Parkinson's Disease, Synucleinopathy
Conditions
Keywords
tenapanor, synucleinopathy, Parkinson's disease, constipation
Brief summary
Investigation of tenapanor as a potential treatment for synucleinopathy-associated constipation
Detailed description
Randomized, double-blind, placebo controlled trial of tenapanor vs. placebo for treating synucleinopathy-associated constipation in Parkinson's disease.
Interventions
DRUGPlacebo
Placebo drug
DRUGTenapanor
Inhibitor of NHE3
Sponsors
Cedar Valley Digestive Health Center
Ardelyx
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Intervention model description
Randomized, double-blind, placebo controlled trial of tenapanor vs. placebo
Eligibility
Sex/Gender
ALL
Age
50 Years to 89 Years
Healthy volunteers
No
Inclusion criteria
1. Age 50-89 years. 2. Diagnosis of PD within Hoehn and Yahr stages 1-3, confirmed by a neurologist per International Parkinson and Movement Disorder Society criteria. 3. Average weekly stool frequency of ≤5 spontaneous bowel movements (SBMs) and ≤2 complete spontaneous bowel movements (CSBMs) over the past 6 months. These criteria will be verified during a 2-week screening period. 4. Stool consistency ≤3 on the Bristol Stool Form Scale (BSFS). This criterion will be verified during a 2-week screening period. 5. Agreement to use contraception, if applicable.
Exclusion criteria
1. Functional diarrhea or IBS-D/M based on Rome IV Criteria. 2. Symptomatic structural GI abnormalities or inflammatory bowel disease. 3. Significant hepatic (ALT or AST ≥ 2.5x the upper limit of normal) or renal (serum creatinine \>2mg/dl) dysfunction. 4. Pregnancy or lactation. 5. Diagnosis of primary dyssynergic defecation by anorectal manometry.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complete spontaneous bowel movements (CSBM) | 6 of 12 weeks | Our primary endpoint will be CSBM response, defined as an increase of at least one CSBM per week compared to baseline for at least 6 of the 12 treatment weeks. A CSBM is defined as a bowel movement that occurs naturally and is accompanied by a feeling of complete evacuation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Abdominal pain and bloating response | 6 of 12 weeks | Decrease in severity score of at least 20% or more from baseline in 6 of 12 weeks (pain visual analog scale 1-10 where 10 is worst pain) |
| Calprotectin | Week 12 | Decrease in fecal calprotectin by 20% or greater |
| Lipopolysaccharide binding protein | Week 12 | Decrease in serum lipopolysaccharide binding protein by 20% compared to baseline |
| Complete spontaneous bowel movements (CSBM) continuous | Week 12 | CSBM treated as a continuous variable. The investigators expect an increase of CSBMs in the treatment group compared to the placebo group. A CSBM is defined as a bowel movement that occurs naturally and is accompanied by a feeling of complete evacuation |
| Plasma zonulin | Week 12 | Decrease in zonulin by 20% compared to baseline |
Countries
United States
Contacts
Primary ContactRichard A. Manfready, MD, AM, FACP
Backup ContactHarichandana Punukula, PharmD, MS
Outcome results
None listed