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

Phase 3

Completed

• Conditions: Health Condition 1: null- Episodic Migraine

• Registration Number: CTRI/2018/02/012059
• Lead Sponsor: ovartis Healthcare Pvt Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 340

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
1. Achievement of at least a 50% reduction from baseline in monthly migraine days at Month 3. <br/ ><br>2. â?¢Change from Baseline in acute migraine-specific medication treatment days at Month 3. <br/ ><br>3. â?¢Change from Baseline in headache impact scores as measured by the HIT-6 at Month 3.Timepoint: 1. Time frame-3 months <br/ ><br>2. Time frame-3 months <br/ ><br>3. Time frame-3 months