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Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
Type of registration
Prospectively registered

Titles & IDs
Public title
Famotidine for dyskinesia in Parkinson's disease
Scientific title
The effect of Famotidine on levodopa-induced Dyskinesia in Parkinson's disease: A double-blind, Placebo-controlled Study
Secondary ID [1] 252594 0
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Parkinson's disease 258093 0
Dyskinesia 258179 0
Condition category
Condition code
Neurological 258273 258273 0 0
Parkinson's disease

Study type
Description of intervention(s) / exposure
Famotidine 40 mg twice daily
3 weeks
oral capsule
Wash out of one week
Intervention code [1] 257119 0
Treatment: Drugs
Comparator / control treatment
Placebo being identical oral capsule administered for 3 weeks during the 3 week placebo stage of the crossover trial
Control group

Primary outcome [1] 259112 0
Change in dyskinesia as per the Rush Dyskinesia rating scale
Timepoint [1] 259112 0
First assessment at 3 weeks following randomisation, then one week wash out and second assessment 3 weeks after starting second stage.
Secondary outcome [1] 265424 0
Unified Dyskinesia rating Scale
Timepoint [1] 265424 0
First assessment at 3 weeks following randomisation, then one week wash out and second assessment 3 weeks after starting second stage.

Key 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
Minimum age
30 Years
Maximum age
85 Years
Both males and females
Can healthy volunteers participate?
Key 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
Purpose of the study
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by computer within pharmacy
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer programme
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

Intervention assignment
Other design features
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment outside Australia
Country [1] 2843 0
New Zealand
State/province [1] 2843 0

Funding & Sponsors
Funding source category [1] 257562 0
Name [1] 257562 0
Auckland City Hospital
Address [1] 257562 0
Park Road
Auckland 1023
Country [1] 257562 0
New Zealand
Primary sponsor type
Auckland City Hospital
Park Road
Auckland 1023
New Zealand
Secondary sponsor category [1] 256785 0
Name [1] 256785 0
Address [1] 256785 0
Country [1] 256785 0

Ethics approval
Ethics application status
Ethics committee name [1] 259584 0
Northern X Regional Ethics Committee
Ethics committee address [1] 259584 0
Ministry of Health
Private Bag 92522
Auckland 1141
Ethics committee country [1] 259584 0
New Zealand
Date submitted for ethics approval [1] 259584 0
Approval date [1] 259584 0
Ethics approval number [1] 259584 0
Ethics committee name [2] 269332 0
New ethics name. Please modify.
Ethics committee address [2] 269332 0
New ethics address. Please modify.
Ethics committee country [2] 269332 0
Date submitted for ethics approval [2] 269332 0
Approval date [2] 269332 0
Ethics approval number [2] 269332 0
New ethics HREC. Please modify.

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.
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 31588 0
Address 31588 0
Country 31588 0
Phone 31588 0
Fax 31588 0
Email 31588 0
Contact person for public queries
Name 14835 0
Dr Mark Simpson
Address 14835 0
Dept of Neurology
Auckland City Hospital
Park Road
Auckland 1023
Country 14835 0
New Zealand
Phone 14835 0
+64 276003636
Fax 14835 0
Email 14835 0
Contact person for scientific queries
Name 5763 0
Dr Mark Simpson
Address 5763 0
Dept of Neurology
Auckland City Hospital
Park Road
Auckland 1023
Country 5763 0
New Zealand
Phone 5763 0
+64 276003636
Fax 5763 0
Email 5763 0

No information has been provided regarding IPD availability
Summary results
No Results