Partial Blocks of Rectus Femoris and Soleus With Botulinum Toxin Type A (Xeomin®) to Improve Gait in Hemiparesis

PHASE2UnknownINTERVENTIONAL
Enrollment

66

Participants

Timeline

Start Date

December 31, 2014

Primary Completion Date

November 30, 2017

Study Completion Date

December 31, 2018

Conditions
Hemiparesis After StrokeTraumatic Brain Injury
Interventions
DRUG

Placebo injection

"Placebo in soleus and placebo in rectus femoris, and placebo in additional muscles as per investigator's choice among tibialis posterior, toe flexors (long or short), gastrocnemius muscles or peroneus longus.~150U (x 7.5 ml) placebo Sol + 150U (x 7.5 ml) placebo RF + 100U (5ml) placebo distributed between tibialis posterior, FHL (flexor hallucis longus), FCB (flexor digitorum brevis), gastrocnemius muscles or peroneus longus, based upon investigator clinical judgment"

DRUG

Botulinum toxin injection

"Botulinum toxin type A in soleus and in rectus femoris, and Botulinum toxin type A in additional muscles as per investigator's choice among tibialis posterior, toe flexors (long or short), gastrocnemius muscles or peroneus longus.~150U (x 7.5 ml) Xeomin® 20U/ml Sol + 150U (x 7.5 ml) Xeomin® 20U/ml RF + 100U (5ml) Xeomin® distributed between tibialis posterior, FHL (flexor hallucis longus), FCB (flexor digitorum brevis), gastrocnemius muscles or peroneus longus, based upon investigator clinical judgment."

DRUG

Placebo injection and botulinum toxin injection

"Botulinum toxin type A in soleus and placebo in rectus femoris, and Botulinum toxin type A in additional muscles as per investigator's choice among tibialis posterior, toe flexors (long or short), gastrocnemius muscles or peroneus longus..~150U (x 7.5 ml) Xeomin® 20U/ml Sol + 150U (x 7.5 ml) placebo RF + 100U (5ml) Xeomin® distributed between tibialis posterior, FHL (flexor hallucis longus), FCB (flexor digitorum brevis), gastrocnemius muscles or peroneus longus, based upon investigator clinical judgment."

Trial Locations (1)

94010

RECRUITING

Henri Mondor Hospital, Créteil

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Merz Pharmaceuticals GmbH

INDUSTRY

lead

Assistance Publique - Hôpitaux de Paris

OTHER

NCT03119948 - Partial Blocks of Rectus Femoris and Soleus With Botulinum Toxin Type A (Xeomin®) to Improve Gait in Hemiparesis | Biotech Hunter | Biotech Hunter