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Lumbar Puncture, Blood Collection · 1 trial · 2 indications
| Arm | Type | Description |
|---|---|---|
| Angelman Syndrome: Group 1 | EXPERIMENTAL | Participants aged 0-6 years old with Angelman Syndrome will undergo lumbar puncture (LP) for CSF and blood collection while under general anesthesia or conscious sedation during or after a prescheduled procedure unrelated to the study. |
| Angelman Syndrome: Group 2 | EXPERIMENTAL | Participants aged 7-12 years old with Angelman Syndrome will undergo lumbar puncture (LP) for CSF and blood collection while under general anesthesia or conscious sedation during or after a prescheduled procedure unrelated to the study. |
| Angelman Syndrome: Group 3 | EXPERIMENTAL | Participants aged 13-18 years old with Angelman Syndrome will undergo lumbar puncture (LP) for CSF and blood collection while under general anesthesia or conscious sedation during or after a prescheduled procedure unrelated to the study. |
| Angelman Syndrome: Group 4 | EXPERIMENTAL | Participants aged 19-50 years old with Angelman Syndrome will undergo lumbar puncture (LP) for CSF and blood collection while under general anesthesia or conscious sedation during or after a prescheduled procedure unrelated to the study. |
| Dup15q Syndrome: Group 1 | EXPERIMENTAL | Participants aged 0-6 years old with Dup15q Syndrome will undergo lumbar puncture (LP) for CSF and blood collection while under general anesthesia or conscious sedation during or after a prescheduled procedure unrelated to the study. |
| Dup15q Syndrome: Group 2 | EXPERIMENTAL | Participants aged 7-12 years old with Dup15q Syndrome will undergo lumbar puncture (LP) for CSF and blood collection while under general anesthesia or conscious sedation during or after a prescheduled procedure unrelated to the study. |
| Dup15q Syndrome: Group 3 | EXPERIMENTAL | Participants aged 13-18 years old with Dup15q Syndrome will undergo lumbar puncture (LP) for CSF and blood collection while under general anesthesia or conscious sedation during or after a prescheduled procedure unrelated to the study. |
| Dup15q Syndrome: Group 4 | EXPERIMENTAL | Participants aged 19-50 years old with Dup15q Syndrome will undergo lumbar puncture (LP) for CSF and blood collection while under general anesthesia or conscious sedation during or after a prescheduled procedure unrelated to the study. |
| Name | Type | Description |
|---|---|---|
| Lumbar Puncture | PROCEDURE | Administered as specified in the treatment arm. |
| Blood Collection | PROCEDURE | Administered as specified in the treatment arm. |
Key Inclusion Criteria: * Ability of the participant's legally authorized representative (LAR) to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use confidential health information in accordance with national and local privacy regula...
Lumbar Puncture, Blood Collection is an investigational procedure being studied for use in Angelman Syndrome. It involves collecting cerebrospinal fluid and blood samples to identify biomarkers for the condition. The procedure is part of a biomarker study, not a therapeutic treatment, and is currently in early Phase 1 clinical development.
Biogen Inc. (NASDAQ: BIIB) is developing Lumbar Puncture, Blood Collection. The company is conducting a biomarker study to evaluate the procedure in patients with Angelman Syndrome and Chromosome 15q Duplication (dup15q) Syndrome. The study is being conducted in the United States.
Lumbar Puncture, Blood Collection is in early Phase 1 clinical development. The single clinical trial for this procedure has been completed. It is an investigational procedure and has not been approved by the FDA for any use. The study enrolled 20 participants and was a controlled, non-randomized trial.
Lumbar Puncture, Blood Collection is associated with one completed clinical trial, NCT04103333, titled "Angelman Syndrome (AS) Biomarker Study." This early Phase 1 study enrolled 20 participants with Angelman Syndrome or Chromosome 15q Duplication (dup15q) Syndrome in the United States. The trial was controlled but not randomized or double-blinded.
No, Lumbar Puncture, Blood Collection is not a therapeutic drug. It is a diagnostic procedure involving the collection of cerebrospinal fluid and blood samples. It is being studied as a biomarker assessment tool for Angelman Syndrome and related conditions. It is not intended to treat or cure the disease.