A Study of Sativex® for Pain Relief Due to Diabetic Neuropathy

NCT00710424 | Completed Phase 3 Results

• 1 other identifier: GWCL0305
• Study Type: interventional
• Target: 297
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the efficacy of Sativex® compared with placebo in relieving pain due to Diabetic Neuropathy.

Conditions

Pain; Diabetic Neuropathy

Keywords

Pain; diabetic neuropathy

Outcome Measures

Primary Outcomes (2)

• The Change From Baseline in Mean Diabetic Neuropathy Pain 0-10 Numerical Rating Scale Score at the End of Treatment (Average of Last 7 Days Treatment)

  The diabetic neuropathy pain Numerical Rating Scale was complete at the end of every day. The patient was asked "on a scale of '0 to 10', please indicate the number that best describes your nerve pain due to diabetes in the last 24 hours" where 0 = no pain and 10 = worst possible pain. No pain relates to the time prior to the onset of pain due to diabetic neuropathy. For those whose evaluable period ended before Day 7, the mean of the available post-randomisation data was used. Those with no post-baseline diary pain 0-10 Numerical Rating Scale scores were excluded from the analysis.

  Day 0 to Day 98

• Number of Responders at the 30% Improvement Level at the End of Treatment

  A positive 30% pain response is defined as a reduction of at least 30% in the mean NRS average pain score from baseline to week 14 (last 7 days). The patient was asked "on a scale of '0 to 10', please indicate the number that best describes your pain or average pain in the last 24 hours" where 0 = no pain and 10 = pain as bad as you can imagine. No pain relates to the time prior to the onset of pain. The average pain NRS was completed at the same time each day, i.e. bedtime in the evening. Estimates were produced for a one-week period, with the evaluable period finishing at the end of the appropriate seven-day period.

  Day 0 - Day 98

Secondary Outcomes (8)

• Change From Baseline in Mean Neuropathic Pain Scale Score at the End of Treatment

  Day 0 to Day 98

• Change From Baseline in Mean Sleep Quality 0-10 Numerical Rating Scale Score at the End of Treatment

  Day 0 - Day 98

• Subject Global Impression of Change at the End of Treatment

  Day 0 and Day 98

• Change From Baseline in Mean Brief Pain Inventory (Short Form)'Pain Severity Composite Score' at the End of Treatment

  Day 0 and Day 98

• Change From Baseline in Mean Quality of Life EuroQol 5-D Weighted Health State Index Score at the End of Treatment Measured by Visual Analogue Scale

  Day 0 and Day 98

Study Arms (2)

Sativex

EXPERIMENTAL

Drug: Sativex

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Sativex DRUG

containing THC (27 mg/ml):CBD (25 mg/ml), in ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavouring. Maximum permitted dose was eight actuations in any three hour period and 24 actuations (THC 65 mg: CBD 60 mg) in 24 hours

Also known as: GW-1000-02

Sativex

Placebo DRUG

containing 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.

Also known as: GW-4001-01

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Willing and able to give informed consent.
• Male or female, aged 18 years or above.
• Ability (in the investigators opinion) and willingness to comply with all study requirements.
• Diagnosed with Type 1 or 2 diabetes mellitus as diagnosed according to the World Health Organisation (WHO) criteria.
• Diagnosed with neuropathic pain due to distal symmetrical diabetic neuropathy of at least six months duration, as defined by a NDS score of at least 4, and in who pain is not wholly relieved with their current therapy. The NDS score must be attained from at least two different test parameters and not only the ankle jerk reflex.
• The last six daily diary 0-10 NRS pain scores before randomisation summed to at least 24.
• Stable dose of regular pain medication and non-pharmacological therapies (including TENS) for at least 14 days prior to the screening visit and willingness for these to be maintained throughout the study.
• Agreement for the responsible authorities (as applicable in individual countries), their primary care physician, and their consultant, if appropriate, to be notified of their participation in the study.

You may not qualify if:

• Concomitant pain thought by the investigator to be of a nature or severity to interfere with their assessment of their painful diabetic neuropathy.
• Uncontrolled diabetes with HbA1c blood levels of more than 11% at Visit1, Day B1.
• Receiving a prohibited medication and were unwilling to stop or comply for the duration of the study.
• Has used cannabinoid based medications within 60 days of study entry and were unwilling to abstain for the duration for the study.
• Has used cannabis within 30 days of study entry and were unwilling to abstain for the duration for the study.
• History of schizophrenia, other psychotic illness, severe personality disorder or other significant psychiatric disorder other than depression associated with their underlying condition.
• Known or suspected history of alcohol or substance abuse.
• History of epilepsy or recurrent seizures.
• Known or suspected hypersensitivity to cannabinoids or any of the excipients of the IMP.
• Postural drop of 20mmHg or more in systolic blood pressure at screening.
• Medical history of gastroparesis.
• Evidence of cardiomyopathy.
• Experienced myocardial infarction or clinically relevant cardiac dysfunction within the last 12 months or had a cardiac disorder that, in the opinion of the investigator would put the subject at risk of a clinically relevant arrhythmia or myocardial infarction.
• QT interval; of \> 450 ms (males) or \> 470 ms (females) at Visit 1.
• Secondary or tertiary AV block or sinus bradycardia (HR \<50bpm) or sinus tachycardia (HR\>110bpm) at Visit 1.

Sponsors & Collaborators

• Jazz Pharmaceuticals: lead

Study Sites (1)

Royal Hallamshire Hospital

Sheffield, Yorkshire, S10 2JF, United Kingdom

Location

MeSH Terms

Conditions

Pain; Diabetic Neuropathies

Interventions

nabiximols

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Results Point of Contact

• Title: Mr Richard Potts, Clinical Operations Director
• Organization: GW Pharm Ltd

rp@gwpharm.com

0044 1223 266800

Study Officials

• Solomon Tesfaye, JCHMT FRCP

  Royal Hallamshire Hospital

  PRINCIPAL INVESTIGATOR

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: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2008
• First Posted: July 4, 2008
• Study Start: July 1, 2005
• Primary Completion: June 1, 2006
• Study Completion: June 1, 2006
• Last Updated: May 3, 2023
• Results First Posted: July 31, 2012

Record last verified: 2023-04

Locations

GB (1)