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Growth Hormone in Amyotrophic Lateral Sclerosis

NCT00635960 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2010-05-27

No results posted yet for this study

Summary

Several drugs have been proposed for ALS. These drugs included: Topiramate, Lamotrigine, creatine, Vit. E, Pentoxifylline, etc. Although most of the trials showed a positive trend, none of them reached a statistically significant result. The only exception is the Riluzole trial, that demonstrated a small but significant reduction in mortality between treated and untreated patients. Aim of our study is to determine if the add-on of GH to treatment with Riluzole is able to reduce neuronal loss in the motor cortex of ALS patients.

Conditions

Interventions

DRUG

Growth Hormone (Somatropin)

The initial dose will be 2U s.c. every other day. The dose will be progressively increased to reach 1.5-2x the normal levels of IGF-I.

DRUG

Placebo

Same as for Growth hormone group

Sponsors & Collaborators

  • Istituto Biostrutture e Immagini, CNR Naples

    collaborator UNKNOWN

  • Agenzia Italiana del Farmaco

    collaborator OTHER_GOV

  • Federico II University

    lead OTHER

Principal Investigators

  • Alessandro Filla, MD · University "Federico II", Naples

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-03-31
Primary Completion
2009-07-31
Completion
2010-05-31

Countries

  • Italy

Study Locations

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Entities

Drugs
Diseases

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 NCT00635960 on ClinicalTrials.gov