Pilot Study, Comparative, Single-center, Randomized, Crossover, Double-blind, Against Placebo, Testing the Effectiveness of Triheptanoin Oil in Alternating Hemiplegia of Childhood

PHASE2CompletedINTERVENTIONAL
Enrollment

10

Participants

Timeline

Start Date

March 25, 2015

Primary Completion Date

April 5, 2017

Study Completion Date

April 5, 2017

Conditions
Alternating Hemiplegia of Childhood
Interventions
DRUG

Triheptanoin

"Triheptanoin is a triglyceride composed of three heptanoate (C7 fatty acid) esters. Triheptanoin is manufactured by chemical synthesis from glycerol and heptanoic acid. Triheptanoin is a liquid, intended for oral (PO) administration.~Participants will be given approximately 1g/kg of Triheptanoin divided at least in three doses (at 8 am, 12 noon, and 8 pm). A one-day titration period will be used, using 0.5 g/kg increments before arriving at the full dose."

DRUG

Placebo

Placebo is a oily liquid, intended for oral (PO) administration. Participants will be given approximately 1g/kg of Placebo divided at least in three doses (at 8 am, 12 noon, and 8 pm). A one-day titration period will be used, using 0.5 g/kg increments before arriving at the full dose.

Trial Locations (1)

75013

Groupe hospitalier Pitié Salpêtrière, Paris

All Listed Sponsors
lead

Institut National de la Santé Et de la Recherche Médicale, France

OTHER_GOV

NCT02408354 - Pilot Study, Comparative, Single-center, Randomized, Crossover, Double-blind, Against Placebo, Testing the Effectiveness of Triheptanoin Oil in Alternating Hemiplegia of Childhood | Biotech Hunter | Biotech Hunter