Autopsy report · NCT01433354

Long-term, Safety and Tolerability Study of AFQ056 in Adolescent Patients With Fragile X Syndrome (Open-label)

“The study treatment failed to demonstrate efficacy in target population in two other clinical studies (CAFQ056B2214 and CAFQ056A2212).”

The sponsor’s own words in the registry.

Life of this trial

• Registered 2 months before it started.
• Ran for about 2 years 10 months before it stopped.
• 119 participants enrolled.
• Results were posted on the registry 1 year 1 month after it ended.

Vital statistics

Status

Terminated

Phase

Phase 2, Phase 3

Sponsor

Novartis Pharmaceuticals

Sponsor type

Industry

Conditions

Fragile X Syndrome

Interventions

AFQ056

Participants

119

Sites

28

Countries

Australia, Belgium, Denmark, France, Germany, Israel, Italy, Netherlands, Spain, Sweden, Switzerland, United Kingdom and more

Trials that died the same way

• A Study With BPS-314d-MR-PAH-303 in Participants With Pulmonary Arterial Hypertension
  “The pivotal study, BPS-314d-MR-PAH-302 (NCT01908699), failed to demonstrate efficacy.” (60% match in meaning)
• Phase IIB Pilot of Atazanavir + Raltegravir
  “Efficacy endpoint met, but overall experimental dosing regimen not considered optimal to support further clinical development in this population.” (59% match in meaning)
• Efficacy and Safety of Uprifosbuvir (MK-3682) + Ruzasvir (MK-8408) in Treating Hepatitis C Virus Infection Genotypes 1-6 (MK-3682-041)
  “The study was terminated based on review of Phase 2 efficacy data” (59% match in meaning)
• Dasatinib in Polycythemia Vera
  “This study was terminated due to lack of efficacy.” (58% match in meaning)
• A Study to Evaluate the Effects of GLPG2737 in Participants With Autosomal Dominant Polycystic Kidney Disease (ADPKD)
  “The study was early terminated due to lack of efficacy.” (58% match in meaning)

Look deeper

• The official registry record (the source of truth)
• Record history: every change the sponsor made
• Open it in the database

Everything here comes from the current ClinicalTrials.gov record. The timeline uses the record’s dates; dates marked planned are the sponsor’s plans. The cause of death is an automatic, unverified label. This is research information, not medical advice.