Sensory NeuropathyPhase 4NCT06183008
IVIG in Painful Sensory Neuropathy
A Phase 4 study testing Intravenous immunoglobulin in people with Sensory Neuropathy and Small Fiber Neuropathy, run by Sorlandet Hospital HF.
Trial summary
The goal of this clinical trial is to assess effect of Intravenous immunoglobulins (antibodies) as compared to Placebo, on pain intensity in patients from 18-65 years with painful sensory neuropathy without a known cause. Effect of the treatment will be recorded by the patient in a digital diary. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Sensory Neuropathy, Small Fiber Neuropathy
- What is being tested?
- Intravenous immunoglobulin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Feb 2024to Dec 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Painful sensory neuropathy fulfilling diagnostic criteria for idiopathic small fiber neuropathy or sensory neuronopathy
- Idiopathic small fiber neuropathy (all of the following)
- Neuropathic pain (length-dependent/non-length dependent/focal) and at least two of the following clinical signs
- Hypoesthesia (tactile, pinprick, or thermal)
- Allodynia (tactile, dynamic, thermal, pressure)
- Hyperalgesia
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- Aftersensation
- Normal nerve conduction studies:
- Reduced intra-epidermal nerve fiber density at the distal leg (IENFD) at the distal leg or Reduced thermal threshold assessed at the foot by QST
- Causal investigation according to clinical guidelines has not revealed a cause of the neuropathy
- Sensory neuronopathy (all of the following)
- Clinical pure sensory neuropathy
- A score >6.5 on the following
- Ataxia in the lower or upper limb: 3.1p
- Asymmetrical distribution of sensory loss: 1.7p IVIGSeN Protocol number 1.2
- Sensory loss not restricted to the lower limb at full development: 2.0 p
- At least 1 sensory action potential absent or 3 sensory action potentials <30% of the lower limit of normal in the upper limbs not explained by entrapment neuropathy: 2.8p
- Less than two nerves with abnormal motor nerve conduction studies in the lower limbs: 3.1p
- Causal investigation according to clinical guidelines has not revealed a cause of the neuropathy
- Pain intensity > 5.0 on a pain score from 0-10, lasting at least 4 weeks
Who cannot join
- Participants are excluded from the study if any of the following criteria apply:
- Medical Conditions
- Previous allergic reaction to IVIG or other blood products)
- Selective IgA deficiency
- Cardiac insufficiency (NYHA III/IV ie marked or severe limitation in activity due to symptoms, even during less-than-ordinary activity)
- Cardiac dysrhythmia requiring treatment
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- Unstable or advanced ischemic heart disease
- Severe hypertension (diastolic >120 or systolic > 170)
- Known hyperviscosity
- Renal insufficiency (GFR < 30 ml/min/1,73m2) or nephrotic syndrome
- Previous thromboembolic event
- Smoking
- Diabetes
- Prolonged immobilization
- Hypercoagulable state
- Prior/Concomitant Therapy
- Change of pain medication in the 30 days prior to inclusion (unchanged pain medication is allowed, provided dosages stay equal during the study)
- Treatment with IVIG the last 4 weeks or other ongoing immunomodulatory treatments
- Use of loop diuretics, Dinutuksimab beta, or Imlifidase Diagnostic assessments
- Predominant clinical or neurographic features of motor nerve fiber involvement Other Exclusions
- Females who are breastfeeding, pregnant or unwilling to practice contraception throughout the study
- Unable to give independent informed consent
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effect of Intravenous Immunoglobulins on Painful Sensory Neuropathy Evaluated by Aggregated N-of-one Trials
The goal of this clinical trial is to assess effect of Intravenous immunoglobulins (antibodies) as compared to Placebo, on pain intensity in patients from 18-65 years with painful sensory neuropathy without a known cause. Effect of the treatment will be recorded by the patient in a digital diary.
Read the detailed description
Patients suffering from idiopathic sensory neuropathies often report excruciating pain that interferes with daily function and leads to impaired quality of life. Current neuropathic pain treatment options are in general insufficient. Autoimmunity may play a role in some patients, and treatment with intravenous immunoglobulins (IVIG) may have a potential beneficial effect. Available scientific documentation on this topic is limited and disparate.
