Famotidine for dyskinesia in Parkinson's disease

Recruiting

• Conditions: Parkinson's disease; Dyskinesia; Neurological - Parkinson's disease

• Registration Number: ACTRN12610000765022
• Lead Sponsor: Auckland City Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-09-15
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1.Have a diagnosis of idiopathic Parkinson’s Disease of more than 3 years duration, with a Hoehn and Yahr stage of I-IV during an off” phase. The diagnosis should be based on medical history and neurological examination.
2.Be between the ages of 30 to 85 years, inclusive, at screening.
3.If female, be either post-menopausal for at least 2 years, surgically sterilised or have undergone hysterectomy or, if of child bearing potential, be willing to avoid pregnancy by using an adequate method of contraception.
4.Be levodopa responsive and have been receiving treatment with a stable dose of levodopa [3-10 doses per day of any levodopa preparation (including controlled release (CR), immediate release (IR) or a combination of CR/IR), plus benserazide/carbidopa; with or without addition of a catechol O methyl transferase (COMT) inhibitor] and may be receiving concomitant treatment with stable doses of a dopamine agonist, an anticholinergic for at least 4 weeks prior to the screening visit.
5.Have daily dyskinesia
6.Willing and able to participate in the trial and has provided written, informed consent.
7.Mini mental Status Examination (MMSE) > 24

Exclusion Criteria

1.Any indication of forms of parkinsonism, other than idiopathic Parkinson’s Disease.
2.Current or recent (within 1 month) use of Amantadine.
3.Current diagnosis of substance abuse or history of alcohol or drug abuse in the past 3 months.
4.Current clinically significant gastrointestinal, renal, hepatic, endocrine, pulmonary or cardiovascular disease, hypertension that is not well controlled
5.Current or recent (within 3 months) treatment with Famotidine or another histamine (H2) antagonist (cimetidine, ranitidine).
6.Concomitant disease likely to interfere with the trial medication (e.g. capable of altering absorption, metabolism or elimination of the trial drug).
7.Current history of severe dizziness or fainting on standing, due to postural hypotension.
8.Stereotactic surgery as a treatment for his/her Parkinson’s Disease.
9.Any abnormality that the investigator deems to be clinically relevant, either on medical history, physical examination, electrocardiogram (ECG) or a diagnostic laboratory test.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in dyskinesia as per the Rush Dyskinesia rating scale[First assessment at 3 weeks following randomisation, then one week wash out and second assessment 3 weeks after starting second stage.]

Secondary Outcome Measures

Name	Time	Method
nified Dyskinesia rating Scale[First assessment at 3 weeks following randomisation, then one week wash out and second assessment 3 weeks after starting second stage.]