Efficacy and Safety of Danzhen

Efficacy and Safety of Danzhen in the Preventive Treatment of Migraine:A Prospective "Real-World" Study.

The purpose is to evaluate the effectiveness and safety profile of Danzhen for the prophylaxis of migraine in a "real-world" setting.

Study Overview

• Status: Unknown
• Conditions: Migraine
• Intervention / Treatment: Drug: Topiramate; Drug: Danzhen

Detailed Description

In adults between 18- and 65-years in China,the prevalence of migraine is 9.3% in general. Migraine is a heterogeneous condition that may produce a range of symptom profiles and various degrees of disability.The disability resulting from migraine can be severe imposing a considerable health burden upon the sufferer and society. The purpose of this study, using topiramate as the control, is to evaluate the effectiveness and safety of Danzhen for the prophylaxis of migraine in a "real-world"setting.Patients are asked to maintain a detailed headache diary via headache diary APP throughout the treatment period.

• Study Type: Interventional
• Enrollment (Anticipated): 3300
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Yajie Wang, MM; Email: 944759069@qq.com

Study Locations

• China
  • Shanxi
    • Xi'an, Shanxi, China, 710032
      • Xijing Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients older than or equal to 18 years and less than 70 years.
• The diagnosis of migraine is made according to 2004 The International Classification of Headache Disorders: 2nd edition (ICHD-II) .
• Consent form signed by the participant or his/her authorized surrogate.

Exclusion Criteria:

• Patients had primary or secondary headache disorders other than migraine.
• Female subjects of childbearing age will be excluded if they were pregnant, lactating or planning apregnancy in the next year or if they were not using an adequate form of birth control.
• Patients will be excluded if they had significant medical or psychiatric disease,or taking another antidepressant for any reason and not able to discontinue.
• Patients used other preventive pharmacological agents during the 1 month prior to baseline period.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Active Comparator:Topiramate; The treatment with TPM is initiated at a 50 mg daily dose and sequentially increase every 7 days, as tolerated, in 25 mg increments up to a target dose of 150 mg total/day.	Drug: Topiramate; Other Names: TPM
Experimental: Experimental:Danzhen; The treatment with Danzhen is 3 tablets triple daily.	Drug: Danzhen

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
A 50% or greater reduction in headache days/month during the third treatment month of maintenance phase relative to baseline phase with one of the study drugs.	at baseline phase/the third treatment month of maintenance phase

Secondary Outcome Measures

Outcome Measure	Time Frame
The decrease of disability days of migraine/month	at baseline phase/the third treatment month of maintenance phase
The decrease of numbers of rescue medication doses used/month	at baseline phase/the third treatment month of maintenance phase
A 30% or greater reduction in headache time	at baseline phase/the third treatment month of maintenance phase
The percentage of discontinued the drug because of side effects	at the third treatment month of maintenance phase
Beck Depression Inventory (BDI) scores	at the third treatment month of maintenance phase
Compliance	at the third treatment month of maintenance phase

Collaborators and Investigators

• Sponsor: Xijing Hospital
• Collaborators: Ecion Pharmaceutical CO..LTD
• Investigators: Study Director: Gang Zhao, MD, Xijing Hospital

Study record dates

Study Major Dates

• Study Start: February 1, 2016
• Primary Completion (Anticipated): July 1, 2017

Study Registration Dates

• First Submitted: December 30, 2015
• First Submitted That Met QC Criteria: December 30, 2015
• First Posted (Estimate): January 1, 2016

Study Record Updates

• Last Update Posted (Estimate): January 1, 2016
• Last Update Submitted That Met QC Criteria: December 30, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Keywords: Migraine; Topiramate; preventive treatment; Danzhen; Headache diary APP
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Migraine Disorders; Hypoglycemic Agents; Physiological Effects of Drugs; Anticonvulsants; Topiramate
• Other Study ID Numbers: Xijing-APP-CER