PATTERN
Research type
Research Study
Full title
Prospective, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of NT 201 in the treatment of lower limb spasticity caused by stroke or traumatic brain injury in adult subjects, followed by an open label extension with or without combined upper limb treatment
IRAS ID
261821
Contact name
Ganesh Bavikatte
Contact email
Sponsor organisation
Merz Pharmaceuticals GmbH
Eudract number
2018-001639-35
Clinicaltrials.gov Identifier
10686, IND
Duration of Study in the UK
5 years, 0 months, 0 days
Research summary
In this clinical study, an investigational drug named NT 201 (Botulinum toxin type A) is being tested. NT 201 is an investigational drug, as its efficacy and safety in treating lower limb spasticity is still being considered in clinical studies. NT 201 is marketed in more than 60 countries under the brand names Xeomin® and Xeomeen® for the treatment of upper limb spasticity with doses up to 500 Units [U]; however, NT 201 has not yet been approved by government agencies in any country as a treatment for lower limb spasticity in adults. Doses up to 800 U and treatment of the lower limb were studied in clinical studies and found to be safe. After a single injection session with NT 201 or placebo, patients experienced reduction of their lower limb spasticity. However the effectiveness of treatment with NT 201 was not different from placebo treatment in this particular study. NT 201 has been tested by the Sponsor in a previous clinical study for the treatment of post stroke lower limb spasticity in 289 subjects. Overall, the study showed that NT 201 was generally safe to use and well tolerated. Furthermore, previous clinical studies have tested the efficacy and safety NT 201 in the treatment of post stroke lower limb spasticity. These studies have tested doses higher than those approved by government agencies. The main purpose of this study is to assess the safety (through symptoms and medical problems you may experience - known as side effects), and efficacy (how well the study drug treats lower limb spasticity) of NT 201. This study will involve approximately 600-800 subjects in approximately 20 countries.
REC name
North West - Liverpool Central Research Ethics Committee
REC reference
19/NW/0413
Date of REC Opinion
23 Aug 2019
REC opinion
Further Information Favourable Opinion