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Tests treatment safety and results for Posttraumatic Headache
Official title Safety and Efficacy of Botulinum Toxin A in Patients With Posttraumatic Headache
ClinicalTrials.gov ID: NCT06839118
What this study is testing
What is Botox 200 UNT Injection?
Botox 200 UNT Injection is an investigational medicine, given as an once-weekly injection under the skin, being studied as a potential treatment for posttraumatic headache.
Also referred to as Botulinumtoxin-A.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study is an investigator-initiated randomized, placebo-controlled, double-blind, parallelgroup trial. Eighty subjects with PTH will be included and randomized 1:1 for treatment with BTX-A or placebo (isotonic saline).
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
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...
- Age between 18 and 80 years.
- people must have headache at least 15 days per month during the last 4 weeks to enter the baseline phase.
- During baseline phase people must experience moderate-to-severe headache at least 8 days and headache at least 15 days to enter the treatment phase...
- Fluency in Danish
You likely can't join if
- More than 2 TBI's.
- Severe cardiovascular and cerebrovascular disease such as ischemic heart disease, myocardial infarction or previous stroke or transient ischemic...
- Expected poor compliance, i.e., considered unlikely to be able to complete all protocol required study visits or procedures, and/or to comply with...
- 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.
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.
- people must have headache at least 15 days per month during the last 4 weeks to enter the baseline phase.
- During baseline phase people must experience moderate-to-severe headache at least 8 days and headache at least 15 days to enter the treatment phase (to be assigned by chance).
- Fluency in Danish
- More than 2 TBI's.
- 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...
- 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 Section 6.4 for a full list of these medications).
- Previous treatment with injections of BTX-A in the head or face.
- Female people 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...
- Age ≥ 55 years with cessation of menses for 12 or more months, OR
- Age \< 55 years but no spontaneous menses for at least 2 years, OR
- Age \ 40 IU/L) or postmenopausal estradiol levels (\< 5 ng/dL) or according to the definition of "postmenopausal range" for the laboratory involved OR underwent bilateral oophorectomy OR underwent hysterectomy OR...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Glostrup Municipality, Denmark
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 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Glostrup Municipality, Denmark. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.