NCT04854811CompletedPhase 2
Roflumilast to Treat Cognitive Sequela After Stroke
A Proof of Concept Phase II Study With the PDE4 Inhibitor Roflumilast in People Suffering From Long-term Cognitive Sequela After Stroke
Source: ClinicalTrials.gov · Last updated 17 Jan 2024
Brief summary (registry, in English)
The aim of the current project is to validate the effects of chronic rolflumilast treatment (12 weeks) on cognitive functions (i.e. episodic memory) by means of behavioral tasks, in people suffering from cognitive impairments at least 1 year after stroke. Secondarily, the effects of roflumilast on daily activities and well-being will be assessed.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 100 (actual)
- First submitted
- 31 Mar 2021
- Start date
- 7 Jul 2021
- Primary completion date
- 1 Dec 2023
- Lead sponsor
- Maastricht University
- Diseases
- Stroke
- NCT number
- NCT04854811
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 100
- From 7 Jul 2021 to the primary completion date, 1 Dec 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- History of schizophrenia, bipolar disorder or psychotic symptoms not otherwise specified or previous treatment for these diseases (lifetime)
- Current treatment with (or illicit use of) cannabis, opiates, benzodiazepines, MDMA and cocaine
- Use of medication showing strong inhibition of either CYP3A4 or CYP1A2
- Patients participating in other drug studies
Other illness
- Parkinson's disease
- HIV/AIDS
- Hepatitis C \& B
- Chronic Obstructive Pulmonary Disease (COPD) type Gold 3 and 4
- Current affective disorder (i.e. anxiety or major depression)
- Cognitive problems due to alcohol abuse, brain tumor, epilepsy, encephalitis or lack of capacity to consent to participation.
Lab values
- Patients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
Age
- Recent Transient Ischemic Attack (TIA) (\< 1 years)
- Cerebrovascular Accident (\<1 years)
Other
- Normal Pressure Hydrocephalus (NPH)
- Morbus Huntington
- Risk of suicidal behaviour
- Patients with moderate or major liver impairments will be excluded (e.g. Child-Pugh B and C).
Who the study is looking for
- Willingness to sign an informed consent
- Body mass index (BMI) between 18.5 and 35
- Suffered a stroke at least one year ago; and at the age of 40 or later
- Objective cognitive complaint: memory performance on the delayed recall in the 15 words VWLT of below the normative score (corrected for education, sex and age)
Age in the registry: 41 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Maastricht University Coordinator of this site? Confirm its status | Maastricht | Netherlands | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.