Infantile Spasms
Conditions
Keywords
GWP42003-P, Cannabidiol
Brief summary
This trial consists of 3 parts: a pilot safety phase, a pivotal randomized controlled phase, and an open-label extension phase. The open-label extension phase only will be described in this record. All participants will receive GWP42003-P.
Interventions
DRUGGWP42003-P
Clear, colorless to yellow solution containing cannabidiol dissolved in the excipients sesame oil and anhydrous ethanol with added sweetener (sucralose) and strawberry flavoring.
Sponsors
Jazz Pharmaceuticals
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
Open-label
Eligibility
Sex/Gender
ALL
Age
1 Months to 24 Months
Healthy volunteers
No
Inclusion criteria
Only participants who completed the pilot or pivotal phases of the trial may proceed to take part in this open-label extension phase of the trial. Key eligibility criteria for the blinded phase were as follows: Key Inclusion Criteria: * Participant is diagnosed with IS and has failed to respond adequately following treatment with 1 or more approved IS therapies. Key
Exclusion criteria
* Participant is currently taking or has taken clobazam or any mammalian target of rapamycin (mTOR) inhibitor within the 2 weeks prior to the screening visit. * Participant has a QT interval, corrected for heart rate with Bazett's formula (QTcB), of 460 msec or greater on ECG. * Participant's caregiver is currently giving or has given recreational or medicinal cannabis, or synthetic cannabinoid-based medications, within the 1 month prior to the screening visit. * Participant's caregiver is unwilling to abstain from giving the participant (including the participant's mother abstaining themselves, if breastfeeding)recreational or medicinal cannabis, or synthetic cannabinoid-based medications (other than the study drug) during the trial. * Participant has any known or suspected hypersensitivity to cannabinoids or any of the excipients of the study drug, such as sesame oil. * Participant has significantly impaired hepatic function at the screening visit. * Participant has received an investigational medicinal product as part of a clinical trial within a minimum of 5 half-lives prior to the screening visit.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Severe Treatment-emergent Adverse Events (TEAEs) | From signing of informed consent up to Day 417 | TEAEs were collected in members of the Safety Population, comprised of all participants who received at least 1 dose of GWP42003-P. TEAEs are defined as all adverse events not present prior to the first investigational medicinal product (IMP) or placebo administration or any event already present that worsened in severity or frequency following IMP. |
| Number of Participants With Any Low or High Hematology Laboratory Parameter Value | Days 19, 29, 43, 71, 127, 211, 295, 379, and 389 | — |
| Number of Participants With Any Low or High Biochemistry Laboratory Parameter Value | Days 19, 29, 43, 71, 127, 211, 295, 379, and 389 | — |
| Number of Participants With Any Clinically Relevant Urinalysis Parameter Value | Days 19, 29, 43, 71, 127, 211, 295, 379, and 389 | Clinical relevance was determined by the investigator. |
| Number of Participants With Clinically Significant Electrocardiogram Findings | From signing of informed consent up to Day 389 | Clinical significance was determined by the investigator. |
| Number of Participants With Clinically Significant Vital Sign Findings | From signing of informed consent up to Day 389 | Clinical significance was determined by the investigator. |
| Number of Participants With Clinically Significant Physical Examination Findings | From signing of informed consent up to Day 389 | Clinical significance was determined by the investigator. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Responders | Days 29, 43, 127, 211, 295, and 379 | A responder is defined as a participant experiencing a resolution of hypsarrhythmia and free of spasms. Test for responders was conducted by VEEG for at least 8 hours and up to 24 hours. |
| Percentage of Responders | Days 29, 43, 127, 211, 295, and 379 | A responder is defined as a participant experiencing a resolution of hypsarrhythmia and free of spasms. Test for responders was conducted by VEEG for at least 8 hours and up to 24 hours. |
| Change From Baseline in Height | Baseline (Day 1 of Pilot Study); Days 29, 43, 71, 127, 211, 295, 379, and 389 | A positive change indicates an increase in the average participant's height. A negative change indicates a decrease in the average participant's height. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. |
| Change From Baseline in Body Weight. | Baseline (Day 1 of Pilot Study); Days 29, 43, 71, 127, 211, 295, 379, and 389 | A positive change indicates an increase in the average participant's weight. A negative change indicates a decrease in the average participant's weight. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. |
| Change From Baseline in Head Circumference | Baseline (Day 1 of PIlot Study); Days 29, 43, 71, 127, 211, 295, 379, and 389 | A positive change indicates an increase in the average participant's head circumference. A negative change indicates a decrease in the average participant's head circumference. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. |
| Caregiver Global Impression of Change (CGIC) | Baseline; Days 29, 43, 71, 127, 211, 295, and 379 | The CGIC is a single-question assessment completed by the caregiver. The question assessed the status of the participant's condition since treatment start. The caregiver provided a rating on a 7-point scale: 1, very much improved; 2, much Improved; 3, slightly improved; 4, no change; 5, slightly worse; 6, much worse; 7, very much worse. |
| Number of Participants With Relapse of Spasms | Day 16 to Day 379 | Analysis could not be conducted for this outcome measure because the study met No Go Criteria. The Pilot Phase concluded after 9 participants completed treatment and demonstrated continued hypsarrhythmia and spasms on follow-up VEEG. The Pivotal Phase was not initiated; however, participants completing the Pilot Phase could roll into the Open Label Extension Phase for up to 1 year. |
| Percentage of Participants With Relapse of Spasms | Day 16 to Day 379 | Analysis could not be conducted for this outcome measure because the study met No Go Criteria. The Pilot Phase concluded after 9 participants completed treatment and demonstrated continued hypsarrhythmia and spasms on follow-up VEEG. The Pivotal Phase was not initiated; however, participants completing the Pilot Phase could roll into the Open Label Extension Phase for up to 1 year. |
| Average Time to Cessation of Spasms | Day 1 to Day 379 | Analysis could not be conducted for this outcome measure because the study met No Go Criteria. The Pilot Phase concluded after 9 participants completed treatment and demonstrated continued hypsarrhythmia and spasms on follow-up VEEG. The Pivotal Phase was not initiated; however, participants completing the Pilot Phase could roll into the Open Label Extension Phase for up to 1 year. |
