A PHASE II, PLACEBO CONTROLLED, DOSE FINDING PILOT STUDY OF PIXANTRONE EFFICACY ADMINISTERED INTRAVENOUSLY IN PATIENTS AFFECTED WITH MYASTHENIA GRAVIS - ND

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2007-002817-37-IT
• Date of registration: 30/06/2008
• Prospective Registration: Yes
• Primary sponsor: ISTITUTO NEUROLOGICO "CARLO BESTA"
• Public title: A PHASE II, PLACEBO CONTROLLED, DOSE FINDING PILOT STUDY OF PIXANTRONE EFFICACY ADMINISTERED INTRAVENOUSLY IN PATIENTS AFFECTED WITH MYASTHENIA GRAVIS - ND
• Scientific title: A PHASE II, PLACEBO CONTROLLED, DOSE FINDING PILOT STUDY OF PIXANTRONE EFFICACY ADMINISTERED INTRAVENOUSLY IN PATIENTS AFFECTED WITH MYASTHENIA GRAVIS - ND
• Date of first enrolment: 29/07/2008
• Recruitment status: Authorised-recruitment may be ongoing or finished
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-002817-37
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: yes Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: yes Other specify the comparator: - same IMP used at different dosage

Countries of recruitment

Italy

Key inclusion & exclusion criteria

Inclusion criteria:
caucasian male or female aged 18 to 55 years inclusive diagnosis of MG classes II, III or IV according to MGFA classification (MG Foundation of America) positive acetylcholine receptor antibodies (AChR Ab) LVEF ≥ 55% no conditions known to be contraindications to the use of PIX written informed consent. Positive response to plasmapheresis, i.e reduction of QMGS of at least 3,5 points (at randomization visit)
Are the trial subjects under 18? yes
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
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
ocular MG (MGFA class I) MG crisis thymectomy in the last 3 months immunosuppressive therapy in the last 3 months other than corticosteroids subjects with history of myocardial infarction subjects with clinically evident cardiac disease (ischemic heart disease or congestive heart failure) subjects with uncontrolled hypertension contraindication to plasmapheresis subjects with active malignancy female subjects who are pregnant or lactating subjects who have received an experimental drug or have participated in a clinical trial within 3 months prior to screening employees of the investigator or study centre with direct involvement in the proposed study or other studies under the direction of that investigator or study centre.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Patients affected with MG showing clinically meaningful improvement after therapeutic plasmapheresis.
MedDRA version: 9.1 Level: LLT Classification code 10028417 Term: Myasthenia gravis

Intervention(s)

Product Name: PIXANTRONE
Product Code: BBR 2778
Pharmaceutical Form: Powder and solvent for suspension for injection
INN or Proposed INN: pixantrone
Current Sponsor code: BBR 2778
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Pharmaceutical form of the placebo: Solvent for parenteral use
Route of administration of the placebo: Intravenous use

Primary Outcome(s)

Main Objective: The primary objective of this pilot study is to obtain preliminary data on the potential therapeutic activity of PIX in patient affected with MG in a short-term. Tolerability and safety will be assessed for all subjects for the entire duration of the study.

Primary end point(s): Primary evaluation parameter will be the QMGS (Quantitative Myasthenia Gravis Score)

Secondary Objective: Select appropriate dose schedules to be further investigated with long-term confirmative studies.

Secondary ID(s)

PIX200701