Multiple SclerosisPhase 3NCT01018485
The Efficacy of Botulinum Toxin in Disabling Multiple Sclerosis (MS) Tremor
A Phase 3 study testing Botulinum Toxin Type A in people with Multiple Sclerosis and Tremor, run by Melbourne Health at 1 site in Australia.
Trial summary
The incidence of tremor in Multiple Sclerosis (MS) has been estimated to affect up to 2/3rds of patients. Over half of the tremors involve the upper limb and frequently lead to further disability. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Multiple Sclerosis, Tremor
- What is being tested?
- Botulinum Toxin Type A
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteAustralia
- Study dates
- Oct 2008to Jun 2010
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Relapsing-remitting MS or secondary progressive MS according to the Mc Donald criteria
- Age 18-80 years of age
- Competent to understand and sign informed consent
- Presence of symptomatic head and/or limb tremor
Who cannot join
- Treatment with botulinum toxin type A of any brand within the 4 months prior to enrollment
- A known contraindication to Botox injection
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Double-Blind, Randomized, Controlled, Cross-over Comparison of Efficacy and Safety of Botulinum Toxin Type A in the Targeted Treatment of Disabling Tremor in Multiple Sclerosis
The incidence of tremor in Multiple Sclerosis (MS) has been estimated to affect up to 2/3rds of patients. Over half of the tremors involve the upper limb and frequently lead to further disability. Medical treatment of MS tremor is generally unrewarding, although carbamazepine, clonazepam, glutethimide, hyoscine, isoniazid, ondansetron, primidone, and tetrahydrocannabinol have been reported to have some beneficial effect but published evidence of effectiveness is very limited. The investigators' experience to date suggests that many of the upper limb tremors may potentially be responsive to Botulinum toxin injection therapy.
Aims:
- The investigators aim to determine the efficacy of commonly used doses of BOTOX on the patients with symptomatic unilateral or bilateral arm tremor due to MS; and any side effects associated with this treatment.
- Conditions
- Multiple Sclerosis, Tremor
- Being tested
- Botulinum Toxin Type A
- Medical subject headings
- Multiple Sclerosis, Tremor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Also called Botox
Intramuscular injection in affected limb up to 100 Units. Two doses (one placebo, one active) 3 months apart.
| Study group | Role | What they receive |
|---|---|---|
| Botulinum Toxin First Dose | Experimental | Blinded and Randomized injection of 20 upper limbs with Botulinum Toxin Type A Receives: Drug: Botulinum Toxin Type A |
| Botulinum Toxin Second Dose | Experimental | 20 patients will receive Placebo as first dose and Botulinum Toxin as second dose injection 3 months after initiation of the study Receives: Drug: Botulinum Toxin Type A |
What is being measured
The primary outcome is the main question the study is designed to answer.
A decrease in tremor
Measured: 6 months
Secondary outcomes (1)
The safety profile of Botulinum Toxin in MS patients
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2009 (estimated)
- Study startOct 2008
- Primary completionFeb 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Melbourne Health
- Sponsor type
- University, hospital or other
- Collaborators
- Eastern Health
- Investigators
- Andrew Evans, MD, Principal investigator, Melbourne Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01018485
- Sponsor's protocol ID
- HREC 2008.022
- Status last verified
- May 2015
- First submitted
- 19 Nov 2009
- Last updated
- 12 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-Blind, Randomized, Controlled, Cross-over Comparison of Efficacy and Safety of Botulinum Toxin Type A in the Targeted Treatment of Disabling Tremor in Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT01018485
- Acronym / sponsor ID
- HREC 2008.022
- Conditions
- Multiple Sclerosis, Tremor
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Melbourne HealthUniversity, hospital or other
- Collaborators
- Eastern Health
- Study start
- Oct 2008
- Primary completion
- Feb 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 23 Nov 2009 (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.
The incidence of tremor in Multiple Sclerosis (MS) has been estimated to affect up to 2/3rds of patients. Over half of the tremors involve the upper limb and frequently lead to further disability. Medical treatment of MS tremor is generally unrewarding, although carbamazepine, clonazepam, glutethimide, hyoscine, isoniazid, ondansetron, primidone, and tetrahydrocannabinol have been reported to have some beneficial effect but published evidence of effectiveness is very limited. The investigators' experience to date suggests that many of the upper limb tremors may potentially be responsive to Botulinum toxin injection therapy.
Aims:
- The investigators aim to determine the efficacy of commonly used doses of BOTOX on the patients with symptomatic unilateral or bilateral arm tremor due to MS; and any side effects associated with this treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Botulinum Toxin First Dose | Experimental | Drug: Botulinum Toxin Type ABlinded and Randomized injection of 20 upper limbs with Botulinum Toxin Type A |
| Botulinum Toxin Second Dose | Experimental | Drug: Botulinum Toxin Type A20 patients will receive Placebo as first dose and Botulinum Toxin as second dose injection 3 months after initiation of the study |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Relapsing-remitting MS or secondary progressive MS according to the Mc Donald criteria
- Age 18-80 years of age
- Competent to understand and sign informed consent
- Presence of symptomatic head and/or limb tremor
Key exclusion criteria (3 listed)
- Treatment with botulinum toxin type A of any brand within the 4 months prior to enrollment
- A known contraindication to Botox injection
- Pregnancy
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 |
|---|---|---|
| Botulinum Toxin Type AAlso: BotoxIntramuscular injection in affected limb up to 100 Units. Two doses (one placebo, one active) 3 months apart. | Drug | Botulinum Toxin First Dose, Botulinum Toxin Second Dose |
Primary outcome
A decrease in tremor
Time frame: 6 months
1 secondary outcome
The safety profile of Botulinum Toxin in MS patients
Time frame: 6 months
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 12 May 2015.
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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.
Andrew Evans, MD principal investigator
Melbourne Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Botulinum Toxin Type A in people with Multiple Sclerosis and Tremor, run by Melbourne Health at 1 site in Australia.
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 3 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 12 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. 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. 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?
A decrease in tremor (time frame: 6 months). 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 12 May 2015.