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Neurologic Signatures of Chronic Pain
NCT02747940Phase 4
Key facts
- Status
- Completed
- Start
- Dec 2015
- Primary completion
- Dec 2019
- Countries
- 1
- Sponsor
- Taipei Veterans General Hospital
- Modality
- Small Molecules
- Conditions
- chronic migrainefibromyalgia (FM)
01
Overview
Phase 4, open-label trial of flunarizine and pregabalin in chronic migraine and fibromyalgia (FM) (3 arms), sponsored by Taipei Veterans General Hospital. Primary endpoints: Clinical improvement after treatment: headache/pain intensity at 4 months, Clinical improvement after treatment: headache/pain frequency at 4 months and 1 more. Started Dec 2015; status: completed.
02
Design
3 arms- Study design
- Non-randomizedOpen-label
Chronic Migraine
Patients treated with flunarizine.
Fibromyalgia
Patients treated with pregabalin.
Chronic Migraine + Fibromyalgia
Patients treated with flunarizine and pregabalin.
03
Who it enrols
Patients with chronic migraine (ICHD-III) or fibromyalgia (ACR 2010), and healthy controls. Excludes patients with major systemic illness, neurological disorders affecting sensation, substance abuse, heavy smoking, pregnancy, or MRI contraindications.
04
Endpoints
Primary
Clinical improvement after treatment: headache/pain intensity
Clinical improvement after treatment: headache/pain frequency
Clinical improvement after treatment: headache/pain duration
Secondary
EEG change after treatment
Sensory and pain threshold change after treatment
Autonomic function change after treatment
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