Fatigue Clinical Trial
Official title:
The Effect of Amantadine on Movement Disorder in Ataxia-Telangiectasia
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.
Ataxia-Telangiectasia (A-T) is a complex multisystem disorder with neurodegenerative course,
immune deficiency, and tendency to develop malignancies .The clinical picture includes
progressive cerebellar ataxia along with a movement disorder (chorea, dystonia or
bradykinesia) that may be even more disabling than the ataxia . Fatigability, drooling and
reduced stamina are other major concerns. Disease course is devastating: towards the second
decade of life the affected children are usually bound to wheelchair and survival beyond the
second decade of life is rare. 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 is a dopaminergic agent approved for prophylaxis of influenza (in children over 1
year of age and adults) as well as for extrapyramidal disorders in adults: Parkinson disease
and drug induced dyskinesias . Amantadine increases dopaminergic transmission by inhibiting
its synaptic uptake, as well as an antagonizing the striatal NMDA receptors). Additional
conditions found to be improved with amantadine are: cerebellar ataxia, vigilance after
brain trauma in adults and children ,attention deficit disorder in children, chorea and
akinesia in Huntington's disease .
Amantadine is an FDA approved drug for treatment and prevention of influenza, Parkinson
disease and drug induced dyskinesia; it is approved for use in adults and children over 1
year of age.
Dosage in children: 5 mg/kg body weight up to 8.8mg/kg/. Dosage in adults: 200 to 300
mg/day. The daily dosage should be divided into 2 to 3 daily portions. Amantadine is a safe
drug with mild side effects: headache, decreased appetite, sedation, fatigue, abdominal
pain, vomiting, insomnia, pedal edema and rash (4-10).
Studies in children proved amantadine to be a safe and tolerable drug. Amantadine was
administered to 24 healthy children with ADHD, aged 5-13 year old . Side effects were
present in 13/24 and were usually mild: decreased appetite, headache, sedation, mild
insomnia, vomiting, fatigue, abdominal pain. One subject dropped out because of headache.
Six low response children after traumatic brain injury were treated with amantadine
(concurrently with other medication) The drug was safe with relatively mild side effects:
sedation, intermittent tremor, dizziness, but no serious side effects requiring
discontinuation of the protocol.
Study purpose 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.
;
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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