| Average Time to Relapse | Day 16 to Day 379 | Analysis could not be conducted for this outcome measure because the study met No Go Criteria. The Pilot Phase concluded after 9 participants completed treatment and demonstrated continued hypsarrhythmia and spasms on follow-up VEEG. The Pivotal Phase was not initiated; however, participants completing the Pilot Phase could roll into the Open Label Extension Phase for up to 1 year. |
| Change From Baseline in Vineland Adaptive Behavior Scales, Second Edition (Vineland-II) Score | Baseline (Day 1 of Pilot Study); Day 211, Day 379 | The Vineland-II scores were assessed by the participant's caregiver. Caregivers were asked to score questions in the following categories: the participant's communication, daily living, physical activity, problem behaviors, and social skills and relationships. Scoring was slightly different for each section, but generally ranged from usually (2) to never (0). The total score is calculated as the sum of standard scores from the domains and converted into the adaptive behavior composite score (ranging from 20 to 160). Higher scores represent greater levels of functioning, and lower scores represent lower levels of functioning. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. |
| Number of Participants Free of Clinical Spasms | Days 29, 43, 127, 211, 295, and 379 | Clinical spasms were determined by video-electroencephalography (VEEG) for at least 8 hours and up to 24 hours. |
| Percentage of Participants Free of Clinical Spasms | Days 29, 43, 127, 211, 295, and 379 | Clinical spasms were determined by VEEG for at least 8 hours and up to 24 hours. |
| Number of Participants With a Resolution of Hypsarrhythmia | Days 29, 43, 127, 211, 295, and 379 | Resolution of hypsarrhythmia was determined by VEEG for at least 8 hours and up to 24 hours. |
| Percentage of Participants With a Resolution of Hypsarrhythmia | Days 29, 43, 127, 211, 295, and 379 | Resolution of hypsarrhythmia was determined by VEEG for at least 8 hours and up to 24 hours. |
| Number of Participants Experiencing Spasms and Seizures by Subtype | Days 19, 29, 127, 211, 295, and 379 | Caregivers recorded the participant's spasms and seizures by category in a daily diary. Subtypes of spasms and seizure included, clonic, tonic-clonic, myoclonic, focal, and absence. |
| Physician Global Impression of Change (PGIC) | Baseline; Days 29, 43, 71, 127, 211, 295, and 379 | The PGIC is a single-question assessment completed by the investigator. The question assessed the status of the participant's condition since treatment start. The investigator provided a rating on a 7-point scale: 1, very much improved; 2, much Improved; 3, slightly improved; 4, no change; 5, slightly worse; 6, much worse; 7, very much worse. |
Countries
Poland, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| GWP42003-P OS Following completion of the Pilot Phase (NCT02953548), participants were eligible to participate in the Open Label Extension Phase. Participants continued on the same dose administered in the Pilot Phase for a maximum of 1 year and completed a 10-day taper after completing the study or withdrawing. Participants were administered GWP42003-P oral solution (OS) orally, twice daily, or three times daily if poorly tolerated. The dosage was split evenly across the two or three daily administrations to equal the target or most tolerable dose. | 9 |
| Total | 9 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lack of Efficacy | 3 |
| Overall Study | Other | 1 |
| Overall Study | Withdrawal by Subject | 3 |
Baseline characteristics
| Characteristic | GWP42003-P OS |
|---|---|
| Age, Continuous | 12.2 years STANDARD_DEVIATION 5.56 |
| Age, Customized Infants and toddlers (28 days-23 months) | 9 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 8 Participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 9 |
| other Total, other adverse events | 7 / 9 |
| serious Total, serious adverse events | 2 / 9 |
Outcome results
Primary
Number of Participants With Any Clinically Relevant Urinalysis Parameter Value
Clinical relevance was determined by the investigator.
Time frame: Days 19, 29, 43, 71, 127, 211, 295, 379, and 389
Population: Safety Analysis Set. Only participants with evaluable data were analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GWP42003-P OS | Number of Participants With Any Clinically Relevant Urinalysis Parameter Value | Day 19 | 0 Participants |
| GWP42003-P OS | Number of Participants With Any Clinically Relevant Urinalysis Parameter Value | Day 29 | 0 Participants |
| GWP42003-P OS | Number of Participants With Any Clinically Relevant Urinalysis Parameter Value | Day 43 | 0 Participants |
| GWP42003-P OS | Number of Participants With Any Clinically Relevant Urinalysis Parameter Value | Day 71 | 1 Participants |
| GWP42003-P OS | Number of Participants With Any Clinically Relevant Urinalysis Parameter Value | Day 127 | 0 Participants |
| GWP42003-P OS | Number of Participants With Any Clinically Relevant Urinalysis Parameter Value | Day 211 | 0 Participants |
| GWP42003-P OS | Number of Participants With Any Clinically Relevant Urinalysis Parameter Value | Day 295 | 0 Participants |
| GWP42003-P OS | Number of Participants With Any Clinically Relevant Urinalysis Parameter Value | Day 379 | 0 Participants |
| GWP42003-P OS | Number of Participants With Any Clinically Relevant Urinalysis Parameter Value | Day 389 | 0 Participants |
Primary
Number of Participants With Any Low or High Biochemistry Laboratory Parameter Value
Time frame: Days 19, 29, 43, 71, 127, 211, 295, 379, and 389
Population: Safety Analysis Set. Only participants with evaluable data were analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GWP42003-P OS | Number of Participants With Any Low or High Biochemistry Laboratory Parameter Value | Day 19, Low | 6 Participants |
| GWP42003-P OS | Number of Participants With Any Low or High Biochemistry Laboratory Parameter Value | Day 19, High | 7 Participants |
| GWP42003-P OS | Number of Participants With Any Low or High Biochemistry Laboratory Parameter Value | Day 29, Low | 6 Participants |
| GWP42003-P OS | Number of Participants With Any Low or High Biochemistry Laboratory Parameter Value | Day 29, High | 6 Participants |
| GWP42003-P OS | Number of Participants With Any Low or High Biochemistry Laboratory Parameter Value | Day 43, Low | 4 Participants |
| GWP42003-P OS | Number of Participants With Any Low or High Biochemistry Laboratory Parameter Value | Day 43, High | 5 Participants |
| GWP42003-P OS | Number of Participants With Any Low or High Biochemistry Laboratory Parameter Value | Day 71, Low | 2 Participants |
| GWP42003-P OS | Number of Participants With Any Low or High Biochemistry Laboratory Parameter Value | Day 71, High | 4 Participants |
| GWP42003-P OS | Number of Participants With Any Low or High Biochemistry Laboratory Parameter Value | Day 127, Low | 4 Participants |
| GWP42003-P OS | Number of Participants With Any Low or High Biochemistry Laboratory Parameter Value | Day 127, High | 3 Participants |
