BOTOX to treat Urinary Incontinence due to NDO in Patients with MS

• Research type

  Research Study

• Full title

  Botox for the Treatment of Urinary Incontinence due to Neurogenic Detrusor Overactivity in Patients with Multiple Sclerosis

• IRAS ID

  120400

• Contact name

  Paraskeve Granitsiotis

• Sponsor organisation

  Allergan

• Eudract number

  2012-000957-30

• Clinicaltrials.gov Identifier

  NCT01600716

• Research summary

  The Allergan clinical development program for BOTOX© in patients with incontinence due to NDO was initiated with pivotal studies 191622-515 and 191622-516. Patients were randomized to 1 of 3 treatment arms (BOTOX 200 U, BOTOX 300 U, or placebo) for the first treatment. The primary measure in both studies was the number of episodes of urinary incontinence and the primary endpoint was at week 6 following the first study treatment. Both pivotal studies achieved the primary efficacy endpoint, i.e., significant reductions in urinary incontinence at week 6, with no difference between the 2 active BOTOX dose groups. Since there was no additional efficacy or benefit with the BOTOX 300 U dose over the BOTOX 200 U dose in the pivotal phase 3 studies, and given that the 200 U dose displayed a better safety profile, the BOTOX 200 U dose group was submitted for licensing registration, and approval has been granted in several countries. On approval of the use of BOTOX© in spinal cord injury and multiple sclerosis patients with urinary incontinence due to Neurogenic Detrusor Overactivity, the Irish Medicines Board (as Reference Member State for the Mutual Recognition Procedure) and AFSSAPS (France, national procedure) requested further investigation of the use of 100 U BOTOX© in a defined population of MS patients with NDO. This study will test the safety and effectiveness of a lower dose of BOTOX© in the treatment of urinary incontinence, specifically in MS patients who are not using a catheter to empty their bladder, and whose symptoms have not been adequately managed with anticholinergic therapy (a medication used to treat urinary incontinence symptoms). The aim is to test whether this new dose is also effective at reducing urinary leakage, and to evaluate the side effects associated with this new dose. A secondary purpose of the study is to explore the BOTOX© injection / paradigm for NDO patients, a commitment made to the Irish Medicines Board. A subset of patients will therefore receive treatment administered via 20 injections instead of 30 injections.

• REC name

  West of Scotland REC 1

• REC reference

  13/WS/0001

• Date of REC Opinion

  5 Mar 2013

• REC opinion

  Further Information Favourable Opinion