Amantadine for Improving Neurologic Symptoms in Ataxia-Telangiectasia
The Effect of Amantadine on Movement Disorder in Ataxia-Telangiectasia
1 other identifier
interventional
30
1 country
1
Brief Summary
Ataxia-Telangiectasia A-T is a neurodegenerative disorder of the cerebellum, manifesting with ataxia, as well as extrapyramidal features. Treatment of A-T is discouraging, since no treatment seems to change the course of disease, but improvement can be achieved by symptomatic treatment of the bothersome movement disorder . While various dopaminergic agents are occasionally used, reports of benefit are rather sparse and anecdotal. Amantadine, a well known drug used in influenza as well as movement disorder of Parkinson, has been proved to improve various other types of movement disorder as ataxia, chorea, dystonia, akinesia and attention span. The purpose of this study is to investigate weather amantadine sulphate improves ataxia and the movement disorder (bradykinesia, parkinsonism, dystonia, chorea), as well as the general well being in patients with A-T.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Nov 2008
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2008
CompletedFirst Submitted
Initial submission to the registry
July 30, 2009
CompletedFirst Posted
Study publicly available on registry
July 31, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2009
CompletedJune 28, 2011
June 1, 2011
1 year
July 30, 2009
June 26, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
improvement in ataxia
2 month
Secondary Outcomes (1)
improvement in extrapyramidal movement disorder
2 month
Study Arms (1)
amantadine (PKMERZ)
EXPERIMENTALInterventions
amantadine 5/mg/kg for 2 month- tapered up during 2 weeks at 1 month possibility to increase dosage to 8 mg/kg or reduce it if there are side effects
Eligibility Criteria
You may qualify if:
- diagnosis of A-T
- significant functional disability
- age over 4 years
You may not qualify if:
- major comorbidity: active malignancy requiring chemotherapy, kidney or liver failure
- sexually active
- known hypersensitivity to amantadine
- previous treatment with amantadine in the 2 months preceding the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sheba Medical Center
Ramat Gan, Israel
Related Publications (1)
Nissenkorn A, Hassin-Baer S, Lerman SF, Levi YB, Tzadok M, Ben-Zeev B. Movement disorder in ataxia-telangiectasia: treatment with amantadine sulfate. J Child Neurol. 2013 Feb;28(2):155-60. doi: 10.1177/0883073812441999. Epub 2012 May 1.
PMID: 22550086DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Andreea Nissenkorn, MD
Sheba Medical Center, Pediatric Neurology and National A-T Clinic
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER GOV
Study Record Dates
First Submitted
July 30, 2009
First Posted
July 31, 2009
Study Start
November 1, 2008
Primary Completion
November 1, 2009
Study Completion
November 1, 2009
Last Updated
June 28, 2011
Record last verified: 2011-06