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| Sponsors and Collaborators: |
Federico II University Istituto Biostrutture e Immagini, CNR Naples Agenzia Italiana del Farmaco |
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| Information provided by: | Federico II University |
| ClinicalTrials.gov Identifier: | NCT00635960 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
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Amyotrophic Lateral Sclerosis |
Drug: Growth Hormone (Somatropin) Drug: Placebo |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study |
| Official Title: | Efficacy, Safety and Tolerability of Growth Hormone in Patients With Amyotrophic Lateral Sclerosis as Add-on Therapy to Riluzole |
| Estimated Enrollment: | 40 |
| Study Start Date: | March 2007 |
| Estimated Study Completion Date: | December 2009 |
| Estimated Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
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1: Experimental
Patients randomly assigned to treatment
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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.
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2: Placebo Comparator
Patients randomly assigned to placebo
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Drug: Placebo
Same as for Growth hormone group
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Several drugs have been proposed for ALS. These drugs included: Topiramate, Lamotrigine, creatine, Vit. E, Pentoxifylline. 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. When administered to SOD-1 transgenic mice, IGF-I prolongs survival, ameliorates muscular strength, and reduces weight and motor neuron loss, astrocyte gliosis, and ubiquitin positive protein inclusions.
Two clinical trials have been performed in ALS patients with s.c. administration of IGF-I indicating a possible beneficial effect, and a third clinical trial is in progress. Methionyl growth hormone (mGH) showed no effect on survival, disease progression and muscular strength. MGH was administered at a fixed dose and peripheral production of IGF-I appeared to be normal. We propose a double-blind trial of Growth Hormone (GH) as add-on therapy to Riluzole, with an individually regulated dose based on the peripheral response of IGF-I. 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. As secondary objectives, effect of GH on mortality, QoL, and motor function will be assessed.
Eligibility| Ages Eligible for Study: | 40 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Italy | |
| Diparimento di Scienze Neurologiche | |
| Naples, Italy, 80131 | |
| Istituto Biostrutture e Bioimmagini, Consiglio Nazionale delle Ricerche | |
| Naples, Italy, 80131 | |
| Principal Investigator: | Alessandro Filla, MD | University "Federico II", Naples |
More Information
| Responsible Party: | Dipartimento di Scienze Neurologiche, "Federico II" University, Naples ( Alessandro Filla, Prof. ) |
| Study ID Numbers: | SLA_GH_1 |
| Study First Received: | March 3, 2008 |
| Last Updated: | February 5, 2009 |
| ClinicalTrials.gov Identifier: | NCT00635960 History of Changes |
| Health Authority: | Italy: Ministry of Health |
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Amyotrophic Lateral Sclerosis ALS Growth Hormone IGF-I |
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Riluzole Spinal Cord Diseases Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Central Nervous System Diseases Sclerosis Neurodegenerative Diseases |
Hormones Neuromuscular Diseases Lou Gehrig's Disease Amyotrophic Lateral Sclerosis Motor Neuron Disease Degenerative Motor System Disease |
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Spinal Cord Diseases Nervous System Diseases Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Central Nervous System Diseases Sclerosis Neurodegenerative Diseases |
Hormones Pharmacologic Actions Pathologic Processes Neuromuscular Diseases Amyotrophic Lateral Sclerosis Motor Neuron Disease |
