NCT01606202

Brief Summary

A study to investigate the effects of sublingual cannabis based medicine extracts on neuropathic pain associated with spinal cord injury.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
116

participants targeted

Target at P25-P50 for phase_3 pain

Timeline
Completed

Started Jul 2002

Typical duration for phase_3 pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2002

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2005

Completed
7.4 years until next milestone

First Submitted

Initial submission to the registry

May 21, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 25, 2012

Completed
4 months until next milestone

Results Posted

Study results publicly available

September 28, 2012

Completed
Last Updated

January 10, 2023

Status Verified

December 1, 2022

Enrollment Period

2.5 years

First QC Date

May 21, 2012

Results QC Date

July 19, 2012

Last Update Submit

December 19, 2022

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

  • Change From Baseline in Mean Central Neuropathic Pain 11-Point Numerical Rating Scale Scores at the End of Treatment (up to 51 Days).

    The Central Neuropathic Pain Numerical Rating Scale score was recorded three times daily, in the morning (on waking), at lunchtime and in the evening using the scale, 0 = 'No Pain' and 10 = 'Worst Possible Pain'. Patients were instructed to relate 'No Pain' to the time before the start of their spinal cord injury. End of Treatment was defined as the mean of the last seven days in the study or the mean of the last three days if the subject withdrew. A negative value indicates an improvement in pain score from baseline.

    Up to 51 days

Secondary Outcomes (13)

  • Change From Baseline in the Mean Percentage of Days on Which Escape Medication Was Used at the End of Treatment

    Up to 51 days

  • Change From Baseline in Mean Spasm Severity Numerical Rating Scale Score at the End of Treatment

    Up to 51 days

  • Change From Baseline in the Percentage of Days on Which Spasm Was Experienced at the End of Treatment

    Up to 51 days

  • Change From Baseline in Mean Spasticity Severity Numerical Rating Scale Scores the End of Treatment.

    0 - 51 days

  • Change From Baseline in the Percentage of Days on Which Spasticity Was Experienced at the End of Treatment

    Up to 51 days

  • +8 more secondary outcomes

Study Arms (2)

GW-1000-02

EXPERIMENTAL

Active treatment.

Drug: GW-1000-02

Placebo

PLACEBO COMPARATOR

Placebo control.

Drug: Placebo

Interventions

GW-1000-02DRUG

Contained delta-9-tetrahydrocannabinol (THC) (27 mg/ml):cannabidiol (CBD) (25 mg/ml) as extract of Cannabis sativa L., with peppermint oil, 0.05% (v/v), in ethanol:propylene glycol (50:50) excipient. Each actuation delivered 100 μl (THC 2.7 mg and CBD 2.5 mg). The maximum permitted dose of study medication was eight actuations in any three-hour period, and 48 actuations in any 24 hour period.

Also known as: Sativex
GW-1000-02
PlaceboDRUG

Contained peppermint oil, 0.05% (v/v), quinoline yellow, 0.005% (w/v), sunset yellow, 0.0025% (w/v), in ethanol:propylene glycol (50:50) excipient. Each actuation delivered 100 μl. The maximum permitted dose of study medication was eight actuations in any three-hour period, and 48 actuations in any 24 hour period.

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Gave informed consent for participation in the study.
  • Male or Female, aged 18 years or above.
  • Diagnosis of non-acute spinal cord injury, with central neuropathic pain not wholly relieved by current therapy.
  • Central neuropathic pain with a mean severity Numerical Rating Scale score at least four during last seven days of the baseline period.
  • Relatively stable neurology during the preceding six months.
  • Stable medication regimen during the preceding four weeks.
  • Agreement, if female and of child bearing potential or if male with a partner of child bearing potential, to ensure that effective contraception was used during the study and for three months thereafter.
  • Had not used cannabinoids for at least the preceding seven days and willing to abstain from any use of cannabinoids during the study.
  • Clinically acceptable laboratory results at Visit 2.
  • Ability (in the investigator's opinion) and willingness to comply with all study requirements.
  • Agreement for the UK Home Office, their general practitioner, and their consultant if appropriate, to be notified of their participation in the study.

You may not qualify if:

  • History of schizophrenia, other psychotic illness, severe personality disorder or other significant psychiatric disorder other than depression associated with their underlying condition.
  • History of alcohol or substance abuse.
  • Severe cardiovascular disorder, such as ischaemic heart disease, arrhythmias (other than well controlled atrial fibrillation), poorly controlled hypertension or severe heart failure.
  • History of autonomic dysreflexia.
  • History of epilepsy.
  • If female, were pregnant or lactating, or were planning a pregnancy to occur during the course of the study.
  • Significant renal or hepatic impairment.
  • Elective surgery or other procedures requiring general anaesthesia scheduled to occur during the study.
  • Terminal illness or were considered inappropriate for placebo medication.
  • Any other significant disease or disorder which, in the opinion of the investigator, may have either put the subject at risk because of participation in the study, or may influenced the result of the study, or the subject's ability to participate in the study.
  • Regular levodopa therapy within the seven days leading to study entry.
  • If male, were receiving and were unwilling to stop sildenafil for the duration of the study.
  • Known or suspected hypersensitivity to cannabinoids or any of the excipients of the study medications.
  • Known or suspected adverse reaction to cannabinoids.
  • Intention to travel internationally during the study.
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Royal National Orthopaedic Hospital

Middlesex, HA7 4LP, United Kingdom

Location

Related Publications (1)

  • Thomas PA, Carter GT, Bombardier CH. A scoping review on the effect of cannabis on pain intensity in people with spinal cord injury. J Spinal Cord Med. 2022 Sep;45(5):656-667. doi: 10.1080/10790268.2020.1865709. Epub 2021 Jan 19.

    PMID: 33465022DERIVED

MeSH Terms

Conditions

Pain

Interventions

nabiximols

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Mr Richard Potts, Clinical Operations Director
Organization
GW Pharma Ltd.
rp@gwpharm.com
0044 1223 266800

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 21, 2012

First Posted

May 25, 2012

Study Start

July 1, 2002

Primary Completion

January 1, 2005

Study Completion

January 1, 2005

Last Updated

January 10, 2023

Results First Posted

September 28, 2012

Record last verified: 2022-12

Locations

GB(1)