| GWP42003-P OS | Number of Participants With Any Low or High Biochemistry Laboratory Parameter Value | Day 211, Low | 2 Participants |
| GWP42003-P OS | Number of Participants With Any Low or High Biochemistry Laboratory Parameter Value | Day 211, High | 3 Participants |
| GWP42003-P OS | Number of Participants With Any Low or High Biochemistry Laboratory Parameter Value | Day 295, Low | 2 Participants |
| GWP42003-P OS | Number of Participants With Any Low or High Biochemistry Laboratory Parameter Value | Day 295, High | 3 Participants |
| GWP42003-P OS | Number of Participants With Any Low or High Biochemistry Laboratory Parameter Value | Day 379, Low | 5 Participants |
| GWP42003-P OS | Number of Participants With Any Low or High Biochemistry Laboratory Parameter Value | Day 379, High | 7 Participants |
| GWP42003-P OS | Number of Participants With Any Low or High Biochemistry Laboratory Parameter Value | Day 389, Low | 3 Participants |
| GWP42003-P OS | Number of Participants With Any Low or High Biochemistry Laboratory Parameter Value | Day 389, High | 2 Participants |
Primary
Number of Participants With Any Low or High Hematology Laboratory Parameter Value
Time frame: Days 19, 29, 43, 71, 127, 211, 295, 379, and 389
Population: Safety Analysis Set. Only participants with evaluable data were analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GWP42003-P OS | Number of Participants With Any Low or High Hematology Laboratory Parameter Value | Day 19, Low | 3 Participants |
| GWP42003-P OS | Number of Participants With Any Low or High Hematology Laboratory Parameter Value | Day 19, High | 4 Participants |
| GWP42003-P OS | Number of Participants With Any Low or High Hematology Laboratory Parameter Value | Day 29, Low | 3 Participants |
| GWP42003-P OS | Number of Participants With Any Low or High Hematology Laboratory Parameter Value | Day 29, High | 4 Participants |
| GWP42003-P OS | Number of Participants With Any Low or High Hematology Laboratory Parameter Value | Day 43, Low | 1 Participants |
| GWP42003-P OS | Number of Participants With Any Low or High Hematology Laboratory Parameter Value | Day 43, High | 2 Participants |
| GWP42003-P OS | Number of Participants With Any Low or High Hematology Laboratory Parameter Value | Day 71, Low | 1 Participants |
| GWP42003-P OS | Number of Participants With Any Low or High Hematology Laboratory Parameter Value | Day 71, High | 3 Participants |
| GWP42003-P OS | Number of Participants With Any Low or High Hematology Laboratory Parameter Value | Day 127, Low | 1 Participants |
| GWP42003-P OS | Number of Participants With Any Low or High Hematology Laboratory Parameter Value | Day 127, High | 3 Participants |
| GWP42003-P OS | Number of Participants With Any Low or High Hematology Laboratory Parameter Value | Day 211, Low | 1 Participants |
| GWP42003-P OS | Number of Participants With Any Low or High Hematology Laboratory Parameter Value | Day 211, High | 2 Participants |
| GWP42003-P OS | Number of Participants With Any Low or High Hematology Laboratory Parameter Value | Day 295, Low | 2 Participants |
| GWP42003-P OS | Number of Participants With Any Low or High Hematology Laboratory Parameter Value | Day 295, High | 0 Participants |
| GWP42003-P OS | Number of Participants With Any Low or High Hematology Laboratory Parameter Value | Day 379, Low | 4 Participants |
| GWP42003-P OS | Number of Participants With Any Low or High Hematology Laboratory Parameter Value | Day 379, High | 4 Participants |
| GWP42003-P OS | Number of Participants With Any Low or High Hematology Laboratory Parameter Value | Day 389, Low | 1 Participants |
| GWP42003-P OS | Number of Participants With Any Low or High Hematology Laboratory Parameter Value | Day 389, High | 4 Participants |
Primary
Number of Participants With Clinically Significant Electrocardiogram Findings
Clinical significance was determined by the investigator.
Time frame: From signing of informed consent up to Day 389
Population: Safety Analysis Set
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GWP42003-P OS | Number of Participants With Clinically Significant Electrocardiogram Findings | 0 Participants |
Primary
Number of Participants With Clinically Significant Physical Examination Findings
Clinical significance was determined by the investigator.
Time frame: From signing of informed consent up to Day 389
Population: Safety Analysis Set
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GWP42003-P OS | Number of Participants With Clinically Significant Physical Examination Findings | 0 Participants |
Primary
Number of Participants With Clinically Significant Vital Sign Findings
Clinical significance was determined by the investigator.
Time frame: From signing of informed consent up to Day 389
Population: Safety Analysis Set
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GWP42003-P OS | Number of Participants With Clinically Significant Vital Sign Findings | 0 Participants |
Primary
Number of Participants With Severe Treatment-emergent Adverse Events (TEAEs)
TEAEs were collected in members of the Safety Population, comprised of all participants who received at least 1 dose of GWP42003-P. TEAEs are defined as all adverse events not present prior to the first investigational medicinal product (IMP) or placebo administration or any event already present that worsened in severity or frequency following IMP.
Time frame: From signing of informed consent up to Day 417
Population: Safety Analysis Set: all participants who had received ≥ 1 dose of GWP42003-P
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GWP42003-P OS | Number of Participants With Severe Treatment-emergent Adverse Events (TEAEs) | 7 Participants |
Secondary
Average Time to Cessation of Spasms
Analysis could not be conducted for this outcome measure because the study met No Go Criteria. The Pilot Phase concluded after 9 participants completed treatment and demonstrated continued hypsarrhythmia and spasms on follow-up VEEG. The Pivotal Phase was not initiated; however, participants completing the Pilot Phase could roll into the Open Label Extension Phase for up to 1 year.
Time frame: Day 1 to Day 379
Population: Safety Analysis Set
Secondary
Average Time to Relapse
Analysis could not be conducted for this outcome measure because the study met No Go Criteria. The Pilot Phase concluded after 9 participants completed treatment and demonstrated continued hypsarrhythmia and spasms on follow-up VEEG. The Pivotal Phase was not initiated; however, participants completing the Pilot Phase could roll into the Open Label Extension Phase for up to 1 year.
Time frame: Day 16 to Day 379
Population: Safety Analysis Set
Secondary
Caregiver Global Impression of Change (CGIC)
The CGIC is a single-question assessment completed by the caregiver. The question assessed the status of the participant's condition since treatment start. The caregiver provided a rating on a 7-point scale: 1, very much improved; 2, much Improved; 3, slightly improved; 4, no change; 5, slightly worse; 6, much worse; 7, very much worse.
