Safety and efficacy of botulinum toxin A in patients with posttraumatic headache: a double-blind, randomized, placebo-controlled, parallel-group trial and investigation of neuro-inflammatory biomarkers as predictors of efficacy.

Conditions

Persistent post-traumatic headache

Brief summary

The proportion of responders in BTX-A and placebo group during the evaluation period (weeks 5 to 8) compared with baseline (weeks -4 to -1). A subject who meets the following criterion will be classified as a responder: Has a reduction of ≥ 30% in number of days having moderate or severe headache

Detailed description

The degree of change in inflammatory biomarkers (See protocol Section 7.2.14 for the full list) in plasma and tears in responders versus non-responders in BTX-A and placebo group., The proportion of responders in BTX-A and placebo group during the evaluation period (weeks 9 to 12) compared with baseline (weeks -4 to -1). proportion of subjects reaching ≥50% reduction in number of days with moderate-to-severe headache during the evaluation period (weeks 5 to 8) compared with baseline (weeks -4 to -1)., The proportion of subjects reaching ≥50% reduction in number of days with moderate-to-severe headache during the evaluation period (weeks 5 to 8) compared with baseline (weeks -4 to -1)., The proportion of subjects reaching ≥75% reduction in number of days with moderate-to-severe headache during the evaluation period (weeks 5 to 8) compared with baseline (weeks -4 to -1)., Proportion of subjects with a PGI-C scale response of “much improved” or “very much improved” at week 8 in BTX-A group and placebo group., Change from baseline to week 5 in the HIT-6, RPQ, HADS & ISI score in BTX-A and placebo group., Proportion of dropouts caused by increased intake of PTH medication or use of prohibited rescue medication in BTX-A group compared to the placebo group., Proportion of subjects with side effects registered in weeks 2 to 5 during treatment with BTX-A compared with placebo.

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Interventions

DRUGNatriumklorid Fresenius Kabi 9 mg/ml

DRUGBOTULINUM TOXIN

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
The proportion of responders in BTX-A and placebo group during the evaluation period (weeks 5 to 8) compared with baseline (weeks -4 to -1). A subject who meets the following criterion will be classified as a responder: Has a reduction of ≥ 30% in number of days having moderate or severe headache	—

Secondary

Measure	Time frame
The degree of change in inflammatory biomarkers (See protocol Section 7.2.14 for the full list) in plasma and tears in responders versus non-responders in BTX-A and placebo group., The proportion of responders in BTX-A and placebo group during the evaluation period (weeks 9 to 12) compared with baseline (weeks -4 to -1). proportion of subjects reaching ≥50% reduction in number of days with moderate-to-severe headache during the evaluation period (weeks 5 to 8) compared with baseline (weeks -4 to -1)., The proportion of subjects reaching ≥50% reduction in number of days with moderate-to-severe headache during the evaluation period (weeks 5 to 8) compared with baseline (weeks -4 to -1)., The proportion of subjects reaching ≥75% reduction in number of days with moderate-to-severe headache during the evaluation period (weeks 5 to 8) compared with baseline (weeks -4 to -1)., Proportion of subjects with a PGI-C scale response of “much improved” or “very much improved” at week 8 in BTX-A grou	—

Measure

Time frame

The degree of change in inflammatory biomarkers (See protocol Section 7.2.14 for the full list) in plasma and tears in responders versus non-responders in BTX-A and placebo group., The proportion of responders in BTX-A and placebo group during the evaluation period (weeks 9 to 12) compared with baseline (weeks -4 to -1). proportion of subjects reaching ≥50% reduction in number of days with moderate-to-severe headache during the evaluation period (weeks 5 to 8) compared with baseline (weeks -4 to -1)., The proportion of subjects reaching ≥50% reduction in number of days with moderate-to-severe headache during the evaluation period (weeks 5 to 8) compared with baseline (weeks -4 to -1)., The proportion of subjects reaching ≥75% reduction in number of days with moderate-to-severe headache during the evaluation period (weeks 5 to 8) compared with baseline (weeks -4 to -1)., Proportion of subjects with a PGI-C scale response of “much improved” or “very much improved” at week 8 in BTX-A grou

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Countries

Denmark

Outcome results

None listed