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placebo + oral baclofen
Baclofen is a GABA-B receptor agonist that enhances inhibitory neurotransmission in the central nervous system to reduce muscle spasticity and hyperreflexia.
Baclofen is a GABA-B receptor agonist that enhances inhibitory neurotransmission in the central nervous system to reduce muscle spasticity and hyperreflexia. Used for Muscle spasticity associated with spinal cord injury, Spasticity in multiple sclerosis, Spasticity from other neurological conditions.
At a glance
| Generic name | placebo + oral baclofen |
|---|---|
| Sponsor | Shaare Zedek Medical Center |
| Drug class | GABA-B receptor agonist |
| Target | GABA-B receptor |
| Modality | Small molecule |
| Therapeutic area | Neurology |
| Phase | FDA-approved |
Mechanism of action
Baclofen acts as a selective agonist at GABA-B receptors, which are inhibitory G-protein coupled receptors found throughout the spinal cord and brain. By activating these receptors, baclofen increases inhibitory neurotransmission, leading to reduced excitability of motor neurons and decreased muscle tone. This mechanism makes it effective for treating spasticity associated with spinal cord injury, multiple sclerosis, and other neurological conditions.
Approved indications
- Muscle spasticity associated with spinal cord injury
- Spasticity in multiple sclerosis
- Spasticity from other neurological conditions
Common side effects
- Drowsiness
- Dizziness
- Weakness
- Fatigue
- Headache
- Nausea
Key clinical trials
- Baclofen for Improving Benzodiazepine Titration in Benzodiazepine Dependence (PHASE2, PHASE3)
- Baclofen for the Treatment of Alcohol Drinkers (PHASE2, PHASE3)
- A Study to Assess the Efficacy and Safety of PXT3003 in Charcot-Marie-Tooth Type 1A (PHASE3)
- Evaluating the Safety of Acute Baclofen in Methadone-maintained Individuals With Opiate Dependence. (PHASE4)
- Neuromodulation to Reduce Muscle Stiffness Following Spinal Cord Injury (EARLY_PHASE1)
- Effect of Baclofen to Prevent Post-Traumatic Stress Disorder
- Safety, Tolerability, and Efficacy of Arbaclofen in 16p11.2 Deletion (PHASE2)
- Phase III Trial Assessing the Efficacy and Safety of PXT3003 in CMT1A Patients (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- placebo + oral baclofen CI brief — competitive landscape report
- placebo + oral baclofen updates RSS · CI watch RSS
- Shaare Zedek Medical Center portfolio CI