Efficacy and Safety of Danzhen

NCT02645370 | Unknown Phase 1 DMC

• 1 other identifier: Xijing-APP-CER
• Study Type: interventional
• Target: 3,300
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Migraine

Keywords

Migraine; Danzhen; Topiramate; Headache diary APP; preventive treatment

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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

Study Arms (2)

Active Comparator:Topiramate

ACTIVE COMPARATOR

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

Experimental:Danzhen

EXPERIMENTAL

The treatment with Danzhen is 3 tablets triple daily.

Drug: Danzhen

Interventions

Danzhen DRUG

Experimental:Danzhen

Topiramate DRUG

Also known as: TPM

Active Comparator:Topiramate

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xijing Hospital: lead
• Ecion Pharmaceutical CO..LTD: collaborator

Study Sites (1)

Xijing Hospital

Xi’an, Shanxi, 710032, China

Location

MeSH Terms

Conditions

Migraine Disorders

Interventions

Topiramate

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Fructose; Hexoses; Monosaccharides; Sugars; Carbohydrates; Ketoses

Study Officials

• Gang Zhao, MD

  Xijing Hospital

  STUDY DIRECTOR

Central Study Contacts

Yajie Wang, MM

CONTACT

944759069@qq.com

Gang Zhao, MD

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 30, 2015
• First Posted: January 1, 2016
• Study Start: February 1, 2016
• Primary Completion: July 1, 2017
• Last Updated: January 1, 2016

Record last verified: 2015-12

Locations

CN (1)