WHO ICTRP trial
A safety and efficacy study of N-Acetyl-L-Leucine on Ataxia-Telangiectasia.
EUCTR2018-004407-39-DE · EU Clinical Trials Register · Authorised
Key facts
| Trial ID | EUCTR2018-004407-39-DE |
|---|---|
| Public title | A safety and efficacy study of N-Acetyl-L-Leucine on Ataxia-Telangiectasia. |
| Scientific title | Effects of N-Acetyl-L-Leucine on Ataxia-Telangiectasia (A-T): A multinational, multicenter, open-label, rater-blinded Phase II study. |
| Primary sponsor | IntraBio Ltd |
| Registry | EU Clinical Trials Register |
| Recruitment status | Authorised |
| Study type | Interventional clinical trial of medicinal product |
| Phase | Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no |
| Countries | United States;United Kingdom;Germany;Spain |
| Conditions | Ataxia-Telangiectasia (A-T) MedDRA version: 20.0 Level: SOC Classification code 10010331 Term: Congenital, familial and genetic disorders System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases… |
| Interventions | Product Name: N-Acetyl-L-Leucine Product Code: IB1001 Pharmaceutical Form: Powder and solvent for oral solution INN or Proposed INN: N-Acetyl-L-leucine Other descriptive name: 2(S)-(ACETYLAMINO)-4-METHYLPENTANOIC ACID Concentration unit: g… |
| Registration date | May 2, 2020 |
| Target size | 39 |
| Secondary IDs | IB1001-203;NCT03759678;2018-004407-39-GB |
| Registry page | clinicaltrialsregister.eu |
At a glance
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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: