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Intravenous VAL-1221 Lafora Expanded Access Protocol

NCT05930223 · Status: AVAILABLE · Type: EXPANDED_ACCESS

Last updated 2023-07-05

No results posted yet for this study

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

  • Lafora Disease

Interventions

DRUG

VAL-1221

VAL-1221 20mg/kg intravenous (IV) infusion every other week

Sponsors & Collaborators

  • Parasail, LLC

    lead INDUSTRY

Eligibility

Min Age
12 Years
Max Age
28 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05930223 on ClinicalTrials.gov