CompletedPhase 3

BX-1 in Spasticity Due to Multiple Sclerosis

Czechia397 participantsStarted 2019-02-18

Plain-language summary

To investigate the efficacy and safety of orally administered BX-1 compared to placebo in patients with spasticity due to multiple sclerosis not sufficiently controlled by current anti-spasticity medication

Who can participate

Age range18 Years – 65 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Male or female patients aged 18 to 65 years
✓. Presence of MS according to 2010 or 2017 revised McDonald criteria
✓. Patients with stable MS for at least 3 months before enrolment in the opinion of the treating physician Note: Patients with a MS relapse during 3 month prior to enrolment are not considered to have stable MS
✓. Ongoing spasticity for at least 3 months before enrolment
✓. Spasticity in at least 2 lower limb muscles
✓. Expanded Disability Status Scale (EDSS) score ≥ 3.0 and ≤ 6.5
✓. Previous treatment with at least two different optimized oral MS anti-spasticity therapies before inclusion. Both treatment attempts must include at least baclofen or oral tizanidine, which can be combined with other anti-spasticity drugs.
✓. Female patients of non-childbearing potential or if of childbearing potential using highly effective contraceptive methods or double barrier contraception.

Exclusion criteria

✕. Any present disease other than MS that could affect spasticity (e.g. traumatic brain injury, spinal cord injury, brain damage due to a lack of oxygen, stroke, encephalitis, meningitis)
✕. Intake of not permitted concomitant medication prior to screening and concomitant medication which should be unaltered prior to screening in an unstable dosage regimen
✕. Significant fixed tendon contractures
✕. History of epileptic seizures
✕. History of or existing relevant CNS disorder (other than MS)
✕. History of or existing relevant psychiatric disorders (e.g. schizophrenia, psychosis, manic disorders, severe depressive disorders, suicidal ideations, drug and/or alcohol abuse etc.)
✕. Patients with a positive drug abuse screening test, except for medications used to treat a medical condition and reported as such by the patient; all patients with a positive result for cannabis/THC
✕. History of or existing cardiac diseases or pathological findings (e.g. chronic insufficiency NYHA III/IV, severe arrhythmia, unstable angina pectoris, myocardial infarction within the past 6 months, QT prolongation)

What they're measuring

Responder analysis: proportion of patients showing improvement in spasticity of 18% or more in average Numerical Rating Scale for Spasticity (NRS-S) assessment at end of treatment

Timeframe: 16 weeks

Trial details

NCT IDNCT03756974

SponsorBionorica SE

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-03-30

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