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|NCT02087631 : Safety and Tolerability of Quetiapine in Multiple Sclerosis|
|Phase||Phase 1/Phase 2|
|Ages||Min: 18 Years Max: 65 Years|
- Age 18 to 65 years
- Sexually active men and women of child-bearing potential, defined as those who are
not postmenopausal (24 consecutive months) or permanently sterilised, must agree to
use adequate contraception. Adequate contraception is defined as methods of birth
control which result in a low failure rate [i.e. less than 1% per year] when used
consistently and correctly such as implants, injectables, combined oral
contraceptives, some intrauterine devices (IUDs), barrier contraceptives, sexual
abstinence or vasectomised partner. Adequate contraception is required during
quetiapine treatment and for one month after stopping treatment.
- MS defined according to the McDonald criteria (2010; Polman et al. 2011)
- RRMS or progressive MS (primary progressive course, secondary progressive course, or
progressive relapsing course) course according to Lublin and Reingold (1996).
- Patients currently on glatiramer acetate, interferon-beta, fingolimod (treatment
longer than 3 months), or dimethyl fumarate as well as those on no treatment.
- Written informed consent
Patients are to be excluded from enrolment if they display any of the following (current
treatment reflects use at the time of screening and 14 days before screening):
- Clinically significant depression, renal, hepatic, cardiovascular, respiratory,
metabolic, ophthalmologic, cerebrovascular, or other serious physical disease
- Inability to perform the 9 hole peg test and the oral SDMT at baseline
- Diagnosis of dementia, diabetes, or cataracts
- History of seizures, tardive dyskinesia, or symptomatic hypotension.
- Clinically significant gastrointestinal or endocrine disorder, such as pancreatitis,
gastrointestinal obstruction, and hypothyroidism
- Poorly managed constipation, defined as a bowel routine that does not result in a
bowel movement at least every other day.
- The presence of any circumstances that may increase the risk of occurrence of torsade
de pointes and/or sudden death including (1) a history of cardiac arrhythmias such as
bradycardia; (2) hypokalemia or hypomagnesaemia; (3) concomitant use of other drugs
that prolong the QTc interval; (4) prolonged QTc at screening; and (5) presence of
congenital prolongation of the QT interval
- Body Mass Index > 30 (obesity)
- Clinically significant abnormal laboratory values, electrocardiogram, or vital signs
at screening or any elevation of fasting glucose
- Pregnant or breastfeeding women
- Current treatment with natalizumab
- Current treatment with immunosuppressive medications other than: steroids for
relapses and the MS disease-modifying therapies mentioned in the inclusion criteria.
Initiation of fingolimod within the previous 3 months
- Substances that are not permitted include current treatment with: potent CYP3A4
inhibitors (e.g. ketoconazole, ritonavir) or potent CYP3A4 inducers (e.g. phenytoin,
rifampin, St. John's Wort), pro- or anti-dopaminergic medications, or medications
that produce clinically significant alterations of QTc interval.
- Previous or current treatment with quetiapine or any other antipsychotic
- Known hypersensitivity to any of the ingredients in quetiapine including lactose
- Inability to swallow pills without chewing or crushing
- Use, within the previous three months, of any experimental MS treatment
- Any other condition or situation that in the opinion of the investigator would either
put the patient at risk of worsening health if enrolled in the trial or would prevent
completion of the trial
- Concurrent participation in any therapeutic clinical trial
|Links||Permanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT02087631
| Link to official Clinicaltrials.gov listing