Clinical Trials Register

Summary
EudraCT Number:	2015-001883-21
Sponsor's Protocol Code Number:	I5Q-MC-CGAI
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2021-10-12
Trial results	View results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Italy - Italian Medicines Agency

A.2

EudraCT number

2015-001883-21

A.3

Full title of the trial

A Phase 3, Randomized, Double-Blind, Placebo-Controlled
Study of LY2951742 in Patients with Chronic Migraine - the REGAIN Study

Studio di Fase III, randomizzato, in doppio cieco, controllato verso placebo volto a valutare LY2951742 in pazienti affetti da emicrania cronica – Studio REGAIN

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

Evaluation of LY2951742 in the Prevention of Chronic Migraine

Valutazione di LY2951742 nella prevenzione dell'emicrania cronica

A.3.2

Name or abbreviated title of the trial where available

REGAIN

A.4.1

Sponsor's protocol code number

I5Q-MC-CGAI

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	ELI LILLY & COMPANY, LILLY CORPORATE CENTER
B.1.3.4	Country	United States
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Eli Lilly and Company
B.4.2	Country	United States
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Eli Lilly
B.5.2	Functional name of contact point	Clinical Trial Registry Office
B.5.3	Address:
B.5.3.1	Street Address	Lilly Corporate Center
B.5.3.2	Town/ city	Indianapolis
B.5.3.3	Post code	DC 1526
B.5.3.4	Country	United States
B.5.4	Telephone number	00390554257386
B.5.5	Fax number	00390554257348
B.5.6	E-mail	EU_Lilly_Clinical_Trials@lilly.com

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	galcanezumab
D.3.2	Product code	[ly2951742]
D.3.4	Pharmaceutical form	Solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Subcutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.2	Current sponsor code	LY2951742
D.3.9.4	EV Substance Code	SUB166280
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	120
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	Yes
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Solution for injection
D.8.4	Route of administration of the placebo	Subcutaneous use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Chronic Migraine Headache

Cefalea emicranica cronica

E.1.1.1

Medical condition in easily understood language

Migraine Headache

Cefalea emicranica

E.1.1.2

Therapeutic area

Diseases [C] - Nervous System Diseases [C10]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
E.1.2	Level	LLT
E.1.2	Classification code	10027602
E.1.2	Term	Migraine headache
E.1.2	System Organ Class	100000004852

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

To test the hypothesis that at least one dose of LY2951742 is superior to placebo in the prevention of
migraine headache in patients with chronic migraine.

Verificare l’ipotesi secondo cui almeno una dose di LY2951742 sia superiore al placebo nella prevenzione dell’emicrania nei pazienti con patologia cronica.

E.2.2

Secondary objectives of the trial

To compare LY2951742 with placebo with respect to 50% response rate

To compare LY2951742 with placebo with respect to 75% response rate

To compare LY2951742 with placebo with respect to 100% response rate

To compare LY2951742 with placebo with respect to change in functioning

To compare LY2951742 with placebo with respect to change in use of acute (abortive) migraine treatment

To compare LY2951742 with placebo with respect to change in global severity of the migraine condition

Confrontare LY2951742 con il placebo in termini di tasso di risposta al 50%

Confrontare LY2951742 con il placebo in termini di tasso di risposta al 75%

Confrontare LY2951742 con il placebo in termini di tasso di risposta al 100%

Confrontare LY2951742 con il placebo in termini di variazione della funzionalità

Confrontare LY2951742 con il placebo in termini di variazione del trattamento acuto dell’emicrania

Confrontare LY2951742 con il placebo in termini di variazione della gravità complessiva dell’emicrania

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Patients are 18 to 65 years of age (inclusive) at the time of screening.

Have a diagnosis of chronic migraine as defined by International
Headache Society (IHS) International Classification of Headache Disorders (ICHD)-3 beta.

Migraine onset prior to age 50.

Pazienti di età compresa tra i 18 e i 65 anni al momento dello screening.

Diagnosi di emicrania cronica come definito dai criteri della Classificazione internazionale delle cefalee, terza edizione, versione beta (CHD-3, International Classification of Headache Disorders, Third Edition, beta version).

Insorgenza dell’emicrania prima dei 50 anni di età.

E.4

Principal exclusion criteria

Are currently enrolled in or have participated within the last 30 days or within 5 half-lives (whichever is longer) in a clinical trial involving an
investigational product.

Current use or prior exposure to LY2951742 or another CGRP antibody

Are currently receiving medication or other treatments for the
prevention of migraine headaches.

Known hypersensitivity to multiple drugs, monoclonal antibodies or
other therapeutic proteins, or to LY2951742.

History of persistent daily headache, cluster headache or migraine subtypes including hemiplegic (sporadic or familial) migraine, ophthalmoplegic migraine, and migraine with brainstem aura (basilar-type migraine) defined by IHS ICHD-3 beta.