Time frame: Baseline; Days 29, 43, 71, 127, 211, 295, and 379
Population: Safety Analysis Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GWP42003-P OS | Caregiver Global Impression of Change (CGIC) | Day 29, Very Much Improved | 1 participants |
| GWP42003-P OS | Caregiver Global Impression of Change (CGIC) | Day 29, Much Improved | 1 participants |
| GWP42003-P OS | Caregiver Global Impression of Change (CGIC) | Day 29, Slightly Improved | 5 participants |
| GWP42003-P OS | Caregiver Global Impression of Change (CGIC) | Day 29, No Change | 1 participants |
| GWP42003-P OS | Caregiver Global Impression of Change (CGIC) | Day 29, Slightly Worse | 0 participants |
| GWP42003-P OS | Caregiver Global Impression of Change (CGIC) | Day 29, Much Worse | 0 participants |
| GWP42003-P OS | Caregiver Global Impression of Change (CGIC) | Day 29, Very Much Worse | 0 participants |
| GWP42003-P OS | Caregiver Global Impression of Change (CGIC) | Day 29, Not Done | 0 participants |
| GWP42003-P OS | Caregiver Global Impression of Change (CGIC) | Day 43, Very Much Improved | 2 participants |
| GWP42003-P OS | Caregiver Global Impression of Change (CGIC) | Day 43, Much Improved | 1 participants |
| GWP42003-P OS | Caregiver Global Impression of Change (CGIC) | Day 43, Slightly Improved | 3 participants |
| GWP42003-P OS | Caregiver Global Impression of Change (CGIC) | Day 43, No Change | 0 participants |
| GWP42003-P OS | Caregiver Global Impression of Change (CGIC) | Day 43, Slightly Worse | 0 participants |
| GWP42003-P OS | Caregiver Global Impression of Change (CGIC) | Day 43, Much Worse | 0 participants |
| GWP42003-P OS | Caregiver Global Impression of Change (CGIC) | Day 43, Very Much Worse | 0 participants |
| GWP42003-P OS | Caregiver Global Impression of Change (CGIC) | Day 43, Not Done | 0 participants |
| GWP42003-P OS | Caregiver Global Impression of Change (CGIC) | Day 71, Very Much Improved | 3 participants |
| GWP42003-P OS | Caregiver Global Impression of Change (CGIC) | Day 71, Much Improved | 0 participants |
| GWP42003-P OS | Caregiver Global Impression of Change (CGIC) | Day 71, Slightly Improved | 1 participants |
| GWP42003-P OS | Caregiver Global Impression of Change (CGIC) | Day 71 No Change | 0 participants |
| GWP42003-P OS | Caregiver Global Impression of Change (CGIC) | Day 71, Slightly Worse | 1 participants |
| GWP42003-P OS | Caregiver Global Impression of Change (CGIC) | Day 71, Much Worse | 0 participants |
| GWP42003-P OS | Caregiver Global Impression of Change (CGIC) | Day 71, Very Much Worse | 0 participants |
| GWP42003-P OS | Caregiver Global Impression of Change (CGIC) | Day 71, Not Done | 0 participants |
| GWP42003-P OS | Caregiver Global Impression of Change (CGIC) | Day 127, Very Much Improved | 2 participants |
| GWP42003-P OS | Caregiver Global Impression of Change (CGIC) | Day 127, Much Improved | 2 participants |
| GWP42003-P OS | Caregiver Global Impression of Change (CGIC) | Day 127, Slightly Improved | 0 participants |
| GWP42003-P OS | Caregiver Global Impression of Change (CGIC) | Day 127, No Change | 0 participants |
| GWP42003-P OS | Caregiver Global Impression of Change (CGIC) | Day 127, Slightly Worse | 0 participants |
| GWP42003-P OS | Caregiver Global Impression of Change (CGIC) | Day 127, Much Worse | 0 participants |
| GWP42003-P OS | Caregiver Global Impression of Change (CGIC) | Day 127, Very Much Worse | 0 participants |
| GWP42003-P OS | Caregiver Global Impression of Change (CGIC) | Day 127, Not Done | 0 participants |
| GWP42003-P OS | Caregiver Global Impression of Change (CGIC) | Day 211, Very Much Improved | 1 participants |
| GWP42003-P OS | Caregiver Global Impression of Change (CGIC) | Day 211, Much Improved | 2 participants |
| GWP42003-P OS | Caregiver Global Impression of Change (CGIC) | Day 211, Slightly Improved | 0 participants |
| GWP42003-P OS | Caregiver Global Impression of Change (CGIC) | Day 211, No Change | 0 participants |
| GWP42003-P OS | Caregiver Global Impression of Change (CGIC) | Day 211, Slightly Worse | 0 participants |
| GWP42003-P OS | Caregiver Global Impression of Change (CGIC) | Day 211, Much Worse | 0 participants |
| GWP42003-P OS | Caregiver Global Impression of Change (CGIC) | Day 211, Very Much Worse | 0 participants |
| GWP42003-P OS | Caregiver Global Impression of Change (CGIC) | Day 211, Not Done | 0 participants |
| GWP42003-P OS | Caregiver Global Impression of Change (CGIC) | Day 295, Very Much Improved | 1 participants |
| GWP42003-P OS | Caregiver Global Impression of Change (CGIC) | Day 295, Much Improved | 2 participants |
| GWP42003-P OS | Caregiver Global Impression of Change (CGIC) | Day 295, Slightly Improved | 0 participants |
| GWP42003-P OS | Caregiver Global Impression of Change (CGIC) | Day 295, No Change | 0 participants |
| GWP42003-P OS | Caregiver Global Impression of Change (CGIC) | Day 295, Slightly Worse | 0 participants |
| GWP42003-P OS | Caregiver Global Impression of Change (CGIC) | Day 295, Much Worse | 0 participants |
| GWP42003-P OS | Caregiver Global Impression of Change (CGIC) | Day 295, Very Much Worse | 0 participants |
| GWP42003-P OS | Caregiver Global Impression of Change (CGIC) | Day 295, Not Done | 0 participants |
| GWP42003-P OS | Caregiver Global Impression of Change (CGIC) | Day 379, Very Much Improved | 2 participants |
| GWP42003-P OS | Caregiver Global Impression of Change (CGIC) | Day 379, Much Improved | 1 participants |
| GWP42003-P OS | Caregiver Global Impression of Change (CGIC) | Day 379, Slightly Improved | 3 participants |
| GWP42003-P OS | Caregiver Global Impression of Change (CGIC) | Day 379, No Change | 0 participants |
| GWP42003-P OS | Caregiver Global Impression of Change (CGIC) | Day 379, Slightly Worse | 1 participants |
| GWP42003-P OS | Caregiver Global Impression of Change (CGIC) | Day 379, Much Worse | 1 participants |
| GWP42003-P OS | Caregiver Global Impression of Change (CGIC) | Day 379, Very Much Worse | 0 participants |
| GWP42003-P OS | Caregiver Global Impression of Change (CGIC) | Day 379, Not Done | 1 participants |
Secondary
Change From Baseline in Body Weight.
