Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Authorised, recruitment pending
Participants planned
24
Countries
1
Sites
1
Parkinson's disease
to evaluate the variation in the serum IgG level reflecting the humoral immune response 6 months after the initiation of treatment with Clozapine.
Key facts
- Sponsor
- Centre Hospitalier Universitaire Amiens Picardie
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nervous System Diseases [C10]
- Decision date (initial)
- 2024-08-23
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- CHU Amiens-Picardie
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy
to evaluate the variation in the serum IgG level reflecting the humoral immune response 6 months after the initiation of treatment with Clozapine.
Secondary objectives 12
- Patient weight
- Infections presented by the patient
- Use of antibiotics by the patient
- Tolerance / adverse effects of treatment with Clozapine
- Motor state, quality of life, depressive syndrome, apathy, global cognitive efficiency and psychotic elements
- Serum IgA levels
- Serum IgM levels
- Serum IgG levels with the IgG1, IgG2, IgG3 and IgG4 subclasses
- Complete blood count (CBC) parameters
- C-reactive protein
- Serum Clozapine level
- T, B and NK lymphocyte subpopulations
Conditions and MedDRA coding
Parkinson's disease
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 2
- Patient ≥ 18 years old with Parkinson's disease
- Psychotic symptoms requiring initiation of treatment with Clozapine
Exclusion criteria 3
- Patients with a contraindication to the use of Clozapine according to the summary of product characteristics (SPC)
- Patient with another potential cause of immunosuppression
- Patient with potentially major cognitive disorders defined by a MoCA score less than or equal to 23
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- change in serum IgG levels before initiation of treatment with clozapine and then 6 months after initiation of treatment.
Secondary endpoints 12
- The variation in the patient's weight (weighed during visits D0, M6 and M12)
- The number of infections presented by the patient (oral collection during visits to M6 and M12)
- The use of antibiotics by the patient (oral collection during visits to M6 and M12)
- Tolerance / adverse effects of treatment with Clozapine (collected during visits to M6 and M12)
- Variation in motor status, quality of life, depressive syndrome, apathy, global cognitive efficiency and psychotic elements assessed on the clinical scales MDS-UPDRS, PDQ39, Goldberg, Starkstein, MoCA and the neuropsychological inventory (NPI) (carried out during visits D0, M6 and M12).
- - Variation in serum IgA level (on blood test taken on D0, M6 and M12)
- Variation in serum IgM level (on blood test taken on D0, M6 and M12)
- Variation in IgG levels with the IgG1, IgG2, IgG3 and IgG4 subclasses (on blood samples taken on D0, M6 and M12)
- Variation in CBC parameters (on blood test taken on D0, M6 and M12)
- Variation in CRP level (on blood test taken on D0, M6 and M12)
- Change in serum Clozapine level (on blood test taken at M6 and M12)
- Variation in T, B and NK lymphocyte subpopulations (on blood samples taken on D0, M6 and M12)
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
SUB06787MIG · Substance
- Active substance
- Clozapine
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 75 mg milligram(s)
- Max total dose
- 900 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Centre Hospitalier Universitaire Amiens Picardie
- Sponsor organisation
- Centre Hospitalier Universitaire Amiens Picardie
- Address
- 1 Rond Point Du Pr Christian Cabrol
- City
- Amiens Cedex 1
- Postcode
- 80054
- Country
- France
Scientific contact point
- Organisation
- Centre Hospitalier Universitaire Amiens Picardie
- Contact name
- Dr Mickaël AUBIGNAT
Public contact point
- Organisation
- Centre Hospitalier Universitaire Amiens Picardie
- Contact name
- Dr Mickaël AUBIGNAT
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Authorised, recruitment pending | 24 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Centre Hospitalier Universitaire Amiens Picardie
Neurologie, 1 Rond Point Du Pr Christian Cabrol, 80054, Amiens Cedex 1
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-05-29 | France | Acceptable 2024-08-23
|
2024-08-23 |