A RANDOMIZED DOUBLE-BLIND TRIAL, USING A SINGLE-BLIND RUN-IN TO ASSESS WITHDRAWAL SYMPTOMS AFTER PROLONGED TREATMENT WITH CANNABIDIOL (GWP42003-P)

Completed

• Conditions: epilepsy; 10039911

• Registration Number: NL-OMON42668
• Lead Sponsor: PRA International EDS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 30

Inclusion Criteria

- healthy male/ female subjects
- 18-45 yrs, inclusive
- BMI: 18.0-28.0 kg/m2, inclusive

Exclusion Criteria

Suffering from hepatitis B, hepatitis C, cancer or HIV/AIDS. In case of participation in another drug study within 90 days before the start of this study or being a blood donor within 60 days from the start of the study. In case of donating more than 1.5 liters of blood (for men) / 1.0 liters of blood (for women) in the 10 months prior the start of this study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To assess the occurrence of withdrawal symptoms induced by GWP42003-P using:<br /><br>- cannabis withdrawal scale<br /><br>- penn physician withdrawal checklist</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The safety and tolerability of GWP42003-P will be assessed with respect to:<br /><br>- adverse events<br /><br>- vital signs<br /><br>- ECG<br /><br>- Clinical laboratory parameters<br /><br>- physical examination<br /><br>- C-SSRS<br /><br>- NRS<br /><br>- ESS<br /><br>- C-SSRS<br /><br>- HAM-D</p><br>