A positive change indicates an increase in the average participant's weight. A negative change indicates a decrease in the average participant's weight. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Time frame: Baseline (Day 1 of Pilot Study); Days 29, 43, 71, 127, 211, 295, 379, and 389
Population: Safety Analysis Set. Only participants with evaluable data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GWP42003-P OS | Change From Baseline in Body Weight. | Baseline (Day 1 of Pilot Study) | 9.92 kilograms | Standard Deviation 3.245 |
| GWP42003-P OS | Change From Baseline in Body Weight. | Day 29, OLE | 0.39 kilograms | Standard Deviation 0.309 |
| GWP42003-P OS | Change From Baseline in Body Weight. | Day 43, OLE | 0.75 kilograms | Standard Deviation 0.809 |
| GWP42003-P OS | Change From Baseline in Body Weight. | Day 71, OLE | 1.10 kilograms | Standard Deviation 0.43 |
| GWP42003-P OS | Change From Baseline in Body Weight. | Day 127, OLE | 1.25 kilograms | Standard Deviation 0.42 |
| GWP42003-P OS | Change From Baseline in Body Weight. | Day 211, OLE | 1.17 kilograms | Standard Deviation 0.503 |
| GWP42003-P OS | Change From Baseline in Body Weight. | Day 295, OLE | 2.10 kilograms | Standard Deviation 0.889 |
| GWP42003-P OS | Change From Baseline in Body Weight. | Day 379, OLE | 1.19 kilograms | Standard Deviation 0.862 |
| GWP42003-P OS | Change From Baseline in Body Weight. | Day 389, OLE | 0.98 kilograms | Standard Deviation 0.637 |
Secondary
Change From Baseline in Head Circumference
A positive change indicates an increase in the average participant's head circumference. A negative change indicates a decrease in the average participant's head circumference. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Time frame: Baseline (Day 1 of PIlot Study); Days 29, 43, 71, 127, 211, 295, 379, and 389
Population: Safety Analysis Set. Only participants with evaluable data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GWP42003-P OS | Change From Baseline in Head Circumference | Baseline (Day 1 of Pilot Study) | 44.71 centimeters | Standard Deviation 2.724 |
| GWP42003-P OS | Change From Baseline in Head Circumference | Day 29, OLE | -0.01 centimeters | Standard Deviation 1.229 |
| GWP42003-P OS | Change From Baseline in Head Circumference | Day 43, OLE | 0.54 centimeters | Standard Deviation 0.288 |
| GWP42003-P OS | Change From Baseline in Head Circumference | Day 71, OLE | 0.70 centimeters | Standard Deviation 0.57 |
| GWP42003-P OS | Change From Baseline in Head Circumference | Day 127, OLE | 1.50 centimeters | Standard Deviation 0.5 |
| GWP42003-P OS | Change From Baseline in Head Circumference | Day 211, OLE | 0.75 centimeters | Standard Deviation 0.354 |
| GWP42003-P OS | Change From Baseline in Head Circumference | Day 295, OLE | -0.3 centimeters | Standard Deviation 2.31 |
| GWP42003-P OS | Change From Baseline in Head Circumference | Day 379, OLE | 1.14 centimeters | Standard Deviation 1.707 |
| GWP42003-P OS | Change From Baseline in Head Circumference | Day 389, OLE | 0.90 centimeters | Standard Deviation 1.782 |
Secondary
Change From Baseline in Height
A positive change indicates an increase in the average participant's height. A negative change indicates a decrease in the average participant's height. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Time frame: Baseline (Day 1 of Pilot Study); Days 29, 43, 71, 127, 211, 295, 379, and 389
Population: Safety Analysis Set. Only participants with evaluable data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GWP42003-P OS | Change From Baseline in Height | Baseline (Day 1 of Pilot Study) | 75.04 centimeters | Standard Deviation 9.557 |
| GWP42003-P OS | Change From Baseline in Height | Day 29, Open-label Extension (OLE) | 0.85 centimeters | Standard Deviation 0.98 |
| GWP42003-P OS | Change From Baseline in Height | Day 43, OLE | 0.92 centimeters | Standard Deviation 1.53 |
| GWP42003-P OS | Change From Baseline in Height | Day 71, OLE | 3.10 centimeters | Standard Deviation 0.652 |
| GWP42003-P OS | Change From Baseline in Height | Day 127, OLE | 3.38 centimeters | Standard Deviation 1.377 |
| GWP42003-P OS | Change From Baseline in Height | Day 211, OLE | 5.33 centimeters | Standard Deviation 1.258 |
| GWP42003-P OS | Change From Baseline in Height | Day 295, OLE | 8.17 centimeters | Standard Deviation 1.528 |
| GWP42003-P OS | Change From Baseline in Height | Day 379, OLE | 5.31 centimeters | Standard Deviation 4.036 |
| GWP42003-P OS | Change From Baseline in Height | Day 389, OLE | 3.55 centimeters | Standard Deviation 4.085 |
Secondary
Change From Baseline in Vineland Adaptive Behavior Scales, Second Edition (Vineland-II) Score
The Vineland-II scores were assessed by the participant's caregiver. Caregivers were asked to score questions in the following categories: the participant's communication, daily living, physical activity, problem behaviors, and social skills and relationships. Scoring was slightly different for each section, but generally ranged from usually (2) to never (0). The total score is calculated as the sum of standard scores from the domains and converted into the adaptive behavior composite score (ranging from 20 to 160). Higher scores represent greater levels of functioning, and lower scores represent lower levels of functioning. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Time frame: Baseline (Day 1 of Pilot Study); Day 211, Day 379
Population: Safety Analysis Set. Only participants with evaluable data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GWP42003-P OS | Change From Baseline in Vineland Adaptive Behavior Scales, Second Edition (Vineland-II) Score | Baseline, Day 1 of Pilot Study | 33.6 score on a scale | Standard Deviation 37.27 |
| GWP42003-P OS | Change From Baseline in Vineland Adaptive Behavior Scales, Second Edition (Vineland-II) Score | Day 211 of OLE | 6.3 score on a scale | Standard Deviation 3.51 |
| GWP42003-P OS | Change From Baseline in Vineland Adaptive Behavior Scales, Second Edition (Vineland-II) Score | Day 379 of OLE | -5.4 score on a scale | Standard Deviation 23.42 |
Secondary
Number of Participants Experiencing Spasms and Seizures by Subtype
Caregivers recorded the participant's spasms and seizures by category in a daily diary. Subtypes of spasms and seizure included, clonic, tonic-clonic, myoclonic, focal, and absence.
