Spasticity Due to Multiple SclerosisPhase 3NCT03756974
BX-1 in Spasticity Due to Multiple Sclerosis
A Phase 3 study testing BX-1 in people with Spasticity Due to Multiple Sclerosis, run by Bionorica SE at 40 sites in 5 countries.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Spasticity Due to Multiple Sclerosis
- What is being tested?
- BX-1
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 397 participants
- Where
- 40 sitesin 5 countries
- Study dates
- 18 Feb 2019to 30 Mar 2021
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
- 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
Who cannot join
- 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.)
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- 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
- Any condition that interferes with the participation in the clinical trial at the discretion of the investigator
- Patients not able to follow study instructions, not able to follow the study assessments defined by the protocol, unable to understand the written and verbal instructions, in particular regarding the risks and inconveniences they will be exposed to during their participation in the clinical trial
- Patients in custody by judicial or official order
- Patients who are members of the staff of the trial centre, staff of the sponsor or CRO, the investigator him/herself or close relatives of the investigator
- Parallel participation in another clinical trial, participation in another trial within less than 30 days or five half-lives of IMP (whatever is longer) to screening, or previous participation in this trial (except one time screening failures). A patient may be re-screened once, if any inclusion criterion is not met or any exclusion criterion is met during the first screening attempt.
Trial locations and contacts
40 sites in 5 countries.
40 sites in 5 countries
Czechia11 sites
Investigative Site
Choceň, 56501
Investigative Site
Havířov, 73601
Investigative Site
Hradec Králové, 50003
Investigative site
Hradec Králové, 50341
Investigative Site
Olomouc, 77520
Investigative Site
Pilsen, 31200
Investigative Site
Prague, 10034
Investigative Site
Prague, 12808
Investigative Site
Prague, 14059
Investigative Site
Prague, 18600
Investigative Site
Teplice, 41529
Poland11 sites
Investigative Site
Bydgoszcz, 85-065
Investigative Site
Częstochowa, 42-280
Investigative Site
Katowice, 40-555
Investigative Site
Katowice, 40-588
Investigative Site
Katowice, 40-611
Investigative Site
Katowice, 40-650
Investigative Site
Krakow, 30-539
Investigative Site
Plewiska, 62-064
Investigative Site
Poznan, 61-853
Investigative Site
Warsaw, 00-874
Investigative Site
Warsaw, 01-684
Hungary9 sites
Investigative Site
Budapest, 1024
Investigative Site
Budapest, 1116
Investigative Site
Budapest, 1145
Investigative Site
Debrecen, 4031
Investigative Site
Győr, 9024
Investigative Site
Miskolc, 3526
Investigative Site
Szeged, 6725
Investigative Site
Szolnok, 5000
Investigative Site
Tatabánya, 2800
Spain7 sites
Investigative Site
Barcelona, 08003
Investigative Site
Barcelona, 08025
Investigative Site
L'Hospitalet de Llobregat, 08907
Investigative Site
Madrid, 28034
Investigative Site
Málaga, 29010
Investigative Site
Salt, 17190
Investigative Site
Valencia, 46026
Germany2 sites
Investigative Site
Freiburg im Breisgau, 79106
Investigative Site
Ulm, 89073
About this study
Official title: A Phase III, Multi-centre, Randomised, Double-blind, Placebo-controlled, Parallel-group Clinical Trial to Investigate the Efficacy and Safety of BX-1 for the Symptomatic Relief of Spasticity in Patients With Multiple Sclerosis (MS)
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
Read the detailed description
The aim of the present phase III clinical trial is to demonstrate superiority of BX-1, an oral solution containing dronabinol, over placebo in patients with spasticity due to MS not sufficiently controlled by their current anti-spasticity medication.
The trial is designed to show that BX-1 is able to reduce spasticity in MS patients not showing sufficient response to their current anti-spasticity treatment.
