TerminatedNCT04203498RELEASE MSS3Updated May 8, 2024Results posted

Safety and Effectiveness of Nabiximols Oromucosal Spray as Add-on Therapy in Participants With Spasticity Due to Multiple Sclerosis

A Phase 3 interventional study of Nabiximols and Placebo in Multiple Sclerosis (MS), sponsored by Jazz Pharmaceuticals. Terminated at 37 sites in 5 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-05-08.

Sponsored by Jazz Pharmaceuticals · Phase 3, Interventional, and Treatment

Why this study was terminated

This study was terminated based on a business decision by the Sponsor.

Phase: Phase 3
Study type: Interventional
Enrollment: 139
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study summary

This trial is being conducted to demonstrate the efficacy of nabiximols, compared with placebo, when added to standard of care, in the treatment of muscle spasms associated with multiple sclerosis (MS).

Read the detailed description

This multicenter, double-blind, placebo-controlled trial includes a 28-day Baseline period, a 12-week treatment period (comprising a 2-week titration phase and a 10-week maintenance phase), and 2-week follow-up period.

Eligible participants will enter the 28-day baseline period. During baseline, participants will maintain their optimized oral MS antispasticity medication regimen and record spasm count using an electronic daily diary. At screening (Day 1), eligible participants will be randomized to either nabiximols or placebo in a 1:1 ratio.

Participants will be advised to titrate the investigational medicinal product (IMP), beginning with 1 spray/day, to an optimized dose or to a maximum of 12 sprays/day over the first 14 days of treatment. Participants may leave a gap between sprays of approximately 15 minutes. Participants should continue at the same dose level achieved at the end of the titration phase ±1 spray divided into a morning dose and an evening dose for the remainder of the treatment period.

Daily spasm count, the participant's symptom experiences, clinician's assessment of spasticity, functional outcomes, health-related quality of life, changes in mood, safety, tolerability, and pharmacokinetics will be evaluated during the treatment period.

Participants who complete the trial will participate for a total of approximately 18 weeks (127 days), including the 28-day baseline period. Participants will have a maximum duration of 85 (±7) days on IMP treatment.

Conditions studied

Multiple Sclerosis (MS)

Browse trials for

Keywords

Spasticity

In context

Muscle Spasticity

703 studies on the registry are indexed under Muscle Spasticity; 148 are open to participants now.

This study's enrollment of 139 is above the median of 36 across 524 interventional studies indexed under Muscle Spasticity.

Browse Muscle Spasticity studies →

Lead sponsor

Jazz Pharmaceuticals is the lead sponsor of 167 studies on the registry; 20 are open to participants now.

Of its 39 completed or terminated interventional studies of FDA-regulated products, 28 (72%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Criteria at screening:

Participant is male or female aged 18 years or above.
Participant has had a diagnosis with any disease subtype of multiple sclerosis (MS), by revised 2017 McDonald criteria, for at least 12 months prior to screening and is expected to remain stable for the duration of the trial.
Participant has had treatment with at least 1 optimized oral antispasticity therapy prior to Visit 1 that must include either oral baclofen or oral tizanidine (monotherapy or combination therapy).
Participant is currently receiving optimized treatment with at least 1 oral antispasticity medication (baclofen, tizanidine, and/or dantrolene) and has been stable for at least 30 days prior to screening.
If the participant is currently receiving an approved MS disease-modifying therapy, it must be at a stable dose for at least 3 months prior to screening and is expected to remain stable for the duration of the trial.

