Overview
Sponsor-declared trial summary
Patients have peristent peripheral neuropathic pain. They are not rare diseases.
To analyse sleep and its microstructure in neuropathic pain patients who have or who do not have a major sleep disturbance, before and during treatment with pregabalin.
Key facts
- Sponsor
- HUS-Yhtymae
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nervous System Diseases [C10]
- Decision date (initial)
- 2024-11-14
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Helsinki University Hospital
External identifiers
- EU CT number
- 2024-515820-35-02
- EudraCT number
- 2020-001957-31
- ClinicalTrials.gov
- NCT06155916
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Therapy, Dose response, Others
To analyse sleep and its microstructure in neuropathic pain patients who have or who do not have a major sleep disturbance, before and during treatment with pregabalin.
Secondary objectives 3
- To find out whether reduced pain by pregabalin associates with improved sleep quality
- To study, using resting state fMRI, brain network connectivity and the volume of the choroid plexus before and during pregabalin treatment.
- To compare the usability and reliability of sleep-related information collected with sleep diaries, Oura-rings, iButtons, and 1-night ambulatory polysomnography.
Conditions and MedDRA coding
Patients have peristent peripheral neuropathic pain. They are not rare diseases.
Regulatory references
- Scientific advice from competent authorities
- Oulu University Hospital
- Plan to share IPD
- No
| EU CT number | Title | Sponsor |
|---|---|---|
| 2024-515820-35-00 | Sleep structure in neuropathic pain patients, psychological factors, brain connectivity, and the effect of pregabalin on sleep and pain | HUS-Yhtymae |
| 2024-515820-35-01 | Sleep structure in neuropathic pain patients, psychological factors, brain connectivity, and the effect of pregabalin on sleep and pain | HUS-Yhtymae |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- Patients with peripheral painful neuropathy, age 18-75 years, pain is chronic (duration >3 months) and moderate to severe intensity (NRS ≥ 4/10) aiming to recruit 20 patients with at least a moderate sleep disturbance as assessed with ISI-questionnaire (>14) and 20 patients without sleep disturbance.
Exclusion criteria 1
- Excessive alcohol consumption (>7 doses/week). If the patient uses gabapentinoids (gabapentin or pregabalin), they are discontinued 2 weeks before the study. Psychotic depression, clinically significant bipolar disorder. Contraindications to brain fMRI.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Pregabalin response to pain. Pain intensity and interference assessed by numeric rating scale
Secondary endpoints 5
- Pregabalin effect on sleep stages. 1-night Ambulatory Polysomnography (NREM stage III).
- Sleep disturbance associations to brain network connectivity. Brain fMRI for brain network connectivity
- Sleep disturbance associations to choroid plexus volume in brain fMRI. Brain fMRI for choroid plexus volume measures
- Pregabalin effect on circadian rhythms. 1-week actigraphy and OURA-ring
- Pregabalin effect on body temperature during sleep. 1-night body temperature measurement by iButton
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 3
PRD10000796 · Product
- Active substance
- Pregabalin
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 600 mg milligram(s)
- Max total dose
- 50400 mg milligram(s)
- Max treatment duration
- 12 Week(s)
- Authorisation status
- Authorised
- ATC code
- N03AX16 — -
- Marketing authorisation
- EU/1/04/279/004
- MA holder
- UPJOHN EESV
- MA country
- Norway
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD10003148 · Product
- Active substance
- Pregabalin
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 600 mg milligram(s)
- Max total dose
- 54000 mg milligram(s)
- Max treatment duration
- 12 Week(s)
- Authorisation status
- Authorised
- ATC code
- N03AX16 — -
- Marketing authorisation
- EU/1/04/279/027
- MA holder
- UPJOHN EESV
- MA country
- Norway
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Pregabalin Pfizer 150 mg hard capsules
PRD10000075 · Product
- Active substance
- Pregabalin
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 600 mg milligram(s)
- Max total dose
- 54000 mg milligram(s)
- Max treatment duration
- 12 Week(s)
- Authorisation status
- Authorised
- ATC code
- N03AX16 — -
- Marketing authorisation
- EU/1/14/916/027
- MA holder
- UPJOHN EESV
- MA country
- Norway
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
HUS-Yhtymae
- Sponsor organisation
- HUS-Yhtymae
- Address
- Stenbackinkatu 9
- City
- Helsinki
- Postcode
- 00290
- Country
- Finland
Scientific contact point
- Organisation
- HUS-Yhtymae
- Contact name
- Hanna Harno
Public contact point
- Organisation
- HUS-Yhtymae
- Contact name
- Hanna Harno
Locations
1 EU/EEA country · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Finland | Authorised, recruitment pending | 40 | 2 |
| Rest of world | — | 0 | — |
Investigational sites
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 5 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | Protocol | 1 |
| Recruitment arrangements (for publication) | Recruitment Arrangements | 1 |
| Subject information and informed consent form (for publication) | Subject information and informed consent form | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Product_summary | 1 |
| Synopsis of the protocol (for publication) | Summary of the study | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-11-01 | Finland | Acceptable 2024-11-12
|
2024-11-14 |