BX-1 in Spasticity Due to Multiple Sclerosis

NCT03756974 | Completed Phase 3

• 1 other identifier: DroSpas-1
• Study Type: interventional
• Target: 397
• Locations: 5 countries
• Sites: 40

Brief 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

Conditions

Spasticity Due to Multiple Sclerosis

Keywords

cannabinoid; dronabinol

Outcome Measures

Primary Outcomes (1)

• 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

  Responder analysis: proportion of patients showing improvement in spasticity (change from baseline corresponding to the mean NRS-S score during 7 days prior to randomisation) of 18% or more in average NRS-S assessment at end of treatment (mean NRS-S score during 7 days prior to Visit 6).

  16 weeks

Secondary Outcomes (20)

• Responder analysis: proportion of patients showing improvement in spasticity (change from baseline) of 30% or more in average NRS-S assessment at end of treatment (Visit 6)

  16 weeks

• Responder analysis: proportion of patients showing improvement in spasticity (change from baseline) of 50% or more in average NRS-S assessment at end of treatment (Visit 6)

  16 weeks

• Time to response: time to reach first improvement in spasticity (change from baseline) of 18% or more, based on patient's daily spasticity assessment on the NRS-S

  16 weeks

• Time to response: time to reach first improvement in spasticity (change from baseline) of 30% or more, based on patient's daily spasticity assessment on the NRS-S

  16 weeks

• Weekly mean of the patient's daily spasticity assessments on the NRS-S during Visit 0 - Visit 6

  21 weeks

Study Arms (2)

BX-1 (dronabinol)

EXPERIMENTAL

BX-1

Drug: BX-1

Placebo

PLACEBO COMPARATOR

Placebo of BX-1

Drug: Placebo

Interventions

BX-1 DRUG

BX-1 (dronabinol), oral solution. All patients enrolled establish their individually tolerable dose by dose Titration.

BX-1 (dronabinol)

Placebo DRUG

Placebo of BX-1, oral solution

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• AND Patients currently receiving an optimized treatment corresponding to the last treatment attempt with stable dosage for at least 30 days prior to Visit 0.
• Female patients of non-childbearing potential or if of childbearing potential using highly effective contraceptive methods or double barrier contraception.
• For men: no specific contraception methods need to be used.
• Willingness to follow the study procedure for the whole duration of the trial and signed informed consent at screening prior to any trial-related procedure

You may not qualify if:

• 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)
• Known HIV, and/or active Hepatitis B or C infection
• History of or existing malignancy during the 5 years before screening except history of basal cell carcinoma and melanoma in situ
• Significantly impaired renal function (estimated Glomerular Filtration Rate (eGFR) \< 60 mL/min/1.73m2)
• Significant impaired hepatic function (Alanine Aminotransferase \> 3 times upper limit of normal or bilirubin \> 2 times upper limit of normal, except Gilbert syndrome)
• Known allergic reactions to the active ingredients used or to constituents of the IMP
• Chronic or active infection requiring a systemic therapy
• Pregnancy, breastfeeding or planned pregnancy

Sponsors & Collaborators

• Bionorica SE: lead

Study Sites (40)

Investigative Site

Choceň, 56501, Czechia

Location

Investigative Site

Havířov, 73601, Czechia

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Hradec Králové, 50003, Czechia

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Hradec Králové, 50341, Czechia

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Olomouc, 77520, Czechia

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Pilsen, 31200, Czechia

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Prague, 10034, Czechia

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Prague, 12808, Czechia

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Prague, 14059, Czechia

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Prague, 18600, Czechia

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Teplice, 41529, Czechia

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Freiburg im Breisgau, 79106, Germany

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Ulm, 89073, Germany

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Budapest, 1024, Hungary

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Budapest, 1116, Hungary

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Budapest, 1145, Hungary

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Debrecen, 4031, Hungary

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Győr, 9024, Hungary

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Miskolc, 3526, Hungary

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Szeged, 6725, Hungary

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Szolnok, 5000, Hungary

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Tatabánya, 2800, Hungary

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Bydgoszcz, 85-065, Poland

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Częstochowa, 42-280, Poland

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Katowice, 40-555, Poland

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Katowice, 40-588, Poland

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Katowice, 40-611, Poland

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Katowice, 40-650, Poland

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Krakow, 30-539, Poland

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Plewiska, 62-064, Poland

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Poznan, 61-853, Poland

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Warsaw, 00-874, Poland

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Warsaw, 01-684, Poland

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Barcelona, 08003, Spain

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Barcelona, 08025, Spain

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L'Hospitalet de Llobregat, 08907, Spain

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Madrid, 28034, Spain

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Málaga, 29010, Spain

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Salt, 17190, Spain

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Valencia, 46026, Spain

Location

Study Officials

• Luitgard Spitznagel-Schminke

  Bionorica SE

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2018
• First Posted: November 28, 2018
• Study Start: February 18, 2019
• Primary Completion: March 30, 2021
• Study Completion: March 30, 2021
• Last Updated: May 5, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

DE (2); PL (11); HU (9); ES (7); CZ (11)