Exclusion criteria

Exclusion Criteria:

Participant has any concomitant disease or disorder that has spasticity-like symptoms or that may influence the participant's level of spasticity.
Participant has had a relapse of MS within the 60 days prior to screening (Visit 1).
Participant is currently using or has used cannabis or a cannabinoid-derived product for medicinal or recreational use (within 30 days of screening) and is unwilling to abstain for the duration of the trial.
Participant is currently using botulinum toxin injection for the relief of spasticity (within 6 months of screening) and is unwilling to abstain for the duration of the trial.
Participant has any known or suspected hypersensitivity to cannabinoids or any of the excipients of the IMP.
Participant is male and fertile unless willing to ensure that he uses male contraception or remains sexually abstinent during the trial and for 3 months thereafter.
Participant is female and of childbearing potential unless willing to ensure that she uses a highly effective method of birth control during the trial and for 3 months thereafter.
Participant is female and pregnant, lactating, or planning pregnancy during the course of the trial or within 3 months thereafter.
Participant has received an IMP within the 30 days prior to screening.
Participant has a history of severe psychiatric disorder that may be exacerbated by the use of a cannabinoid-containing product.
Participant has any known or suspected history of alcohol or substance abuse (including opiate abuse) or dependence within 1 year prior to screening.
Participant is currently taking drugs that are solely metabolized by UGT1A9 and UGT2B7.
Participant is currently taking strong currently taking strong CYP3A4 inducers (e.g., rifampicin, carbamazepine, phenytoin, phenobarbital, St John's Wort).

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Investigator)
Enrollment: 139 participants (actual)

Study arms

Experimental
Nabiximols
Drug: Nabiximols
Placebo comparator
Placebo
Drug: Placebo

Interventions

DrugNabiximols
Nabiximols is a complex botanical medicine formulated from extracts of the cannabis plant that contains the principal cannabinoids delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD) and also contains minor constituents, including other cannabinoid and non-cannabinoid plant components, such as terpenes, sterols, and triglycerides.Nabiximols will be self-administered by participants as an oromucosal spray in the morning and evening, up to a maximum of 12 sprays per day for 12 weeks.
Also known as: GW-1000-02, Sativex
DrugPlacebo
Placebo to match nabiximols will be presented as an oromucosal spray containing the excipients ethanol and propylene glycol (50% v/v) with colorings and flavored with peppermint oil (0.05% v/v). Each spray will deliver 100 microliters (μL) containing no active ingredients. Placebo will be self-administered by participants as an oromucosal spray in the morning and evening, up to a maximum of 12 sprays per day for 12 weeks.

What researchers measure

Primary outcomes

Change in Average Daily Spasm Count From Baseline to Week 12 By 4-Week Period During the 12-Week Randomized Period
The change in the average daily spasm count was assessed compared to the baseline period.
Time frame: Baseline to Week 12

Secondary outcomes

Change in Multiple Sclerosis Spasticity Scale (MSSS-88) Total Score
The MSSS-88 is a self-reported measure of the impact of spasticity (muscle stiffness and spasms) in MS. This 88-item scale captures the patient experience and impact of spasticity, including muscle stiffness, pain and discomfort, muscle spasms, effect on daily activities, ability to walk, body movement, patient feelings, and social functioning. Responses to individual questions can range from "1 - not at all bothered" to "4 - extremely bothered", ranging from 88 to 352 total score. Scores are summed and higher scores indicate poor clinical outcome. Least square means are being reported, with greater negative values indicating better outcome.
Time frame: Week 8 and Week 12
Number of Patients Reporting Any Treatment-emergent Adverse Events
A TEAE is an adverse event that started, or worsened in severity or seriousness, following the first dose of the investigational medicinal product.
Time frame: From date of first dose of IMP up to 30 days after last dose, up to approximately 16 weeks
Change From Baseline in Clinical Laboratory Test Values
Time frame: Baseline up to Week 12
Change From Baseline in Erythrocytes
Time frame: Baseline up to Week 12
Change From Baseline in Hemoglobin
Time frame: Baseline up to Week 12
Change From Baseline in Hematocrit Ratio
The hematocrit ratio measures the volume of red blood cells compared to the total blood volume.
Time frame: Baseline up to Week 12
Change From Baseline in Erythrocyte Mean Corpuscular Hemoglobin
Time frame: Baseline up to Week 12
Change From Baseline in Blood Pressure
Time frame: Baseline up to Week 12
Change From Baseline in Heart Rate
Time frame: Baseline up to Week 12
Change From Baseline in Electrocardiogram Parameters
Time frame: Baseline up to Week 12
Change From Baseline in Electrocardiogram Pulse Rate
Time frame: Baseline up to Week 12
Change From Baseline in Weight
Time frame: Baseline up to Week 12
Change in Body Mass Index
Time frame: Baseline up to Week 12
Number of Patients With Suicidal Ideation or Behavior Based on Columbia-Suicide Severity Rating Scale (C-SSRS)
The C-SSRS is a short questionnaire that is used to assess suicidal ideation (5 questions) and behavior (5 questions) since last patient visit. The questionnaire is completed by participants answering yes or no to each question.
Time frame: Screening up to Week 12

