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

18 september 2015 uppdaterad av: 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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Faktisk)

52

Fas

  • Fas 4

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 65 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Trippel

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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.
Biologisk: 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.
Andra namn:
  • BOTOX®
  • botulinumtoxin typ A
Placebo-jämförare: Placebo (Normal saline)
Placebo (Normal saline) injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
Läkemedel: Normal saline (placebo)
Placebo (Normal saline) injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change From Baseline in the Assessment of Chronic Migraine Impacts (ACM-I) Questionnaire Total Score
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change From Baseline in the Symptom Severity Score (SSS) Subdomain of the Assessment of Chronic Migraine Symptoms (ACM-S) Questionnaire
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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

Samarbetspartners och utredare

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Sponsor

Allergan

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 april 2013

Primärt slutförande (Faktisk)

1 september 2014

Avslutad studie (Faktisk)

1 september 2014

Studieregistreringsdatum

Först inskickad

12 april 2013

Först inskickad som uppfyllde QC-kriterierna

12 april 2013

Första postat (Uppskatta)

16 april 2013

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

21 oktober 2015

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

18 september 2015

Senast verifierad

1 september 2015

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • GMA-BTX-CM-12-545

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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