Effects of promethazine and altered gravity on bimanual coordination

2023-504256-10-00 Protocol BMC in AG Therapeutic use (Phase IV) Ended

Start 10 Jun 2023 · End 15 Jun 2023 · Status Ended · 1 EU/EEA countries · 1 sites · Protocol BMC in AG

Overview

Sponsor-declared trial summary

Phase Therapeutic use (Phase IV)
Status Ended
Participants planned 16
Countries 1
Sites 1

Healthy volunteers

The objectives of this study are to: 1. Generate dose-response relationships between bimanual coordination operational variables as a function of g-levels. 2. Test whether repeated exposure to altered g-levels affects performance on bimanual coordination tasks. 3. Test whether promethazine affects operational performan…

Key facts

Sponsor
Novespace
Participant type
Healthy volunteers
Age range
18-64 years
Gender
Male and Female
Therapeutic area
Phenomena and Processes [G] - Physiological processes [G07]
Trial duration
10 Jun 2023 → 15 Jun 2023
Decision date (initial)
2023-06-02
Transition trial
No
Low-intervention
Yes
Rare-disease indication
No
Vulnerable population
No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Others

The objectives of this study are to:
1. Generate dose-response relationships between bimanual coordination operational variables as a function of g-levels.
2. Test whether repeated exposure to altered g-levels affects performance on bimanual coordination tasks.
3. Test whether promethazine affects operational performance in bimanual coordination tasks during various g-levels and during the rapid g-level transitions during parabolic flight.

Conditions and MedDRA coding

Healthy volunteers

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 8

  1. Healthy volunteers (men or women)
  2. Aged from 18-55
  3. With a body mass index (BMI) < 30 (non-obese subjects)
  4. Affiliated to a Social Security system and, for non-French resident, holding a European Health Insurance Card (EHIC) or a Global Health Insurance Card (GHIC)
  5. Who accepted to take part in the study
  6. Who have given their written stated consent
  7. Who have passed a medical examination similar to a standard aviation medical examination for private pilot aptitude (JAR FCL3 Class 2 medical examination)
  8. Who are right hand dominant (Laterality Quotient Score in the Edinburgh Handedness Questionnaire ≥ +60, in a scale of -100 to + 100, Oldfield, 1971)

Exclusion criteria 7

  1. Persons who took part in a previous biomedical research protocol, of which exclusion period is not terminated
  2. Persons in a subordinate relationship with the investigator or the program director
  3. Persons with contraindications to promethazine
  4. People who report that they experience back pain may not be able to sit for the requisite time periods
  5. Persons who score > 95% in the MSSQ-Short questionnaire (Motion Sickness Susceptibility Questionnaire, Golding, 1998)
  6. Pregnant or nursing women (urine pregnancy test for women of childbearing potential)
  7. Protected adults (guardianship, curatorship, safeguard of justice)

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

  1. Bimanual coordination performance, assessed by the harmonicity

Investigational products

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

Test 1

PHENERGAN 25 mg, comprimé enrobe.

PRD9936948 · Product

Active substance
Promethazine Hydrochloride
Substance synonyms
PROMETHAZINE HCL
Pharmaceutical form
COATED TABLET
Route of administration
ORAL
Max daily dose
25 mg milligram(s)
Max total dose
50 mg milligram(s)
Max treatment duration
4 Day(s)
Authorisation status
Authorised
ATC code
R06AD02 — PROMETHAZINE
Marketing authorisation
34009 301 879 3 7
MA holder
LABORATOIRES FRILAB
MA country
France
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Placebo 1

Comprimé placebo à usage thérapeutique commercialisé par centrelab sous la référence f00199. Composition : - hydrogénophosphate de calcium dihydraté : 244,4 mg - amidon de maïs : 13 mg - stéarate de magnésium : 2,6 mg

N/A · Product

Other product name
N/A
Pharmaceutical form
N/A
ATC code
N/A — N/A
Marketing authorisation
N/A
MA holder
N/A
MA country
Iceland
Paediatric formulation
No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Novespace

Sponsor organisation
Novespace
Address
29 Rue Marcel Issartier
City
Merignac
Postcode
33700
Country
France

Scientific contact point

Organisation
Novespace
Contact name
Alexandra Jaquemet

Public contact point

Organisation
Novespace
Contact name
Thierry Gharib

Locations

1 EU/EEA country · 1 investigational sites

By country

CountryMS statusPlanned subjectsSites
France Ended 16 1
Rest of world — 0 —

Investigational sites

France

1 site · Ended
Novespace
Novespace, 29 Rue Marcel Issartier, 33700, Merignac

Country notifications

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

Country Trial startTrial end Recruitment startRecruitment end Early termination
France 2023-06-10 2023-06-15 2023-06-10

Results and documents

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

Summary of results Art. 37(4) CTR

TitleSubmission dateStatusType
RESUME DES RESULTATS DE L’ESSAI CLINIQUE - Version 1
SUM-43490
 2024-08-30T15:21:17 Submitted Summary of Results
RESUME DES RESULTATS DE L’ESSAI CLINIQUE - Version 2
SUM-110464
 2025-12-10T15:03:02 Submitted Summary of Results

Layperson summary Annex V

TitleSubmission dateStatusType
RESUME DES RESULTATS DE L’ESSAI CLINIQUE A DESTINATION DES PERSONNES PROFANES - Version 1 2024-08-30T15:21:24 Submitted Laypersons Summary of Results
RESUME DES RESULTATS DE L’ESSAI CLINIQUE A DESTINATION DES PERSONNES PROFANES - Version 2 2025-12-10T15:02:57 Submitted Laypersons Summary of Results

Documents 4 files

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

TypeTitleVersion
Laypersons summary of results (for publication) 2023-504256-10-00_Lay person summary of results_202420830 1
Laypersons summary of results (for publication) 2023-504256-10-00_Lay person summary of results_20251210 2
Summary of results (for publication) 2023-504256-10-00_Summary of results_20240830 1
Summary of results (for publication) 2023-504256-10-00_Summary of results_20251210 2

Application history

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

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2023-03-15 France Acceptable
2023-06-01
 2023-06-02

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