NCT06861738

Brief Summary

Tension-type headache (TTH) affects about 1 person in 5 worldwide. It is divided into infrequent episodic TTH (fewer than one headache per month), frequent episodic TTH (two to 14 headaches per month), and chronic TTH (15 headache days a month or more). Paracetamol (acetaminophen) is one of a number of analgesics suggested for acute treatment of headaches in frequent episodic TTH.Objectives To assess the efficacy and safety of paracetamol for the acute treatment of frequent episodic TTH in adults.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P25-P50 for phase_3

Timeline
11mo left

Started Mar 2025

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress57%
Mar 2025Apr 2027

First Submitted

Initial submission to the registry

March 1, 2025

Completed
Same day until next milestone

Study Start

First participant enrolled

March 1, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 6, 2025

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2026

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2027

Expected
Last Updated

March 6, 2025

Status Verified

January 1, 2025

Enrollment Period

1 year

First QC Date

March 1, 2025

Last Update Submit

March 1, 2025

Conditions

Headache

Keywords

paracetamol

Outcome Measures

Primary Outcomes (1)

  • pain score VAS score

    VAS Score for pain

    24 hours

Study Arms (2)

Group A

ACTIVE COMPARATOR

patients will recive paracetamol

Drug: Paracetamol (acetaminophen)

groupB

PLACEBO COMPARATOR

patients will recive placebo

Drug: Paracetamol Placebo

Interventions

Paracetamol (acetaminophen)DRUG

oral paracetamol 500mg three times per day

Group A
Paracetamol PlaceboDRUG

placebo tab three time per day

groupB

Eligibility Criteria

Age18 Years - 65 Years
Sexall(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • both sex
  • years old to 65 years
  • free ct brain

You may not qualify if:

  • migrane
  • any brain pathology

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Headache

Interventions

Acetaminophen

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Central Study Contacts

alaa B Dardir, residant doctor

CONTACT

+201155836349ala223897@gmail.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
residant doctor at Assiut university hospital

Study Record Dates

First Submitted

March 1, 2025

First Posted

March 6, 2025

Study Start

March 1, 2025

Primary Completion

March 1, 2026

Study Completion (Estimated)

April 1, 2027

Last Updated

March 6, 2025

Record last verified: 2025-01