NCT04857671

Botulinum Toxin A in Frequent and Chronic Tension-type Headache

BACT - Botulinum Toxin A in Frequent and Chronic Tension-type Headache With the FollowTheSutures Paradigm. A Double Blind, Randomized, Placebo-controlled Cross-over Trial

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 66 (actual)
• Sponsor: Helse Nord-Trøndelag HF · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

BACT studies the efficacy of treatment with botulinum toxin with a follwthestuture injection regime in frequent and chronic tension type headache (TTH). This is be a randomized, placebo-controlled, triple blind, cross-over trial. The primary efficacy variable is the difference in monthly headache days in the active period versus the placebo period. In this study, injections will follow a slightly modified FollowTheSutures injection protocol. Study duration is 36 weeks long. The target population is male and female patients 18 to 75 years of age with TTH, with 10 or more headache days per month.

Conditions

• Tension-Type Headache

Interventions

Type	Name	Description
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

Timeline

• Start date: 2022-10-03
• Primary completion: 2024-12-04
• Completion: 2024-12-04
• First posted: 2021-04-23
• Last updated: 2025-03-13

Locations

1 site across 1 country: Norway