None listed
Conditions
Brief summary
Dyskinesia is the jerking or twisting movement that can occur in patients with Parkinson’s disease when their medication is working. Dyskinesia impacts on quality of life in Parkinson’s disease. Treatment of dyskinesia is difficult. Recent scientific evidence from an animal model of Parkinson’s disease suggests that Famotidine, a medication used in the treatment of excess stomach acid, may reduce dyskinesia in Parkinson’s disease. Famotidine works by blocking histamine receptors. Histamine receptors are present in the stomach and also in the brain. In this study we will test the effectiveness of Famotidine on dyskinesia in Parkinson’s disease. The study will be a cross over design. 25 patients will be randomised to either Famotidine or placebo. At the end of the first three weeks the study participants will present for a levodopa challenge. During a levodopa challenge, the patient is given 1.5 times their normal morning Parkinson’s medication, the degree of dyskinesia will be assessed. The patient will then cross over and after another 3 weeks, the levodopa challenge will be repeated. The levodopa challenge and dyskinesia assessments will be videotaped and rated by a neurologist unaware of which treatment the patient had been taking.
Interventions
Famotidine 40 mg twice daily
3 weeks
oral capsule
Wash out of one week
Sponsors
Auckland City Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
30 Years to 85 Years
Healthy volunteers
No
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.
Outcome results
None listed