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Supplementation of VigantOL� Oil Versus Placebo as Add-on in Patients With Relapsing Remitting Multiple Sclerosis Receiving Rebif� Treatment

Information source: Merck KGaA
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Relapsing-Remitting Multiple Sclerosis

Intervention: VigantOL® oil plus interferon beta-1a (Rebif®) (Drug); Placebo plus interferon beta-1a (Rebif®) (Drug); Interferon beta-1a (Rebif®) alone (Biological)

Phase: Phase 2

Status: Completed

Sponsored by: Merck KGaA

Official(s) and/or principal investigator(s):
Manolo Beelke, MD, PhD, Study Director, Affiliation: WCT Worldwide Clinical Trials GER GmbH Germany
Prof. Dr. Raymond Hupperts, MD, Principal Investigator, Affiliation: Dept of Neurology, Orbis Medical Center Sittard, Maastricht University, The Netherlands

Summary

The drug being tested is called VigantOL® oil - a very effective form of Vitamin D hormone

supplement (cholecalciferol). Low levels of Vitamin D have been described to be associated with a higher risk of developing Multiple Sclerosis (MS), and it is known that up to 90% of patients with Multiple Sclerosis have Vitamin D deficiency. Rebif® is known to be an effective treatment for slowing down the progression of MS. The purpose of this research trial is to evaluate if VigantOL® oil on top of Rebif® has any benefit on the progression of MS compared to Rebif® and placebo. Disease activity will be assessed by clinical examination and Magnetic Resonance Imaging (MRI). The planned study treatment duration for each study participant is 48 weeks, and the study consists of a total of 8 visits. Study participants who are already passed Week 48 at the time of approval of Protocol Amendment 5 will have a study duration of 96 weeks and a total of 12 visits. During the study, the participant will undergo physical examination, neurological assessments, safety assessments, blood tests and urinalysis (including pregnancy tests).

Clinical Details

Official title: A Three Arm, Randomized, Double Blind, Placebo Controlled, Multicenter, Phase II Study to Evaluate the Efficacy of Vigantol Oil as Add on Therapy in Subjects With Relapsing Remitting Multiple Sclerosis Receiving Treatment With 44mg Tiw of Rebif

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Percentage of subjects with disease activity free status (no relapses, no EDSS progression and no new Gd-enhancing or T2 MRI lesions) at Week 48

Secondary outcome:

Percentage of relapse-free subjects at Week 48

Percentage of subjects free from any Expanded Disability Status Scale (EDSS) progression at Week 48

Time to confirmed EDSS progression

Percentage of subjects free from confirmed EDSS progression at Week 48

Cumulative number of T1 gadolinium enhancing lesions at Week 48

Mean number of combined unique active (CUA) lesions per subject per scan at Week 48

Cumulative number of new combined unique active (CUA) lesions at Week 48

Mean change from baseline in the total volume of T2 lesions at Week 48 (T2 Burden of disease)

Percentage of subjects free from T1 gadolinium enhancing lesions at Week 48

Percentage of subjects free from new T1 hypointense lesions (black holes) at Week 48

Percentage of new T1 hypointense lesions (black holes) at Week 48 within the subgroup of new or enlarging non-enhancing T2 lesions

Time to first documented relapse

Annualised relapse rate at Week 48

Total number of reported relapses at all time points up to 48 weeks

Percentage of subjects treated with glucocorticoids due to relapses

Mean change from baseline in the total volume of T1 hypointense lesions at Week 48

Eligibility

Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Diagnosis of a relapsing-remitting form of MS

- Brain and/or spinal MRI with findings typical of MS

- A first clinical event prior to Screening.

- Disease activity

- EDSS score of less than, or equal to 4. 0 at Screening.

- Currently treated with interferon-beta-1a 44mg (tiw) sc

- Willingness and ability to comply with the protocol

- Written informed consent

Exclusion Criteria:

- Pregnancy and lactation period

- Any disease other than MS that could better explain signs and symptoms.

- Complete transverse myelitis or bilateral optic neuritis.

