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Amyotrophic Lateral SclerosisPhase 118F-RoSMALSNCT05880563

Investigation of Cannabinoid 2-receptor Expression in the Brain and Spine of ALS-patients Compared to Healthy Controls With PET (18F-RoSMALS)

A Phase 1 study testing [18F]-RoSMA-18-d6 in people with Amyotrophic Lateral Sclerosis, run by Markus Weber at 1 site in Switzerland.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This clinical trial is a phase 1 study in which investigations with the weakly radioactive substance [18F]-RoSMA-18-d6 are being carried out for the first time. This radiolabeled substance will be used to study a specific protein in the brain and spinal cord of patients with ALS and healthy individuals. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Amyotrophic Lateral Sclerosis
What is being tested?
[18F]-RoSMA-18-d6
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteSwitzerland
Study dates
Aug 2023to Sep 2026
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Age ≥18 years
  • Able to provide written informed consent prior to study participation
  • Body weight of ≥ 50 kg and a body mass index (BMI) between 19-30 kg/m2
  • Vital signs measured after three minutes resting in the supine position must be within the following ranges:
  • oral body temperature: 35.0-37.5 °C
  • systolic blood pressure: 90-140 mm Hg
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  • diastolic blood pressure: 50-90 mm Hg
  • pulse rate: 40-90 bpm
  • Clinically probable, probable laboratory supported, or definite ALS-diagnosis according to the revised version of the El Escorial World Federation of Neurology criteria (EEC) (46)
  • Disease duration ≤ 18 months since date of diagnosis
  • Slow vital capacity (sVC) ≥ 80 % of normal (best of three measurements)
  • Pre-study ALSFRS-R progression between disease onset and screening of -0.4 points/month or worse (calculated by ALSFRS-R score decline from 48 divided by months since symptom onset until screening)
  • Patient has to be on a stable dose of disease modifying treatments (Edaravone 60 mg i.v.
  • on ten days/month, Riluzole 100 mg/day)
  • nclusion Criteria Healthy controls
  • Age ≥ 18 years
  • Able to provide written informed consent prior to study participation
  • Body weight of ≥ 50 kg and a body mass index (BMI) between 19-30 kg/m2
  • Vital signs measured after 3 minutes resting in the supine position must be within the following ranges:
  • oral body temperature: 35.0-37.5 °C
  • systolic blood pressure: 90-140 mm Hg
  • diastolic blood pressure: 50-90 mm Hg
  • pulse rate: 40-90 bpm

