.
The YGTSS was administered by the investigator (or qualified designee) using a computer-based structured clinical interview.
The TTS is the sum of the 5 motor tic items and the 5 phonic (vocal) tic items and ranges from 0 to 50, with higher scores representing greater severity
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Baseline, Week 8
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Clinical Global Impression of Change Tourette Syndrome (CGI-TS)-Improvement Score at Week 8
Tidsramme: Week 8
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The CGI-TS-Improvement scale is used to assess overall improvement since the initiation of study drug dosing on a 7-point scale.
Each of the CGI-TS-Improvement response categories was assigned a numerical score as follows: 1 = Very much improved; 2 = Much improved; 3 = Minimally improved; 4 = Not changed; 5 = Minimally worse; 6 = Much worse; 7 = Very much worse.
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Week 8
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Change From Baseline to Week 8 in the Clinical Global Impression of Tics (CGI-Tics)-Severity Score
Tidsramme: Baseline, Week 8
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The CGI-Tics-Severity scale is used to assess overall severity on a 7-point scale.
Each of the CGI-Tics-Severity response categories was assigned a numerical score as follows: 1 = Normal, not at all ill; 2 = Borderline ill; 3 = Mildly ill; 4 = Moderately ill; 5 = Markedly ill; 6 = Severely ill; 7 = Among the most extremely ill patient.
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Baseline, Week 8
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Change From Baseline to Last Visit in the Rush Video-based Tic Rating Scale (RTRS) Total Score
Tidsramme: Baseline, Week 8
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A modified RTRS was used in this study that includes short video recordings to measure 5 tic variables: number of body areas affected, frequency of motor and phonic tics, and severity of motor and phonic tics.
The RTRS total score is calculated as the sum of the 5 domain scores, and ranges from 0 to 20, with higher scores representing greater severity.
The final on-treatment visit was used in subjects who discontinued prior to Week 8.
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Baseline, Week 8
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Change From Baseline to Week 8 in the YGTSS Global Tic Severity Score
Tidsramme: Baseline, Week 8
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The YGTSS Global Tic Severity score is the sum of the YGTSS TTS and the YGTSS Impairment score and ranges from 0 to 100, with higher scores representing greater severity.
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Baseline, Week 8
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Change From Baseline to Week 8 in the Premonitory Urge for Tics Scale (PUTS) Total Score
Tidsramme: Baseline, Week 8
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The PUTS is an instrument for quantifying the premonitory urge phenomena associated with tics.
It consists of 9 items, each of which is scored on a 4-point scale (1=not at all true, 2=a little true, 3=pretty much true, 4=very much true).
The PUTS total score is calculated as the sum of the scores for the 9 items.
The maximum possible total score is 36.
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Baseline, Week 8
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
1. november 2015
Primær fullføring (Faktiske)
1. desember 2016
Studiet fullført (Faktiske)
1. desember 2016
Datoer for studieregistrering
Først innsendt
19. oktober 2015
Først innsendt som oppfylte QC-kriteriene
19. oktober 2015
Først lagt ut (Anslag)
21. oktober 2015
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
7. mai 2020
Siste oppdatering sendt inn som oppfylte QC-kriteriene
27. april 2020
Sist bekreftet
1. april 2020
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Psykiske lidelser
- Patologiske prosesser
- Hjernesykdommer
- Sykdommer i sentralnervesystemet
- Sykdommer i nervesystemet
- Sykdom
- Genetiske sykdommer, medfødte
- Basal ganglia sykdommer
- Bevegelsesforstyrrelser
- Nevrodegenerative sykdommer
- Heredodegenerative lidelser, nervesystemet
- Nevroutviklingsforstyrrelser
- Tic lidelser
- Syndrom
- Tourettes syndrom
Andre studie-ID-numre
- NBI-98854-1505
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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