- Conditions
- Spasticity Due to Multiple Sclerosis
- Being tested
- BX-1, Placebo
- Keywords
- cannabinoid, dronabinol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BX-1Drug
BX-1 (dronabinol), oral solution. All patients enrolled establish their individually tolerable dose by dose Titration.
PlaceboDrug
Placebo of BX-1, oral solution
| Study group | Role | What they receive |
|---|---|---|
| BX-1 (dronabinol) | Experimental | BX-1 Receives: Drug: BX-1 |
| Placebo | Placebo comparator | Placebo of BX-1 Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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
Measured: 16 weeks
Weekly mean of the patient's daily spasticity assessments on the NRS-S during Visit 0 - Visit 6
Measured: 21 weeks
Weekly mean of the patient's daily pain assessments on the Numerical Rating Scale for Pain (NRS-P) during Visit 0 - Visit 6
Measured: 21 weeks
Responder analysis: proportion of patients showing improvement in pain (change from baseline) of 15% or more in average NRS-P assessment at end of treatment (Visit 6)
Measured: 16 weeks
Responder analysis: proportion of patients showing improvement in pain (change from baseline) of 30% or more in average NRS-P assessment at end of treatment (Visit 6)
Measured: 16 weeks
Time to response: time to reach first improvement in pain (change from baseline) of 15% or more, based on patient's pain assessment on the NRS-P
Measured: 16 weeks
Time to response: time to reach first improvement in pain (change from baseline) of 30% or more, based on patient's pain assessment on the NRS-P
Measured: 16 weeks
Weekly mean of the patient's daily spasm frequency and severity assessments on the Penn Spasm Frequency Scale (PSFS) during Visit 0 - Visit 6
Measured: 21 weeks
Mean change from baseline of spasm frequency and severity assessments on the PSFS at end of treatment (Visit 6)
Measured: 16 weeks
Mean change from baseline of Timed 25-Foot Walk (T25-FW) at Visit 4 and Visit 6
Measured: 16 weeks
Responder analysis: proportion of patients showing improvement in TF25-FW (change from baseline) of 20% or more at Visit 6
Measured: 16 weeks
Mean change from baseline of the physical and psychological impact of multiple sclerosis assessed with the Multiple Sclerosis Impact Scale- 29 version 2 (MSIS-29 v2) at Visit 4 and Visit 6
Measured: 16 weeks
Mean change from baseline of quality of life measured with Short-Form Health Survey of the Medical Outcomes Study Version 2 (SF-36 v2) at Visit 6
Measured: 16 weeks
Mean change from baseline of sleep quality measured with the Numerical Rating Scale for Sleep Quality (NRS-SQ) at Visit 3 - Visit 6
Measured: 12 weeks
Mean change from baseline of fatigue measured with the Numerical Rating Scale for Fatigue (NRS-F) at Visit 3 - Visit 6
Measured: 12 weeks
Overall patients' status measured by Patient´s Global Impression of Change scale (PGIC) at Visit 5 and Visit 6
Measured: 16 weeks
Overall patients' status measured by Clinical Global Impression - Improvement scale (CGI-I) at Visit 5 and Visit 6
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2018
- Study start18 Feb 2019
- Primary completion30 Mar 2021
- Study completion30 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spasticity Due to Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 397 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bionorica SE
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Luitgard Spitznagel-Schminke, Study director, Bionorica SE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03756974
- Sponsor's protocol ID
- DroSpas-1
- Status last verified
- May 2021
- First submitted
- 20 Nov 2018
- Last updated
- 5 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Multi-centre, Randomised, Double-blind, Placebo-controlled, Parallel-group Clinical Trial to Investigate the Efficacy and Safety of BX-1 for the Symptomatic Relief of Spasticity in Patients With Multiple Sclerosis (MS)
- ClinicalTrials.gov ID
- NCT03756974
- Acronym / sponsor ID
- DroSpas-1
- Conditions
- Spasticity Due to Multiple Sclerosis
- Keywords
- cannabinoid, dronabinol
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 397 participants (actual)
- Lead sponsor
- Bionorica SEIndustry (pharma, biotech, devices)
- Study start
- 18 Feb 2019 (actual)
- Primary completion
- 30 Mar 2021 (actual)
- Study completion
- 30 Mar 2021 (actual)
- First posted
- 28 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
The aim of the present phase III clinical trial is to demonstrate superiority of BX-1, an oral solution containing dronabinol, over placebo in patients with spasticity due to MS not sufficiently controlled by their current anti-spasticity medication.
