BACKGROUND: Trigeminal @entity9 is characterized by paroxysmal @entity158 attacks. Adequate prophylactic drug therapy is often limited by the lack of efficacy and intolerance due to central nervous system side effects. Subcutaneous injections of botulinum toxin type A are a promising treatment option for @entity1 with unsatisfactory response to drug therapy or neurosurgical intervention. Its effects are expected to last for at least 3 months, so it could be a potential long-term treatment. This is the study protocol of a prospective, placebo-controlled, double blind clinical trial investigating the add-on therapy of subcutaneous administration of botulinum toxin type A injections to standard treatment in therapy-refractory classical @entity4254 . METHODS AND DESIGN: BoTN is a prospective, double blind, placebo-controlled trial with a randomized withdrawal design in which a single blind phase is followed by a double blind phase (see also Methods and design). Eligible @entity1 with classical @entity4254 who are otherwise refractory to medical and neurosurgical treatment will receive subcutaneous injections of botulinum toxin type A into injection sites of the affected trigeminal branch. In the first phase all @entity1 will receive botulinum toxin type A in a single blinded intervention. Twelve weeks later therapy responders will be allocated to the verum or placebo (saline) arm in a double blind, randomized manner. These injections will be performed at the same sites as the first injections. This trial will be conducted in a tertiary outpatient clinic specialized in the treatment of @entity10 and @entity158 . There will be three investigators performing the injections who are experienced in the treatment of @entity10 and @entity158 and trained in botulinum toxin type A injections. DISCUSSION: BoTN is designed to assess the efficacy and safety of subcutaneous botulinum toxin type A injections in addition to standard prophylactic treatment in therapy-refractory @entity4254 . TRIAL REGISTRATION NUMBER: EU Clinical Trials Register: EudraCT-No: 2014-001959-24 https://www.clinicaltrialsregister.eu/ctr-search/rest/download/trial/2014-001959-24/DE Date of trial registration 26 August 2014.

Botulinum neurotoxin type A in the treatment of classical XXXX (BoTN): study protocol for a randomized controlled trial.

@entity1 :: ('9606', 'Species') :: ['patients'] @entity4254 :: ('MESH:D014277', 'Disease') :: ['trigeminal neuralgia'] @entity158 :: ('MESH:D010146', 'Disease') :: ['facial pain'] @entity10 :: ('MESH:D006261', 'Disease') :: ['headache'] @entity9 :: ('MESH:D009437', 'Disease') :: ['neuralgia']
@entity4254 :: (MESH:D014277,Disease) :: ['Trigeminal Neuralgia']
