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Trial of Efficacy and Safety of Sirolimus in Tuberous Sclerosis and LAM

NCT00490789 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2008-04-30

No results posted yet for this study

Summary

The purpose of this study is to determine the safety and efficacy of the mTOR inhibitor sirolimus as a treatment for renal angiomyolipomas in patients with tyberous sclerosis complex or sporadic lymphangioleiomyomatosis.

Conditions

  • Tuberous Sclerosis
  • Lymphangioleiomyomatosis

Interventions

DRUG

sirolimus

daily oral sirolimus with dosage individualised by trough blood levels

Sponsors & Collaborators

  • University of Nottingham

    collaborator OTHER

  • St Georges Hospital Medical School

    collaborator UNKNOWN

  • Royal Sussex County Hospital

    collaborator OTHER

  • The Tuberous Sclerosis Association

    collaborator OTHER

  • Wyeth is now a wholly owned subsidiary of Pfizer

    collaborator INDUSTRY

  • Cardiff University

    lead OTHER

Principal Investigators

  • Julian R Sampson, DM · Cardiff Univeristy

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-10-31
Primary Completion
2009-09-30
Completion
2009-09-30

Countries

  • United Kingdom

Study Locations

More Related Trials

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 NCT00490789 on ClinicalTrials.gov