Deze pagina is automatisch vertaald en de nauwkeurigheid van de vertaling kan niet worden gegarandeerd. Raadpleeg de Engelse versie voor een brontekst.

Use of a Treatment Benefit Questionnaire in Patients With Chronic Migraine Treated With OnabotulinumtoxinA (BOTOX®)

18 september 2015 bijgewerkt door: Allergan
This study will evaluate the use of the Assessment of Chronic Migraine Impacts (ACM-I) Questionnaire in assessing the impact and benefit of treatment with onabotulinumtoxinA (BOTOX®) in adults with chronic migraine.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Werkelijk)

52

Fase

  • Fase 4

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 65 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

  • History of chronic migraine for at least 6 months prior to the screening visit
  • Fifteen or more headache days during the 4-week screening period (≥4 headache episodes lasting ≥4 hours and ≥50 % of headache days are migraine)

Exclusion Criteria:

  • Conditions causing chronic facial pain such as Temporomandibular Disorder (TMD) and fibromyalgia
  • Use of headache prophylaxis medication within 4 weeks of the screening visit
  • Diagnosis of Myasthenia gravis, Eaton-Lambert Syndrome, Amyotrophic Lateral Sclerosis
  • Previous use of any botulinum toxin of any serotype for any reason
  • Skin infections or acne that would interfere with the injection sites
  • Acupuncture, transcutaneous electrical nerve stimulation (TENS), cranial traction, dental splints for headache, nociceptive trigeminal inhibition, occipital nerve block treatments, or injection of anesthetics/steroids within 4 weeks of screening.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Verdrievoudigen

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: OnabotulinumtoxinA
OnabotulinumtoxinA (botulinum toxin Type A) 155 units (U) total dose per treatment injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
Biologisch: OnabotulinumtoxinA
OnabotulinumtoxinA (botulinum toxin Type A) 155 U total dose per treatment injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
Andere namen:
  • BOTOX®
  • botulinetoxine type A
Placebo-vergelijker: Placebo (Normal saline)
Placebo (Normal saline) injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
Geneesmiddel: Normal saline (placebo)
Placebo (Normal saline) injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change From Baseline in the Assessment of Chronic Migraine Impacts (ACM-I) Questionnaire Total Score
Tijdsspanne: Baseline, Week 24
The ACM-I is a 24 question scale used to measure the impact of chronic migraine on daily activities and patient-treatment benefit over the past 7 days. The total score ranged from 0 (lower impact chronic migraine) to 100 (highest impact chronic migraine). A negative number change from baseline indicates an improvement, and a positive number change from baseline indicates a worsening.
Baseline, Week 24

