The role of brain neurotransmission in fatigue

2024-514038-19-00 Phase III and Phase IV (Integrated) Ended

Start 15 Sep 2025 · End 10 Jan 2026 · Status Ended · 1 EU/EEA countries · 1 sites

Overview

Sponsor-declared trial summary

Phase Phase III and Phase IV (Integrated)
Status Ended
Participants planned 59
Countries 1
Sites 1

None

To investigate the role of neurotransmitters in fatigue

Key facts

Sponsor
Vrije Universiteit Brussel
Participant type
Healthy volunteers
Age range
18-64 years
Gender
Male and Female
Therapeutic area
Not possible to specify
Trial duration
15 Sep 2025 → 10 Jan 2026
Decision date (initial)
2024-08-29
Transition trial
Yes
Low-intervention
Yes
Rare-disease indication
No
Vulnerable population
No

External identifiers

EU CT number
2024-514038-19-00
EudraCT number
2022-002836-30
ClinicalTrials.gov
NCT05880342

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Others

To investigate the role of neurotransmitters in fatigue

Conditions and MedDRA coding

None

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

  1. 18-35 years old
  2. Healthy male and female individuals
  3. No use of medications (contraceptives are allowed)
  4. No indication of risk in general fatigue, depression and burnout
  5. Non-smoking

Exclusion criteria 7

  1. Pregnancy
  2. Allergies to specific substances utilized in the current study
  3. Injuries of any kind in the past six months that hinder participation
  4. History of suffering from any mental/psychiatric disorder
  5. Participation in any concomitant care or research trials
  6. Suffering from color vision deficiencies
  7. Suffering from any chronic health condition diagnosed by a medical professional

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 3

  1. Physiological changes during the onset and impact of fatigue under influence of elevated brain neurotransmitters
  2. Behavioral changes during the onset and impact of fatigue under influence of elevated brain neurotransmitters
  3. Subjective changes during the onset and impact of fatigue under influence of elevated brain neurotransmitters

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 3

Rilatine Modified Release 10 mg Hartkapseln mit veränderter Wirkstofffreisetzung

PRD9824672 · Product

Active substance
Methylphenidate Hydrochloride
Pharmaceutical form
MODIFIED-RELEASE CAPSULE, HARD
Route of administration
ORAL
Max daily dose
20 mg milligram(s)
Max total dose
20 mg milligram(s)
Max treatment duration
1 Day(s)
Authorisation status
Authorised
ATC code
N06BA04 — METHYLPHENIDATE
Marketing authorisation
BE426413
MA holder
INFECTOPHARM ARZNEIMITTEL UND CONSILIUM GMBH
MA country
Belgium
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Edronax 4 mg Tabletten

PRD1883184 · Product

Active substance
Reboxetine
Pharmaceutical form
TABLET
Route of administration
ORAL
Max daily dose
8 mg milligram(s)
Max total dose
8 mg milligram(s)
Max treatment duration
1 Day(s)
Authorisation status
Authorised
ATC code
N06AX18 — REBOXETINE
Marketing authorisation
BE190251
MA holder
PFIZER S.A.
MA country
Belgium
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

P-Tabletten weiß 7 mm Lichtenstein

PRD6671968 · Product

Active substance
Placebo
Pharmaceutical form
TABLET
Route of administration
ORAL
Max daily dose
10 mg milligram(s)
Max total dose
10 mg milligram(s)
Max treatment duration
1 Day(s)
Authorisation status
Authorised
ATC code
NOTASSIGN — -
Marketing authorisation
6866372.00.00
MA holder
WINTHROP ARZNEIMITTEL GMBH
MA country
Germany
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Vrije Universiteit Brussel

3 Total trials 1 Recruiting 1 Ended
Academic / Non-commercial
Sponsor organisation
Vrije Universiteit Brussel
Address
Laarbeeklaan 101
City
Jette
Postcode
1090
Country
Belgium

Scientific contact point

Organisation
Vrije Universiteit Brussel
Contact name
Laurisa Arenales

Public contact point

Organisation
Vrije Universiteit Brussel
Contact name
Laurisa Arenales

Locations

1 EU/EEA country · 1 investigational sites

By country

CountryMS statusPlanned subjectsSites
Belgium Ended 59 1
Rest of world — 0 —

Investigational sites

Belgium

1 site · Ended
Vrije Universiteit Brussel
Human physiology and sports physiotherapy, Pleinlaan 2, 1050, Elsene

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country Trial startTrial end Recruitment startRecruitment end Early termination
Belgium 2025-09-15 2026-01-10 2025-09-15

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 5 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

TypeTitleVersion
Protocol (for publication) D1_Protocol_2022-401 1
Recruitment arrangements (for publication) Statement_Not Applicable 1
Subject information and informed consent form (for publication) L1_SIS and ICF participants MFPF 1
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC rilatine-edronax-placebo 1
Synopsis of the protocol (for publication) Statement_Not Applicable 1

Application history

1 submissions — initial application plus substantial / non-substantial modifications

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2024-08-21 Belgium Acceptable with conditions
2024-08-29
 2024-08-29

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