Study on Baclofen for Pulmonary and Sleep Disorders in Spinal Cord Injury Patients

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What is this study about?

This clinical trial is focused on studying the effects of a treatment for people with Spinal Cord Injury. The treatment being tested is called Baclofen, which is given as a solution for infusion directly into the spinal area, known as intrathecal administration. The main goal of the study is to ensure that this method of delivering Baclofen is safe and does not negatively affect lung function or increase the risk of sleep-related breathing problems, such as sleep apnea.

Participants in the study will receive the Baclofen treatment over a period of time, and their health will be closely monitored. The study will look at how the treatment affects their breathing and sleep, as well as how it impacts muscle stiffness, which is a common issue for people with spinal cord injuries. The study will also gather feedback from participants about their satisfaction with the treatment and how it affects their daily activities.

The study aims to provide valuable information about the safety and effectiveness of using Baclofen in this way, helping to improve treatment options for individuals with spinal cord injuries. Participants will be observed to ensure that their breathing remains within safe limits and that any necessary adjustments to their treatment are made to maintain their well-being.

1 initial assessment

The study begins with an initial assessment to confirm eligibility. This includes verifying the level of spinal cord injury, the presence of generalized spasticity, and ensuring that previous treatments were ineffective or had too many side effects.

Eligibility criteria include being over 18 years old, having a stable medical condition, and not having received muscle or nerve blocks in the last six months.

2 medication administration

The medication used in this study is baclofen, administered intrathecally, which means it is delivered directly into the spinal canal.

The specific product used is Baclofen Sintetica Intrathecaal 0.5 mg/ml solution for infusion.

3 monitoring and evaluation

Throughout the study, the primary focus is on safety, particularly regarding pulmonary and respiratory function. This involves monitoring carbon dioxide levels and the apnea-hypopnea index (AHI), which measures sleep-related breathing disorders.

If a continuous positive airway pressure (CPAP) device is used, adjustments may be made to ensure safety, and these adjustments will be recorded.

4 secondary assessments

Secondary assessments include evaluating the level of spasticity, patient satisfaction, and the patient’s level of function and activities.

These assessments help determine the overall effectiveness of the treatment beyond safety.

5 conclusion of trial

The trial is expected to conclude by January 3, 2026. At the end of the study, all collected data will be analyzed to assess the safety and effectiveness of the treatment.

Who Can Join the Study?

The patient must have a spinal cord injury at the neck level, specifically between C1 and Th1. This refers to the location on the spine where the injury has occurred.
The patient should have generalized spasticity in the upper limbs that affects daily function. Spasticity means the muscles are continuously contracted, causing stiffness or tightness.
The patient must have tried oral medications or local treatments for spasticity, but they either didn’t work well or caused too many side effects.
The patient should be classified under the American Spinal Injury Association (ASIA) Impairment Scale as A, B, C, or D. This scale measures the severity of the spinal cord injury.
The injury must have occurred more than 1 year ago.
The patient must be over 18 years old.
The patient should not have a disease that is getting worse over time.
The patient’s medical condition should be stable enough to undergo the trial and potentially have a baclofen pump implanted. A baclofen pump is a device that delivers medication directly to the spinal fluid to help reduce spasticity.
The patient should not have had any muscle or nerve blocks within 6 months before starting the study. Muscle or nerve blocks are treatments that temporarily reduce muscle activity.

Who Cannot Join the Study?

Patients with a history of severe allergic reactions to the study medication.
Individuals with uncontrolled high blood pressure.
Patients who have had a recent heart attack.
People with severe liver or kidney disease.
Individuals who are pregnant or breastfeeding.
Patients with a history of drug or alcohol abuse.
People who are currently participating in another clinical trial.
Individuals with certain types of infections.
Patients with a history of certain types of cancer.
People who have had a recent surgery.

Where you can join this trial?

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Site Name	City	Country	Status
Medisch Spectrum Twente	Enschede	The Netherlands
Rcbgfeswr Cqbkcmo Vlgi Rlsclbsrklc	Enschede	The Netherlands

Trial status

Country	Status	Recruitment Start
The Netherlands	Not recruiting	23.05.2023

Trial locations

Investigated drugs:

Baclofen

Baclofen is a medication used in this study to help manage muscle spasticity. It is administered intrathecally, which means it is delivered directly into the spinal fluid. The study aims to ensure that this method of delivery is safe for patients with spinal cord injuries, particularly focusing on its effects on lung function and sleep-related breathing disorders.

Investigated diseases:

Spinal cord injury

Spinal Cord Injury – Spinal cord injury refers to damage to the spinal cord that results in a loss of function, such as mobility or sensation. The severity of the injury depends on the location of the injury along the spinal cord and the extent of the damage. It can lead to partial or complete loss of motor control and sensation below the site of the injury. Over time, individuals may experience changes in muscle tone, such as spasticity or flaccidity. The injury can also affect other bodily functions, including bladder and bowel control, respiratory function, and sexual function. Recovery and adaptation vary widely among individuals, depending on the nature and extent of the injury.

Trial ID:

2023-508143-51-01

Protocol code:

NL 68837.091.21

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Baclofen for Pulmonary and Sleep Disorders in Spinal Cord Injury Patients

What is this study about?

Who Can Join the Study?

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