Results

Posted May 8, 2024

Limitations and caveats

Study enrollment was ended early and did not reach the planned number of participants.

Participant flow

Participant flow — Overall Study
Milestone	Nabiximols	Placebo
Started	69	70
Safety analysis set	67	70
Completed	55	66
Not completed	14	4
Withdrew: Decision by the investigator, gw, or authority	0	1
Withdrew: Withdrawal of patient consent	7	2
Withdrew: Adverse event	4	1
Withdrew: Drug not dispensed due to endpoint error	1	0
Withdrew: Did not receive imp	2	0

Outcome measures

PrimaryChange in Average Daily Spasm Count From Baseline to Week 12 By 4-Week Period During the 12-Week Randomized Period

The change in the average daily spasm count was assessed compared to the baseline period.

Time frame:: Baseline to Week 12
Reported as:: Least squares mean · daily spasm count

Change in Average Daily Spasm Count From Baseline to Week 12 By 4-Week Period During the 12-Week Randomized Period
daily spasm count	Nabiximols	Placebo
Week 1 to 4	-2.23 ± 0.412	-1.62 ± 0.394
Week 5 to 8	-3.42 ± 0.607	-2.62 ± 0.583
Week 9 to 12	-3.84 ± 0.689	-3.11 ± 0.659

Statistical analysis

Nabiximols vs Placebo · Linear mixed model repeated measures · p = =0.4263 · Difference in least squares means: -0.73 · 95% CI -2.54 to 1.08

SecondaryChange in Multiple Sclerosis Spasticity Scale (MSSS-88) Total Score

The MSSS-88 is a self-reported measure of the impact of spasticity (muscle stiffness and spasms) in MS. This 88-item scale captures the patient experience and impact of spasticity, including muscle stiffness, pain and discomfort, muscle spasms, effect on daily activities, ability to walk, body movement, patient feelings, and social functioning. Responses to individual questions can range from "1 - not at all bothered" to "4 - extremely bothered", ranging from 88 to 352 total score. Scores are summed and higher scores indicate poor clinical outcome. Least square means are being reported, with greater negative values indicating better outcome.

Time frame:: Week 8 and Week 12
Reported as:: Least squares mean · unit on a scale

Change in Multiple Sclerosis Spasticity Scale (MSSS-88) Total Score
unit on a scale	Nabiximols	Placebo
Week 8	-21.64 ± 5.775	-26.11 ± 5.461
Week 12	-26.53 ± 5.807	-23.18 ± 5.426

SecondaryNumber of Patients Reporting Any Treatment-emergent Adverse Events

A TEAE is an adverse event that started, or worsened in severity or seriousness, following the first dose of the investigational medicinal product.