The trial is designed to show that BX-1 is able to reduce spasticity in MS patients not showing sufficient response to their current anti-spasticity treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BX-1 (dronabinol) | Experimental | Drug: BX-1BX-1 |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo of BX-1 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (20 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BX-1BX-1 (dronabinol), oral solution. All patients enrolled establish their individually tolerable dose by dose Titration. | Drug | BX-1 (dronabinol) |
| PlaceboPlacebo of BX-1, oral solution | Drug | Placebo |
Primary outcome
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
Time frame: 16 weeks
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).
20 secondary outcomes
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)
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 16 weeks
Weekly mean of the patient's daily spasticity assessments on the NRS-S during Visit 0 - Visit 6
Time frame: 21 weeks
Weekly mean of the patient's daily pain assessments on the Numerical Rating Scale for Pain (NRS-P) during Visit 0 - Visit 6
Time frame: 21 weeks
Responder analysis: proportion of patients showing improvement in pain (change from baseline) of 15% or more in average NRS-P assessment at end of treatment (Visit 6)
Time frame: 16 weeks
Responder analysis: proportion of patients showing improvement in pain (change from baseline) of 30% or more in average NRS-P assessment at end of treatment (Visit 6)
Time frame: 16 weeks
Time to response: time to reach first improvement in pain (change from baseline) of 15% or more, based on patient's pain assessment on the NRS-P
Time frame: 16 weeks
Time to response: time to reach first improvement in pain (change from baseline) of 30% or more, based on patient's pain assessment on the NRS-P
Time frame: 16 weeks
Weekly mean of the patient's daily spasm frequency and severity assessments on the Penn Spasm Frequency Scale (PSFS) during Visit 0 - Visit 6
Time frame: 21 weeks
Mean change from baseline of spasm frequency and severity assessments on the PSFS at end of treatment (Visit 6)
Time frame: 16 weeks
Mean change from baseline of Timed 25-Foot Walk (T25-FW) at Visit 4 and Visit 6
Time frame: 16 weeks
Responder analysis: proportion of patients showing improvement in TF25-FW (change from baseline) of 20% or more at Visit 6
Time frame: 16 weeks
Mean change from baseline of the physical and psychological impact of multiple sclerosis assessed with the Multiple Sclerosis Impact Scale- 29 version 2 (MSIS-29 v2) at Visit 4 and Visit 6
Time frame: 16 weeks
Mean change from baseline of quality of life measured with Short-Form Health Survey of the Medical Outcomes Study Version 2 (SF-36 v2) at Visit 6
Time frame: 16 weeks
Mean change from baseline of sleep quality measured with the Numerical Rating Scale for Sleep Quality (NRS-SQ) at Visit 3 - Visit 6
Time frame: 12 weeks
Mean change from baseline of fatigue measured with the Numerical Rating Scale for Fatigue (NRS-F) at Visit 3 - Visit 6
Time frame: 12 weeks
Overall patients' status measured by Patient´s Global Impression of Change scale (PGIC) at Visit 5 and Visit 6
Time frame: 16 weeks
Overall patients' status measured by Clinical Global Impression - Improvement scale (CGI-I) at Visit 5 and Visit 6
Time frame: 16 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2021.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luitgard Spitznagel-Schminke study director
Bionorica SE
40 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing BX-1 in people with Spasticity Due to Multiple Sclerosis, run by Bionorica SE at 40 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 40 sites in Czechia, Poland, Hungary, Spain, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2021.