VIBRANT HD
En pause
UPDATES: Novartis letter to the community about the Status of VIBRANT-HD
Il s’agit de la première étude du médicament branaplam chez des adultes atteints d’HD afin de déterminer la dose correcte nécessaire pour abaisser les taux de mHTT dans le LCR à un degré censé être efficace sur de plus longues périodes.
Date estimée de fin de l’étude : 17 février 2025
Ages éligibles
pour l'étude:
25 ans à 75 ans
(adulte, adulte plus âgé)
Sexes éligibles
pour l'étude:
Tous
Accepte les volontaires en bonne santé:
Non
Critères d'inclusion
- Signed informed consent must be obtained prior to participation in the study.
- Clinically diagnosed Stage 1 or 2 Huntington’s disease with a diagnostic confidence level (DCL) = 4 and a United Huntington’s Disease Rating Scale (UHDRS) Total Functional Capacity (TFC) >8 at screening.
- Genetically confirmed Huntington’s disease, with presence of ≥40 cytosine-adenineguanine (CAG) repeats in the huntingtin gene.
- Male and female participants between 25 to 75 years of age, inclusive, on the day of Informed Consent signature.
Critères d'exclusion
- Prior participation in clinical trial investigating a huntingtin-lowering therapy (unless participant received only placebo).
- Participants taking medications prohibited by the protocol.
- Any medical history, lumbar surgery or condition that would interfere with the ability to complete the protocol specified assessments,
- Participant has other severe, acute or chronic medical conditions including unstable psychiatric conditions, or laboratory abnormalities that in the opinion of the Investigator may increase the risk associated with study participation, or that may interfere with the interpretation of the study results.
- Any surgical or medical condition which might put the participant at risk in case of participation in the study. The Investigator should make this determination in consideration of the participant’s medical history and/or clinical or laboratory evidence at the Screening visit:
FRANCE
- TRIAL SITE:
Novartis Investigative Site - Address: Angers Cedex 1, France, 49033
- TRIAL SITE:
Novartis Investigative Site - Address: Creteil, France, 94010
- TRIAL SITE:
Novartis Investigative Site - Address: Lille Cedex, France, 59037
HUNGARY
- TRIAL SITE:
Novartis Investigative Site - Address: Szeged, Hungary, 6725
- TRIAL SITE:
Novartis Investigative Site - Address: Szeged, Hungary, 6725
GERMANY
- TRIAL SITE:
Novartis Investigative Site - Address: Muenster, Germany, 48149
- TRIAL SITE:
Novartis Investigative Site - Address: Ulm, Germany, 89081
- TRIAL SITE:
Novartis Investigative Site - Address: Erlangen, Germany, 91054
SPAIN
- TRIAL SITE:
Novartis Investigative Site - Address: Barcelona, Catalunya, Spain, 08036
- TRIAL SITE: Novartis Investigative Site
- Address: Barcelona, Spain, 08041
- TRIAL SITE: Novartis Investigative Site
- Address: Madrid, Spain, 28034