Time frame:: From date of first dose of IMP up to 30 days after last dose, up to approximately 16 weeks
Reported as:: Count of participants · Participants

Number of Patients Reporting Any Treatment-emergent Adverse Events
Participants	Nabiximols	Placebo
Number of Patients Reporting Any Treatment-emergent Adverse Events	47	32

SecondaryChange From Baseline in Clinical Laboratory Test Values

Time frame:: Baseline up to Week 12
Reported as:: Mean · 10^9 cells/liter

Change From Baseline in Clinical Laboratory Test Values
10^9 cells/liter	Nabiximols	Placebo
Basophils	-0.009 ± 0.030	0.002 ± 0.037
Eosinophils	-0.007 ± 0.110	0.006 ± 0.086
Leukocytes	0.146 ± 1.095	0.139 ± 1.881
Lymphocytes	-0.056 ± 0.368	0.009 ± 0.315
Monocytes	0 ± 0.120	0.001 ± 0.126
Neutrophils	0.217 ± 1.004	0.083 ± 1.788
Platelets	-0.085 ± 42.392	5.290 ± 49.972

SecondaryChange From Baseline in Erythrocytes

Time frame:: Baseline up to Week 12
Reported as:: Mean · 10^12 cells/liter

Change From Baseline in Erythrocytes
10^12 cells/liter	Nabiximols	Placebo
Change From Baseline in Erythrocytes	0.010 ± 0.241	-0.007 ± 0.251

SecondaryChange From Baseline in Hemoglobin

Time frame:: Baseline up to Week 12
Reported as:: Mean · g/dL

Change From Baseline in Hemoglobin
g/dL	Nabiximols	Placebo
Change From Baseline in Hemoglobin	-0.025 ± 0.735	-0.021 ± 0.726

SecondaryChange From Baseline in Hematocrit Ratio

The hematocrit ratio measures the volume of red blood cells compared to the total blood volume.

Time frame:: Baseline up to Week 12
Reported as:: Mean · ratio of packed cells to total volume

Change From Baseline in Hematocrit Ratio
ratio of packed cells to total volume	Nabiximols	Placebo
Change From Baseline in Hematocrit Ratio	-0.002 ± 0.025	-0.002 ± 0.027

SecondaryChange From Baseline in Erythrocyte Mean Corpuscular Hemoglobin

Time frame:: Baseline up to Week 12
Reported as:: Mean · pg

Change From Baseline in Erythrocyte Mean Corpuscular Hemoglobin
pg	Nabiximols	Placebo
Change From Baseline in Erythrocyte Mean Corpuscular Hemoglobin	-0.156 ± 0.608	-0.005 ± 0.881

SecondaryChange From Baseline in Blood Pressure

Time frame:: Baseline up to Week 12
Reported as:: Mean · mmHg

Change From Baseline in Blood Pressure
mmHg	Nabiximols	Placebo
Systolic Blood Pressure	-1.6 ± 10.95	2.6 ± 11.31
Diastolic Blood Pressure	0.3 ± 8.20	2.7 ± 13.38

SecondaryChange From Baseline in Heart Rate

Time frame:: Baseline up to Week 12
Reported as:: Mean · beats/minute

Change From Baseline in Heart Rate
beats/minute	Nabiximols	Placebo
Change From Baseline in Heart Rate	2.5 ± 7.70	0.4 ± 10.14

SecondaryChange From Baseline in Electrocardiogram Parameters

Time frame:: Baseline up to Week 12
Reported as:: Mean · msec

Change From Baseline in Electrocardiogram Parameters
msec	Nabiximols	Placebo
PR interval, aggregate	5.5 ± 20.51	1.3 ± 21.05
QRS duration	1.9 ± 9.89	-6.5 ± 37.08
QTcB interval	1.5 ± 29.58	-2.4 ± 33.29
QTcF interval	2.9 ± 26.69	-3.2 ± 32.40

SecondaryChange From Baseline in Electrocardiogram Pulse Rate

Time frame:: Baseline up to Week 12
Reported as:: Mean · beats/min

Change From Baseline in Electrocardiogram Pulse Rate
beats/min	Nabiximols	Placebo
Change From Baseline in Electrocardiogram Pulse Rate	-2.6 ± 10.21	0.5 ± 8.74

