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

Phase 1

• Conditions: Amyotrophic lateral sclerosis (ALS); MedDRA version: 20.1Level: LLTClassification code 10036704Term: Primary lateral sclerosisSystem Organ Class: 100000004852; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2018-000142-18-FI
• Lead Sponsor: Turku University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-05-08
• Last Update Posted: 21 May 2018

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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):