Who cannot join

  • Previous participation in another clinical study involving trial medication within the preceding 12 weeks prior to [18F]RoSMA-18-d6 administration
  • Tracheostomy or continuous assisted ventilation of any type, or any other significant pulmonary disorder not attributed to ALS
  • Structural brain or spinal cord abnormalities on MRI (e.g. evidence of stroke, infarct, or other space-occupying lesion or structural abnormality in brain and/or spinal cord.)
  • Significant illness within two weeks prior to dosing
  • History of clinically significant drug allergy; history of atopic allergy (asthma, urticaria, eczematous dermatitis). A known hypersensitivity to the study drug or drugs similar to the study drug
  • History of allergic reaction to drugs or anaphylactic shock.
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  • History of myocardial infarction or history of treated cancer[18F]RoSMA-18-d6 in ALS brain and spinal cord_ Version 1.1_29.11.2022 Page 45 of 98
  • Current clinically significant systemic illness or symptoms (e.g., respiratory or cardiovascular disease) that may deteriorate or affect the patient's safety or ability to cooperate during the study.
  • Gastrostomy
  • Any medical condition known to have an association with motor neuron dysfunction or involving neuromuscular weakness or another neurodegenerative disease, e.g. Parkinson's Disease (PD) or Alzheimer's disease (AD), which might confound or obscure the diagnosis of ALS
  • Major internal disorders (e.g. arterial hypertension, diabetes, evidence suggestive of liver or renal disease (bilirubin >1.6 mg/dL, creatinine > 150 μM).
  • Presence of any concomitant life-threatening disease or impairment likely to interfere with functional assessment
  • Donation or loss of 400 mL or more of blood within eight weeks prior to dosing.
  • Clinically relevant abnormalities on blood screening (see 4.3.1)
  • Use of any prescription drug with central action or over-the-counter (OTC) medication within two weeks prior to dosing, except ALS-medication and Paracetamol which are acceptable.
  • Use of tobacco products in the previous three months
  • History of drug (e.g. Cannabis) or alcohol abuse within 12 months prior to dosing
  • Pregnancy or breast feeding
  • Significant neurological or psychiatric disease
  • Significant illness within two weeks prior to dosing
  • History of clinically significant drug allergy; history of atopic allergy (asthma, urticaria, eczematous dermatitis). A known hypersensitivity to the study drug or drugs similar to the study drug.
  • History of myocardial infarction or history of treated cancer
  • Current clinically significant systemic illness or symptoms (e.g., respiratory or cardiovascular disease) that may deteriorate or affect the patient's safety or ability to cooperate during the study.
  • Major internal disorders (e.g. arterial hypertension, diabetes, evidence of suggestive liver or renal disease (bilirubin >1.6 mg/dL, creatinine > 150 μM).
  • Other clinically significant abnormality on physical, neurological, or laboratory examination that, in the opinion of the investigator precludes the patient from the study.
  • Clinically significant abnormality on electrocardiogram (ECG) that, in the opinion of the investigator, precludes the patient from the study.
  • A past medical history of clinically significant ECG abnormalities or a family history of a prolonged QT-interval syndrome.
  • Structural brain or spinal cord abnormalities on MRI (e.g., evidence of stroke, infarct, or other space-occupying lesion or structural abnormality in brain and/or spinal cord). History of allergic disease or anaphylactic shock.
  • Presence of any concomitant life-threatening disease or impairment likely to interfere with functional assessment
  • Use of any prescription drug or over-the-counter (OTC) medication within two weeks prior to dosing. Paracetamol is acceptable.
  • Use of tobacco products in the previous three months.
  • History of drug (e.g. Cannabis) or alcohol abuse within 12 months prior to dosing.
  • Participation in any clinical investigation within four weeks prior to dosing or any ever participation in a research study with an amyloid lowering objective.
  • Donation or loss of 400 mL or more of blood within eight weeks prior to dosing.
  • Clinically relevant abnormalities on blood screening (see 4.3.1)
  • Significant radiation exposure, especially in the last quarter (either X-ray or nuclear medicine studies). Any earlier nuclear medicine studies.
  • Pregnancy or breast feeding

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

  • Muskelzentrum/ALS-Clinic, Kantonsspital St. Gallen

    Sankt Gallen, 9000

    Markus Weber, Prof. Dr. med., +41714943580, markus.weber@kssg.ch

    Thomas Pyka, PD Dr.

Other trials in Switzerland

About this study

Official title: A Monocentric, Controlled, Open Label, Phase I, First-in-human Trial to Investigate the Regional Distribution of [18F]RoSMA-18-d6 in the Brain and Spinal Cord to Assess Cannabinoid Type 2 Receptor (CB2R) Expression in Healthy Volunteers and Patients With Amyotrophic Lateral Sclerosis (ALS) by Positron Emission Tomography (PET)

This clinical trial is a phase 1 study in which investigations with the weakly radioactive substance [18F]-RoSMA-18-d6 are being carried out for the first time.

This radiolabeled substance will be used to study a specific protein in the brain and spinal cord of patients with ALS and healthy individuals. This particular protein, the cannabinoid type 2 receptor, is thought to play a role in the disease process of ALS. Furthermore, it is assumed that this protein is found more frequently in the brain and spinal cord of patients with ALS compared to healthy individuals.