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change From Baseline in the Symptom Severity Score (SSS) Subdomain of the Assessment of Chronic Migraine Symptoms (ACM-S) Questionnaire
Tijdsspanne: Baseline, Week 24
The ACM-S is 12 question migraine symptom scale over the past 24 hours. The SSS subdomain score ranges from 0 (no symptoms) to 100 (more severe symptoms). A negative number change from baseline indicates an improvement, and a positive number change from baseline indicates a worsening in the ACM-S SSS.
Baseline, Week 24
Change From Baseline in the Symptom Experience Score (SES) Subdomain of the ACM-S Questionnaire
Tijdsspanne: Baseline, Week 24
The ACM-S is 12 question migraine symptom scale over the past 24 hours. The SES subdomain score ranges from 0 (no symptoms) to 12 (all symptoms experienced). A negative number change from baseline indicates an improvement, and a positive number change from baseline indicates a worsening in the ACM-S SES.
Baseline, Week 24
Change From Baseline in the Activities of Daily Living Impact (ADL-I) Domain of the ACM-I Questionnaire
Tijdsspanne: Baseline, Week 12, Week 22, Week 24
The ACM-I is a 24 question scale used to measure the impact of chronic migraine on daily activities and patient-treatment benefit over the past 7 days. The ADL-I is a subdomain on the ACM-I. The ADL-I score ranged from 0 (lowest impact) to 100 (highest impact). A negative number change from baseline indicates an improvement, and a positive number change from baseline indicates a worsening in the ADL-I.
Baseline, Week 12, Week 22, Week 24
Change From Baseline in the Emotions Impact (EMO-I) Domain of the ACM-I Questionnaire
Tijdsspanne: Baseline, Week 12, Week 22, Week 24
The ACM-I is a 24 question scale used to measure the impact of chronic migraine on daily activities and patient-treatment benefit over the past 7 days. The EMO-I is a subdomain on the ACM-I. The EMO-I score ranged from 0 (lowest impact) to 100 (highest impact). A negative number change from baseline indicates an improvement, and a positive number change from baseline indicates a worsening in the EMO-I.
Baseline, Week 12, Week 22, Week 24
Change From Baseline in the Work/School Impact (WS-I) Domain of the ACM-I Questionnaire
Tijdsspanne: Baseline, Week 12, Week 22, Week 24
The ACM-I is a 24 question scale used to measure the impact of chronic migraine on daily activities and patient-treatment benefit over the past 7 days. The WS-I is a subdomain on the ACM-I. The WS-I score ranged from 0 (lowest impact) to 100 (highest impact). A negative number change from baseline indicates an improvement, and a positive number change from baseline indicates a worsening in the WS-I.
Baseline, Week 12, Week 22, Week 24
Change From Baseline in the Social Impact (SOC-I) Domain of the ACM-I Questionnaire
Tijdsspanne: Baseline, Week 12, Week 22, Week 24
The ACM-I is a 24 question scale used to measure the impact of chronic migraine on daily activities and patient-treatment benefit over the past 7 days. The SOC-I is a subdomain on the ACM-I. The SOC-I score ranged from 0 (lowest impact) to 100 (highest impact). A negative number change from baseline indicates an improvement, and a positive number change from baseline indicates a worsening in the SOC-I.
Baseline, Week 12, Week 22, Week 24
Change From Baseline in the Leisure Activities Impact (LEA-I) Domain of the ACM-I Questionnaire
Tijdsspanne: Baseline, Week 12, Week 22, Week 24
The ACM-I is a 24 question scale used to measure the impact of chronic migraine on daily activities and patient-treatment benefit over the past 7 days. The LEA-I is a subdomain on the ACM-I. The LEA-I score ranged from 0 (lowest impact) to 100 (highest impact). A negative number change from baseline indicates an improvement, and a positive number change from baseline indicates a worsening in the LEA-I.
Baseline, Week 12, Week 22, Week 24
Change From Baseline in the Household Activities Impact (HOS-I) Domain of the ACM-I Questionnaire
Tijdsspanne: Baseline, Week 12, Week 22, Week 24
The ACM-I is a 24 question scale used to measure the impact of chronic migraine on daily activities and patient-treatment benefit over the past 7 days. The HOS-I is a subdomain on the ACM-I. The HOS-I score ranged from 0 (lowest impact) to 100 (highest impact). A negative number change from baseline indicates an improvement, and a positive number change from baseline indicates a worsening in the HOS-I.
Baseline, Week 12, Week 22, Week 24
Change From Baseline in the Energy Impact (ENE-I) Domain of the ACM-I Questionnaire
