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ORPHELIA PHARMA

🇫🇷France
Ownership
-
Employees
-
Market Cap
-
Website

Clinical Trials

10

Active:5
Completed:5

Trial Phases

3 Phases

Phase 1:8
Phase 2:1
Not Applicable:1

Drug Approvals

4

CIMA_AEMPS:3
EMA:1

Drug Approvals

Kigabeq

Authorization Status
Authorised
Approval Date
Sep 20, 2018
EMA

Clinical Trials

Distribution across different clinical trial phases (10 trials with phase data)• Click on a phase to view related trials

Phase 1
8 (80.0%)
Not Applicable
1 (10.0%)
Phase 2
1 (10.0%)

TEMOkids Study : A Phase I Pediatric Study for KIMOZO, Oral Suspension of Temozolomide

Phase 1
Completed
Conditions
Pediatric Cancer
Interventions
First Posted Date
2020-10-30
Last Posted Date
2025-07-31
Lead Sponsor
Orphelia Pharma
Target Recruit Count
49
Registration Number
NCT04610736
Locations
🇫🇷

Centre Oscar Lambret, Lille, France

🇫🇷

Institut d'Hématologie et d'Oncologie Pédiatrique, Lyon, France

🇫🇷

CHU Timone Enfants, Marseille, France

and more 8 locations

Bioequivalence Study of Vigabatrin ORPHELIA Pharma 500mg Soluble Tablets and SabrilTM 500mg Granules for Oral Administration

Phase 1
Completed
Conditions
Therapeutic Equivalency
Interventions
Drug: VGB-ST
First Posted Date
2020-07-13
Last Posted Date
2020-07-13
Lead Sponsor
Orphelia Pharma
Target Recruit Count
20
Registration Number
NCT04468282
Locations
🇫🇷

Eurofins Optimed, Gières, France

Bioequivalence Study Between Temozolomide Oral Suspension (Ped-TMZ) and Temodal® Capsules

Phase 1
Completed
Conditions
Therapeutic Equivalency
Interventions
First Posted Date
2020-07-13
Last Posted Date
2022-02-23
Lead Sponsor
Orphelia Pharma
Target Recruit Count
36
Registration Number
NCT04467346
Locations
🇫🇷

Service de neuro-oncologie - Hospices Civils de Lyon, Bron, Rhône, France

🇫🇷

CHU de Bordeaux, Bordeaux, France

🇫🇷

Hôpital de la Timone (AP-HM), Marseille, France

Acceptability Study of a New Paediatric Form of Vigabatrin in Infants and Children With Infantile Spasms or Pharmacoresistant Partial Epilepsy

Not Applicable
Completed
Conditions
Infantile Spasms
First Posted Date
2014-08-19
Last Posted Date
2018-04-24
Lead Sponsor
Orphelia Pharma
Target Recruit Count
38
Registration Number
NCT02220114
Locations
🇫🇷

Service de neurologie pédiatrique - CHU, Angers, France

🇫🇷

Service de neuropédiatrie - CHU Pellegrin Enfants, Bordeaux, France

🇫🇷

Service de neurologie infantile - Hôpital Salengro, Lille, France

and more 8 locations

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