Study seeks participants in multiple sclerosis drug test
Pamela Fayerman
Sun
An old-fashioned, inexpensive antibiotic, commonly used to clear up pimply faces and bacterial infections, is about to be put to the test as a weapon against multiple sclerosis.
A $4-million study will try to confirm that minocycline pills can help stop MS in its early stages from progressing.
Up to 40 B.C. residents are being sought for participation in the B.C. part of the trial, being conducted by the University of B.C.‘s MS clinic. Two hundred individuals elsewhere in Canada will also take part.
Dr. Tony Traboulsee, a neurologist at the MS clinic, said the trial stems from animal research done by a former UBC scientist, V. Wee Yong, showing that minocycline — a member of the tetracycline family of antibiotics — has the ability to inhibit the activities of an enzyme and cells that initiate MS attacks, and that it has anti-inflammatory action that may protect myelin, the protective sheath around the nerve fibres of the brain and spinal cord.
Yong, a professor of oncology and clinical neurosciences, is now at the University of Calgary, the centre leading the two-year minocycline trial, which will begin on Jan. 1.
Yong’s earlier research, published in the journal Brain in 2002 and 2003, was the springboard for a small pilot trial in which Yong and his Calgary co-researchers gave minocycline to 10 MS patients.
Their data, published in 2004, showed minocycline had a profound effect in decreasing brain lesions in MS patients, as evidenced by brain-imaging scans.
Earlier this year, at the American Academy of Neurology meeting in Boston, the same Calgary-based researchers presented as-yet unpublished findings in another trial (also including Vancouver patients) using minocycline taken in combination with an injectable MS drug called Copaxone.
That nine-month trial, according to Traboulsee, showed “a trend towards improvement” in those who took the combination, but he said the patients in that study had more advanced disease and the theory is that minocycline is most beneficial at the outset of disease symptoms, when it can actually halt progression.
In 2001, American and German scientific collaborators reported in the Annals of Neurology that minocycline given to rats with a disease mimicking MS had a helpful effect. The authors of that study postulated that minocycline had anti-inflammatory action that was as beneficial against MS as it is with rheumatoid arthritis, another autoimmune disease for which the drug is already used.
There are nearly 9,000 MS patients in B.C. Minocycline is not yet recommended for them because it has not yet been validated in large-scale trials like the one being planned.
Traboulsee conceded in an interview that the challenge in enrolling trial participants for the study is that they must be quickly referred to the study, by their family doctors, opthalmologists or other specialists, within 90 days of their first MS symptoms. Those symptoms may include any of the following:
– Loss of vision in one or both eyes that lasts at least 24 hours.
– Loss of feeling in leg(s) or arm(s) that lasts at least 24 hours.
– Double vision for at least 24 hours.
– Loss of balance lasting at least 24 hours.
The trial will exclude anyone who waits longer than three months after the first symptoms, which means doctors must maintain a high index of awareness about the trial and its time constraints. Those who already have been diagnosed with MS will not be eligible for the trial.
“The benefits of minocycline are straightforward,” said Dr. Luanne Metz, principal investigator in the trial and director of the Foothills Hospital MS Clinic in Calgary.
“It’s relatively cheap [$800 per patient per year compared with other drug treatments that can cost up to $40,000 a year], has few side effects and can be taken in pill format,” Metz said. “The aim of our research is to see if this common drug can reduce the occurrence of further disease activity in people who have experienced an initial attack of MS symptoms, and who are at high risk of progressing to definite MS.”
Metz said two-thirds of people who have an initial attack of MS symptoms will be diagnosed with MS within six months, but if minocycline is used at the outset of symptoms, “we believe we can reduce this number.”
Traboulsee, who is on the clinical steering committee for the trial along with UBC radiologist Dr. David Li, said while long-term antibiotic use may lead to the development of antibiotic resistance, it is not considered a major concern in the MS trial because the drug is not being used to treat infection.
On a lighter note, Traboulsee noted that minocycline is often prescribed for acne, and participants in the pilot study commented that their skin looked lovely while taking the pills.
“We can’t use that as a selling point to promote the trial,” he said, “but certainly, anecdotally, that came up often.”
The minocycline trial, sponsored by the MS Society of Canada, is also going to run at the MS clinic at Burnaby Hospital, where the site investigator is neurologist Dr. Galina Vorobeychik.
