Study of Efficacy and Safety of AMG 334 in Adult Episodic Migraine Patients

• Register: CTRI
• Last refreshed on: 24 November 2021
• Main ID: CTRI/2018/02/012059
• Date of registration: 21-02-2018
• Prospective Registration: Yes
• Primary sponsor: Novartis Healthcare Pvt Ltd
• Public title: Study of Efficacy and Safety of AMG 334 in Adult Episodic Migraine Patients
• Scientific title: A 12-week double-blind, randomized, multi-center study comparing the efficacy and safety of once monthly subcutaneous AMG 334 against placebo in adult episodic migraine patients (EMPOwER)
• Date of first enrolment: 24-04-2018
• Target sample size: 880
• Recruitment status: Completed
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=20815
• Study type: Interventional
• Study design: Other; Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Centralized Blinding and masking:Participant and Investigator Blinded
• Phase: Phase 3

Countries of recruitment

India, Taiwan

Contacts

• Name: Murugananthan K
• Affiliation: Novartis Healthcare Pvt. Ltd

• Name: Murugananthan K
• Affiliation: Novartis Healthcare Pvt. Ltd

Key inclusion & exclusion criteria

Inclusion criteria: 1.Adults >=18 to <=65 years of age upon entry into screening

2.Documented history of migraine (with or without aura) for >=12 months prior to screening according to the ICHD-3

3. 4-14 days per month of migraine symptoms (based on ICHD-3 criteria) on average across the 3 months prior to screening

4. <15 days per month of headache symptoms (ie migraine and non-migraine) on average across the 3 months prior to screening

5.During baseline: Confirmed migraine frequency of 4-14 migraine days

6. During baseline: >=80% compliance with the headache diary

7. Adults >=18 to <=65 years of age

8.Documented history of migraine (with or without aura) for >=12 months prior to screening according to the ICHD-3


Exclusion criteria: Key exclusion criteria:

1. >50 years old at migraine onset

2.Pregnant or nursing

3.History of cluster or hemiplegic headache

4.Evidence of seizure or major psychiatric disorder

5.Score of 19 or higher on the BDI

6.Active chronic pain syndrome

7.Cardiac or hepatic disease



Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Health Condition 1: null- Episodic Migraine

Intervention(s)

Intervention1: AMG 334 70 mg/1 mL: AMG 334 70 mg/1 mL pre-filled syringe
Control Intervention1: Matching placebo: Matching placebo in 1 mL pre-filled syringe, identical in appearance

Primary Outcome(s)

Change from baseline in monthly migraine days at the last month (Month 3) of the double-blind treatment period (DBTP)Timepoint: 3 months.

Secondary Outcome(s)

1. Achievement of at least a 50% reduction from baseline in monthly migraine days at Month 3.

2. â?¢Change from Baseline in acute migraine-specific medication treatment days at Month 3.

3. â?¢Change from Baseline in headache impact scores as measured by the HIT-6 at Month 3.Timepoint: 1. Time frame-3 months

2. Time frame-3 months

3. Time frame-3 months

Secondary ID(s)

CAMG334A2302 Protocol Version 00(Original)

Source(s) of Monetary Support

Novartis Pharma AG, Novartis Campus 4056 â?? Basel, Switzerland

Ethics review

Status: Approved
Approval date: 14/12/2017
Contact:

Institutional Ethics Committee - Clinical Studies (IEC-CS)-Dr. Mukesh Sharma

Status: Approved
Approval date: 21/12/2017
Contact:

Institutional Ethics Committee-Dr. Jitenndra Singh

Status: Approved
Approval date: 06/01/2018
Contact:

Vijan Hospital Ethics Committee-Dr Rahul Baviskar

Status: Approved
Approval date: 12/01/2018
Contact:

Ethics Committee of Sri Aurobindo SevaKendra-Dr. Pahari Ghosh

Status: Approved
Approval date: 19/01/2018
Contact:

Sahyadri Hospital Ltd. Ethics Committee- Dr. Suyog Doshi

Status: Approved
Approval date: 24/01/2018
Contact:

Instititional Ethics Committee-Dr Praveen

Status: Approved
Approval date: 02/02/2018
Contact:

Ethics Committee Paras HMRI Hospital-Dr. Sanjeev Kumar

Status: Approved
Approval date: 03/03/2018
Contact:

Ethics KHM and GCH

Status: Approved
Approval date: 06/03/2018
Contact:

Sir Ganga Ram Hospital Ethics Committee-Dr Ish Anand

Status: Approved
Approval date: 16/03/2018
Contact:

Drug Trial Ethics Committee-Dr. Gagandeep Singh

Status: Approved
Approval date: 27/03/2018
Contact:

Institutional Ethics Committee-Dr Pradeep

Status: Approved
Approval date: 11/04/2018
Contact:

Institutional Ethics Committee-Dr Boby Varkey

Status: Approved
Approval date: 25/04/2018
Contact:

Institutional Ethics committee-Dr Suresh Kumar

Status: Approved
Approval date: 02/05/2018
Contact:

BhaktiVedanta Hospital Ehics Committee-Dr. Manoj Hunnur 

Status: Approved
Approval date: 05/05/2018
Contact:

Getwell Institutional Ethics Committee-Dr Shembalkar

Status: Approved
Approval date: 14/05/2018
Contact:

Institutional Ethics Committee-Dr Madhusudan

Status: Approved
Approval date: 22/05/2018
Contact:

MS RAMAIAH MEDICAL COLLEGE AND HOSPITALS ETHICS COMMITTEE-Dr Srinivasa Rangasetty

Status: Approved
Approval date: 30/05/2018
Contact:

Institutional Ethics Committee-Dr Rahul Kulkarni

Status: Approved
Approval date: 02/06/2018
Contact:

Institutional Ethics Committee-Dr Saroja

Status: Approved
Approval date: 08/06/2018
Contact:

Lalitha Superspeciality Hospitals Ethics Committee-Dr Vijaya

Status: Approved
Approval date: 12/06/2018
Contact:

Institutional Ethics Committee-Dr Priyanka K

Status: Approved
Approval date: 11/10/2018
Contact:

Institutional Ethics Committee-Dr. Rahul Chakor

Status: Approved
Approval date: 19/10/2018
Contact:

Magna Care Ethics committee-Dr Yeole

Status: Approved
Approval date: 01/11/2018
Contact:

Institute of Neurosciences Kolkata-Dr. Hrishikesh Kumar

Status: Approved
Approval date: 28/12/2018
Contact:

Institutional Ethics Committee-Dr. Charulata Savant Sankhala

Status: Approved
Approval date: 09/04/2019
Contact:

Manavata Clinical Research lnstitute Ethics committee-Dr Gulhane

Status: Not Approved
Approval date:
Contact:

Ethics Committee, AIIMS Hospital-Dr Padma

Status: Not Approved
Approval date:
Contact:

Human Ethics Committee-Dr Thomas Iype

Status: Not Approved
Approval date:
Contact:

Institutional Ethics Committee- Dr. Sangeeta Ravat

Status: Not Approved
Approval date:
Contact:

Institutional Ethics Committee-Dr. Jayantee Kalita

Status: Not Approved
Approval date:
Contact:

Institutional Ethics Committee-Dr. Jaydip Chaudhuri