Safety and Tolerability of Quetiapine in Multiple Sclerosis

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02087631
• Date of registration: 12/03/2014
• Prospective Registration: Yes
• Primary sponsor: University of Calgary
• Public title: Safety and Tolerability of Quetiapine in Multiple Sclerosis
• Scientific title: A Dose-finding, Safety and Tolerability Trial of Extended-release Quetiapine in Relapsing-remitting and Progressive Multiple Sclerosis
• Date of first enrolment: December 2014
• Target sample size: 14
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02087631
• Study type: Interventional
• Study design: Intervention model: Sequential Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1/Phase 2

Countries of recruitment

Canada

Contacts

• Name: Luanne M Metz, MD,FRCPC
• Affiliation: University of Calgary

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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)

- Progressive MS (primary progressive course, secondary progressive course, or
progressive relapsing course) course according to Lublin and Reingold (1996).

NOTE: No longer recruiting RRMS patients

- 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

Exclusion Criteria:

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



Age minimum: 18 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Multiple Sclerosis

Intervention(s)

Drug: Extended-release quetiapine fumarate

Primary Outcome(s)

Dose-limiting toxicity [Time Frame: 4 weeks]

Secondary Outcome(s)

Adverse events [Time Frame: 4 weeks]

Secondary ID(s)

QTPMS01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Multiple Sclerosis Society of Canada