SecondaryChange From Baseline in Weight

Time frame:: Baseline up to Week 12
Reported as:: Mean · kg

Change From Baseline in Weight
kg	Nabiximols	Placebo
Change From Baseline in Weight	-0.338 ± 3.198	-0.394 ± 3.578

SecondaryChange in Body Mass Index

Time frame:: Baseline up to Week 12
Reported as:: Mean · kg/m^2

Change in Body Mass Index
kg/m^2	Nabiximols	Placebo
Change in Body Mass Index	-0.086 ± 1.052	-0.159 ± 1.287

SecondaryNumber of Patients With Suicidal Ideation or Behavior Based on Columbia-Suicide Severity Rating Scale (C-SSRS)

The C-SSRS is a short questionnaire that is used to assess suicidal ideation (5 questions) and behavior (5 questions) since last patient visit. The questionnaire is completed by participants answering yes or no to each question.

Time frame:: Screening up to Week 12
Reported as:: Count of participants · Participants

Number of Patients With Suicidal Ideation or Behavior Based on Columbia-Suicide Severity Rating Scale (C-SSRS)
Participants	Nabiximols	Placebo
Screening: Ideation, Wish to be dead	1	1
Screening: Ideation, Non-specific active thoughts	1	1
Screening: Ideation, Active any method no intent	0	1
Screening: Ideation, Active intent to act, no plan	0	0
Screening: Ideation, Active specific plan/intent	0	0
Screening: Behavior, Preparatory acts or behavior	0	0
Screening: Behavior, Aborted attempt	0	0
Screening: Behavior, Interrupted attempt	0	0
Screening: Behavior, Actual attempt	0	1
Screening: Behavior, Completed suicide	0	0
Screening: Suicidal ideation or behavior	1	1
Screening: Self-injurious behavior without suicidal intent	0	0
Baseline: Ideation, Wish to be dead	0	0
Baseline: Ideation, Non-specific active thoughts	0	0
Baseline: Ideation, Active any method no intent	0	0
Baseline: Ideation, Active intent to act, no plan	0	0
Baseline: Ideation, Active specific plan/intent	0	0
Baseline: Behavior, Preparatory acts or behavior	0	0
Baseline: Behavior, Aborted attempt	0	0
Baseline: Behavior, Interrupted attempt	0	0
Baseline: Behavior, Actual attempt	0	0
Baseline: Behavior, Completed suicide	0	0
Baseline: Suicidal ideation or behavior	0	0
Baseline: Self-injurious behavior without suicidal intent	0	0
Week 2: Ideation, Wish to be dead	1	0
Week 2: Ideation, Non-specific active thoughts	0	0
Week 2: Ideation, Active any method no intent	0	0
Week 2: Ideation, Active intent to act, no plan	0	0
Week 2: Ideation, Active specific plan/intent	0	0
Week 2: Behavior, Preparatory acts or behavior	0	0
Week 2: Behavior, Aborted attempt	0	0
Week 2: Behavior, Interrupted attempt	0	0
Week 2: Behavior, Actual attempt	0	0
Week 2: Behavior, Completed suicide	0	0
Week 2: Suicidal ideation or behavior	1	0
Week 2: Self-injurious behavior without suicidal intent	0	0
Week 4: Ideation, Wish to be dead	0	0
Week 4: Ideation, Non-specific active thoughts	0	0
Week 4: Ideation, Active any method no intent	0	0
Week 4: Ideation, Active intent to act, no plan	0	0
Week 4: Ideation, Active specific plan/intent	0	0
Week 4: Behavior, Preparatory acts or behavior	0	0
Week 4: Behavior, Aborted attempt	0	0
Week 4: Behavior, Interrupted attempt	0	0
Week 4: Behavior, Actual attempt	0	0
Week 4: Behavior, Completed suicide	0	0
Week 4: Suicidal ideation or behavior	0	0
Week 4: Self-injurious behavior without suicidal intent	0	0
Week 8: Ideation, Wish to be dead	0	0
Week 8: Ideation, Non-specific active thoughts	0	0
Week 8: Ideation, Active any method no intent	0	0
Week 8: Ideation, Active intent to act, no plan	0	0
Week 8: Ideation, Active specific plan/intent	0	0
Week 8: Behavior, Preparatory acts or behavior	0	0
Week 8: Behavior, Aborted attempt	0	0
Week 8: Behavior, Interrupted attempt	0	0
Week 8: Behavior, Actual attempt	0	0
Week 8: Behavior, Completed suicide	0	0
Week 8: Suicidal ideation or behavior	0	0
Week 8: Self-injurious behavior without suicidal intent	0	0
Week 12: Ideation, Wish to be dead	0	0
Week 12: Ideation, Non-specific active thoughts	0	0
Week 12: Ideation, Active any method no intent	0	0
Week 12: Ideation, Active intent to act, no plan	0	0
Week 12: Ideation, Active specific plan/intent	0	0
Week 12: Behavior, Preparatory acts or behavior	0	0
Week 12: Behavior, Aborted attempt	0	0
Week 12: Behavior, Interrupted attempt	0	0
Week 12: Behavior, Actual attempt	0	0
Week 12: Behavior, Completed suicide	0	0
Week 12: Suicidal ideation or behavior	0	0
Week 12: Self-injurious behavior without suicidal intent	0	1