The main purpose of this trial is to assess effect of IVIG as compared to placebo on pain intensity in patients >18 years with idiopathic painful small fiber neuropathy or sensory neuronopathy.
Each patient will during the 30-week trial period get 3 IVIG courses and 3 placebo courses in a randomized order, given every 5 week on an outpatient basis for three consecutive days. Outcome measures will be recorded by the patient in a digital diary
- Conditions
- Sensory Neuropathy, Small Fiber Neuropathy
- Being tested
- Intravenous immunoglobulin, Placebo
- Keywords
- nervous system diseases, neuromuscular diseases, peripheral nervous system diseases, small fiber neuropathy, sensory neuronopathy, sensory neuropathy, IVIG, Intravenous immunoglobulin, n-of-1, Sørlandet sykehus, Sorlandet hospital, Kristiansand, polyneuropathy, Intravenous immune globulin
- Medical subject headings
- Small Fiber Neuropathy, Nervous System Diseases, Neuromuscular Diseases, Peripheral Nervous System Diseases, Polyneuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous immunoglobulinDrug
Also called IVIG, Privigen
Each patient will during the 30-week trial period get 3 IVIG courses (each total dose 2g/kg) for three consecutive days
PlaceboDrug
Also called 0.9% saline
Each patient will during the 30-week trial period get 3 placebo courses (each 0.9% saline similar volume) for three consecutive days
| Study group | Role | What they receive |
|---|---|---|
| Intravenous Immunoglobulin | Experimental | 3 courses Intravenous immunoglobulin, Infusion solution, 100mg/ml, 2g/kg over 3 days Receives: Drug: Intravenous immunoglobulin |
| Placebo | Placebo comparator | 3 courses Saline infusion solution 0,9%, same volume as IVIG over 3 days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity the second week
Pain intensity after IVIG/Placebo infusions scored on a numeric rating scale (NRS) ranging from 0 to 10
Measured: The second week after start of IVIG/Placebo infusions (mean of days 8, 10 and 13)
Secondary outcomes (4)
Pain intensity across 4 weeks
Pain intensity across 4 weeks after start of each infusion (mean of scoring three times per week from)
Measured: Day 8 to 34 after start of each infusion
Disability and quality of life
Scored on: Polyneuropathy Patient-reported Index (CAPPRI)
Measured: At the end of the third week after infusion
Anti-FGF3 antibodies
Blood samples will be tested for anti-FGF3 antibodies to evaluate their association with the observed clinical response in terms of pain relief to IVIG.
Measured: Before start of infusion of IVIG/Placebo week 1, 5, 11, 16, 21 and 26
Adverse events
Recording adverse events
Measured: From start to end of interventions week 1 - 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2023
- Study startFeb 2024 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sensory NeuropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- N-of-one trial, individual randomized, double-blind, and multiple crossover comparisons of an interventional treatment and placebo
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sorlandet Hospital HF
- Sponsor type
- Other government
- Collaborators
- Oslo University Hospital, University Hospital of North Norway, University Hospital of Saint-Etienne
- Responsible party
- Sponsor
- Investigators
- Jon-Marius Ørnes, Cand.med, Principal investigator, Sorlandet Hospital HF, Department of NeurologyUnn Ljøstad, Cand.med PhD, Study director, Sorlandet Hospital HF, Department of NeurologyÅse Mygland, Cand.med PhD, Study director, Sorlandet Hospital HF, Department of Neurology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06183008
- Sponsor's protocol ID
- IVIGSeN
- Status last verified
- Mar 2023
- First submitted
- 13 Dec 2023
- Last updated
- 27 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intravenous Immunoglobulins on Painful Sensory Neuropathy Evaluated by Aggregated N-of-one Trials
- ClinicalTrials.gov ID
- NCT06183008
- Acronym / sponsor ID
- IVIGSeN
- Conditions
- Sensory Neuropathy, Small Fiber Neuropathy
- Keywords
- nervous system diseases, neuromuscular diseases, peripheral nervous system diseases, small fiber neuropathy, sensory neuronopathy, sensory neuropathy, IVIG, Intravenous immunoglobulin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Sorlandet Hospital HFOther government
- Collaborators
- Oslo University Hospital, University Hospital of North Norway, University Hospital of Saint-Etienne
- Study start
- Feb 2024 (estimated)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 27 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to assess effect of Intravenous immunoglobulins (antibodies) as compared to Placebo, on pain intensity in patients from 18-65 years with painful sensory neuropathy without a known cause. Effect of the treatment will be recorded by the patient in a digital diary.
