Feasibility and effects of subcutaneously given combination of dexmedetomidine and ketamine in ALS patients receiving palliative care

Feasibility and pharmacodynamics of subcutaneously given combination of dexmedetomidine and ketamine infusion in ALS patients receiving palliative care

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-000142-18-FI

Enrollment

Registered

2018-05-08

Start date

2018-05-09

Completion date

Unknown

Last updated

2025-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Amyotrophic lateral sclerosis (ALS) MedDRA version: 20.1 Level: LLT Classification code 10036704 Term: Primary lateral sclerosis System Organ Class: 100000004852

Interventions

Trade Name: Dexdor Pharmaceutical Form: Concentrate for concentrate for solution for infusion INN or Proposed INN: DEXMEDETOMIDINE CAS Number: 113775-47-6 Trade Name: Ketanest-S Pharmaceutical Form:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Diagnosed ALS 2. Age = 18 years 3. Written informed consent from the patient or adjacent 4. Finnish spoken as mother language Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1. Previous history of intolerance to the study drug or related compounds and additives. 2. Significant cognitive dysfunction or lack of ability to communicate 3. Psychological or other emotional problems that are likely to invalidate informed consent, or limit the ability of the subject to comply with the protocol requirements.

Design outcomes

Primary

Measure	Time frame
Main Objective: The aim is to investigate the pharmacodynamics and feasibility of subcutaneously administered dexmedetomidine-ketamine-infusion in ALS patient receiving palliative care. The subjective ESAS (Edmonton Symptom Assessment Scale) will be measured. ;Secondary Objective: We will report the effects of treatment on vital signs such as systemic blood pressure, heart rate and sedation. We will also monitor the local and systemic safety and tolerability of subcutaneously administered dexmedetomidine-ketamine-infusion.;Primary end point(s):	—

Measure

Time frame

Main Objective: The aim is to investigate the pharmacodynamics and feasibility of subcutaneously administered dexmedetomidine-ketamine-infusion in ALS patient receiving palliative care. The subjective ESAS (Edmonton Symptom Assessment Scale) will be measured. ;Secondary Objective: We will report the effects of treatment on vital signs such as systemic blood pressure, heart rate and sedation. We will also monitor the local and systemic safety and tolerability of subcutaneously administered dexmedetomidine-ketamine-infusion.;Primary end point(s):

—

Countries

Finland

Contacts

Public ContactDivision of Perioperative Services

Turku University Hospital

35823130000

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026