Time frame: Days 19, 29, 127, 211, 295, and 379
Population: Safety Analysis Set
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GWP42003-P OS | Number of Participants Experiencing Spasms and Seizures by Subtype | Day 379, Focal | 1 Participants |
| GWP42003-P OS | Number of Participants Experiencing Spasms and Seizures by Subtype | Day 19, Clonic | 0 Participants |
| GWP42003-P OS | Number of Participants Experiencing Spasms and Seizures by Subtype | Day 19, Tonic-Clonic | 0 Participants |
| GWP42003-P OS | Number of Participants Experiencing Spasms and Seizures by Subtype | Day 19, Atonic | 0 Participants |
| GWP42003-P OS | Number of Participants Experiencing Spasms and Seizures by Subtype | Day 19, Myoclonic | 0 Participants |
| GWP42003-P OS | Number of Participants Experiencing Spasms and Seizures by Subtype | Day 19, Focal | 1 Participants |
| GWP42003-P OS | Number of Participants Experiencing Spasms and Seizures by Subtype | Day 19, Absence | 0 Participants |
| GWP42003-P OS | Number of Participants Experiencing Spasms and Seizures by Subtype | Day 19, Not Done | 0 Participants |
| GWP42003-P OS | Number of Participants Experiencing Spasms and Seizures by Subtype | Day 29, Clonic | 0 Participants |
| GWP42003-P OS | Number of Participants Experiencing Spasms and Seizures by Subtype | Day 29, Tonic-Clonic | 0 Participants |
| GWP42003-P OS | Number of Participants Experiencing Spasms and Seizures by Subtype | Day 29, Atonic | 0 Participants |
| GWP42003-P OS | Number of Participants Experiencing Spasms and Seizures by Subtype | Day 29, Myoclonic | 0 Participants |
| GWP42003-P OS | Number of Participants Experiencing Spasms and Seizures by Subtype | Day 29, Focal | 1 Participants |
| GWP42003-P OS | Number of Participants Experiencing Spasms and Seizures by Subtype | Day 29, Absence | 0 Participants |
| GWP42003-P OS | Number of Participants Experiencing Spasms and Seizures by Subtype | Day 29, Not Done | 0 Participants |
| GWP42003-P OS | Number of Participants Experiencing Spasms and Seizures by Subtype | Day 127, Clonic | 0 Participants |
| GWP42003-P OS | Number of Participants Experiencing Spasms and Seizures by Subtype | Day 127, Tonic-Clonic | 1 Participants |
| GWP42003-P OS | Number of Participants Experiencing Spasms and Seizures by Subtype | Day 127, Atonic | 0 Participants |
| GWP42003-P OS | Number of Participants Experiencing Spasms and Seizures by Subtype | Day 127, Myoclonic | 1 Participants |
| GWP42003-P OS | Number of Participants Experiencing Spasms and Seizures by Subtype | Day 127, Focal | 0 Participants |
| GWP42003-P OS | Number of Participants Experiencing Spasms and Seizures by Subtype | Day 127, Absence | 1 Participants |
| GWP42003-P OS | Number of Participants Experiencing Spasms and Seizures by Subtype | Day 127, No Done | 0 Participants |
| GWP42003-P OS | Number of Participants Experiencing Spasms and Seizures by Subtype | Day 211, Clonic | 0 Participants |
| GWP42003-P OS | Number of Participants Experiencing Spasms and Seizures by Subtype | Day 211, Tonic-Clonic | 1 Participants |
| GWP42003-P OS | Number of Participants Experiencing Spasms and Seizures by Subtype | Day 211, Atonic | 0 Participants |
| GWP42003-P OS | Number of Participants Experiencing Spasms and Seizures by Subtype | Day 211, Myoclonic | 0 Participants |
| GWP42003-P OS | Number of Participants Experiencing Spasms and Seizures by Subtype | Day 211, Focal | 0 Participants |
| GWP42003-P OS | Number of Participants Experiencing Spasms and Seizures by Subtype | Day 211, Absence | 1 Participants |
| GWP42003-P OS | Number of Participants Experiencing Spasms and Seizures by Subtype | Day 211, Not Done | 0 Participants |
| GWP42003-P OS | Number of Participants Experiencing Spasms and Seizures by Subtype | Day 295, Clonic | 0 Participants |
| GWP42003-P OS | Number of Participants Experiencing Spasms and Seizures by Subtype | Day 295, Tonic-Clonic | 1 Participants |
| GWP42003-P OS | Number of Participants Experiencing Spasms and Seizures by Subtype | Day 295, Atonic | 1 Participants |
| GWP42003-P OS | Number of Participants Experiencing Spasms and Seizures by Subtype | Day 295, Myoclonic | 0 Participants |
| GWP42003-P OS | Number of Participants Experiencing Spasms and Seizures by Subtype | Day 295, Focal | 0 Participants |
| GWP42003-P OS | Number of Participants Experiencing Spasms and Seizures by Subtype | Day 295, Absence | 1 Participants |
| GWP42003-P OS | Number of Participants Experiencing Spasms and Seizures by Subtype | Day 295, Not Done | 0 Participants |
| GWP42003-P OS | Number of Participants Experiencing Spasms and Seizures by Subtype | Day 379, Clonic | 1 Participants |
| GWP42003-P OS | Number of Participants Experiencing Spasms and Seizures by Subtype | Day 379, Tonic-Clonic | 1 Participants |
| GWP42003-P OS | Number of Participants Experiencing Spasms and Seizures by Subtype | Day 379, Atonic | 0 Participants |
| GWP42003-P OS | Number of Participants Experiencing Spasms and Seizures by Subtype | Day 379, Myoclonic | 0 Participants |
| GWP42003-P OS | Number of Participants Experiencing Spasms and Seizures by Subtype | Day 379, Absence | 1 Participants |
| GWP42003-P OS | Number of Participants Experiencing Spasms and Seizures by Subtype | Day 379, Not Done | 0 Participants |
Secondary
Number of Participants Free of Clinical Spasms
Clinical spasms were determined by video-electroencephalography (VEEG) for at least 8 hours and up to 24 hours.