Pazienti attualmente arruolati o che abbiano partecipato nei 30 giorni precedenti o entro un periodo pari a 5 emivite (considerando il periodo più lungo) a uno studio clinico che abbia previsto l’impiego del prodotto sperimentale

Uso corrente o esposizione pregressa a LY2951742 o a un anticorpo per CGRP

Attuale assunzione di un farmaco o di un altro trattamento per la prevenzione dell’emicrania.

Ipersensibilità nota a più farmaci, anticorpi monoclonali o altre proteine proteine terapeutiche o a LY2951742

Anamnesi di cefalea giornaliera persistente, cefalea a grappolo o sottotipi di emicrania tra cui emicrania emiplegica (sporadica o familiare), emicrania oftalmoplegica ed emicrania con aura del tronco encefalico (emicrania di tipo basilare) definite dai criteri IHS ICHD-3 beta

E.5 End points

E.5.1

Primary end point(s)

Mean change in the number of migraine headache days during the 3 month double-blind treatment phase.

Variazione media del numero di giorni in cui i pazienti sperimentano emicrania durante la fase di trattamento in doppio cieco di tre mesi.

E.5.1.1

Timepoint(s) of evaluation of this end point

Baseline period to month 3 of the double-blinded treatment phase.

Periodo dal basale al mese 3 della fase di trattamento in doppio cieco.

E.5.2

Secondary end point(s)

The proportion of patients with reduction from baseline =50% in migraine headache days; The proportion of patients with reduction from baseline =75% in monthly migraine headache days
during the 3-month double-blind treatment phase; The proportion of patients with reduction from baseline of 100% in monthly migraine headache days during the 3-month double-blind treatment phase; Mean change from baseline in the total score of the Migraine-Specific Quality of Life Questionnaire version 2.1 (MSQ v2.1); Assessment of change from baseline in the number of migraine headache days requiring medication for the acute treatment of migraine or headache; Mean change from baseline in the Patient Global Impression of Severity (PGI-S) score at Month 3

Percentuale di pazienti con una riduzione rispetto al basale =50% del numero di giorni caratterizzati da emicrania; Percentuale di pazienti con una riduzione rispetto al basale =75% del numero di giorni al mese caratterizzati da emicrania durante la fase di trattamento in doppio cieco di tre mesi; Percentuale di pazienti con una riduzione rispetto al basale del 100% del numero di giorni al mese caratterizzati da emicrania durante la fase di trattamento in doppio cieco di tre mesi; Variazione media rispetto al basale del punteggio totale della versione 2.1 del questionario MSQ (Migraine-Specific Quality of Life); Valutazione della variazione rispetto al basale del numero di giorni caratterizzati da emicrania che hanno richiesto l’uso di farmaci per il trattamento acuto dell’emicrania o della cefalea; Variazione media rispetto al basale del punteggio sull’impressione globale di gravità del paziente (PGI-S) al Mese 3

E.5.2.1

Timepoint(s) of evaluation of this end point

Baseline to end of 3 month double-blinded treatment period; Baseline to end of 3 month double-blinded treatment period; Baseline to end of 3 month double-blinded treatment period; Baseline to end of 3 month double-blinded treatment period; Baseline to end of 3 month double-blinded treatment period; Baseline to end of 3 month double-blinded treatment period

Dal basale alla fine del mese 3 del periodo di trattamento in doppio cieco; Dal basale alla fine del mese 3 del periodo di trattamento in doppio cieco; Dal basale alla fine del mese 3 del periodo di trattamento in doppio cieco; Dal basale alla fine del mese 3 del periodo di trattamento in doppio cieco; Dal basale alla fine del mese 3 del periodo di trattamento in doppio cieco; Periodo dal basale al mese 3 della fase di trattamento in doppio cieco

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

Yes

E.6.3

Therapy

Yes

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

Yes

E.6.7

Pharmacodynamic

Yes

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

Yes

E.6.11

Pharmacogenomic

Yes

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

Yes

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

Yes

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

Yes

E.8.5.1

Number of sites anticipated in the EEA

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

Information not present in EudraCT

E.8.6.3

If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned

Brazil

Canada

Israel

Korea, Republic of

Mexico

Puerto Rico

Taiwan

United States

Germany

Italy

Netherlands

Spain

United Kingdom

Czechia

Argentina

E.8.7

Trial has a data monitoring committee

Yes

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

LVLS

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

816

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.4.2

For a multinational trial

F.4.2.1

In the EEA

250

F.4.2.2

In the whole clinical trial

825

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

None; Investigational product will not be made available to patients after conclusion of this study

Nessuno; il farmaco non sarà reso disponibile per i pazienti dopo la conclusione dello studio

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2015-12-29

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2015-11-30

P. End of Trial
P.	End of Trial Status	Completed

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