- Currently receiving or use at any time of monoclonal antibodies, mitoxantrone,

cytotoxic or immunosuppressive therapy (excluding systemic steroids and adrenocorticotrophic hormone [ACTH]), B cell modulating therapies (e. g. RituxiMab or BelimuMab), total lymphoid irradiation or bone marrow transplantation.

- Use of any cytokine other than interferon or anti-cytokine therapy, intravenous

immunoglobulin, plasmapheresis, or any investigational drug or experimental procedure

- Use of oral or systemic corticosteroids or ACTH

- Have abnormalities of Vitamin D related hormonal system other than low dietary intake

or decreased sun exposure, i. e. primary hyperparathyroidism or granulomatous disorders.

- Have an urine calcium/creatinine (mmol/mmol) ratio greater than 1. 0 or

hypercalcaemia

- Are taking medications that influence Vitamin D metabolism other than

corticosteroids, e. g., phenytoin, barbiturates, thiazide diuretics and cardiac glycosides.

- Are taking more than 1000 IU (25 µg) of Vitamin D supplement daily.

- Have conditions with increased susceptibility to hypercalcaemia, e. g., known

arrhythmia or heart disease, treatment with Digitalis, or Hydrochlorothiazide and those who suffer from nephrolithiasis.

- Have inadequate liver function

- Moderate to severe renal impairment

- Inadequate bone marrow reserve

- History or presence of serious or acute heart disease such as uncontrolled cardiac

dysrhythmia or arrhythmia, uncontrolled angina pectoris, cardiomyopathy, or uncontrolled congestive heart failure (NYHA class 3 or 4).

- History or presence of severe depression, history of suicide attempt, or current

suicidal ideation.

- Epilepsy or seizures not adequately controlled by treatment.

- Current or past alcohol or drug abuse.

- Any major medical or psychiatric illness (such as psychosis, bipolar disorder) that

in the opinion of the Investigator could create undue risk to the subject or could affect adherence with the trial protocol.

- Known contra-indication to treatment with vitamin D

- Known hypersensitivity to interferon or its excipient(s)

- Known hypersensitivity to gadolinium.

- Any other condition that would prevent the subject from undergoing an MRI scan.

- Signs and symptoms suggestive of transmissible spongiform encephalopathy, or family

members who suffer(ed) from such.

- Positive HIV, hepatitis C, or hepatitis B (HBsAg and HBc antibody) serology (test

performed at screening).

- Legal incapacity or limited legal capacity.

- Another current autoimmune disease, except diabetes.

- Have experienced a relapse within 30 days.

Locations and Contacts

Research Site, Vienna, Austria

Research Site, Esbjerg, Denmark

Research Site, Glostrup, Denmark

Research Site, Sønderborg, Denmark

Research Site, Vejle, Denmark

Research Site, Viborg, Denmark

Research Site, Tallinn, Estonia

Research Site, Helsinki, Finland

Research Site, Turku, Finland

Research Site, Bad Neustadt / Saale, Germany

Research Site, Bamberg, Germany

Research Site, Berlin, Germany

Research Site, Erlangen, Germany

Research Site, Freiburg, Germany

Research Site, Hannover, Germany

Research Site, Köln, Germany

Research Site, Münster, Germany

Research Site, Regensburg, Germany

Research Site, Rostock, Germany

Research Site, Cefalu, Italy

Research Site, Riga, Latvia

Research Site, Kaunas, Lithuania

Research Site, Amsterdam, Netherlands

Research Site, Gouda, Netherlands

Research Site, Nieuwegein, Netherlands

Research Site, Rotterdam, Netherlands

Research Site, Sittard, Netherlands

Research Site, Bergen, Norway

Research Site, Lørenskog, Norway

Research Site, Tromsø, Norway

Research Site, Amadora, Portugal

Research Site, Lisboa, Portugal

Research Site, Porto, Portugal

Research Site, Bern, Switzerland

Research Site, Lausanne, Switzerland

Research Site, Lugano, Switzerland

Research Site, St. Gallen, Switzerland

Research Site, Zurich, Switzerland

Additional Information

Starting date: March 2011
Last updated: June 3, 2015

Page last updated: August 23, 2015

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