Informations générales (source: ClinicalTrials.gov)
A Randomized, Double-Blind, Placebo-Controlled Study of Galcanezumab in Adolescent Patients 12 to 17 Years of Age With Chronic Migraine - the REBUILD-2 Study (REBUILD-2)
Interventional
Phase 3
Eli Lilly and Company (Voir sur ClinicalTrials)
novembre 2020
mars 2026
11 octobre 2024
The main purpose of this study is to evaluate the efficacy and safety of galcanezumab for
the preventive treatment of chronic migraine in participants 12 to 17 years of age. The
primary objective is to demonstrate the superiority of galcanezumab versus placebo in the
reduction of monthly migraine headache days across the 3-month double-blind treatment
period.
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| AP-HP - Hôpital Armand Trousseau-La Roche Guyon | Contact (sur clinicalTrials) | ||||
| CHI DE CRETEIL | Contact (sur clinicalTrials) | ||||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Assistance Publique Hôpitaux de Marseille - Hôpital de la Timone - 13385 - Marseille - Bouches-du-Rhône - France | Contact (sur clinicalTrials) | ||||
| Bordeaux University Hospital - Pellegrin - 33076 - Bordeaux - Gironde - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Régional Universitaire de Lille - Hôpital Roger Salengro - 59037 - Lille - Nord-Pas-de-Calais - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Universitaire de Clermont Ferrand - Hopital Estaing - 63100 - Clermont-Ferrand - Puy-de-Dôme - France | Contact (sur clinicalTrials) | ||||
| CHU d'Amiens-Picardie - Hôpital Sud - 80054 - Amiens - Somme - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
Inclusion Criteria:
- Have a diagnosis of chronic migraine as defined by the IHS ICHD-3 guidelines (1.3
according to ICHD-3 [2018]), that is, a headache occurring on 15 or more days per
month for at least the last 3 months, which has the features of migraine headache on
at least 8 days per month.
- Have a diagnosis of chronic migraine as defined by the IHS ICHD-3 guidelines (1.3
according to ICHD-3 [2018]), that is, a headache occurring on 15 or more days per
month for at least the last 3 months, which has the features of migraine headache on
at least 8 days per month.
- Participants who are taking, or are expected to take, therapeutic antibodies during
the course of the study (adalimumab, infliximab, trastuzumab, bevacizumab, etc.).
Prior use of therapeutic antibodies is allowed if that use was more than 12 months
prior to baseline, except for antibodies to CGRP or its receptor, which are not
allowed at any time prior to study entry.
- Known hypersensitivity monoclonal antibodies or other therapeutic proteins, or to
galcanezumab or its excipients.
- Current use or prior exposure to galcanezumab, another CGRP antibody, or CGRP
receptor antibody, including those who have previously completed or withdrawn from
this study or any other study investigating a CGRP antibody. Participant must also
not have prior oral CGRP antagonist use within 30 days prior to baseline.
- History of IHS ICHD-3 diagnosis of new daily persistent headache, cluster headache
or migraine subtypes including hemiplegic (sporadic or familial) migraine and
migraine with brainstem aura (previously basilar-type migraine).
- History of significant head or neck injury within 6 months prior to screening; or
traumatic head injury at any time that is associated with significant change in the
quality or frequency of their headaches, including new onset of migraine following
traumatic head injury.
- Participants with a known history of intracranial tumors or developmental
malformations including Chiari malformations.