BridgeMD
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.
EU CTIS ID: 2024-515901-24-00
What this study is testing
To investigate if botulinum toxin type A (BTX-A) is safe and more effective than placebo to lower the number of moderate-to-severe headache days in the evaluation period (weeks 5 to 8) compared to baseline (weeks -4 to -1)
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- A diagnosis of persistent PTH according to criteria 5.2.2 Persistent headache attributed to mild traumatic injury to the head according to The International Classification of Headache Disorders 3rd edition.
- Age between 18 and 80 years.
- Subjects must have headache at least 15 days per month during the last 4 weeks to enter the baseline phase.
- During baseline phase subjects must experience moderate-to-severe headache at least 8 days and headache at least 15 days to enter the treatment phase (to be randomized).
- Fluency in Danish.
You likely can't join if
- More than two incidences of traumatic brain injuries.
- Previous treatment with injections of BTX-A in the head or face.
- Female subjects either pregnant, breastfeeding or with planned conception within the study period.
- Female subject of childbearing potential who is unwilling to use an acceptable method of effective contraception during the study. Acceptable methods of effective birth control include not having intercourse (true abstinence, when this is in line with the preferred and usual lifestyle of the subject), hormonal birth control methods (pills, shots/injections, implants, or patches), intrauterine devices, surgical contraceptive methods (vasectomy with medical assessment of the surgical success of this procedure or bilateral tubal ligation).
- Known allergy to any component of BTX-A.
- Infection at the proposed injection site.
See the full eligibility criteria
- A diagnosis of persistent PTH according to criteria 5.2.2 Persistent headache attributed to mild traumatic injury to the head according to The International Classification of Headache Disorders 3rd edition.
- Age between 18 and 80 years.
- Subjects must have headache at least 15 days per month during the last 4 weeks to enter the baseline phase.
- During baseline phase subjects must experience moderate-to-severe headache at least 8 days and headache at least 15 days to enter the treatment phase (to be randomized).
- Fluency in Danish.
- More than two incidences of traumatic brain injuries.
- Previous treatment with injections of BTX-A in the head or face.
- Female subjects either pregnant, breastfeeding or with planned conception within the study period.
- Female subject of childbearing potential who is unwilling to use an acceptable method of effective contraception during the study. Acceptable methods of effective birth control include not having intercourse (true abstinence, when this is in line with the preferred and usual lifestyle of the subject), hormonal birth control methods (pills, shots/injections, implants, or patches), intrauterine devices, surgical contraceptive methods (vasectomy with medical assessment of the surgical success of this procedure or bilateral tubal ligation).
- Known allergy to any component of BTX-A.
- Infection at the proposed injection site.
- Known severe neuromuscular disorders or any degree of disorder affecting the neuromuscular transmission.
- Known comprised respiratory function.
- Member of investigational site staff or relative of the investigator.
- Severe cardiovascular and cerebrovascular disease such as ischemic heart disease, myocardial infarction or previous stroke or transient ischemic attack, major CVD interventions during the last three months.
- Expected poor compliance, i.e., considered unlikely to be able to complete all protocol required study visits or procedures, and/or to comply with all required study procedures to the best of the subject’s and investigator’s knowledge.
- Ongoing and unstable severe psychiatric disease.
- Anamnestic or clinical symptoms of any kind that are deemed relevant for study participation by the physician who examines the patient.
- A history of migraine or tension-type headache more than 5 days per month before the TBI.
- Medication-overuse headache according to the according to The International Classification of Headache Disorders 3rd edition.
- A history of moderate-to-severe TBI, whiplash injury, or craniotomy.
- Change of preventive PTH treatment or treatment dose within two months prior to the baseline visit (see protocol Section 6.4 for a full list of these medications).
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.