Detailed description
Patients suffering from idiopathic sensory neuropathies often report excruciating pain that interferes with daily function and leads to impaired quality of life. Current neuropathic pain treatment options are in general insufficient. Autoimmunity may play a role in some patients, and treatment with intravenous immunoglobulins (IVIG) may have a potential beneficial effect. Available scientific documentation on this topic is limited and disparate.
The main purpose of this trial is to assess effect of IVIG as compared to placebo on pain intensity in patients >18 years with idiopathic painful small fiber neuropathy or sensory neuronopathy.
Each patient will during the 30-week trial period get 3 IVIG courses and 3 placebo courses in a randomized order, given every 5 week on an outpatient basis for three consecutive days. Outcome measures will be recorded by the patient in a digital diary
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- N-of-one trial, individual randomized, double-blind, and multiple crossover comparisons of an interventional treatment and placebo
| Arm | Type | Receives |
|---|---|---|
| Intravenous Immunoglobulin | Experimental | Drug: Intravenous immunoglobulin3 courses Intravenous immunoglobulin, Infusion solution, 100mg/ml, 2g/kg over 3 days |
| Placebo | Placebo comparator | Drug: Placebo3 courses Saline infusion solution 0,9%, same volume as IVIG over 3 days |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Painful sensory neuropathy fulfilling diagnostic criteria for idiopathic small fiber neuropathy or sensory neuronopathy
- Idiopathic small fiber neuropathy (all of the following)
- Sensory neuronopathy (all of the following)
- Pain intensity > 5.0 on a pain score from 0-10, lasting at least 4 weeks
Key exclusion criteria (22 listed)
- Medical Conditions
- Previous allergic reaction to IVIG or other blood products)
- Selective IgA deficiency
- Cardiac insufficiency (NYHA III/IV ie marked or severe limitation in activity due to symptoms, even during less-than-ordinary activity)
- Cardiac dysrhythmia requiring treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intravenous immunoglobulinAlso: IVIG, PrivigenEach patient will during the 30-week trial period get 3 IVIG courses (each total dose 2g/kg) for three consecutive days | Drug | Intravenous Immunoglobulin |
| PlaceboAlso: 0.9% salineEach patient will during the 30-week trial period get 3 placebo courses (each 0.9% saline similar volume) for three consecutive days | Drug | Placebo |
Primary outcome
Pain intensity the second week
Time frame: The second week after start of IVIG/Placebo infusions (mean of days 8, 10 and 13)
Pain intensity after IVIG/Placebo infusions scored on a numeric rating scale (NRS) ranging from 0 to 10
4 secondary outcomes
Pain intensity across 4 weeks
Time frame: Day 8 to 34 after start of each infusion
Disability and quality of life
Time frame: At the end of the third week after infusion
Anti-FGF3 antibodies
Time frame: Before start of infusion of IVIG/Placebo week 1, 5, 11, 16, 21 and 26
Adverse events
Time frame: From start to end of interventions week 1 - 30
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jon-Marius Ørnes, Cand.med principal investigator
Sorlandet Hospital HF, Department of Neurology
Unn Ljøstad, Cand.med PhD study director
Sorlandet Hospital HF, Department of Neurology
Åse Mygland, Cand.med PhD study director
Sorlandet Hospital HF, Department of Neurology
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Intravenous immunoglobulin in people with Sensory Neuropathy and Small Fiber Neuropathy, run by Sorlandet Hospital HF.
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 20 inclusion and 22 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: opening soon, as of the sponsor's last update on 27 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ørnes (+47 38125396, Jon-Marius.Rognhaug.Ornes@sshf.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity the second week (time frame: The second week after start of IVIG/Placebo infusions (mean of days 8, 10 and 13)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Dec 2023.