A Phase 1 interventional study of Danzhen and Topiramate in Migraine, sponsored by Xijing Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2016-01-01.
Sponsored by Xijing Hospital · Phase 1, Interventional, and Prevention
The purpose is to evaluate the effectiveness and safety profile of Danzhen for the prophylaxis of migraine in a "real-world" setting.
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.
1,558 studies on the registry are indexed under Migraine Disorders; 301 are open to participants now.
This study's planned enrollment of 3,300 is above the median of 80 across 1,197 interventional studies indexed under Migraine Disorders.
Browse Migraine Disorders studies →Xijing Hospital is the lead sponsor of 474 studies on the registry; 159 are open to participants now.
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Exclusion Criteria:
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
The treatment with Danzhen is 3 tablets triple daily.
Drug: Danzhen
Also known as: TPM
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.
Time frame: at baseline phase/the third treatment month of maintenance phase
The decrease of disability days of migraine/month
Time frame: at baseline phase/the third treatment month of maintenance phase
The decrease of numbers of rescue medication doses used/month
Time frame: at baseline phase/the third treatment month of maintenance phase
A 30% or greater reduction in headache time
Time frame: at baseline phase/the third treatment month of maintenance phase
The percentage of discontinued the drug because of side effects
Time frame: at the third treatment month of maintenance phase
Beck Depression Inventory (BDI) scores
Time frame: at the third treatment month of maintenance phase
Compliance
Time frame: at the third treatment month of maintenance phase
This study is status unknown, as verified in Dec 2015. You cannot join it, but the record below documents what was studied.
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