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An Open-label Extension Study to Investigate Possible Drug-drug Interactions Between Clobazam and Cannabidiol

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ClinicalTrials.gov Identifier: NCT02564952
Recruitment Status : Completed
First Posted : October 1, 2015
Results First Posted : September 11, 2018
Last Update Posted : September 11, 2018
Sponsor:
Information provided by (Responsible Party):
GW Research Ltd

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Other
Condition Epilepsy
Interventions Drug: GWP42003-P
Drug: Clobazam
Enrollment 18
Recruitment Details All participants were enrolled by invitation into the open-label extension (OLE) phase after completing the double-blind phase of the study.
Pre-assignment Details Two of the 18 participants withdrew during the OLE titration period: 1 met protocol-specified withdrawal criteria; 1 had GWP42003-P withdrawn due to adverse events (AEs) ongoing at entry to the OLE phase.
Arm/Group Title GWP42003-P
Hide Arm/Group Description

Participants who transferred from the double blind (DB) phase (NCT02565108) to the OLE (still blinded at that stage) tapered off their GWP42003-P or placebo treatment by reducing their maintenance dose by 10% per day and concomitantly titrating GWP42003-P to 20 mg/kg/day initially for the OLE; doses could then be adjusted up or down, dependent on investigator opinion, to a maximum of 30 mg/kg/day GWP42003-P.

Clobazam (CLB) was administered in line with the physician’s preferred CLB dosing regimen for each participant.

Period Title: Overall Study
Started 18
Received at Least 1 Dose of Study Drug 18
Completed OLE Titration Period [1] 16
Completed 7
Not Completed 11
Reason Not Completed
Adverse Event             6
Lost to Follow-up             1
Participant Withdrawn by Investigator             1
Withdrawal by Subject             1
Low Efficacy             1
Participant Met Withdrawal Criteria             1
[1]
OLE population: enrolled participants with ≥1 dose of study drug from Day 2 of Visit 4 onwards.
Arm/Group Title GWP42003-P
Hide Arm/Group Description

Participants who transferred from the DB phase (NCT02565108) to the OLE (still blinded at that stage) tapered off their GWP42003-P or placebo treatment by reducing their maintenance dose by 10% per day and concomitantly titrating GWP42003-P to 20 mg/kg/day initially for the OLE; doses could then be adjusted up or down, dependent on investigator opinion, to a maximum of 30 mg/kg/day GWP42003-P.

CLB was administered in line with the physician’s preferred CLB dosing regimen for each participant.

Overall Number of Baseline Participants 18
Hide Baseline Analysis Population Description
The study population included all participants who completed the GWEP1428 double-blind phase and entered the OLE phase of the study.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 18 participants
36.35  (9.05)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants
Female
8
  44.4%
Male
10
  55.6%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
18
 100.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Any History Of Current Seizures  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants
18
 100.0%
1.Primary Outcome
Title Number Of Participants Who Experienced Severe OLE-Emergent AEs
Hide Description

An OLE-emergent AE was defined as an AE with an onset date after the first dose of IMP in the OLE phase of the study. The number of participants who experienced 1 or more severe OLE-emergent AEs after the first dose of IMP in the OLE phase of the study up to the Safety follow-up visit (28 [± 3] days following the last dose of IMP) is presented.

A summary of serious and all other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module.

Time Frame Postdose on Day 2 of Visit 4 up to Safety follow-up (28 [± 3] days following the last dose of IMP)
Hide Outcome Measure Data
Hide Analysis Population Description
The OLE population included all participants who completed the double-blind phase and entered the OLE phase of the study. The OLE population was the primary analysis set for all safety endpoints reported.
Arm/Group Title GWP42003-P
Hide Arm/Group Description:

Participants who transferred from the DB phase (NCT02565108) to the OLE (still blinded at that stage) tapered off their GWP42003-P or placebo treatment by reducing their maintenance dose by 10% per day and concomitantly titrating GWP42003-P to 20 mg/kg/day initially for the OLE; doses could then be adjusted up or down, dependent on investigator opinion, to a maximum of 30 mg/kg/day GWP42003-P.

CLB was administered in line with the physician’s preferred CLB dosing regimen for each participant.

Overall Number of Participants Analyzed 18
Measure Type: Count of Participants
Unit of Measure: Participants
4
  22.2%
Time Frame Postdose on Day 2 of Visit 4 up to Safety follow-up (28 [± 3] days following the last dose of IMP)
Adverse Event Reporting Description The number of participants who experienced OLE-emergent AEs after the first dose of IMP in the OLE phase of the study up to the Safety follow-up visit (28 [± 3] days following the last dose of IMP) is presented. The OLE population was the primary analysis set for all safety endpoints reported. Participants’ expected seizure types were not routinely documented as AEs. However, any worsening, including change in the pattern or severity of seizures, was documented as an AE.
 
