Evicenter
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Aqneursa (levacetylleucine)

Ataxia-telangiectasia

Also known as IB1001
Manufacturer
IntraBio
Last updated
206 sources

Product information and disease descriptionProduct descriptionProduct information

Co-prescribed/Concomitant therapies

5 evidence topics · 4 sources

N-acetyl-DL-leucine products

“N-acetyl-DL-leucine or N-acetyl-D-leucine: Avoid concomitant use with AQNEURSA.” (opens the prescribing information at this quote)

“Levacetylleucine is the L-enantiomer of N-acetyl-DL-leucine, a modified amino acid that has been available in France as a solution for injection and in tablet form since 1957, under the trade name Tanganil (Pierre Fabre Laboratories) as a treatment for acute vertigo.” (opens the source at this quote in a new tab)

Medications prohibited in the pivotal A-T trial

“Patients unwilling and/or not able to undergo a 42-day washout period from any of the following prohibited medication prior to Visit 1 (Baseline 1) and remain without prohibited medication through Visit 6.” (opens the source at this quote in a new tab)

“N-Acetyl-DL-Leucine (e.g. Tanganil®);” (opens the source at this quote in a new tab)

“N-Acetyl-L-Leucine (prohibited if not provided as IMP in the IB1001-303 trial);” (opens the source at this quote in a new tab)

“Sulfasalazine;” (opens the source at this quote in a new tab)

“Rosuvastatin.” (opens the source at this quote in a new tab)

Conditions for other concomitant therapies in the pivotal A-T trial

“Patients are willing to disclose their existing medications/therapies for (the symptoms) of A-T, including those on the prohibited medication list.” (opens the source at this quote in a new tab)

“The Investigator does not believe the medication/therapy will interfere with the study protocol/results” (opens the source at this quote in a new tab)

“Patients have been on a stable dose/duration and type of therapy for at least 42 days before Visit 1 (Baseline 1)” (opens the source at this quote in a new tab)

“Patients are willing to maintain a stable dose/do not change their therapy throughout the duration of the study.” (opens the source at this quote in a new tab)

Medications prohibited in the phase 2 master protocol that included A-T
ItemProtocol text
Washout requirement“Patients unwilling and/or not able to undergo a 42-day washout period from any of the following prohibited medication prior to Visit 1 (Baseline 1) and remain without prohibited medication through Visit 6.”
a“Aminopyridines (including sustained-release form);”
b“N-Acetyl-DL-Leucine (e.g. Tanganil®) ;”
c“N-Acetyl-L-Leucine (prohibited if not provided as IMP);”
d“Riluzole;”
e“Gabapentin;”
f“Varenicline;”
g“Chlorzoxazone;”
h“Sulfasalazine;”
i“Rosuvastatin.”
Standard-of-care and supportive-care medication in clinical trials

“No data on pharmacology drug interaction with levacetylleucine were provided. However, during Phase II and III clinical trials, levacetylleucine was combined with a broad spectrum of standard-of-care and supportive-care medication and no potential for respective pharmacodynamic drug-drug interactions was identified.” (opens the source at this quote in a new tab)