Status:
COMPLETED
Growth Hormone in Amyotrophic Lateral Sclerosis
Lead Sponsor:
Federico II University
Collaborating Sponsors:
Istituto Biostrutture e Immagini, CNR Naples
Agenzia Italiana del Farmaco
Conditions:
Amyotrophic Lateral Sclerosis
Eligibility:
All Genders
40-85 years
Phase:
PHASE2
Brief 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 reache...
Detailed Description
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 s...
Eligibility Criteria
Inclusion
- Definite/probable ALS according to El Escorial criteria
- Aged \> 40, \< 85 years
- Progression from onset
- Disease duration ≤3 years
- Treatment with Riluzole
Exclusion
- Rapid disease progression in the first 6 months after diagnosis
- Patients with tracheostomy and/or Gastrostomy
- Disease duration \> 3 years
- Patient with exclusive bulbar or 2° motorneuron involvement
- Hepatic/renal failure
- Pregnant or breastfeeding
- Signs of active neoplasia
- Complicated Diabetes
- Severe hypertension
- Unable to undergo MRI exams
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2010
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00635960
Start Date
March 1 2007
End Date
May 1 2010
Last Update
May 27 2010
Active Locations (2)
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1
Diparimento di Scienze Neurologiche
Naples, Italy, 80131
2
Istituto Biostrutture e Bioimmagini, Consiglio Nazionale delle Ricerche
Naples, Italy, 80131