Spasticity in Spinal Cord Injured PersonsPhase 2NCT00623376
Randomized Double Blind Cross Over Study for Nabilone in Spasticity in Spinal Cord Injury Persons
A Phase 2 study of Spasticity in Spinal Cord Injured Persons, run by University of Manitoba at 1 site in Canada.
Trial summary
Objectives: To determine whether nabilone, a synthetic cannabinoid, alleviates spasticity in people with spinal cord injury (SCI). Methods: Twelve subjects were enrolled in this double-blind, placebo-controlled, crossover study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spasticity in Spinal Cord Injured Persons
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- Not given
- Where
- 1 siteCanada
- Study dates
- Jul 2007to Dec 2007
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with spinal cord injury were eligible for the study if they are 18-65 years old, have C5 (ASIA A-D) and below and the injury occurred greater than 1 year previously. They had to have stable neurological level of injury with moderate spasticity (Ashworth >/= 3) and no cognitive impairments. The spasticity medications needed to be unchanged for at least 30 days before inclusion, and no botulinum toxin injections for > 4 months.
Who cannot join
- They were excluded if they had:
- Heart disease as cannabinoids can reduce heart rate and blood pressure
- History of psychotic disorders, schizophrenia or any active psychological disorder
- Previously documented sensitivity to marijuana or other cannabinoid agents
- Severe liver dysfunction
- Cognitive impairment
Show all 11Show fewer
- Major illness in another body area
- If they were pregnant or nursing mother
- Had history of drug dependency
- Used smoked cannabis < 30 days before the onset of the study or were unwilling not to smoke during the study; OR
- If they fixed tendon contractures
Trial locations and contacts
1 site in 1 country.
Canada1 site
Rehabilitation hospital ,800 sherbrook St.
Winnipeg, Manitoba, R3A 1M4
About this study
Official title: Randomized Double Blind Cross Over Study Assessing the Effect of Cannabiniods on Spasticity in Spinal Cord Injured Persons :A Pilot Study
Objectives: To determine whether nabilone, a synthetic cannabinoid, alleviates spasticity in people with spinal cord injury (SCI).
Methods: Twelve subjects were enrolled in this double-blind, placebo-controlled, crossover study. They received either nabilone or placebo during the first four-week period (0.5mg OD with option to increase to 0.5mg BID), then outcome measures were assessed. After a two-week washout, subjects were crossed-over to the opposite arm.
The primary outcome was the Ashworth scale for spasticity in the most involved muscle group, chosen by the subject and clinician. The secondary outcomes included Spasm Frequency Scale, Visual Analog Scale, Wartenberg Pendulum Test, sum of the Ashworth Scale in eight muscle groups of each side of the body, and the Clinician's and Subject's Global Impression of Change .
- Being tested
- nabilone then placebo, placebo then nabilone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nabilone then placeboDrug
The subjects were first on Nabilone, then crossed over to placebo
placebo then nabiloneDrug
the subjects were first on placebo then crossed over to nabilone
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | first on treatment then on Placebo Receives: Drug: nabilone then placebo |
| 2 | Placebo comparator | first on placebo then on treatment Receives: Drug: placebo then nabilone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ashworth scale in most involved group muscles
Measured: 10 weeks
Secondary outcomes (1)
The secondary outcomes included Spasm Frequency Scale, Visual Analog Scale, Wartenberg Pendulum Test, sum of the Ashworth Scale in eight muscle groups of each side of the body, and the Clinician's and Subject's Global Impression of Change .
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2008 (estimated)
- Study startJul 2007
- Primary completionNov 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spasticity in Spinal Cord Injured PersonsStudies 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 2
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Collaborators
- Valeant Canada Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00623376
- Sponsor's protocol ID
- 4940
- Status last verified
- Jun 2007
- First submitted
- 14 Feb 2008
- Last updated
- 26 Feb 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Double Blind Cross Over Study Assessing the Effect of Cannabiniods on Spasticity in Spinal Cord Injured Persons :A Pilot Study
- ClinicalTrials.gov ID
- NCT00623376
- Acronym / sponsor ID
- 4940
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Collaborators
- Valeant Canada Limited
- Study start
- Jul 2007
- Primary completion
- Nov 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 26 Feb 2008 (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.
Objectives: To determine whether nabilone, a synthetic cannabinoid, alleviates spasticity in people with spinal cord injury (SCI).
Methods: Twelve subjects were enrolled in this double-blind, placebo-controlled, crossover study. They received either nabilone or placebo during the first four-week period (0.5mg OD with option to increase to 0.5mg BID), then outcome measures were assessed. After a two-week washout, subjects were crossed-over to the opposite arm.
The primary outcome was the Ashworth scale for spasticity in the most involved muscle group, chosen by the subject and clinician. The secondary outcomes included Spasm Frequency Scale, Visual Analog Scale, Wartenberg Pendulum Test, sum of the Ashworth Scale in eight muscle groups of each side of the body, and the Clinician's and Subject's Global Impression of Change .
Study design
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: nabilone then placebofirst on treatment then on Placebo |
| 2 | Placebo comparator | Drug: placebo then nabilonefirst on placebo then on treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with spinal cord injury were eligible for the study if they are 18-65 years old, have C5 (ASIA A-D) and below and the injury occurred greater than 1 year previously. They had to have stable neurological level of injury with moderate spasticity (Ashworth >/= 3) and no cognitive impairments. The spasticity medications needed to be unchanged for at least 30 days before inclusion, and no botulinum toxin injections for > 4 months.
Key exclusion criteria (11 listed)
- Heart disease as cannabinoids can reduce heart rate and blood pressure
- History of psychotic disorders, schizophrenia or any active psychological disorder
- Previously documented sensitivity to marijuana or other cannabinoid agents
- Severe liver dysfunction
- Cognitive impairment
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 |
|---|---|---|
| nabilone then placeboThe subjects were first on Nabilone, then crossed over to placebo | Drug | 1 |
| placebo then nabilonethe subjects were first on placebo then crossed over to nabilone | Drug | 2 |
Primary outcome
Ashworth scale in most involved group muscles
Time frame: 10 weeks
1 secondary outcome
The secondary outcomes included Spasm Frequency Scale, Visual Analog Scale, Wartenberg Pendulum Test, sum of the Ashworth Scale in eight muscle groups of each side of the body, and the Clinician's and Subject's Global Impression of Change .
Time frame: 10 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 26 Feb 2008.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study of Spasticity in Spinal Cord Injured Persons, run by University of Manitoba at 1 site in Canada.
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 1 inclusion and 11 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 26 Feb 2008. 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 Canada. 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 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 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?
Ashworth scale in most involved group muscles (time frame: 10 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 26 Feb 2008.