Overview
Sponsor-declared trial summary
Phase
Phase II and Phase III (Integrated)
Status
Authorised, recruitment pending
Participants planned
30
Countries
1
Sites
1
Idiopathic painful small fiber neuropathy or sensory neuronopathy.
Investigate the efficacy of IVIG treatment for pain alleviation in patients with well-defined idiopathic sensory neuropathy
Key facts
- Sponsor
- Sorlandet Sykehus HF
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nervous System Diseases [C10]
- Decision date (initial)
- 2022-12-09
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Sørlandet Hospital Trust
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy
Investigate the efficacy of IVIG treatment for pain alleviation in patients with well-defined idiopathic sensory neuropathy
Secondary objectives 6
- Investigate the efficacy of IVIG functional level and quality of life in well-defined idiopathic sensory neuropathy
- Chart the frequency of anti- FGFR3 antibodies in well-defined idiopathic sensory neuropathy
- Chart predictors of response to IVIG treatment, including anti- FGFR3 antibodies and clinical features, in well-defined idiopathic sensory neuropathy
- Implement the use of individual N-of-one trials
- Implement the use of digital home-monitoring of patient-reported outcome measures (PROMS) to evaluate IVIG response (use of digital home-monitoring will not be researched as part of this trial, but rather will be implemented as a tool to collect data)
- Chart side-effects of IVIG treatment in patients with idiopathic sensory neuropathy
Conditions and MedDRA coding
Idiopathic painful small fiber neuropathy or sensory neuronopathy.
Regulatory references
- Plan to share IPD
- No
| EU CT number | Title | Sponsor |
|---|---|---|
| 2022-501112-34-00 | Effect of intravenous immunoglobulins on painful sensory neuropathy evaluated by aggregated N-of-one trials | Sorlandet Sykehus HF |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- 18-65 years
- Painful sensory neuropathy fulfilling diagnostic criteria for idiopathic small fiber neuropathy or idiopathic sensory neuronopathy
- Pain intensity at least 5.0 on Numeric Rating Scale (NRS) lasting at least 4 weeks
- Signed written informed consent
Exclusion criteria 4
- Change of pain medication in the 30 days prior to inclusion
- Treatment with IVIG or other immunomodulatory agents the last 4 weeks
- Contraindications to IVIG ie previous stroke, myocardial infarction, or other thrombotic events, hypertension (uncorrected), smoking, diabetes, prolonged immobilization, hypercoagulable state, IgA deficiency, renal failure, ongoing heart disease, hypovolemia, previous allergic reactions to IVIG
- Females who are breastfeeding, pregnant, or unwilling to practice adequate contraception throughout the study
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Pain intensity the second week (mean of days 8, 10 and 13) after start of IVIG/placebo infusions scored on a numeric rating scale (NRS) ranging from 0 to 10
Secondary endpoints 4
- Pain intensity across 4 weeks after start of each infusion (mean of scoring three times per week from day 8 to 34)
- Disability and quality of life at the end of the third week after infusion scored on: Polyneuropathy Patient-reported Index (CAPPRI)
- Anti-FGF3 antibodies
- Adverse events
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Privigen 100 mg/ml solution for infusion
PRD339229 · Product
- Active substance
- Human Normal Immunoglobulin
- Substance synonyms
- IMMUNOGLOBULIN HUMAN NORMAL
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 666 mg/kg milligram(s)/kilogram
- Max total dose
- 2000 mg/kg milligram(s)/kilogram
- Max treatment duration
- 30 Week(s)
- Authorisation status
- Authorised
- ATC code
- J06BA02 — IMMUNOGLOBULINS, NORMAL HUMAN, FOR INTRAVASCULAR ADM.
- Marketing authorisation
- EU/1/08/446/006
- MA holder
- CSL BEHRING GMBH
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Placebo 2
Natriumklorid Fresenius Kabi 9 mg/ml infusjonsvæske, oppløsning
PRD2128245 · Product
- Active substance
- Sodium Chloride
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENIOUS INFUSION
- Max daily dose
- 500 ml millilitre(s)
- Max total dose
- 4500 ml millilitre(s)
- Max treatment duration
- 30 Week(s)
- Authorisation status
- Authorised
- ATC code
- B05BB01 — ELECTROLYTES
- Marketing authorisation
- 5846
- MA holder
- FRESENIUS KABI NORGE AS
- MA country
- Norway
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Sorlandet Sykehus HF
2
Total trials
Academic / Non-commercial
- Sponsor organisation
- Sorlandet Sykehus HF
- Address
- Egsveien 100
- City
- Kristiansand S
- Postcode
- 4615
- Country
- Norway
Scientific contact point
- Organisation
- Sorlandet Sykehus HF
- Contact name
- Jon-Marius Rognhaug Ørnes
Public contact point
- Organisation
- Sorlandet Sykehus HF
- Contact name
- Jon-Marius Rognhaug Ørnes
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Norway | Authorised, recruitment pending | 30 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Sorlandet Sykehus HF
Research department, Egsveien 100, 4615, Kristiansand S
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 14 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | CRF nov | 2 |
| Protocol (for publication) | Protocol for publication | 1.3 |
| Protocol (for publication) | Protocol signed | 1 |
| Recruitment arrangements (for publication) | Recruitment arrangements | 1 |
| Recruitment arrangements (for publication) | Recruitment arrangements nov | 1.2 |
| Subject information and informed consent form (for publication) | Informed consent form for publication | 2 |
| Subject information and informed consent form (for publication) | Informed consent form for publication version 3 | 3 |
| Subject information and informed consent form (for publication) | Informed consent form not for publication | 2 |
| Subject information and informed consent form (for publication) | Informed consent form not for publication version 4 | 4 |
| Subject information and informed consent form (for publication) | Informed consent form not for publication version 4 with tracked changes | 4 |
| Subject information and informed consent form (for publication) | Samtykke I | 1 |
| Subject information and informed consent form (for publication) | Samtykke II | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | spc privigen | 1 |
| Synopsis of the protocol (for publication) | Norwegian protocol synopsis november | 1.2 |
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2022-08-25 | Norway | Acceptable 2022-12-05
|
2022-12-09 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2023-01-09 | Norway | Acceptable 2022-12-05
|
2023-01-09 |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-07-20 | Norway | Acceptable 2023-08-29
|
2023-08-29 |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-11-08 | Norway | Acceptable 2024-12-19
|
2024-12-19 |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2026-02-26 | Norway | Acceptable 2024-12-19
|
2026-02-26 |