CTRI/2021/07/034818
Recruiting
Phase 3
A Randomized, Double-Blind, Placebo-Controlled Study ofGalcanezumab in Adolescent Patients 12 to 17 Years ofAge with Chronic Migraine – the REBUILD-2 Study
Eli Lilly and Company India Pvt Ltd0 sites0 target enrollmentTBD
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Health Condition 1: G437- Chronic migraine without aura
- Sponsor
- Eli Lilly and Company India Pvt Ltd
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
Exclusion Criteria
- •1\. 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, other than antibodies to calcitonin gene\-related peptide (CGRP) or its receptor, is allowed if that use was more than 12 months prior to baseline.
- •2\. Known hypersensitivity to multiple drugs, monoclonal antibodies or other therapeutic proteins, or to galcanezumab or its excipients.
- •3\. 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to galcanezumab, another CGRP antibody, or CGRP receptor antibody, including those who have previously completed or withdrawn from this study or any other study investigating a CGRP antibody.
- •4\. History of persistent daily headache, cluster headache or migraine subtypes including hemiplegic (sporadic or familial) migraine and migraine with brainstem aura (previously basilar\-type migraine) as defined by IHS ICHD\-3\.
- •5\. 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.
- •6\. Participants with a known history of intracranial tumors or developmental malformations including Chiari malformations.
Outcomes
Primary Outcomes
Not specified
Similar Trials
Active, not recruiting
Phase 1
An Efficacy and Safety Study of Alirocumab in Children and Adolescents with Heterozygous Familial HypercholesterolemiaHypercholesterolaemiaMedDRA version: 20.0Level: PTClassification code 10020603Term: HypercholesterolaemiaSystem Organ Class: 10027433 - Metabolism and nutrition disordersTherapeutic area: Diseases [C] - Cardiovascular Diseases [C14]EUCTR2017-001903-60-DKSanofi-aventis recherche & développement500
Active, not recruiting
Phase 1
An Efficacy and Safety Study of Alirocumab in Children and Adolescents with Heterozygous Familial HypercholesterolemiaHypercholesterolaemiaMedDRA version: 20.0Level: PTClassification code 10020603Term: HypercholesterolaemiaSystem Organ Class: 10027433 - Metabolism and nutrition disordersTherapeutic area: Diseases [C] - Cardiovascular Diseases [C14]EUCTR2017-001903-60-HUSanofi-aventis recherche & développement500
Active, not recruiting
Phase 1
Study to Evaluate the Safety and Efficacy of Crinecerfont in Pediatric Patients With Classic Congenital Adrenal HyperplasiaClassic Congenital Adrenal Hyperplasia (CAH)MedDRA version: 20.0Level: LLTClassification code 10010323Term: Congenital adrenal hyperplasiaSystem Organ Class: 100000004850Therapeutic area: Diseases [C] - Hormonal diseases [C19]EUCTR2020-004381-19-ESeurocrine Biosciences, Inc.81
Active, not recruiting
Phase 1
This is a Study to Evaluate the Safety and Efficacy of ABBV-154 in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response to Biologic and/or Targeted Synthetic Disease-Modifying Anti-Rheumatic Drugs (b/tsDMARDs)Moderate to Severe Rheumatoid ArthritisMedDRA version: 23.1Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersTherapeutic area: Diseases [C] - Immune System Diseases [C20]EUCTR2020-005303-39-GRAbbVie Deutschland GmbH & Co. KG425
Active, not recruiting
Not Applicable
A study to evaluate the effect and safety of a 4 week treatment plan of Alirocumab in patients with high cholesterolPrimary HypercholesterolemiaMedDRA version: 16.1Level: LLTClassification code 10020604Term: HypercholesterolemiaSystem Organ Class: 100000004861Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]EUCTR2013-002343-29-SKRegeneron Pharmaceuticals, Inc.803