Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000765022
Ethics application status
Approved
Date submitted
30/08/2010
Date registered
15/09/2010
Date last updated
1/07/2011
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
Nil
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

Intervention/exposure
Study type
Interventional
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
Placebo

Outcomes
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.

Eligibility
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
Sex
Both males and females
Can healthy volunteers participate?
No
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
Treatment
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
Crossover
Other design features
Phase
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/10/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment outside Australia
Country [1] 2843 0
New Zealand
State/province [1] 2843 0

Funding & Sponsors
Funding source category [1] 257562 0
Hospital
Name [1] 257562 0
Auckland City Hospital
Country [1] 257562 0
New Zealand
Primary sponsor type
Hospital
Name
Auckland City Hospital
Address
Park Road
Grafton
Auckland 1023
Country
New Zealand
Secondary sponsor category [1] 256785 0
None
Name [1] 256785 0
Address [1] 256785 0
Country [1] 256785 0

Ethics approval
Ethics application status
Approved
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
17/09/2010
Approval date [1] 259584 0
03/11/2010
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.

Summary
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

Contacts
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
Grafton
Auckland 1023
Country 14835 0
New Zealand
Phone 14835 0
+64 276003636
Fax 14835 0
Email 14835 0
marks@adhb.govt.nz
Contact person for scientific queries
Name 5763 0
Dr Mark Simpson
Address 5763 0
Dept of Neurology
Auckland City Hospital
Park Road
Grafton
Auckland 1023
Country 5763 0
New Zealand
Phone 5763 0
+64 276003636
Fax 5763 0
Email 5763 0
marks@adhb.govt.nz

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided
Current supporting documents:



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.