Arm/Group Title GWP42003-P
Hide Arm/Group Description

Participants who transferred from the DB phase (NCT02565108) to the OLE (still blinded at that stage) tapered off their GWP42003-P or placebo treatment by reducing their maintenance dose by 10% per day and concomitantly titrating GWP42003-P to 20 mg/kg/day initially for the OLE; doses could then be adjusted up or down, dependent on investigator opinion, to a maximum of 30 mg/kg/day GWP42003-P.

CLB was administered in line with the physician’s preferred CLB dosing regimen for each participant.

All-Cause Mortality
GWP42003-P
Affected / at Risk (%)
Total   0/18 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
GWP42003-P
Affected / at Risk (%)
Total   2/18 (11.11%) 
Investigations   
Alanine aminotransferase abnormal  1  1/18 (5.56%) 
Aspartate aminotransferase abnormal  1  1/18 (5.56%) 
Gamma-glutamyltransferase abnormal  1  1/18 (5.56%) 
Nervous system disorders   
Seizure  1  1/18 (5.56%) 
Status epilepticus  1  1/18 (5.56%) 
1
Term from vocabulary, MedDRA (18.1)
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
GWP42003-P
Affected / at Risk (%)
Total   17/18 (94.44%) 
Gastrointestinal disorders   
Diarrhoea  1  8/18 (44.44%) 
Vomiting  1  3/18 (16.67%) 
Abdominal pain  1  1/18 (5.56%) 
Dyspepsia  1  1/18 (5.56%) 
General disorders   
Fatigue  1  2/18 (11.11%) 
Gait disturbance  1  1/18 (5.56%) 
Peripheral swelling  1  1/18 (5.56%) 
Pyrexia  1  1/18 (5.56%) 
Infections and infestations   
Respiratory tract infection  1  2/18 (11.11%) 
Cystitis  1  1/18 (5.56%) 
Eczema infected  1  1/18 (5.56%) 
Infected bite  1  1/18 (5.56%) 
Tonsillitis  1  1/18 (5.56%) 
Urinary tract infection  1  1/18 (5.56%) 
Injury, poisoning and procedural complications   
Ligament sprain  1  1/18 (5.56%) 
Toxicity to various agents  1  1/18 (5.56%) 
Investigations   
Eosinophil count increased  1  1/18 (5.56%) 
Gamma-glutamyltransferase increased  1  1/18 (5.56%) 
Haemoglobin decreased  1  1/18 (5.56%) 
Platelet count decreased  1  1/18 (5.56%) 
Weight decreased  1  1/18 (5.56%) 
White blood cell count decreased  1  1/18 (5.56%) 
Metabolism and nutrition disorders   
Hyponatraemia  1  2/18 (11.11%) 
Musculoskeletal and connective tissue disorders   
Back pain  1  1/18 (5.56%) 
Musculoskeletal pain  1  1/18 (5.56%) 
Nervous system disorders   
Somnolence  1  7/18 (38.89%) 
Dizziness  1  4/18 (22.22%) 
Headache  1  4/18 (22.22%) 
Seizure  1  2/18 (11.11%) 
Dysarthria  1  1/18 (5.56%) 
Sedation  1  1/18 (5.56%) 
Psychiatric disorders   
Irritability  1  2/18 (11.11%) 
Abnormal behaviour  1  1/18 (5.56%) 
Affect lability  1  1/18 (5.56%) 
Hallucination, visual  1  1/18 (5.56%) 
Panic attack  1  1/18 (5.56%) 
Tearfulness  1  1/18 (5.56%) 
Respiratory, thoracic and mediastinal disorders   
Asthma  1  1/18 (5.56%) 
Dysphonia  1  1/18 (5.56%) 
Skin and subcutaneous tissue disorders   
Eczema  1  1/18 (5.56%) 
Rash  1  1/18 (5.56%) 
Skin lesion  1  1/18 (5.56%) 
1
Term from vocabulary, MedDRA (18.1)
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Medical Enquiries
Organization: GW Research Ltd
Phone: +44 01223 238170; +18778862810
EMail: medinfo@gwpharm.com, medinfo@greenwichbiosciences.com
Layout table for additonal information
Responsible Party: GW Research Ltd
ClinicalTrials.gov Identifier: NCT02564952     History of Changes
Other Study ID Numbers: GWEP1428 Open-Label Extension
2014-002942-33 ( EudraCT Number )
First Submitted: September 29, 2015
First Posted: October 1, 2015
Results First Submitted: July 11, 2018
Results First Posted: September 11, 2018
Last Update Posted: September 11, 2018