Adverse events

Collected over Adverse event data were collected from baseline up to 14 days after the end of treatment visit, up to Day 99 (safety follow up visit).. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Nabiximols	0/67 (0%)	3/67 (4.5%)	46/67 (68.7%)
Placebo	0/70 (0%)	5/70 (7.1%)	19/70 (27.1%)

Most frequent serious events

Most frequent serious events
Event	Nabiximols	Placebo
COVID-19Infections and infestations	2/67	2/70
SARS-CoV-2 test positiveInvestigations	0/67	2/70
CellulitisInfections and infestations	1/67	0/70
Arthritis bacterialInfections and infestations	0/67	1/70
PneumoniaInfections and infestations	0/67	1/70

Most frequent other events

Most frequent other events
Event	Nabiximols	Placebo
DizzinessNervous system disorders	14/67	5/70
FatigueGeneral disorders	8/67	2/70
SomnolenceNervous system disorders	7/67	2/70
VertigoEar and labyrinth disorders	6/67	0/70
AstheniaGeneral disorders	4/67	2/70
Taste disorderNervous system disorders	4/67	0/70
NauseaGastrointestinal disorders	3/67	4/70
Urinary tract infectionInfections and infestations	3/67	4/70

Baseline characteristics

Baseline characteristics are reported from the Full Analysis Set defined as all patients from the Safety Analysis Set who signed the informed consent and are randomized by interactive response technology.

Age, Continuous
Age, Continuous(years)	Nabiximols	Placebo	Total
Mean	52.1 ± 10.4	53.0 ± 10.2	52.6 ± 10.2

Age, Customized
Age, Customized(Participants)	Nabiximols	Placebo	Total
<18 years	0	0	0
≥18 years to <45 years	14	15	29
≥45 years to <65 years	44	46	90
≥65 years	9	9	18

Sex: Female, Male
Sex: Female, Male(Participants)	Nabiximols	Placebo	Total
Female	43	52	95
Male	24	18	42

Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)	Nabiximols	Placebo	Total
White	62	68	130
Black or African American	3	1	4
Asian	0	0	0
American Indian or Alaska Native	0	0	0
Native Hawaiian or Other Pacific Islander	0	0	0
Other	2	1	3

