Pulmonary function and sleep related disorders during cervical admission of intrathecal baclofen in spinal cord injury; a safety study

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Roessingh Centrum Voor Revalidatie

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Nervous System Diseases [C10]

Trial duration

9 Mar 2026 → ongoing

Decision date (initial)

2024-05-06

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

neurobionic foundation · Medtronic · Roessingh

External identifiers

EU CT number

2023-508143-51-01

EudraCT number

2021-004994-30

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety

The primary goal of the study is to demonstrate that cervical admission of intrathecal baclofen is a safe treatment without deterioration of pulmonary and respiratory function and possible increased risk or increased severity of sleep apneu syndrom

Secondary objectives 1

1. Secondary goal of the study is to explore the effect of cervical admission of ITB on reduction of spasticity (both functional en satisfaction) and improvement at the level of patients functions and activities.

Conditions and MedDRA coding

Spinal cord Injury

Regulatory references

Plan to share IPD

No

IPD plan description

not applicable

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

1. In order to be eligible to participate in this study, a subject must meet all of the following criteria: • Cervical SCI neurological level C1-Th1, • Functionally hindering generalized spasticity of the upper extremities with insufficient effect or too many side effects of oral spasmolytics and/or local treatments • American Spinal Injury Association (ASIA) Impairment Scale: A,B,C,D • > 1 year after onset of SCI • Over 18 years old • No progressive disease • Stabile medical situation for undergoing the ITB-trial and a final implantation of a baclofen pump after positive test • No muscle or nerve blocks < 6 months for start of study

Exclusion criteria 1

1. A potential subject who meets any of the following criteria will be excluded from participation in this study: • Pregnancy • Women of child bearing potential • Nursing women • Allergy baclofen • Contra indication ITB (increased bleeding tendency, increased intracranial pressure, severe pressure ulcer) • Oral anticoagulants • Severe depression • excessive alcohol use • Patients depending on ventilation • Not adequately treated SAS • PcCO2 > 6,5 KPa

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The primary endpoint of the study is treatment safety, which is defined as PcCO2 between 4,7 kPa and 6,5 kPa and an AHI < 15 without complaints of SAS in patients without SAS and an AHI < 5 in patients with treated SAS. If patients use a CPAP device, it may be adjusted to stay within the safe margin. This adjustment will be registered. The spirometry is not used for safety reasons but to determine the effect of ITB on pulmonary function

Secondary endpoints 1

1. Secondary endpoints are the amount of spasticity, patients satisfaction and patients level of function and activities.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Roessingh Centrum Voor Revalidatie

Sponsor organisation

Roessingh Centrum Voor Revalidatie

Address

Roessinghsbleekweg 33

City

Enschede

Postcode

7522 AH

Country

Netherlands

Scientific contact point

Organisation

Roessingh Centrum Voor Revalidatie

Contact name

Ellen Maas

Public contact point

Organisation

Roessingh Centrum Voor Revalidatie

Contact name

Ellen Maas

Locations

1 EU/EEA country · 2 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 3 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications