Tension Type Headache
Conditions
Brief summary
To evaluate whether Desvenlafaxine can reduce the frequency and severity of TTH attacks in patients.
Detailed description
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.
Interventions
DRUGDesvenlafaxine
Desvenlafaxine
DRUGPlacebo
Placebo
Sponsors
Tongji Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Male or female subjects aged 18-65 years 2. Meeting the diagnostic criteria for tension-type headache (TTH) according to ICHD-3; with ≥6 but \<15 attack days per month in the past 3 months and MIDAS score \>21; onset of TTH before age 50, with a history exceeding 1 year 3. Informed consent obtained from the patient
Exclusion criteria
1. History of allergy to Desvenlafaxine, or use of Desvenlafaxine within 4 weeks prior to the start of the treatment period; currently taking or requiring concomitant administration of drugs contraindicated in the package insert, such as monoamine oxidase inhibitors (MAOIs); 2. Diagnosable with chronic tension-type headache or medication overuse headache; 3. Comorbid with other types of headaches, such as trigeminal autonomic cephalalgias, migraine attacks \>1 time/month within 3 months, or secondary headaches (e.g., those caused by intracranial infections, craniocerebral trauma, cerebrovascular diseases); 4. Severe psychiatric disorders such as schizophrenia, moderate to severe anxiety-depression (Hamilton scale ≥12 points); poorly controlled epilepsy, cognitive impairments, and other chronic pain conditions; serious organic diseases that pose significant health risks, including uncontrolled hypertension, cardiac disease, hepatic dysfunction, renal insufficiency, infections; any medical condition or prior surgery likely to affect the absorption, metabolism, or excretion of the study drug; 5. Concomitant use of venlafaxine analogues such as serotonin-norepinephrine reuptake inhibitors (SNRIs); unstable use of other preventive medications for TTH, including amitriptyline, mirtazapine (≤3 months); discontinuation of currently reported effective prophylactic drugs or overused analgesics for ≥3 months may allow re-enrollment; 6. Alcohol dependence or substance abuse; 7. Inability to comprehend the study protocol due to low education level, impaired verbal/language function, visual or auditory deficits; failure to accurately complete research materials like headache diaries or cooperate with scale assessments; 8. Women who are planning pregnancy, pregnant, breastfeeding, or not using contraception; 9. Participation in other interventional clinical studies that may influence outcome evaluations.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) | 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) |
| 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) | 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) |
| Acute analgesic consumption: number of days and dosage | 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 |
| Treatment effectiveness criterion: reduction in headache days by ≥50% during the third 4-week intervention period compared to the screening period | during the third 4-week intervention period | Treatment effectiveness criterion: reduction in headache days by ≥50% during the third 4-week intervention period compared to the screening period |
| Safety assessment and tolerability evaluation | During the 12-week intervention period (reported in 4-week intervals: Weeks 0-4, 5-8, and 9-12) | Safety and tolerability will be evaluated by: Continuous recording of treatment-emergent adverse events (TEAEs, graded by CTCAE v5.0) throughout the study. |
| Change in headache impact on daily life as assessed by the 6-item Headache Impact Test (HIT-6) total score | During the 12-week intervention period (reported in 4-week intervals: Weeks 0-4, 5-8, and 9-12) | 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). |
Countries
China
Contacts
PRINCIPAL_INVESTIGATORWensheng Qu
Tongji Hospital
Outcome results
None listed