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

• Register: EUCTR
• Last refreshed on: 21 May 2018
• Main ID: EUCTR2018-000142-18-FI
• Date of registration: 08/05/2018
• Prospective Registration: Yes
• Primary sponsor: Turku University Hospital
• Public title: Feasibility and effects of subcutaneously given combination of dexmedetomidine and ketamine in ALS patients receiving palliative care
• Scientific title: Feasibility and pharmacodynamics of subcutaneously given combination of dexmedetomidine and ketamine infusion in ALS patients receiving palliative care
• Date of first enrolment: 09/05/2018
• Target sample size: 20
• Recruitment status: Authorised-recruitment may be ongoing or finished
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2018-000142-18
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): yes

Countries of recruitment

Finland

Contacts

• Name: Division of Perioperative Services
• Affiliation: Turku University Hospital

• Name: Division of Perioperative Services
• Affiliation: Turku University Hospital

Key inclusion & exclusion 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:
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.



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

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

Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Intervention(s)

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: Infusion
INN or Proposed INN: ESKETAMINE
CAS Number: 33643-46-8

Primary Outcome(s)

Primary end point(s):

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.

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 ID(s)

1.0