This is a double-blinded, placebo-controlled clinical trial of a single-blinded, single-sequence, randomized, double-dummy crossover design between Lilly and United Kingdom (UK) Baclofen for the treatment of spasticity of spinal cord: a double-blinded, single-sequence, placebo-controlled clinical study. Patients were required to have a spinal cord injury, and all the participants were instructed in the correct dosage of the medication. They were randomly allocated to either a baclofen capsule (5 mg, 25 mg or 50 mg) plus placebo (10 mg or 20 mg), or a placebo capsule (5 mg, 25 mg or 50 mg) plus baclofen (20 mg or 40 mg) in a 1:1 ratio (1:1 = 1:1). The study followed a similar design to that of previous studies with the same design as with our previous study. Patients received a maximum dose of 80 mg of Baclofen orally and were required to be unable to swallow capsules. Patients were asked to stop taking the capsules before the end of the study. The study was stopped if patients withdrew from the study due to adverse events (AEs) or from the need for treatment. Patients were monitored every 2 weeks for AEs, with a maximum of 6 weeks following study discontinuation of all study medication. There was no difference between the baclofen capsules and placebo capsules in the rate of discontinuation of study medication (0.7% vs 0.1%; P=0.73) and the rate of baclofen capsules discontinuation (0.4% vs 0.1%; P=0.76) during the study period. However, there was a trend in the rate of baclofen capsule discontinuation during the first 6 weeks of the study (0.7% vs 0.1%; P=0.06) and a trend in the rate of baclofen capsule discontinuation during the first month (0.4% vs 0.1%; P=0.06) after stopping the study medication. The number of baclofen capsules treated with baclofen were similar during the first 6 weeks of the study (2.4% vs 2.3%; P=0.62) and 1 month (2.1% vs 2.1%; P=0.67). The study was stopped if patients withdrew due to the need for baclofen.
The study was stopped if patients withdrew from the study due to the need for baclofen due to adverse events (AEs) (1% vs 2.3%; P=0.06), and in the first 6 weeks of the study (2.1% vs 2.1%; P=0.67).
Figure 1Trial design for Baclofen for the treatment of spasticity of spinal cord
Figure 2Effect of baclofen capsule on spasticity in patients receiving Baclofen capsule
Figure 3Safety results of baclofen capsule vs placebo for spasticity of spinal cord
The Lilly and UK study design is a double-blinded, placebo-controlled clinical study with a placebo-controlled design. The trial was designed to be a double-blinded, double-dose- randomized, placebo-controlled study of the treatment of spasticity of spinal cord. Patients were randomly allocated to the baclofen capsule group (5 mg, 25 mg or 50 mg) or the placebo capsule (5 mg, 25 mg or 50 mg) in a 1:1 ratio (1:1 = 1:1). In the baclofen capsule group, baclofen capsules were first administered to the patients and then to each patient at the maximum dose of 80 mg of baclofen orally. The study was stopped if patients withdrew from the study due to the need for baclofen due to adverse events (AEs).
Baclofen is used to treat muscle spasms caused due to cerebral palsy, multiple sclerosis, stroke or due to any other nerve or spinal cord disorders.
Baclofen: Muscle Relaxants
Baclofen is a muscle relaxant. It acts by increasing the effects of certain chemical messengers (such as GABA) in the spinal cord that induces muscle relaxation. As a result, it prevents muscle twitching, relieves pain caused due to muscle spasms and improves muscle movement.
Consult your doctor:
Baclofen, an antidepressant, is an atypical and first-line therapy in the treatment of intrathecal neuropathic pain. Baclofen has demonstrated excellent pain and neuropathic pain relief, but it also has serious adverse effects. Baclofen has a low potential for abuse potential, but this has been largely overlooked, primarily due to its limited abuse potential in the treatment of intrathecal neuropathic pain. The primary goal of intrathecal Baclofen therapy is to reduce pain and improve the function of the spinal cord. The purpose of this study was to examine the efficacy of baclofen for the treatment of intrathecal neuropathic pain.
This is a double-blind, randomized, placebo-controlled study designed to evaluate the efficacy of baclofen in the treatment of intrathecal neuropathic pain. In this study, patients were randomized to receive either a placebo or baclofen 10 mg/day (n = 30) or baclofen 100 mg/day (n = 30). The primary efficacy measure was change in the Global Assessment of Functioning (GAFF) score at week 12 in patients treated with baclofen.
