Muscle Spasticity Due to Multiple SclerosisPhase 2NCT01649050
Efficacy of 5 Weeks of Treatment With BGG492 in Patients With Spasticity Due to Multiple Sclerosis
A Phase 2 study testing BGG492 in people with Muscle Spasticity Due to Multiple Sclerosis, run by Novartis Pharmaceuticals.
Trial summary
To evaluate efficacy and safety of BGG492 versus placebo on moderate to severe spasticity due to multiple sclerosis Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Muscle Spasticity Due to Multiple Sclerosis
- What is being tested?
- BGG492
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Oct 2016to Mar 2018
- Phase
- Phase 2
- 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
- Diagnosis of multiple sclerosis (MS) of any type.
- MS diagnosis at least 6 months prior to screening.
- Stable MS with no relapse within 3 months prior to screening.
- Treated or untreated spasticity due to MS for at least 3 months prior to screening, not wholly relieved with antispasticity medications.
Who cannot join
- Patients with symptoms of spasticity not due to MS.
- Patients taking three or more different anti-spasticity medications.
- Acute MS exacerbation requiring treatment within 3 months of the Screening Visit.
- Initiation of, or the discontinuation of interferon beta or any other disease modifying therapy for MS within 3 months of the Screening Visit.
- Use of baclofen pump at any time.
- Wheelchair or bed-bound patients.
About this study
Official title: A Multicenter, Randomized, Double-blind, Placebo Controlled, Parallel-group Study to Assess the Efficacy of 5 Weeks of Treatment With BGG492 in Patients With Spasticity Due to Multiple Sclerosis
To evaluate efficacy and safety of BGG492 versus placebo on moderate to severe spasticity due to multiple sclerosis
- Being tested
- BGG492, Placebo
- Keywords
- Spasticity, Multiple Sclerosis
- Medical subject headings
- Muscle Spasticity, Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BGG492Drug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| BGG492 | Experimental | BGG492 tablets administered orally Receives: Drug: BGG492 |
| Placebo | Placebo comparator | Matching placebo administered orally Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in spasticity NRS score from baseline to 5 weeks
The spasticity Numeric Rating Scale is a 0 to 10 patient reported scale of spasticity severity, with 0 being no spasticity and 10 being worst possible spasticity.
Measured: 5 weeks
PGIC score at 5 weeks
The Patient Global Impression of Change is a patient reported one item mesaure of overall improvement in condition since the previous visit. The patient is asked to choose one of 7 sentences from very much improved to very much worse, that best describes his present condition.
Measured: 5 weeks
Secondary outcomes (2)
Change from baseline to 5 weeks in Ashworth spasticity score
The Ashworth spasticity score is a physician assessed rating of spasticity using a five point score from 0 to 4 for each muscle group tested.
Measured: 5 weeks
Safety and tolerability
Number of patients with adverse events (AE).
Measured: average of 70 days, maximum from day -19 to day 52, i.e. from first baseline up to study completion visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2012 (estimated)
- Study startOct 2016
- Primary completionMar 2018 (estimated)
- Study completionMar 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle Spasticity Due to Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01649050
- Sponsor's protocol ID
- CBGG492A2215
- Other IDs
- 2012-002783-27
- Status last verified
- Aug 2014
- First submitted
- 6 Jul 2012
- Last updated
- 20 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Placebo Controlled, Parallel-group Study to Assess the Efficacy of 5 Weeks of Treatment With BGG492 in Patients With Spasticity Due to Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT01649050
- Acronym / sponsor ID
- CBGG492A2215
- Keywords
- Spasticity, Multiple Sclerosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Oct 2016
- Primary completion
- Mar 2018 (estimated)
- Study completion
- Mar 2018 (estimated)
- First posted
- 25 Jul 2012 (estimated)
- 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 evaluate efficacy and safety of BGG492 versus placebo on moderate to severe spasticity due to multiple sclerosis
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 |
|---|---|---|
| BGG492 | Experimental | Drug: BGG492BGG492 tablets administered orally |
| Placebo | Placebo comparator | Drug: PlaceboMatching placebo administered orally |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of multiple sclerosis (MS) of any type.
- MS diagnosis at least 6 months prior to screening.
- Stable MS with no relapse within 3 months prior to screening.
- Treated or untreated spasticity due to MS for at least 3 months prior to screening, not wholly relieved with antispasticity medications.
Key exclusion criteria (6 listed)
- Patients with symptoms of spasticity not due to MS.
- Patients taking three or more different anti-spasticity medications.
- Acute MS exacerbation requiring treatment within 3 months of the Screening Visit.
- Initiation of, or the discontinuation of interferon beta or any other disease modifying therapy for MS within 3 months of the Screening Visit.
- Use of baclofen pump at any time.
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 |
|---|---|---|
| BGG492 | Drug | BGG492 |
| Placebo | Drug | Placebo |
Primary outcome
Change in spasticity NRS score from baseline to 5 weeks
Time frame: 5 weeks
The spasticity Numeric Rating Scale is a 0 to 10 patient reported scale of spasticity severity, with 0 being no spasticity and 10 being worst possible spasticity.
PGIC score at 5 weeks
Time frame: 5 weeks
The Patient Global Impression of Change is a patient reported one item mesaure of overall improvement in condition since the previous visit. The patient is asked to choose one of 7 sentences from very much improved to very much worse, that best describes his present condition.
2 secondary outcomes
Change from baseline to 5 weeks in Ashworth spasticity score
Time frame: 5 weeks
Safety and tolerability
Time frame: average of 70 days, maximum from day -19 to day 52, i.e. from first baseline up to study completion visit
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2017.
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.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BGG492 in people with Muscle Spasticity Due to Multiple Sclerosis, run by Novartis Pharmaceuticals.
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 4 inclusion and 6 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: withdrawn, as of the sponsor's last update on 20 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was withdrawn before enrolling participants, so there are no results.
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?
Change in spasticity NRS score from baseline to 5 weeks (time frame: 5 weeks). The study lists 2 primary outcomes in all. 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 20 Apr 2017.