To evaluate whether Desvenlafaxine can reduce the frequency and severity of TTH attacks in patients.
This randomized, double-blind, placebo-controlled trial aims to assess the efficacy of Desvenlafaxine (a serotonin-norepinephrine reuptake inhibitor) in reducing the frequency and severity of tension-type headache (TTH) attacks in adult patients with episodic TTH.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
432
Desvenlafaxine
Placebo
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
Days with tension-type headache (TTH) during the 12-week intervention period (reported in 4-week intervals: Weeks 0-4, 5-8, and 9-12)
Days with tension-type headache (TTH) during the 12-week intervention period (reported in 4-week intervals: Weeks 0-4, 5-8, and 9-12)
Time frame: During the 12-week intervention period (reported in 4-week intervals: Weeks 0-4, 5-8, and 9-12)
Total headache index AUC (area under the curve) during the 12-week intervention period (reported in 4-week intervals: Weeks 0-4, 5-8, and 9-12)
Total headache index AUC (area under the curve) during the 12-week intervention period (reported in 4-week intervals: Weeks 0-4, 5-8, and 9-12)
Time frame: during the 12-week intervention period (reported in 4-week intervals: Weeks 0-4, 5-8, and 9-12)
Headache severity (VAS 0-10) and duration (hours per day) during the 12-week intervention period (reported in 4-week intervals: Weeks 0-4, 5-8, and 9-12)
Headache severity (VAS 0-10) and duration (hours per day) during the 12-week intervention period (reported in 4-week intervals: Weeks 0-4, 5-8, and 9-12)
Time frame: during the 12-week intervention period (reported in 4-week intervals: Weeks 0-4, 5-8, and 9-12)
Acute analgesic consumption: number of days and dosage
Acute analgesic consumption: number of days and dosage
Time frame: during the 12-week intervention period (reported in 4-week intervals: Weeks 0-4, 5-8, and 9-12)
Treatment effectiveness criterion: reduction in headache days by ≥50% during the third 4-week intervention period compared to the screening period
Treatment effectiveness criterion: reduction in headache days by ≥50% during the third 4-week intervention period compared to the screening period
Time frame: during the third 4-week intervention period
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Safety assessment and tolerability evaluation
Safety and tolerability will be evaluated by: Continuous recording of treatment-emergent adverse events (TEAEs, graded by CTCAE v5.0) throughout the study.
Time frame: During the 12-week intervention period (reported in 4-week intervals: Weeks 0-4, 5-8, and 9-12)
Change in headache impact on daily life as assessed by the 6-item Headache Impact Test (HIT-6) total score
The HIT-6 questionnaire measures the adverse impact of headache on daily functioning in six domains (pain, social functioning, role functioning, vitality, cognitive functioning, psychological distress).
Time frame: During the 12-week intervention period (reported in 4-week intervals: Weeks 0-4, 5-8, and 9-12)