Drug intelligence / Profile preview

baclofen + placebo botulinum toxin

Development stage
Unknown
Lead developer
CHU de Toulouse
Modality
Small Molecules
Administration
Oral, Intramuscular
01

Overview

This refers to a specific treatment arm in the **Baclotox** clinical trial (NCT00515398), a Phase 4 multicenter study sponsored by the **University Hospital, Toulouse** (CHU de Toulouse). This treatment regimen consists of active oral **baclofen** administered alongside a placebo intramuscular injection (placebo botulinum toxin) to maintain a double-blind, double-dummy design. Baclofen is a small molecule **GABA-B receptor agonist** used to treat muscle spasticity by inhibiting monosynaptic and polysynaptic reflexes at the spinal level. The trial specifically investigates whether early treatment of spasticity (within 2 months post-stroke) affects motor recovery, comparing the efficacy of oral baclofen against botulinum toxin type A injections. Merz Pharma provided financing and drug supplies for the study.

Other names
placebo + baclofenbaclofen arm of Baclotox trial
02

Targets

GABA-B (Gamma-aminobutyric acid receptor type B)

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