Study locations

37 sites

University of Alabama at Birmingham School of Medicine
Birmingham, Alabama 35233, United States
Neurostudies - Port Charlotte
Port Charlotte, Florida 33952, United States
University of South Florida
Tampa, Florida 33613, United States
Accel Research Sites - Enterprise
Tampa, Florida 33634, United States
Shepherd Center
Atlanta, Georgia 30309, United States
Consultants in Neurology - Northbrook
Northbrook, Illinois 60062, United States
American Health Network of Indiana
Avon, Indiana 46123, United States
Ochsner Medical Center
New Orleans, Louisiana 70121, United States
The Multiple Sclerosis Center For Innovations In Care
Saint Louis, Missouri 63131, United States
Raleigh Neurology Associates - Raleigh Location
Raleigh, North Carolina 27607, United States
University of Cincinnati (UC) Health
Dayton, Ohio 45417, United States
Neurology Clinic - Cordova
Cordova, Tennessee 38018, United States
Hope Neurology
Knoxville, Tennessee 37922, United States
University of Texas Southwestern Medical Center
Dallas, Texas 75390, United States
Central Texas Neurology Consultants
Round Rock, Texas 78681, United States
Poliklinika Choceň
Choceň, Pardubice 565 01, Czechia
Neurologie Taláb Radomír Doc. MUDr., CSc
Hradec Králové, 500 03, Czechia
Nemocnice Jihlava
Jihlava, 586 01, Czechia
Fakultní Nemocnice Královské Vinohrady
Praha 10, 100 34, Czechia
Krajská Zdravotní - Nemocnice Teplice
Teplice, 415 29, Czechia
Wromedica Centrum Zdrowia
Wrocław, Dolnoslaskie 51-685, Poland
Centrum Medyczne Neuromed - Ośrodek Badań Klinicznych
Bydgoszcz, Kujawsko-Pomorskie 85-163, Poland
Centrum Medyczne Neuroprotect
Warszawa, Mazowieckie 01-684, Poland
Centrum Medyczne Pratia - Warszawa
Warszawa, Mazowieckie 01-868, Poland
Neuro-Medic Janusz Zbrojkiewicz
Katowice, Slaskie 40-555, Poland
Wielospecjalistyczne Centrum Medyczne Ibismed
Zabrze, Slaskie 41-800, Poland
RESMEDICA Poradnia Neurologiczna
Kielce, Swietokrzyskie 25-726, Poland
Niepubliczny Zakład Opieki Zdrowotnej NEURO - KARD
Poznań, Wielkopolskie 61-853, Poland
Centrum Medyczne Oporów
Lublin, 20-855, Poland
Neurologiczny NZOZ Centrum Leczenia SM Ośrodek Badań Klinicznych im. dr n. med. Hanki Hertmanowskiej Witosław Cieślak
Plewiska, 62-064, Poland
Wromedica Centrum Zdrowia
Wrocław, 51-685, Poland
SP ZOZ Uniwersytecki Szpital Kliniczny Nr 1 im. Norberta Barlickiego w Łodzi
Łódź, 90-001, Poland
Spitalul Municipal Caracal
Caracal, 235200, Romania
Spitalul Clinic Cai Ferate Constanta
Constanţa, 900123, Romania
Centrul Medical Clubul Sanatatii
Câmpulung, 115100, Romania
Spitalul Municipal Sf. Dr. Cosma si Damian Radauti
Rădăuți, 725400, Romania
Barts Health NHS Trust
London, England E1 1BB, United Kingdom

References and documents

Study documents

Study protocol · Jun 1, 2021
Statistical analysis plan · Mar 22, 2022

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on May 8, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT04203498
Lead sponsor: Jazz Pharmaceuticals
Responsible party: Sponsor
First posted: Dec 18, 2019
Start date: Oct 1, 2020
Primary completion: Feb 10, 2023
Completion: Feb 28, 2023
Results posted: May 8, 2024
Last update: May 8, 2024

Oversight

Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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