BridgeMD
New treatment option for Parkinson Disease
Official title Pyridostigmine for the Treatment of Constipation in Parkinson Disease
ClinicalTrials.gov ID: NCT05603715
What this study is testing
What is Pyridostigmine Bromide?
Pyridostigmine Bromide is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for parkinson disease.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Constipation is a common and debilitating non-motor symptom of Parkinson disease (PD) that often precedes the onset of classic motor symptoms by decades. There is no standardized algorithm for managing constipation in this patient population, nor are there dedicated treatments.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age ≥ 18 years
- Be able to provide signed informed consent
- Stated ability and willingness to comply with all study procedures
- Able to take oral medications
- Females of reproductive potential who are sexually active must be willing to use two of the following highly effective methods of contraception for...
You likely can't join if
- Diagnosis of atypical parkinsonism
- Diagnosis of drug-induced parkinsonism
- Diagnosis of vascular parkinsonism
- Known allergy to pyridostigmine bromide or other study drug components
- Current or recent (within 90 days of enrollment) use of pyridostigmine for any reason
- History of any bowel surgery
See the full eligibility criteria
- Age ≥ 18 years
- Be able to provide signed informed consent
- Stated ability and willingness to comply with all study procedures
- Able to take oral medications
- Females of reproductive potential who are sexually active must be willing to use two of the following highly effective methods of contraception for the duration of study participation and for an additional 28 days after...
- Males of reproductive potential who are sexually active must be willing to use the following highly effective methods of contraception for the duration of study participation and for an additional 28 days after the end...
- Meet United Kingdom Parkinson's Disease Society Brain Bank Criteria: A. Diagnosis of a parkinsonism:
- Bradykinesia, plus at least one of the following:
- Muscular rigidity
- 4-6 Hz resting tremor
- Postural stability not caused by primary visual, vestibular, cerebellar or proprioceptive dysfunction B. At least three supportive criteria:
- Unilateral onset of symptoms
- Rest tremor
- Progressive symptoms
- Persistent asymmetry affecting the side of onset most
- Excellent response to levodopa
- Severe levodopa-induced chorea
- Levodopa response for five years or more
- Clinical course of 10 years or more
- Fulfill the ROME IV Criteria for Functional Constipation, with a specific requirement that the patient must have three or fewer defecations per week (criterion Ai):
- Must include two or more of the following: i. Three or fewer defecations per week ii. Straining during \> 25% of defecations iii. Lumpy or hard stools in \> 25% of defecations iv. Sensation of incomplete evacuation for...
- Loose stools are rarely present without the use of laxatives
- Insufficient criteria for irritable bowel syndrome
- Criteria 1-3 must be fulfilled for at least three months with onset of symptoms at least six months prior to diagnosis
- Diagnosis of atypical parkinsonism
- Diagnosis of drug-induced parkinsonism
- Diagnosis of vascular parkinsonism
- Known allergy to pyridostigmine bromide or other study drug components
- Current or recent (within 90 days of enrollment) use of pyridostigmine for any reason
- History of any bowel surgery
- History of bladder or bowel obstruction
- Severe asthma or chronic obstructive pulmonary disease
- Meet exclusion criteria noted in the UK Parkinson's Disease Society Brain Bank Criteria, at the PI's discretion: A.Exclusion of any of the following:
- Repeated strokes with stepwise progression of parkinsonian features
- Repeated head injury
- Definite encephalitis
- Oculogyric crises
- Neuroleptic treatment at onset of symptoms
- Greater than one affected relative
- Sustained remission
- Strictly unilateral features after 3 years
- Supranuclear gaze palsy
- Cerebellar signs
- Early severe autonomic involvement
- Early severe dementia
- Babinski sign
- Cerebral tumor or communicating hydrocephalus
- Negative response to large doses of levodopa
- 1-methyl-4-phenyl-1,2,3,6-tetrahydropyridine exposure
- Significant abnormalities on laboratory analysis (complete blood count, comprehensive metabolic panel, thyroid stimulating hormone) conducted at the screening visit or within the three months prior if available for...
- Significant abnormalities on screening electrocardiogram conducted at the screening visit or within the three months prior if available for review
- Positive pregnancy test (if female of child-bearing age)
- Antibiotic use within two weeks prior to enrollment
The study team makes the final eligibility decision.
Where it's taking place
- Burlington, Vermont, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Burlington, Vermont, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.