Time frame: Days 29, 43, 127, 211, 295, and 379
Population: Safety Analysis Set. Only participants with evaluable data were analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GWP42003-P OS | Number of Participants Free of Clinical Spasms | Day 29 | 1 Participants |
| GWP42003-P OS | Number of Participants Free of Clinical Spasms | Day 43 | 2 Participants |
| GWP42003-P OS | Number of Participants Free of Clinical Spasms | Day 127 | 1 Participants |
| GWP42003-P OS | Number of Participants Free of Clinical Spasms | Day 211 | 1 Participants |
| GWP42003-P OS | Number of Participants Free of Clinical Spasms | Day 295 | 1 Participants |
| GWP42003-P OS | Number of Participants Free of Clinical Spasms | Day 379 | 3 Participants |
Secondary
Number of Participants With a Resolution of Hypsarrhythmia
Resolution of hypsarrhythmia was determined by VEEG for at least 8 hours and up to 24 hours.
Time frame: Days 29, 43, 127, 211, 295, and 379
Population: Safety Analysis Set. Only participants with evaluable data were analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GWP42003-P OS | Number of Participants With a Resolution of Hypsarrhythmia | Day 29 | 1 Participants |
| GWP42003-P OS | Number of Participants With a Resolution of Hypsarrhythmia | Day 43 | 0 Participants |
| GWP42003-P OS | Number of Participants With a Resolution of Hypsarrhythmia | Day 127 | 1 Participants |
| GWP42003-P OS | Number of Participants With a Resolution of Hypsarrhythmia | Day 211 | 0 Participants |
| GWP42003-P OS | Number of Participants With a Resolution of Hypsarrhythmia | Day 295 | 1 Participants |
| GWP42003-P OS | Number of Participants With a Resolution of Hypsarrhythmia | Day 379 | 3 Participants |
Secondary
Number of Participants With Relapse of Spasms
Analysis could not be conducted for this outcome measure because the study met No Go Criteria. The Pilot Phase concluded after 9 participants completed treatment and demonstrated continued hypsarrhythmia and spasms on follow-up VEEG. The Pivotal Phase was not initiated; however, participants completing the Pilot Phase could roll into the Open Label Extension Phase for up to 1 year.
Time frame: Day 16 to Day 379
Population: Safety Analysis Set
Secondary
Number of Responders
A responder is defined as a participant experiencing a resolution of hypsarrhythmia and free of spasms. Test for responders was conducted by VEEG for at least 8 hours and up to 24 hours.
Time frame: Days 29, 43, 127, 211, 295, and 379
Population: Safety Analysis Set. Only participants with evaluable data were analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GWP42003-P OS | Number of Responders | Day 29 | 1 Participants |
| GWP42003-P OS | Number of Responders | Day 43 | 0 Participants |
| GWP42003-P OS | Number of Responders | Day 127 | 0 Participants |
| GWP42003-P OS | Number of Responders | Day 211 | 0 Participants |
| GWP42003-P OS | Number of Responders | Day 295 | 1 Participants |
| GWP42003-P OS | Number of Responders | Day 379 | 3 Participants |
Secondary
Percentage of Participants Free of Clinical Spasms
Clinical spasms were determined by VEEG for at least 8 hours and up to 24 hours.
Time frame: Days 29, 43, 127, 211, 295, and 379
Population: Safety Analysis Set. Only participants with evaluable data were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GWP42003-P OS | Percentage of Participants Free of Clinical Spasms | Day 29 | 11.1 percentage of participants |
| GWP42003-P OS | Percentage of Participants Free of Clinical Spasms | Day 43 | 22.2 percentage of participants |
| GWP42003-P OS | Percentage of Participants Free of Clinical Spasms | Day 127 | 11.1 percentage of participants |
| GWP42003-P OS | Percentage of Participants Free of Clinical Spasms | Day 211 | 11.1 percentage of participants |
| GWP42003-P OS | Percentage of Participants Free of Clinical Spasms | Day 295 | 11.1 percentage of participants |
| GWP42003-P OS | Percentage of Participants Free of Clinical Spasms | Day 379 | 33.3 percentage of participants |
Secondary
Percentage of Participants With a Resolution of Hypsarrhythmia
Resolution of hypsarrhythmia was determined by VEEG for at least 8 hours and up to 24 hours.
Time frame: Days 29, 43, 127, 211, 295, and 379
Population: Safety Analysis Set. Only participants with evaluable data were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GWP42003-P OS | Percentage of Participants With a Resolution of Hypsarrhythmia | Day 29 | 11.1 percentage of participants |
| GWP42003-P OS | Percentage of Participants With a Resolution of Hypsarrhythmia | Day 43 | 0 percentage of participants |
| GWP42003-P OS | Percentage of Participants With a Resolution of Hypsarrhythmia | Day 127 | 11.1 percentage of participants |
| GWP42003-P OS | Percentage of Participants With a Resolution of Hypsarrhythmia | Day 211 | 0 percentage of participants |
| GWP42003-P OS | Percentage of Participants With a Resolution of Hypsarrhythmia | Day 295 | 11.1 percentage of participants |
| GWP42003-P OS | Percentage of Participants With a Resolution of Hypsarrhythmia | Day 379 | 33.3 percentage of participants |
Secondary
Percentage of Participants With Relapse of Spasms
Analysis could not be conducted for this outcome measure because the study met No Go Criteria. The Pilot Phase concluded after 9 participants completed treatment and demonstrated continued hypsarrhythmia and spasms on follow-up VEEG. The Pivotal Phase was not initiated; however, participants completing the Pilot Phase could roll into the Open Label Extension Phase for up to 1 year.
Time frame: Day 16 to Day 379
Population: Safety Analysis Set
Secondary
Percentage of Responders
A responder is defined as a participant experiencing a resolution of hypsarrhythmia and free of spasms. Test for responders was conducted by VEEG for at least 8 hours and up to 24 hours.
Time frame: Days 29, 43, 127, 211, 295, and 379
Population: Safety Analysis Set. Only participants with evaluable data were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GWP42003-P OS | Percentage of Responders | Day 29 | 11.1 percentage of participants |
| GWP42003-P OS | Percentage of Responders | Day 43 | 0 percentage of participants |
| GWP42003-P OS | Percentage of Responders | Day 127 | 0 percentage of participants |
| GWP42003-P OS | Percentage of Responders | Day 211 | 0 percentage of participants |
| GWP42003-P OS | Percentage of Responders | Day 295 | 11.1 percentage of participants |
| GWP42003-P OS | Percentage of Responders | Day 379 | 33.3 percentage of participants |
Secondary
Physician Global Impression of Change (PGIC)
The PGIC is a single-question assessment completed by the investigator. The question assessed the status of the participant's condition since treatment start. The investigator provided a rating on a 7-point scale: 1, very much improved; 2, much Improved; 3, slightly improved; 4, no change; 5, slightly worse; 6, much worse; 7, very much worse.
