Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Authorised, recruitment pending
Participants planned
28
Countries
1
Sites
1
Complete to incomplete (AIS A-C) sub-acute cervical or thoracic (NLI C4-T10) spinal cord injury (SCI) with severe spastic motor behaviour
To prove better efficacy of Pregabalin in SCI patients with predominant phasic (dynamic) component of spastic motor behaviour compared to Baclofen.
Key facts
- Sponsor
- Fakultni Nemocnice V Motole
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Musculoskeletal Diseases [C05], Diseases [C] - Nervous System Diseases [C10]
- Decision date (initial)
- 2025-10-20
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Motol University Hospital
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy
To prove better efficacy of Pregabalin in SCI patients with predominant phasic (dynamic) component of spastic motor behaviour compared to Baclofen.
Secondary objectives 2
- To prove better efficacy of Baclofen in SCI patients with predominant tonic (static) component of spastic motor behaviour compared to Pregabalin
- To confirm that optimization of spastic motor behaviour treatment according to its predominant tonic or phasic component has a positive effect on ADL, functioning and quality of life after SCI
Conditions and MedDRA coding
Complete to incomplete (AIS A-C) sub-acute cervical or thoracic (NLI C4-T10) spinal cord injury (SCI) with severe spastic motor behaviour
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 8
- Sub-acute (2-40 days after the injury) cervical or thoracic (NLI C4-T10) spinal cord lesion (SCI), complete or incomplete (AIS A-C), with severe spastic motor behaviour (static or dynamic)
- Age: 18-75 years old
- MAS or MES 3 or higher during at least 3 days from 5
- Ability and will to cooperate in the study
- Written informed consent. If the patient is only able to consent orally a witness signs and confirms the patient’s consent.
- Absence of serious comorbidities influencing spastic motor behaviour (serious infection, recent surgery…)
- Hemodynamic and clinical stability
- Males and Females of childbearing potential willing to use highly effective method of contraception (hormonal contraception, intrauterine device or sexual abstinence) during the treatment period and for at least one month after the last dose of study drug.
Exclusion criteria 7
- History of hypersensitivity to IMP (Pregabalin and/or Baclofen)
- Neuropathic pain stronger than VAS 5
- Previous medication for spastic motor behaviour or neuropathic pain or epilepsy (pregabalin, neurontin, baclofen, rivotril, sirdalud...)
- Pregnancy or breastfeeding
- Renal dysfunction (creatinine level over 120 umol/l, urea level over 10 mmol/l)
- Liver dysfunction (liver enzymes over 2,5 ukat/l)
- BMI ˃ 35kg/m2
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Per-patient average of MES scores across the 30 days treatment.
Secondary endpoints 6
- Per-patient average of MAS scores across the 30 days treatment
- Proportion of days when MES score is 3 or higher.
- Proportion of days when MAS score is 3 or higher.
- ADL evaluated by SCI-SET (relevant questions).
- Functioning assessed by the Spinal Cord Independence Measure (SCIM-III).
- Quality of life evaluated by WHOQOL-BREF questionnaire.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
Pregabalin Sandoz 50 mg hard capsules
PRD6059719 · Product
- Active substance
- Pregabalin
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 600 mg milligram(s)
- Max total dose
- 600 mg milligram(s)
- Max treatment duration
- 1 Month(s)
- Authorisation status
- Authorised
- ATC code
- N03AX16 — -
- Marketing authorisation
- EU/1/15/1011/013
- MA holder
- SANDOZ GMBH
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- For blinding reasons, the drug will be incorporated into Fagron CapsiCard capsules, size 2, white, in the pharmacy. More information in the Technological prescription
BACLOFEN POLPHARMA 10 mg tablety
PRD310042 · Product
- Active substance
- Baclofen
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 100 mg milligram(s)
- Max total dose
- 100 mg milligram(s)
- Max treatment duration
- 30 Day(s)
- Authorisation status
- Authorised
- ATC code
- M03BX01 — BACLOFEN
- Marketing authorisation
- 63/102/81-A/C
- MA holder
- ZAKLADY FARMACEUTYCZNE POLPHARMA S.A.
- MA country
- Czech Republic
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- For blinding reasons, the drug will be incorporated into Fagron CapsiCard capsules, size 2, white, in the pharmacy. More information in the Technological prescription
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Fakultni Nemocnice V Motole
- Sponsor organisation
- Fakultni Nemocnice V Motole
- Address
- V Uvalu 84/1, Motol Motol
- City
- Prague
- Postcode
- 150 00
- Country
- Czechia
Scientific contact point
- Organisation
- Fakultni Nemocnice V Motole
- Contact name
- Principal Investigator
Public contact point
- Organisation
- Fakultni Nemocnice V Motole
- Contact name
- Clinical Trial Department
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Czechia | Authorised, recruitment pending | 28 | 1 |
| 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 32 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_2024-518824-56-00 | 1 |
| Protocol (for publication) | D1_Protocol_2024-518824-56-00_01Sep2025 | 1 |
| Protocol (for publication) | D1_Protocol_2024-518824-56-00_01Sep2025_TC | 1 |
| Protocol (for publication) | D1_Protocol_2024-518824-56-00_ver3_29Sep2025 | 3 |
| Protocol (for publication) | D1_Protocol_2024-518824-56-00_ver3_29Sep2025_TC | 3 |
| Protocol (for publication) | D1_Protocol_2024-518824-56-00_ver4_14Oct2025 | 4 |
| Protocol (for publication) | D1_Protocol_2024-518824-56-00_ver4_14Oct2025_TC | 4 |
| Protocol (for publication) | Protocol Appendix 1 - Spastic Motor Behavior Evaluation eng | 1 |
| Protocol (for publication) | Protocol Appendix 2 - ISNCSCI eng | 1 |
| Protocol (for publication) | Protocol Appendix 3 - SCI-SET eng | 1 |
| Protocol (for publication) | Protocol Appendix 4 - SCIM III eng | 1 |
| Protocol (for publication) | Protocol Appendix 5 - International Spinal Cord Injury Pain Basic Data Set eng | 1 |
| Protocol (for publication) | Protocol Appendix 6 - WHOQOL-BREF eng | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_2024-518824-56-00_sablona SUKL 1 | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_2024-518824-56-00_patient_CZ | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_2024-518824-56-00_patient_CZ_10Sep2025_Clean | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_2024-518824-56-00_patient_CZ_10Sep2025_Clean_redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_2024-518824-56-00_patient_CZ_10Sep2025_TC | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_2024-518824-56-00_patient_CZ_redacted | 1 |
| Subject information and informed consent form (for publication) | L2_GDPR ICF_2024-518824-56-00_patient_CZ | 1 |
| Subject information and informed consent form (for publication) | L2_GDPR ICF_2024-518824-56-00_patient_CZ_redacted | 1 |
| Subject information and informed consent form (for publication) | L2_GDPR infromation_2024-518824-56-00_patient_CZ | 1 |
| Subject information and informed consent form (for publication) | L2_GDPR infromation_2024-518824-56-00_patient_CZ_redacted | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Baclofen Polpharma_CZ | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Pregabalin Sandoz_CZ | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2024-518824-56-00 | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2024-518824-56-00_01Sep2025 | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2024-518824-56-00_TC_01Sep2025 | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2024-518824-56-00_ver3_29Sep2025 | 3 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2024-518824-56-00_ver3_29Sep2025_TC | 3 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2024-518824-56-00_ver4_14Oct2025 | 4 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2024-518824-56-00_ver4_14Oct2025_TC | 4 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-07-01 | Czechia | Acceptable 2025-10-20
|
2025-10-20 |