Randomized Double Blind Cross Over Study for Nabilone in... | NCT00623376

Studies
Randomized Double Blind Cross Over Study for Nabilone in Spasticity in Spinal Cord Injury Persons

NCT00623376

Sponsor

University of Manitoba

Status

Completed

Last Update Posted

Feb 26, 2008Estimated

Enrollment

Not provided

Phase

Phase 2

Conditions

Spasticity in Spinal Cord Injured Persons

Interventions

nabilone then placebo
placebo then nabilone

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2007

Primary Completion Date

Nov 2007Actual

Completion Date

Dec 2007Actual

First Submitted Date

Feb 14, 2008

First Submission Date that Met QC Criteria

Feb 25, 2008

First Posted Date

Feb 26, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 25, 2008

Last Update Posted Date

Feb 26, 2008Estimated

Name	Class
Valeant Canada Limited	INDUSTRY

Description Module

Brief 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. 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 .

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

No data available

No data is available for this block.

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Active Comparator	first on treatment then on Placebo	Drug: nabilone then placebo
2	Placebo Comparator	first on placebo then on treatment	Drug: placebo then nabilone

Interventions

Name	Type	Description	Arm Group Labels	Other Names
nabilone then placebo	Drug	The subjects were first on Nabilone, then crossed over to placebo	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Ashworth scale in most involved group muscles		10 weeks

Secondary Outcomes

Measure	Description	Time Frame
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 .		10 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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
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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided