{
  "topic": {
    "stem": "VAMOROLONE_DMD_REVIEW",
    "name": "Vamorolone in Duchenne",
    "ncts": [
      "NCT03439670",
      "NCT03038399"
    ],
    "drug_patterns": [
      "vamorolone"
    ],
    "condition_patterns": [
      "duchenne",
      "muscular"
    ]
  },
  "trials": [
    {
      "gates": {
        "A_aact_exists": true,
        "B_drug_in_intvs": true,
        "C_condition_in_aact": true,
        "D_pmid_topic_match": true,
        "E_two_arms": true,
        "F_primary_outcome_known": true
      },
      "extracted": {
        "nct": "NCT03439670",
        "aact_title": "A Study to Assess the Efficacy and Safety of Vamorolone in Boys With Duchenne Muscular Dystrophy (DMD)",
        "aact_acronym": "",
        "start_date": "2018-06-29",
        "primary_completion_date": "2021-02-23",
        "aact_intvs": [
          "Vamorolone",
          "Prednisone",
          "Placebo",
          "Vamorolone",
          "Prednisone",
          "Placebo",
          "Vamorolone",
          "Vamorolone"
        ],
        "aact_conditions": [
          "duchenne muscular dystrophy"
        ],
        "pmid": "36036925",
        "pubmed_year": 2022,
        "pubmed_doi": "10.1001/jamaneurol.2022.2480",
        "aact_per_arm_counts": {
          "BG000": 28,
          "BG001": 28,
          "BG002": 15,
          "BG003": 15,
          "BG004": 14,
          "BG005": 14
        },
        "aact_primary_outcome_measure": "Efficacy Measured by Time to Stand Test (TTSTAND) Velocity in Rises/Second Change From Baseline",
        "aact_outcome_count_rows": []
      }
    },
    {
      "gates": {
        "A_aact_exists": true,
        "B_drug_in_intvs": true,
        "C_condition_in_aact": true,
        "D_pmid_topic_match": true,
        "E_two_arms": true,
        "F_primary_outcome_known": true
      },
      "extracted": {
        "nct": "NCT03038399",
        "aact_title": "Long-term Extension Study to Assess Vamorolone in Boys With Duchenne Muscular Dystrophy (DMD)",
        "aact_acronym": "",
        "start_date": "2017-02-02",
        "primary_completion_date": "2020-04-30",
        "aact_intvs": [
          "Vamorolone 0.25 mg/day/day",
          "Vamorolone 0.75 mg/day/day",
          "Vamorolone 2.0 mg/day/day",
          "Vamorolone 6.0 mg/day/day"
        ],
        "aact_conditions": [
          "duchenne muscular dystrophy"
        ],
        "pmid": "32956407",
        "pubmed_year": 2020,
        "pubmed_doi": "10.1371/journal.pmed.1003222",
        "aact_per_arm_counts": {
          "BG000": 11,
          "BG001": 12,
          "BG002": 12,
          "BG003": 11
        },
        "aact_primary_outcome_measure": "Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE Version 4.03",
        "aact_outcome_count_rows": [
          [
            "OG000",
            "4.0"
          ],
          [
            "OG001",
            "14.0"
          ],
          [
            "OG002",
            "29.0"
          ],
          [
            "OG003",
            "1.0"
          ],
          [
            "OG004",
            "39.0"
          ],
          [
            "OG000",
            "15.0"
          ],
          [
            "OG001",
            "34.0"
          ],
          [
            "OG002",
            "203.0"
          ],
          [
            "OG003",
            "5.0"
          ],
          [
            "OG004",
            "302.0"
          ]
        ]
      }
    }
  ],
  "gate_summary": {
    "A_aact_exists": 2,
    "B_drug_in_intvs": 2,
    "C_condition_in_aact": 2,
    "D_pmid_topic_match": 2,
    "E_two_arms": 2,
    "F_primary_outcome_known": 2
  },
  "n_total": 2,
  "n_pass_all": 2,
  "pass_rate": 1.0,
  "verdict": "VIABLE"
}