Botulinum Toxin A in Frequent and Chronic Tension-type Headache

Phase 3

Completed

• Conditions: Tension-Type Headache
• Interventions: Drug: Botulinum Toxin Type A in saline water; Drug: Isotone saline water

• Registration Number: NCT04857671
• Lead Sponsor: Helse Nord-Trøndelag HF

Brief 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.

Study Timeline

• Study First Submitted: 2021-04-20
• Study First Submitted QC: 2021-04-22
• Study First Posted: 2021-04-23
• Study Start: 2022-10-03
• Primary Completion: 2024-12-04
• Study Completion: 2024-12-04
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-10
• Last Update Posted: 2025-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Botulinum toxin A injections	Botulinum Toxin Type A in saline water	Botulinum toxin A (Botox)
placebo injections	Botulinum Toxin Type A in saline water	Isotone saline water
Botulinum toxin A injections	Isotone saline water	Botulinum toxin A (Botox)
placebo injections	Isotone saline water	Isotone saline water

Primary Outcome Measures

Name	Time	Method
Difference in TTH-headache days in week 5-8 of the active period versus the placebo period.	36 weeks	Difference in TTH- headache days in week 5-8 of the active period versus the placebo period.

Secondary Outcome Measures

Name	Time	Method
30% responders (30% reduction in TTH-headache days from baseline) in week 1-4, 5-8 and 9-12	36 weeks	30% responders (30% reduction in TTH-headache days from baseline) in week 1-4, 5-8 and 9-12
Headache Impact Test (HIT-6)	36 weeks	HIT-6 at week 8 and 12 after injection
Average number of headache hours per day in week 1-4, 5-8 and 9-12.	36 weeks	Average number of headache hours per day in week 1-4, 5-8 and 9-12.
Acceptability	36 weeks	Acceptability
50% responders (50% reduction in TTH-headache days from baseline) in week 1-4, 5-8 and 9-12	36 weeks	50% responders (50% reduction in TTH-headache days from baseline) in week 1-4, 5-8 and 9-12
Quality of life score on EQ-5D-5L	36 weeks	EQ-5D-5L at week 8 and 12 after injection
Average maximum pain intensity in Numeric Rating Scale (NRS from 0 to10) in week 1-4, 5-8 and 9-12	36 weeks	NRS scale: 0 meaning no pain and 10 meaning the worst pain imaginable)
Average number of days with intake of painkillers per month in week 1-4, 5-8 and 9-12	36 weeks	Average number of days with intake of painkillers per month in week 1-4, 5-8 and 9-12
Difference in TTH-headache days in week 1-4 and 9-12, and in the entire treatment period	36 weeks	Difference in TTH-headache days in week 1-4 and 9-12, and in the entire treatment period
Patient Global Impression of Improvement (PGI-I)	36 weeks	scale 7-points - (very much better) to 7 (very much worse) 8 and 12 after injection
Difference in occurrence of adverse events and serious adverse events in the active period and the placebo period	36 weeks	Difference in occurrence of adverse events and serious adverse events in the active period and the placebo period

Trial Locations

Locations (1)

Namsos Sykehus; 🇳🇴 Namsos, Norway