BASIC Study

• Research type

  Research Study

• Full title

  BASIC - Botulinum toxin type A blockade of the sphenopalatine ganglion in treatment-refractory chronic cluster headache

• IRAS ID

  254230

• Contact name

  Manjit Matharu

• Contact email

  manjit.matharu@nhs.net

• Sponsor organisation

  Norwegian University of Science and Technology

• Eudract number

  2018-003148-21

• Clinicaltrials.gov Identifier

  NCT03944876

• Clinicaltrials.gov Identifier

  SMR-3545, CRO

• Duration of Study in the UK

  2 years, 0 months, 27 days

• Research summary

  This is a multicentre, randomised, placebo controlled, parallel group proof-of-concept phase three study with a five level blinding design. A total of 112 patients with chronic cluster headaches will be included to determine the effect of botulinum toxin A (Botox) in the treatment of chronic cluster headaches.
  Botox is a muscle relaxant used to treat a number of conditions within the body including neurologic disorders like migraine, bladder disorders and skin disorders. It works by partially blocking the nerve impulses to muscles that have been injected and reduces excessive contractions of these muscles. In the case of chronic migraine, it is thought that Botox blocks pain signals, which indirectly block the development of a migraine.
  Patients with cluster headaches have one of the worst pain conditions ('suicide headache') known to man and this subgroup of cluster headache patients have already tried available standard treatment approaches that have limited effect. 56 patients will be included in the placebo group and 56 patients in the Botox group. The screening/baseline period will be at least 8 -12 weeks, where patients will fill out a headache diary. At the end of this period, patients will get a CT scan of their sinuses. This will be followed by randomisation and the injection of Botox or placebo into a structure called the sphenopalatine ganglion (a large collection of neurons outside the central nervous system located inside the head behind the sinuses) through the cheek. After the injection, the participant will have a follow-up period of 12 weeks where patients will fill out a Headache Diary and record adverse events. The study will last approximately 24 weeks.

• REC name

  East Midlands - Nottingham 2 Research Ethics Committee

• REC reference

  21/EM/0097

• Date of REC Opinion

  23 Jun 2021

• REC opinion

  Further Information Favourable Opinion