A 56-year-old female with a past medical history of hypertension and diabetes mellitus was evaluated by a neuroendocrinologist. She was receiving a pump implantation device (Dermis, Evra, Linn) under the care of her primary care physician, who prescribed baclofen for the pain of the lower leg. A spinal cord injury diagnosis (lumbar puncture) was suspected (n = 11) but there was no history of any neurological disorder. She was started on baclofen 10 mg/day and gradually tapered off. At week 12, she reported significant pain. At the end of the study, she rated her GAFF score on a scale of 0 to 10 and was assessed for pain by the Global Assessment of Functioning (GAFF) scale. She also rated the severity of her pain on a scale of 0 to 5 and reported moderate to severe pain (pain score of 4 or less) with no significant analgesia. The pain intensity was assessed using the Global Assessment of Functioning (GAFF) scale at week 12. Her GAFF score was higher at 12 weeks compared to baseline at week 24. She was also assessed for other side effects, including dizziness and nausea, which were not significantly different from baseline. She rated her GAFF score at week 12 and did not use any other treatment. The GAFF scores at weeks 12 and 24 were significantly different compared to baseline (p<0.001). In terms of the pain intensity, baclofen significantly reduced the GAFF scores compared to baseline (p<0.001). The pain intensity did not significantly differ between baclofen and placebo (p>0.05). Baclofen did not improve the GAFF score or the severity of her pain. Her GAFF scores at week 12 were lower than those reported at baseline (p<0.05). Her GAFF scores were also lower than the GAFF scores at baseline (p<0.05). Baclofen significantly decreased the GAFF score (p<0.001), and pain severity was decreased (p <0.05). Baclofen significantly improved the GAFF score (p<0.001), pain severity was improved (p<0.001), and GAFF score at week 12 was lower (p<0.001). Baclofen did not significantly improve the GAFF score, pain severity, or GAFF score at week 12 compared to baseline. She discontinued baclofen for several days.
At the last follow-up visit, the GAFF scores at baseline and at week 12 were similar to baseline (p=0.095). However, at week 24, her GAFF score at baseline was significantly lower than the GAFF scores at baseline (p<0.001). Baclofen also significantly decreased the GAFF score (p<0.001), and pain severity was decreased (p<0.001). The GAFF scores at baseline and at week 24 were significantly different compared to baseline (p=0.014). Baclofen significantly improved the GAFF score (p<0.001), and pain severity was improved (p<0.001) at week 12 compared to baseline (p=0.039). Baclofen significantly improved the GAFF score (p<0.001), pain severity was decreased (p=0.001), and GAFF score at week 24 was lower (p=0.
The muscle is contracted to the bone, causing the muscles to rub together and the joint to tighten. This causes the blood vessels to bulge out and the muscles to relax. It is a muscle relaxant, meaning it helps to relieve the muscle strain caused by a sprain and strain on the bones. It is taken by mouth, with or without food. It is taken up to two weeks before the muscle becomes a full muscle. If you have problems with the way your muscles are feeling, you should talk to your doctor about ways to relax and restore the strength.
Baclofen, also known as the “toxin”, is a commonly prescribed medication for spasticity. Baclofen is an anti-muscle relaxant that is commonly prescribed to muscle spasms. It works by relaxing the blood vessels, reducing the strain on the bones and relieving the spasms.
When taking baclofen, it is important to know that it is not suitable for everyone. In some people, baclofen can cause side effects such as muscle pain, weakness and tiredness. In others, baclofen can cause side effects such as dizziness, nausea, vomiting, and constipation. If you are suffering from any of these, you should discuss the risks and benefits of taking baclofen with your doctor.
Before you start taking baclofen, it is important to inform your doctor about any existing medical problems. This includes:
Baclofen is taken with or without food. It is important to follow the doctor’s advice and to take the medicine as prescribed by your doctor. It is safe to take baclofen for as long as your doctor prescribes it.
Baclofen is known to cause side effects such as:
If you have kidney disease or are taking medicines called anticoagulants, you should only take baclofen if your doctor prescribes it. In this case, the doctor will determine the dosage and duration of treatment. This can be done under the supervision of your doctor. The dosage is usually given in divided doses to help you get the best results from your medicine.
Some of the side effects of baclofen may include:
It is important to tell your doctor immediately if you experience any of the following side effects:
Before you start taking baclofen, inform your doctor if you have any of the following conditions:
The doctor will carefully monitor your progress and determine if baclofen is working or not.
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