Overview
Sponsor-declared trial summary
ALS (Amyotrophic Lateral Sclerosis)
This project seeks to detect and characterize metabolic impairment in patients with Amyotrophic Lateral Sclerosis and patients with Transient Ischemic attack with a new MRI technique termed Hyperpolarized Pyruvate MRI
Key facts
- Sponsor
- Aarhus Universitet
- Participant type
- Patients, Healthy volunteers
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Investigative Techniques [E05]
- Trial duration
- 1 May 2020 → ongoing
- Decision date (initial)
- 2024-09-12
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-516954-24-00
- EudraCT number
- 2020-000352-36
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Diagnosis
This project seeks to detect and characterize metabolic impairment in patients with Amyotrophic Lateral Sclerosis and patients with Transient Ischemic attack with a new MRI technique termed Hyperpolarized Pyruvate MRI
Conditions and MedDRA coding
ALS (Amyotrophic Lateral Sclerosis)
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- All participants: 1) Age 18-85 years. 2) Pre-menopausal women must be confirmed non-pregnant by an onsite test. ALS group: 1) Fulfilling the 2021 Gold Coast criteria. 2) Upper motor neuron symptoms. TIA-group: 1) TIA within the last 10 days. 2) Symptoms must include unilateral weakness of limb or face. 3) Duration af symptoms minimum 10 minutes
Exclusion criteria 1
- Contraindications for MRI with contrast: Chronic kidney disease,- Significant cardiac disease such as severe left ventricular outflow obstruction, -Significant obstructive lung disease or severe asthma,- Pacemaker, neurostimulator or cholera implant,- Metal foreign bodies such as fragments and irremovable piercings,- Unsafe medical implants (safety of heart valves, hips and the like must be confirmed),- Intracranial clips or coils,- Claustrophobia,- Largest circumference including arms > 160 cm. Competing neurological, psychiatric, liver or systemic disease including diabetes (except prior TIA, unspecific brain MRI findings, hypertension, atherosclerosis and hyperlipidemia/cholesterolemia which are allowed). Allergy to pyruvate.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Cerebral metabolism as assesed with 13C label exchange from hyperpolarized pyruvate to bicarbonate, lactate and alanine
Secondary endpoints 1
- Disease characterization from clinical exsamination, interviews and patient records.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Hyperpolarized [1-13C]pyruvate
PRD10284730 · Product
- Active substance
- Pyruvic Acid
- Pharmaceutical form
- INJECTION
- Route of administration
- INTRAVENOUS BOLUS INJECTION/IV INFUSION
- Max daily dose
- 18.92 mg/kg milligram(s)/kilogram
- Max total dose
- 18.92 mg/kg milligram(s)/kilogram
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- AARHUS UNIVERSITY
- Paediatric formulation
- No
- Orphan designation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Aarhus Universitet
- Sponsor organisation
- Aarhus Universitet
- Address
- Palle Juul-Jensens Boulevard 82
- City
- Aarhus N
- Postcode
- 8200
- Country
- Denmark
Scientific contact point
- Organisation
- Aarhus Universitet
- Contact name
- MR Research Centre Aarhus University
Public contact point
- Organisation
- Aarhus Universitet
- Contact name
- MR Research Centre Aarhus University
Third parties 1
| Organisation | City, country | Duties |
|---|---|---|
| Aarhus Universitet ORG-100028380
|
Aarhus N, Denmark | On site monitoring |
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Ongoing, recruiting | 46 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Denmark | 2020-05-01 | 2020-10-08 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 7 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_EU CT Number 2024-516954-24-00 | 1.1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_placeholder document | 1 |
| Subject information and informed consent form (for publication) | L1_ICF | 1 |
| Subject information and informed consent form (for publication) | L1_SIS_ALS | 1 |
| Subject information and informed consent form (for publication) | L1_SIS_TIA | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Blank_reference for SmPC | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_DK EU CT Number 2024-516954-24-00 | 1.0 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-08-15 | Denmark | Acceptable 2024-09-12
|
2024-09-12 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-11-22 | Denmark | Acceptable 2024-09-12
|
2024-11-22 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-01-12 | Denmark | Acceptable 2025-01-17
|
2025-01-17 |