Trials / Available
AvailableNCT05930223
Intravenous VAL-1221 Lafora Expanded Access Protocol
Intravenous VAL-1221 Lafora Expanded Access Protocol (LEAP)
- Status
- Available
- Phase
- —
- Study type
- Expanded Access
- Enrollment
- —
- Sponsor
- Parasail, LLC · Industry
- Sex
- All
- Age
- 12 Years – 28 Years
- Healthy volunteers
- —
Summary
Only qualified physicians treating a Lafora Disease patient may request VAL-1221 Expanded Access treatment under the Parasail Lafora Expanded Access Protocol (LEAP). According to FDA guidance, this protocol can enroll up to 10 patients. However, individual patient inclusion will ultimately be dependent on protocol eligibility, site geography, treatment requirements, and available supply of the investigational therapy. Inquiring physicians can submit a request by contacting the Central Contact personnel listed below in Contacts/Locations.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | VAL-1221 | VAL-1221 20mg/kg intravenous (IV) infusion every other week |
Timeline
- First posted
- 2023-07-05
- Last updated
- 2023-07-05
Source: ClinicalTrials.gov record NCT05930223. Inclusion in this directory is not an endorsement.