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Botulinum Toxin A in Frequent and Chronic Tension-type Headache

NCT04857671 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2025-03-13

No results posted yet for this study

Summary

Chronic tension-type headache (CTTH) is an underestimated disabling condition that affects a large number of patients. The treatment options for both episodic tension-type headaches, but especially CTTH are few. Poor long-term effects of existing treatment for CTTH (Sarotex, SSRIs, physiotherapy) are reported. Patients with CTTH also have a high risk of developing drug overdose headache (MOH). Non-drug treatments with physiotherapy or alternative medicine also show poor long-term effects. Literature reviews show that there is surprisingly little research on CTTH. Some small clinical trials report a good effect of treatment with botulinum toxin A, but larger controlled trials are needed to confirm or deny this.

The investigators will study effect of treatment with botulinum toxin A in CTTH in BACT study, and will include participants with both frequent and chronic TTH with 10 or more headache days per month.

If BACT outcomes are positive, this will open a possibility for a new treatment for TTH patients.

Conditions

  • Tension-Type Headache

Interventions

DRUG

Botulinum Toxin Type A in saline water

100 Allergan units Botulinum toxin A in a total of 2 ml sodium chloride (NaCl) 0,9% Braun. 5 IU of Botox per injection point (0,1ml); in total 100 IU per 20 injections points.

DRUG

Isotone saline water

2ml Na Cl (sodium chloride) 0,9% Braun. 0,1ml per injection point in total 20 injections points

Sponsors & Collaborators

  • Norwegian University of Science and Technology

    collaborator OTHER

  • Sandvika Nevrosenter

    collaborator UNKNOWN

  • Helse Nord-Trøndelag HF

    lead OTHER

Principal Investigators

  • Norunn Hanssen Hestvik · Clinic for Medicine and rehabilitation, Nord Trøndelag Trust HNT

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-03
Primary Completion
2024-12-04
Completion
2024-12-04

Countries

  • Norway

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04857671 on ClinicalTrials.gov