Read more

The following questions will be answered by this clinical trial.

  1. Is this protein found, as suspected, increased in the brain and spinal cord of ALS patients compared to healthy individuals ?
  2. Does the amount of this protein change during the course of the disease?
  3. Are there any correlations between the observed changes in the amount of protein and the assessment of the course of the disease?
Being tested
[18F]-RoSMA-18-d6
Keywords
Amyotrophic Lateral Sclerosis (ALS)
Medical subject headings
Amyotrophic Lateral Sclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • [18F]-RoSMA-18-d6Drug

    [18F]-RoSMA-18-d6 will be administered intravenously by a bolus injection followed by a subsequent PET/CT-scan of the brain and the spine

Study groups in NCT05880563
Study groupRoleWhat they receive
ALS patientsExperimentalALS patients will get two imaging sessions with [18F]RoSMA-18-d6 PET/CT and MRI-scans one year apart
Receives: Drug: [18F]-RoSMA-18-d6
Healthy volunteersExperimentalHealthy volunteers will get only one pair of [18F]RoSMA-18-d6 PET/CT and MRI scans
Receives: Drug: [18F]-RoSMA-18-d6

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Difference of [18F]RoSMA-18-d6 uptake in the brain and spinal cord between ALS patients (at baseline and day 360) and healthy, age- and gender-matched subjects, as assessed by PET and MRI to allow morphological mapping

    Voxelwise maps of the total distribution volume (VT; ml g-

    1. of [18F]RoSMA-18-d6 are calculated using the Logan method (42) as well as compartmental modelling i.e., the evaluation of the microparameters of a two-tissue reversible binding model (43) Mean parametric maps for brain are calculated for the baseline and follow-up conditions in the controls and ALS patient groups. Furthermore, standardized uptake values (SUV) regarding tracer uptake after 15, 30, 60 and - if available - 90 minutes will be determined

    Measured: Baseline and day 360

Secondary outcomes (4)

  1. [18F]RoSMA-18-d6 uptake at month twelve (360 days) compared with uptake at baseline as assessed by PET/CT of the brain and spinal cord.

    Measured: Baseline and day 360

  2. Correlation of [18F]RoSMA-18-d6 uptake with corresponding ALSFRS-Score from baseline to day 360.

    Measured: Baseline and day 360

  3. Correlation of [18F]RoSMA-18-d6 uptake with corresponding respiratory function measurements (FVC, SNIP) from baseline to day 360.

    Measured: Baseline and day 360

  4. Correlation of the change of [18F]RoSMA-18-d6 endpoints (Δ-CB2R; baseline to day 360) with corresponding changes of the-ECAS score

    Measured: Baseline and day 360

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 May 2023
  2. Study startAug 2023 (estimated)
  3. Primary completionSep 2026 (estimated)
  4. Study completionSep 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Basic science
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
This is a controlled, open-label, first in man study to evaluate the regional distribution and brain-kinetics of \[18F\]RoSMA-18-d6 in ALS patients (n=20) and healthy volunteers (n=10). ALS patients will get two imaging sessions with \[18F\]RoSMA-18-d6 PET/CT and MRI-scans one year apart. Healthy volunteers will get only one pair of \[18F\]RoSMA-18-d6 PET/CT and MRI scans
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05880563
Sponsor's protocol ID
18F-RoSMALS
Acronym
18F-RoSMALS
Status last verified
May 2023
First submitted
19 May 2023
Last updated
30 May 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing [18F]-RoSMA-18-d6 in people with Amyotrophic Lateral Sclerosis, run by Markus Weber at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 23 inclusion and 37 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 30 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Difference of [18F]RoSMA-18-d6 uptake in the brain and spinal cord between ALS patients (at baseline and day 360) and healthy, age- and gender-matched subjects, as assessed by PET and MRI to allow morphological mapping (time frame: Baseline and day 360). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05880563.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2023.

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