Trial · NCT03424018
An Extension Study to Evaluate the Efficacy and Safety of BMN 111 in Children With Achondroplasia
NCT03424018, Phase 3, Active not recruiting, BioMarin Pharmaceutical
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. An Extension Study to Evaluate the Efficacy and Safety of BMN 111 in Children With Achondroplasia. Trials, record NCT03424018. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03424018
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- An Extension Study to Evaluate the Efficacy and Safety of BMN 111 in Children With Achondroplasia
- NCT number
- NCT03424018
- Status
- Active not recruiting
- Phases
- Phase 3
- Enrollment
- 119 participants, actual
- Lead sponsor
- BioMarin Pharmaceutical
- Conditions
- Achondroplasia
- Interventions
- BMN 111
- First posted
- 2018-02-06
- Last updated
- 2026-03-13
- Other registries' IDs
- eudract:2017-002404-28
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change from baselines in mean annualized growth velocity | Through study completion, an average of 1 year | Long term efficacy as measured by change in annualized growth velocity |
| Secondary | Changes in health-related quality of life as measured by the Quality of Life in Short-Statured Youth questionnaire | Through study completion, every 6-12 months | |
| Secondary | Potential changes in daily activity performance as measured by Activities of Daily Living questionnaire | Through study completion, every 12 months | |
| Secondary | Characterize maximum concentration (Cmax) of BMN 111 in plasma | Through study completion, every 12 months | |
| Secondary | Characterize the area under the plasma concentration time-curve from time 0 to infinity (AUC0-∞) | Through study completion, every 12 months | |
| Secondary | Characterize the area under the plasma concentration time-curve from time 0 to the last measurable concentration (AUC0-t) | Through study completion, every 12 months | |
| Secondary | Characterize the elimination half-life of BMN 111 (t1⁄2) | Through study completion, every 12 months | |
| Secondary | Characterize the apparent clearance of drug | Through study completion, every 12 months | |
| Secondary | Characterize the apparent volume of distribution based upon the terminal phase (Vz/F) | Through study completion, every 12 months | |
| Secondary | Characterize the amount of time BMN 111 is present at maximum concentration (Tmax) | Through study completion, every 12 months |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers3
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03424018
GET https://conductscience.org/api/trials/v1/NCT03424018/registered