Time frame: Baseline; Days 29, 43, 71, 127, 211, 295, and 379
Population: Safety Analysis Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GWP42003-P OS | Physician Global Impression of Change (PGIC) | Day 29, Very Much Improved | 1 participants |
| GWP42003-P OS | Physician Global Impression of Change (PGIC) | Day 29, Much Improved | 1 participants |
| GWP42003-P OS | Physician Global Impression of Change (PGIC) | Day 29, Slightly Improved | 2 participants |
| GWP42003-P OS | Physician Global Impression of Change (PGIC) | Day 29, No Change | 4 participants |
| GWP42003-P OS | Physician Global Impression of Change (PGIC) | Day 29, Slightly Worse | 0 participants |
| GWP42003-P OS | Physician Global Impression of Change (PGIC) | Day 29, Much Worse | 0 participants |
| GWP42003-P OS | Physician Global Impression of Change (PGIC) | Day 29, Very Much Worse | 0 participants |
| GWP42003-P OS | Physician Global Impression of Change (PGIC) | Day 29, Not Done | 0 participants |
| GWP42003-P OS | Physician Global Impression of Change (PGIC) | Day 43, Very Much Improved | 1 participants |
| GWP42003-P OS | Physician Global Impression of Change (PGIC) | Day 43, Much Improved | 0 participants |
| GWP42003-P OS | Physician Global Impression of Change (PGIC) | Day 43, Slightly Improved | 4 participants |
| GWP42003-P OS | Physician Global Impression of Change (PGIC) | Day 43, No Change | 1 participants |
| GWP42003-P OS | Physician Global Impression of Change (PGIC) | Day 43, Slightly Worse | 0 participants |
| GWP42003-P OS | Physician Global Impression of Change (PGIC) | Day 43, Much Worse | 0 participants |
| GWP42003-P OS | Physician Global Impression of Change (PGIC) | Day 43, Very Much Worse | 0 participants |
| GWP42003-P OS | Physician Global Impression of Change (PGIC) | Day 43, Not Done | 0 participants |
| GWP42003-P OS | Physician Global Impression of Change (PGIC) | Day 71, Very Much Improved | 1 participants |
| GWP42003-P OS | Physician Global Impression of Change (PGIC) | Day 71, Much Improved | 2 participants |
| GWP42003-P OS | Physician Global Impression of Change (PGIC) | Day 71, Slightly Improved | 1 participants |
| GWP42003-P OS | Physician Global Impression of Change (PGIC) | Day 71, No Change | 1 participants |
| GWP42003-P OS | Physician Global Impression of Change (PGIC) | Day 71, Slightly Worse | 0 participants |
| GWP42003-P OS | Physician Global Impression of Change (PGIC) | Day 71, Much Worse | 0 participants |
| GWP42003-P OS | Physician Global Impression of Change (PGIC) | Day 71, Very Much Worse | 0 participants |
| GWP42003-P OS | Physician Global Impression of Change (PGIC) | Day 71, Not Done | 0 participants |
| GWP42003-P OS | Physician Global Impression of Change (PGIC) | Day 127, Very Much Improved | 1 participants |
| GWP42003-P OS | Physician Global Impression of Change (PGIC) | Day 127, Much Improved | 2 participants |
| GWP42003-P OS | Physician Global Impression of Change (PGIC) | Day 127, Slightly Improved | 1 participants |
| GWP42003-P OS | Physician Global Impression of Change (PGIC) | Day 127, No Change | 0 participants |
| GWP42003-P OS | Physician Global Impression of Change (PGIC) | Day 127, Slightly Worse | 0 participants |
| GWP42003-P OS | Physician Global Impression of Change (PGIC) | Day 127, Much Worse | 0 participants |
| GWP42003-P OS | Physician Global Impression of Change (PGIC) | Day 127, Very Much Worse | 0 participants |
| GWP42003-P OS | Physician Global Impression of Change (PGIC) | Day 127, Not Done | 0 participants |
| GWP42003-P OS | Physician Global Impression of Change (PGIC) | Day 211, Very Much Improved | 0 participants |
| GWP42003-P OS | Physician Global Impression of Change (PGIC) | Day 211, Much Improved | 1 participants |
| GWP42003-P OS | Physician Global Impression of Change (PGIC) | Day 211, Slightly Improved | 1 participants |
| GWP42003-P OS | Physician Global Impression of Change (PGIC) | Day 211, No Change | 1 participants |
| GWP42003-P OS | Physician Global Impression of Change (PGIC) | Day 211, Slightly Worse | 0 participants |
| GWP42003-P OS | Physician Global Impression of Change (PGIC) | Day 211, Much Worse | 0 participants |
| GWP42003-P OS | Physician Global Impression of Change (PGIC) | Day 211, Very Much Worse | 0 participants |
| GWP42003-P OS | Physician Global Impression of Change (PGIC) | Day 211, Not Done | 0 participants |
| GWP42003-P OS | Physician Global Impression of Change (PGIC) | Day 295, Very Much Improved | 0 participants |
| GWP42003-P OS | Physician Global Impression of Change (PGIC) | Day 295, Much Improved | 1 participants |
| GWP42003-P OS | Physician Global Impression of Change (PGIC) | Day 295, Slightly Improved | 0 participants |
| GWP42003-P OS | Physician Global Impression of Change (PGIC) | Day 295, No Change | 1 participants |
| GWP42003-P OS | Physician Global Impression of Change (PGIC) | Day 295, Slightly Worse | 0 participants |
| GWP42003-P OS | Physician Global Impression of Change (PGIC) | Day 295, Much Worse | 1 participants |
| GWP42003-P OS | Physician Global Impression of Change (PGIC) | Day 295, Very Much Worse | 0 participants |
| GWP42003-P OS | Physician Global Impression of Change (PGIC) | Day 295, Not Done | 0 participants |
| GWP42003-P OS | Physician Global Impression of Change (PGIC) | Day 379, Very Much Improved | 0 participants |
| GWP42003-P OS | Physician Global Impression of Change (PGIC) | Day 379, Much Improved | 1 participants |
| GWP42003-P OS | Physician Global Impression of Change (PGIC) | Day 379, Slightly Improved | 3 participants |
| GWP42003-P OS | Physician Global Impression of Change (PGIC) | Day 379, No Change | 2 participants |
| GWP42003-P OS | Physician Global Impression of Change (PGIC) | Day 379, Slightly Worse | 1 participants |
| GWP42003-P OS | Physician Global Impression of Change (PGIC) | Day 379, Much Worse | 1 participants |
| GWP42003-P OS | Physician Global Impression of Change (PGIC) | Day 379, Very Much Worse | 0 participants |
| GWP42003-P OS | Physician Global Impression of Change (PGIC) | Day 379, Not Done | 1 participants |