Tijdsspanne: Baseline, Week 12, Week 22, Week 24
The ACM-I is a 24 question scale used to measure the impact of chronic migraine on daily activities and patient-treatment benefit over the past 7 days. The ENE-I is a subdomain on the ACM-I. The ENE-I score ranged from 0 (lowest impact) to 100 (highest impact). A negative number change from baseline indicates an improvement, and a positive number change from baseline indicates a worsening in the ENE-I.
Baseline, Week 12, Week 22, Week 24
Change From Baseline in the Cognitive Impact (COG-I) Domain of the ACM-I Questionnaire
Tijdsspanne: Baseline, Week 12, Week 22, Week 24
The ACM-I is a 24 question scale used to measure the impact of chronic migraine on daily activities and patient-treatment benefit over the past 7 days. The COG-I is a subdomain on the ACM-I. The COG-I score ranged from 0 (lowest impact) to 100 (highest impact). A negative number change from baseline indicates an improvement, and a positive number change from baseline indicates a worsening in the COG-I.
Baseline, Week 12, Week 22, Week 24
Change From Baseline in the General Impact (GEN-I) Domain of the ACM-I Questionnaire
Tijdsspanne: Baseline, Week 12, Week 22, Week 24
The ACM-I is a 24 question scale used to measure the impact of chronic migraine on daily activities and patient-treatment benefit over the past 7 days. The GEN-I is a subdomain on the ACM-I. The GEN-I score ranged from 0 (lowest impact) to 100 (highest impact). A negative number change from baseline indicates an improvement, and a positive number change from baseline indicates a worsening in the GEN-I.
Baseline, Week 12, Week 22, Week 24
Change From Baseline in the Headache Impact Test-6 (HIT-6) Questionnaire Total Score
Tijdsspanne: Baseline, Week 24
The HIT-6 is a 6 question 5-point scale used to measure the impact of headaches on daily life. The total score ranged from 36 (no impact) to 78 (worst impact). A negative number change from baseline indicates an improvement, and a positive number change from baseline indicates a worsening.
Baseline, Week 24
Change From Baseline in the Role Function-Restrictive (RR) Domain of the Migraine Specific Questionnaire (MSQ)
Tijdsspanne: Baseline, Week 24
The MSQ is 14 question scale that measures health-related impairments attributed to migraines over the past 4 weeks. The RR domain score ranges from 0 (no symptoms) to 100 (symptoms experienced all the time). A negative number change from baseline indicates an improvement, and a positive number change from baseline indicates a worsening in the RR.
Baseline, Week 24
Change From Baseline in the Role Function-Preventive (RP) Domain of the MSQ
Tijdsspanne: Baseline, Week 24
The MSQ is 14 question scale that measures health-related impairments attributed to migraines over the past 4 weeks. The RP domain score ranges from 0 (no symptoms) to 100 (symptoms experienced all the time). A negative number change from baseline indicates an improvement, and a positive number change from baseline indicates a worsening in the RP.
Baseline, Week 24
Change From Baseline in the Emotional Function (EF) Domain of the MSQ
Tijdsspanne: Baseline, Week 24
The MSQ is 14 question scale that measures health-related impairments attributed to migraines over the past 4 weeks. The EF domain score ranges from 0 (no symptoms) to 100 (symptoms experienced all the time). A negative number change from baseline indicates an improvement, and a positive number change from baseline indicates a worsening in the EF.
Baseline, Week 24

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Allergan

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 april 2013

Primaire voltooiing (Werkelijk)

1 september 2014

Studie voltooiing (Werkelijk)

1 september 2014

Studieregistratiedata

Eerst ingediend

12 april 2013

Eerst ingediend dat voldeed aan de QC-criteria

12 april 2013

Eerst geplaatst (Schatting)

16 april 2013

Updates van studierecords

Laatste update geplaatst (Schatting)

21 oktober 2015

Laatste update ingediend die voldeed aan QC-criteria

18 september 2015

Laatst geverifieerd

1 september 2015

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • GMA-BTX-CM-12-545

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Klinische onderzoeken op OnabotulinumtoxinA

Zoek naar vergelijkbare onderzoeken

Sponsors en medewerkers

Medische omstandigheden

Geneesmiddelinterventies

CROs by country

CROs in Gabon

Voorwaarden

Zeldzame ziekten

Geneesmiddelinterventies

Voedingssupplementen

Sponsor / medewerkers

Locaties

3
Abonneren