THERAPY DOSSIER · th-f893846e0206

Baclofen

Drug · GABA-B receptor agonist

No trauma translation Suggest a correction

Review required. This record is flagged as borderline.

This record is classified as “NO TRAUMA TRANSLATION”. Read the indication and notes below for the specific context.

Evidence & regulatory context

Mechanism: GABA-B receptor agonist
Target: CHEMBL2111463 (GABA-B receptor)
Injury models: Spinal cord injury · TBI
Reported indication: GABA-B agonist approved for treatment of spasticity (multiple sclerosis and spinal cord injury/disease); intrathecal baclofen for severe spasticity; first approval 1977
First approval: 1977
Development stage: Approved for chronic spasticity (incl. spinal cord origin); acute-injury neuroprotection/recovery use not approved
ChEMBL record: CHEMBL701 ↗
ChEMBL max phase: 4 / 4 (development scale, not regulatory approval)
Synonyms: Baclofen; Lioresal; Lioresal Intrathecal; Gablofen; Ozobax; Lyvispah; Fleqsuvy; Kemstro; Lyflex; BA-34647; NSC-755906; (RS)-baclofen
Note: Not recorded

Clinical trials 12

6 linked trials carry an injury-indication flag. These flags support record-level exploration and sit alongside the stringent aggregate counts described in Methods.

NCT06564714 ↗Injury indicationPHASE4not yet recruiting

Early pharmacological treatment of acute spasticity after spinal cord injury to promote long-term neurofunctional recovery

Traumatic Spinal Cord Injury

Enrolment: 55 · Results not recorded

NCT04471714 ↗Injury indicationPHASE2withdrawn

Effects of baclofen on presynaptic inhibition in humans

Spasticity, Muscle · Spinal Cord Injuries

Enrolment: 0 · Results not recorded

NCT00221689 ↗Injury indicationPHASE2terminated

Early treatment of paroxysmal dysautonomia and hypertonia in severe brain injury by intrathecal baclofen

Traumatic Brain Injury · Cerebral Anoxia · Coma · Hypertonia · Dysautonomia

Enrolment: 4 · Results not recorded

NCT06274021 ↗Injury indicationEARLY_PHASE1unknown

Shared and distinct antispastic effects of electrical and pharmacological neuromodulation (baclofen arm)

Spinal Cord Injuries

Enrolment: 16 · Results not recorded

NCT00871455 ↗Injury indicationNAcompleted

Effect of low-dose baclofen administration on the GH-IGF1 axis in spinal cord injury

Spinal Cord Injury

Enrolment: 20 · Results not recorded

NCT04530955 ↗Injury indicationNAunknown

Transitioning to a valve-gated intrathecal drug delivery system: dose reduction in intrathecal baclofen patients

Injuries, Spinal Cord · Traumatic Brain Injury · Muscle Spasticity · Cerebral Palsy · Multiple Sclerosis · Stroke

Enrolment: 92 · Results not recorded

NCT01032239 ↗PHASE4completed

A Randomized, Controlled, Open-label, Parallel-group, Multi-center Study to Compare the Effect of Intrathecal Baclofen Therapy Versus Best Medical Treatment on Severe Spasticity in Post-stroke Patients After 6 Months Active Treatment

Severe Spasticity

Enrolment: 61 · Results not recorded

NCT01520545 ↗PHASE3completed

Study to Assess the Safety of 3 mg/mL Gablofen (Baclofen Injection) Delivered by Intrathecal Administration Using the Synchromed II Programmable Infusion System

Severe Spasticity

Enrolment: 153 · Results not recorded

NCT00367068 ↗PHASE3completed

Intrathecal Baclofen. Evaluation of a Therapy for Refractory Spasticity in Children With Cerebral Palsy

Cerebral Palsy · Spasticity

Enrolment: 18 · Results not recorded

NCT02705950 ↗NAcompleted

Effect of intrathecal baclofen bolus on neuropathic pain in spinal cord injury patients

Neuropathic Pain

Enrolment: 12 · Results not recorded

NCT05817409 ↗NAnot yet recruiting

Predictive Factors for Treatment Success of Intrathecal Baclofen Therapy in Children With Cerebral Palsy

Cerebral Palsy · Intrathecal Baclofen

Enrolment: 75 · Results not recorded

NCT06844734 ↗NArecruiting

Intrathecal Baclofen for the Management of Hereditary Spastic Paraparesis: a Prospective Cohort Study

Hereditary Spastic Paraplegia

Enrolment: 50 · Results not recorded

Preclinical evidence 2

2 studies reported at therapy level; 2 evidence entries itemised.

PMID 24074748 ↗2013Reported benefit

Repeated Baclofen treatment ameliorates motor dysfunction, suppresses reflex activity and decreases the expression of signaling proteins in reticular nuclei and lumbar motoneurons after spinal trauma in rats.

RatSpinal cord injuryComplete transectionWistarMaleOral, in drinking water30 mg per body weight as reported by the authors, diluted i…Started at week 1 after injury

Model: Complete spinal cord transection at the Th9 level

Repeated discontinuous baclofen improved motor function and suppressed reflex activity, with a considerable decrease in neuronal nitric oxide synthase staining correlating with improved motor dysfunction.

Extraction: extract · Subtype source: rule · Supplied extraction confidence: 0.65. Machine-extracted fields require source verification.

PMID 23268729 ↗2013Reported benefit

Effects of acute intrathecal baclofen in an animal model of TBI-induced spasticity, cognitive, and balance disabilities.

RatTBIWeight-drop / impact-accelerationSprague-DawleyIntrathecal, delivered by Alzet osmotic pump0.8 microgram per hourTreatment initiated at post-injury week 1

Model: Closed head traumatic brain injury using the Marmarou weight-drop model

One month of intrathecal baclofen begun at week 1 blocked early-onset spasticity, attenuated late-onset spasticity and anxiety-like behaviour without adverse effects on cognition or balance, and increased spinal GABA and GABA-B, noradrenaline and brain-derived neurotrophic factor expression.

Extraction: extract · Subtype source: rule · Supplied extraction confidence: 0.7. Machine-extracted fields require source verification.

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